MDedge ObGyn

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?

First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.

Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.

Many employers like PTO because there is less paperwork involved and less abuse of sick leave – and they don’t have to make any decisions about whether an employee is actually sick. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.

Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)

Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.

Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.

The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.

When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.

What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.

When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.

What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.

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

It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?

First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.

Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.

Many employers like PTO because there is less paperwork involved and less abuse of sick leave – and they don’t have to make any decisions about whether an employee is actually sick. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.

Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)

Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.

Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.

The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.

When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.

What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.

When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.

What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.

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

It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?

First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.

Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.

Many employers like PTO because there is less paperwork involved and less abuse of sick leave – and they don’t have to make any decisions about whether an employee is actually sick. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.

Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)

Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.

Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.

The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.

When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.

What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.

When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.

What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.

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

Over the past few years, there has been rampant misinformation regarding gender-affirming care for transgender youth. In particular, there has been confusion regarding how care is administered, and what types of care are considered at various stages of development. This primer will help you understand the developmental approach to supporting transgender youth.

Gender-affirming care is a broad term that can encapsulate many different domains: social, legal, medical, and surgical affirmation. While people generally think of medical and surgical aspects of gender-affirming care, other domains can be just as important. For example, a 2020 publication in The Lancet Public Health found that access to gender-congruent government identification documents was associated with lower odds of severe psychological distress and suicidality.¹ 

Stanford Lucille Packard Children's Hospital.

Considerations for prepubertal children

The youngest developmental stage at which a young person may seek care regarding gender diversity is the prepubertal childhood stage. Guidelines set forth by The Endocrine Society and The World Professional Association for Transgender Health make it clear that no medical or surgical interventions are considered at this developmental stage.^2,3 However, some young people may choose to pursue a “social transition.” Though this may sound like one thing, social transition can mean very different things for different people. It may include any combination of adopting a new name, pronouns, hairstyle, clothing, etc. Young people may also choose to pursue these various aspects of social transition in all settings, or sometimes only in some settings (for example, only at home if they don’t yet feel comfortable doing so at school). Research so far shows that prepubertal children who are allowed to socially transition have levels of anxiety and depression nearly indistinguishable from their cisgender peers.⁴ While some in the past have raised the question of whether a social transition increases a child’s degree of gender incongruence and thus their likelihood to “persist” in a transgender identity, research has suggested this is not the case, and that gender identity does not meaningfully differ before and after a social transition.⁵ It’s worth noting, that “desistance” of a young person’s transgender identity is generally not considered an ethical goal and that gender identity conversion efforts (that is, attempts to force transgender people to be cisgender) have been labeled unethical by the American Academy of Child & Adolescent Psychiatry.

Sadly, transgender children are victims of bullying at high rates in their schools and communities. Creating safe and affirming school and community environments can be some of the highest yield ways in which providers can support the mental health of gender-diverse youth at this stage. Gender Spectrum is an excellent nonprofit that provides resources to help families and communities with some of these nonmedical supports.

 

Early adolescence and pubertal suppression

The earliest gender-affirming medical intervention that may be considered is pubertal suppression. Pubertal suppression is achieved with gonadotropin-releasing hormone agonists. This class of medications is Food and Drug Administration approved in pediatrics for precocious puberty – a condition in which young people enter puberty much earlier than expected (sometimes as early as age 3). For that condition, the rationale is to delay puberty until the patient reaches a more developmentally normative age for puberty to begin. The rationale for pubertal suppression for adolescent gender dysphoria is somewhat similar – these medications allow for the temporary pausing of puberty, which can be particularly helpful for adolescents who are having severe negative psychological reactions to the ways in which their bodies are developing. The major advantage here is that pubertal suppression can be reversed (if the medication is stopped, endogenous puberty will proceed), whereas puberty itself cannot be easily reversed (resulting in adult transgender people needing surgery and other interventions later in life, if these changes can be fully undone at all). As with all medications, puberty blockers do carry known side effects, including falling behind on bone density (sex hormones are needed to mineralize bones). Because of this, it is generally recommended that adolescents have their bone density monitored during treatment, pursue avenues to improve bone health (for example, exercise), and either stop the puberty blocker to undergo endogenous puberty or start gender-affirming hormones (estrogen or testosterone) by around age 16. 

It is also important to note that, under current guidelines, an adolescent must first undergo a comprehensive biopsychosocial mental health evaluation prior to starting pubertal suppression to ensure the clinical team has a comprehensive understanding of the adolescent’s mental health, that all potential gender supports that are needed are put into place, and that the adolescent and their guardians have a strong understanding of the medical intervention, its risks, side effects, and potential benefits. In addition, consent must be provided by parents or legal guardians, whereas adolescents themselves provide assent. Several studies have linked access to pubertal suppression, when indicated for gender dysphoria, to improved mental health outcomes (for example, van der Miesen and colleagues, Turban and colleagues, de Vries and colleagues, and Costa and colleagues).^6-9

 

Later adolescence and gender-affirming hormones

Later in adolescence, transgender youth may be candidates for gender-affirming hormone treatment (for example, estrogen or testosterone) to induce pubertal changes that align with their gender identities. Once again, under current guidelines, a comprehensive mental health biopsychosocial evaluation must be conducted prior to initiation of these treatments. Part of this evaluation includes fertility counseling and consideration of fertility preservation (for example, oocyte or semen cryopreservation), given the potential for these medications to impact fertility. It also involves discussion of several of the physiologic changes from these medications that can be irreversible (for example, voice changes from testosterone are particularly difficult to reverse in the future). Tables of the physical changes from these medications, when they begin after starting, and when they generally reach their maximum are available in the Endocrine Society guidelines.² The past endocrine society guidelines recommended not initiating gender-affirming hormones until age 16. The most recent guidelines note that there may be instances in which providers may consider starting them as early as age 13 (for example, to reduce risk of falling behind on bone density, or if a patient is having psychological distress related to their peers going through puberty while they are still in a prepubertal state). The latest World Professional Association for Transgender Health Standards of Care removed specific age cutoffs, highlighting the importance of a multidisciplinary team of mental health and hormone prescribing providers working together to understand the best course of action for a particular patient. As with pubertal suppression, several studies have linked access to gender-affirming hormones to improve mental health for adolescents with gender dysphoria (for example, Turban and colleagues, Chen and colleagues, de Vries and colleagues, Allen and colleagues, and Tordoff and colleagues).^10-14

Gender-affirming surgeries

The vast majority of gender-affirming surgeries are not considered until adulthood. The most notable exception to this is masculinizing top surgery for trans masculine and nonbinary adolescents. As with all surgeries, this is a major decision, and requires agreement from a mental health provider, a medical provider, and the surgeon. Early research suggests such surgeries result in improved chest dysphoria and that regret rates appear to be low.^15,16 While the latest World Professional Association for Transgender Health similarly removed strict age cutoffs for gender-affirming surgery, again noting the importance of individualized care, I suspect most will read this change in the context of the Endocrine Society guidelines and past WPATH guidelines that noted gender-affirming genital surgeries are not offered until adulthood (a rare exception perhaps being someone pursuing a gender-affirming vaginoplasty at say age 17 in the summer prior to college to avoid needing to take off from school for surgical recovery). Gender-affirming genital surgeries are generally much more involved surgeries with prolonged recovery times. 

Given the substantial proportion of young people who openly identify as transgender,¹⁷ and the proliferation of misinformation, political rhetoric, and legislation that can impact gender-affirming care for adolescents with gender dysphoria,¹⁸ it is essential that providers have accurate, up-to-date information on what this care entails and how it is provided.

Dr. Turban is director of the gender psychiatry program at the University of California, San Francisco, where he is an assistant professor of child & adolescent psychiatry and affiliate faculty at the Philip R. Lee Institute for Health Policy Studies. He is on Twitter @jack_turban.
 

References

1. Malta M et al. Lancet Public Health. 2020 Apr;5(4):e178-9.

2. Hembree WC et al. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.

3. Coleman E et al. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-259.

4. Durwood L et al. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):116-23.e2.

5. Rae JR et al. Psychol Sci. 2019 May;30(5):669-81.

6. van der Miesen AIR et al. J Adolesc Health. 2020 Jun;66(6):699-704.

7. Turban JL et al. Pediatrics. 2020 Feb;145(2):e20191725.

8. de Vries ALC et al. J Sex Med. 2011 Aug;8(8):2276-83.

9. Costa R et al. J Sex Med. 2015 Nov;12(11):2206-14.

10. Turban JL et al. PLoS One. 2022 Jan 12;17(1):e0261039.

11. Chen D et al. N Engl J Med. 2023;388:240-50.

12. de Vries ALC et al. Pediatrics. 2014 Oct;134(4):696-70.

13. Allen LR et al. Clin Pract Pediatr Psychol. 2019. doi: 10.1037/cpp0000288.

14. Tordoff DM et al. JAMA Netw Open. 2022 Feb 1;5(2):e220978.

15. Olson-Kennedy J et al. JAMA Pediatr. 2018;172(5):431-6.

16. Tang A et al. Ann Plast Surg. 2022 May;88(4 Suppl):S325-31

17. Johns MM et al. Morb Mortal Wkly Rep. 2019 Jan 25;68(3):67-71.

18. Turban JL et al. JAMA. 2021;325(22):2251-2.

Over the past few years, there has been rampant misinformation regarding gender-affirming care for transgender youth. In particular, there has been confusion regarding how care is administered, and what types of care are considered at various stages of development. This primer will help you understand the developmental approach to supporting transgender youth.

Gender-affirming care is a broad term that can encapsulate many different domains: social, legal, medical, and surgical affirmation. While people generally think of medical and surgical aspects of gender-affirming care, other domains can be just as important. For example, a 2020 publication in The Lancet Public Health found that access to gender-congruent government identification documents was associated with lower odds of severe psychological distress and suicidality.¹ 

Stanford Lucille Packard Children's Hospital.

Considerations for prepubertal children

The youngest developmental stage at which a young person may seek care regarding gender diversity is the prepubertal childhood stage. Guidelines set forth by The Endocrine Society and The World Professional Association for Transgender Health make it clear that no medical or surgical interventions are considered at this developmental stage.^2,3 However, some young people may choose to pursue a “social transition.” Though this may sound like one thing, social transition can mean very different things for different people. It may include any combination of adopting a new name, pronouns, hairstyle, clothing, etc. Young people may also choose to pursue these various aspects of social transition in all settings, or sometimes only in some settings (for example, only at home if they don’t yet feel comfortable doing so at school). Research so far shows that prepubertal children who are allowed to socially transition have levels of anxiety and depression nearly indistinguishable from their cisgender peers.⁴ While some in the past have raised the question of whether a social transition increases a child’s degree of gender incongruence and thus their likelihood to “persist” in a transgender identity, research has suggested this is not the case, and that gender identity does not meaningfully differ before and after a social transition.⁵ It’s worth noting, that “desistance” of a young person’s transgender identity is generally not considered an ethical goal and that gender identity conversion efforts (that is, attempts to force transgender people to be cisgender) have been labeled unethical by the American Academy of Child & Adolescent Psychiatry.

Sadly, transgender children are victims of bullying at high rates in their schools and communities. Creating safe and affirming school and community environments can be some of the highest yield ways in which providers can support the mental health of gender-diverse youth at this stage. Gender Spectrum is an excellent nonprofit that provides resources to help families and communities with some of these nonmedical supports.

 

Early adolescence and pubertal suppression

The earliest gender-affirming medical intervention that may be considered is pubertal suppression. Pubertal suppression is achieved with gonadotropin-releasing hormone agonists. This class of medications is Food and Drug Administration approved in pediatrics for precocious puberty – a condition in which young people enter puberty much earlier than expected (sometimes as early as age 3). For that condition, the rationale is to delay puberty until the patient reaches a more developmentally normative age for puberty to begin. The rationale for pubertal suppression for adolescent gender dysphoria is somewhat similar – these medications allow for the temporary pausing of puberty, which can be particularly helpful for adolescents who are having severe negative psychological reactions to the ways in which their bodies are developing. The major advantage here is that pubertal suppression can be reversed (if the medication is stopped, endogenous puberty will proceed), whereas puberty itself cannot be easily reversed (resulting in adult transgender people needing surgery and other interventions later in life, if these changes can be fully undone at all). As with all medications, puberty blockers do carry known side effects, including falling behind on bone density (sex hormones are needed to mineralize bones). Because of this, it is generally recommended that adolescents have their bone density monitored during treatment, pursue avenues to improve bone health (for example, exercise), and either stop the puberty blocker to undergo endogenous puberty or start gender-affirming hormones (estrogen or testosterone) by around age 16. 

It is also important to note that, under current guidelines, an adolescent must first undergo a comprehensive biopsychosocial mental health evaluation prior to starting pubertal suppression to ensure the clinical team has a comprehensive understanding of the adolescent’s mental health, that all potential gender supports that are needed are put into place, and that the adolescent and their guardians have a strong understanding of the medical intervention, its risks, side effects, and potential benefits. In addition, consent must be provided by parents or legal guardians, whereas adolescents themselves provide assent. Several studies have linked access to pubertal suppression, when indicated for gender dysphoria, to improved mental health outcomes (for example, van der Miesen and colleagues, Turban and colleagues, de Vries and colleagues, and Costa and colleagues).^6-9

 

Later adolescence and gender-affirming hormones

Later in adolescence, transgender youth may be candidates for gender-affirming hormone treatment (for example, estrogen or testosterone) to induce pubertal changes that align with their gender identities. Once again, under current guidelines, a comprehensive mental health biopsychosocial evaluation must be conducted prior to initiation of these treatments. Part of this evaluation includes fertility counseling and consideration of fertility preservation (for example, oocyte or semen cryopreservation), given the potential for these medications to impact fertility. It also involves discussion of several of the physiologic changes from these medications that can be irreversible (for example, voice changes from testosterone are particularly difficult to reverse in the future). Tables of the physical changes from these medications, when they begin after starting, and when they generally reach their maximum are available in the Endocrine Society guidelines.² The past endocrine society guidelines recommended not initiating gender-affirming hormones until age 16. The most recent guidelines note that there may be instances in which providers may consider starting them as early as age 13 (for example, to reduce risk of falling behind on bone density, or if a patient is having psychological distress related to their peers going through puberty while they are still in a prepubertal state). The latest World Professional Association for Transgender Health Standards of Care removed specific age cutoffs, highlighting the importance of a multidisciplinary team of mental health and hormone prescribing providers working together to understand the best course of action for a particular patient. As with pubertal suppression, several studies have linked access to gender-affirming hormones to improve mental health for adolescents with gender dysphoria (for example, Turban and colleagues, Chen and colleagues, de Vries and colleagues, Allen and colleagues, and Tordoff and colleagues).^10-14

Gender-affirming surgeries

The vast majority of gender-affirming surgeries are not considered until adulthood. The most notable exception to this is masculinizing top surgery for trans masculine and nonbinary adolescents. As with all surgeries, this is a major decision, and requires agreement from a mental health provider, a medical provider, and the surgeon. Early research suggests such surgeries result in improved chest dysphoria and that regret rates appear to be low.^15,16 While the latest World Professional Association for Transgender Health similarly removed strict age cutoffs for gender-affirming surgery, again noting the importance of individualized care, I suspect most will read this change in the context of the Endocrine Society guidelines and past WPATH guidelines that noted gender-affirming genital surgeries are not offered until adulthood (a rare exception perhaps being someone pursuing a gender-affirming vaginoplasty at say age 17 in the summer prior to college to avoid needing to take off from school for surgical recovery). Gender-affirming genital surgeries are generally much more involved surgeries with prolonged recovery times. 

Given the substantial proportion of young people who openly identify as transgender,¹⁷ and the proliferation of misinformation, political rhetoric, and legislation that can impact gender-affirming care for adolescents with gender dysphoria,¹⁸ it is essential that providers have accurate, up-to-date information on what this care entails and how it is provided.

Dr. Turban is director of the gender psychiatry program at the University of California, San Francisco, where he is an assistant professor of child & adolescent psychiatry and affiliate faculty at the Philip R. Lee Institute for Health Policy Studies. He is on Twitter @jack_turban.
 

References

1. Malta M et al. Lancet Public Health. 2020 Apr;5(4):e178-9.

2. Hembree WC et al. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.

3. Coleman E et al. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-259.

4. Durwood L et al. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):116-23.e2.

5. Rae JR et al. Psychol Sci. 2019 May;30(5):669-81.

6. van der Miesen AIR et al. J Adolesc Health. 2020 Jun;66(6):699-704.

7. Turban JL et al. Pediatrics. 2020 Feb;145(2):e20191725.

8. de Vries ALC et al. J Sex Med. 2011 Aug;8(8):2276-83.

9. Costa R et al. J Sex Med. 2015 Nov;12(11):2206-14.

10. Turban JL et al. PLoS One. 2022 Jan 12;17(1):e0261039.

11. Chen D et al. N Engl J Med. 2023;388:240-50.

12. de Vries ALC et al. Pediatrics. 2014 Oct;134(4):696-70.

13. Allen LR et al. Clin Pract Pediatr Psychol. 2019. doi: 10.1037/cpp0000288.

14. Tordoff DM et al. JAMA Netw Open. 2022 Feb 1;5(2):e220978.

15. Olson-Kennedy J et al. JAMA Pediatr. 2018;172(5):431-6.

16. Tang A et al. Ann Plast Surg. 2022 May;88(4 Suppl):S325-31

17. Johns MM et al. Morb Mortal Wkly Rep. 2019 Jan 25;68(3):67-71.

18. Turban JL et al. JAMA. 2021;325(22):2251-2.

Over the past few years, there has been rampant misinformation regarding gender-affirming care for transgender youth. In particular, there has been confusion regarding how care is administered, and what types of care are considered at various stages of development. This primer will help you understand the developmental approach to supporting transgender youth.

Gender-affirming care is a broad term that can encapsulate many different domains: social, legal, medical, and surgical affirmation. While people generally think of medical and surgical aspects of gender-affirming care, other domains can be just as important. For example, a 2020 publication in The Lancet Public Health found that access to gender-congruent government identification documents was associated with lower odds of severe psychological distress and suicidality.¹ 

Stanford Lucille Packard Children's Hospital.

Considerations for prepubertal children

The youngest developmental stage at which a young person may seek care regarding gender diversity is the prepubertal childhood stage. Guidelines set forth by The Endocrine Society and The World Professional Association for Transgender Health make it clear that no medical or surgical interventions are considered at this developmental stage.^2,3 However, some young people may choose to pursue a “social transition.” Though this may sound like one thing, social transition can mean very different things for different people. It may include any combination of adopting a new name, pronouns, hairstyle, clothing, etc. Young people may also choose to pursue these various aspects of social transition in all settings, or sometimes only in some settings (for example, only at home if they don’t yet feel comfortable doing so at school). Research so far shows that prepubertal children who are allowed to socially transition have levels of anxiety and depression nearly indistinguishable from their cisgender peers.⁴ While some in the past have raised the question of whether a social transition increases a child’s degree of gender incongruence and thus their likelihood to “persist” in a transgender identity, research has suggested this is not the case, and that gender identity does not meaningfully differ before and after a social transition.⁵ It’s worth noting, that “desistance” of a young person’s transgender identity is generally not considered an ethical goal and that gender identity conversion efforts (that is, attempts to force transgender people to be cisgender) have been labeled unethical by the American Academy of Child & Adolescent Psychiatry.

Sadly, transgender children are victims of bullying at high rates in their schools and communities. Creating safe and affirming school and community environments can be some of the highest yield ways in which providers can support the mental health of gender-diverse youth at this stage. Gender Spectrum is an excellent nonprofit that provides resources to help families and communities with some of these nonmedical supports.

 

Early adolescence and pubertal suppression

The earliest gender-affirming medical intervention that may be considered is pubertal suppression. Pubertal suppression is achieved with gonadotropin-releasing hormone agonists. This class of medications is Food and Drug Administration approved in pediatrics for precocious puberty – a condition in which young people enter puberty much earlier than expected (sometimes as early as age 3). For that condition, the rationale is to delay puberty until the patient reaches a more developmentally normative age for puberty to begin. The rationale for pubertal suppression for adolescent gender dysphoria is somewhat similar – these medications allow for the temporary pausing of puberty, which can be particularly helpful for adolescents who are having severe negative psychological reactions to the ways in which their bodies are developing. The major advantage here is that pubertal suppression can be reversed (if the medication is stopped, endogenous puberty will proceed), whereas puberty itself cannot be easily reversed (resulting in adult transgender people needing surgery and other interventions later in life, if these changes can be fully undone at all). As with all medications, puberty blockers do carry known side effects, including falling behind on bone density (sex hormones are needed to mineralize bones). Because of this, it is generally recommended that adolescents have their bone density monitored during treatment, pursue avenues to improve bone health (for example, exercise), and either stop the puberty blocker to undergo endogenous puberty or start gender-affirming hormones (estrogen or testosterone) by around age 16. 

It is also important to note that, under current guidelines, an adolescent must first undergo a comprehensive biopsychosocial mental health evaluation prior to starting pubertal suppression to ensure the clinical team has a comprehensive understanding of the adolescent’s mental health, that all potential gender supports that are needed are put into place, and that the adolescent and their guardians have a strong understanding of the medical intervention, its risks, side effects, and potential benefits. In addition, consent must be provided by parents or legal guardians, whereas adolescents themselves provide assent. Several studies have linked access to pubertal suppression, when indicated for gender dysphoria, to improved mental health outcomes (for example, van der Miesen and colleagues, Turban and colleagues, de Vries and colleagues, and Costa and colleagues).^6-9

 

Later adolescence and gender-affirming hormones

Later in adolescence, transgender youth may be candidates for gender-affirming hormone treatment (for example, estrogen or testosterone) to induce pubertal changes that align with their gender identities. Once again, under current guidelines, a comprehensive mental health biopsychosocial evaluation must be conducted prior to initiation of these treatments. Part of this evaluation includes fertility counseling and consideration of fertility preservation (for example, oocyte or semen cryopreservation), given the potential for these medications to impact fertility. It also involves discussion of several of the physiologic changes from these medications that can be irreversible (for example, voice changes from testosterone are particularly difficult to reverse in the future). Tables of the physical changes from these medications, when they begin after starting, and when they generally reach their maximum are available in the Endocrine Society guidelines.² The past endocrine society guidelines recommended not initiating gender-affirming hormones until age 16. The most recent guidelines note that there may be instances in which providers may consider starting them as early as age 13 (for example, to reduce risk of falling behind on bone density, or if a patient is having psychological distress related to their peers going through puberty while they are still in a prepubertal state). The latest World Professional Association for Transgender Health Standards of Care removed specific age cutoffs, highlighting the importance of a multidisciplinary team of mental health and hormone prescribing providers working together to understand the best course of action for a particular patient. As with pubertal suppression, several studies have linked access to gender-affirming hormones to improve mental health for adolescents with gender dysphoria (for example, Turban and colleagues, Chen and colleagues, de Vries and colleagues, Allen and colleagues, and Tordoff and colleagues).^10-14

Gender-affirming surgeries

The vast majority of gender-affirming surgeries are not considered until adulthood. The most notable exception to this is masculinizing top surgery for trans masculine and nonbinary adolescents. As with all surgeries, this is a major decision, and requires agreement from a mental health provider, a medical provider, and the surgeon. Early research suggests such surgeries result in improved chest dysphoria and that regret rates appear to be low.^15,16 While the latest World Professional Association for Transgender Health similarly removed strict age cutoffs for gender-affirming surgery, again noting the importance of individualized care, I suspect most will read this change in the context of the Endocrine Society guidelines and past WPATH guidelines that noted gender-affirming genital surgeries are not offered until adulthood (a rare exception perhaps being someone pursuing a gender-affirming vaginoplasty at say age 17 in the summer prior to college to avoid needing to take off from school for surgical recovery). Gender-affirming genital surgeries are generally much more involved surgeries with prolonged recovery times. 

Given the substantial proportion of young people who openly identify as transgender,¹⁷ and the proliferation of misinformation, political rhetoric, and legislation that can impact gender-affirming care for adolescents with gender dysphoria,¹⁸ it is essential that providers have accurate, up-to-date information on what this care entails and how it is provided.

Dr. Turban is director of the gender psychiatry program at the University of California, San Francisco, where he is an assistant professor of child & adolescent psychiatry and affiliate faculty at the Philip R. Lee Institute for Health Policy Studies. He is on Twitter @jack_turban.
 

References

1. Malta M et al. Lancet Public Health. 2020 Apr;5(4):e178-9.

2. Hembree WC et al. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.

3. Coleman E et al. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-259.

4. Durwood L et al. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):116-23.e2.

5. Rae JR et al. Psychol Sci. 2019 May;30(5):669-81.

6. van der Miesen AIR et al. J Adolesc Health. 2020 Jun;66(6):699-704.

7. Turban JL et al. Pediatrics. 2020 Feb;145(2):e20191725.

8. de Vries ALC et al. J Sex Med. 2011 Aug;8(8):2276-83.

9. Costa R et al. J Sex Med. 2015 Nov;12(11):2206-14.

10. Turban JL et al. PLoS One. 2022 Jan 12;17(1):e0261039.

11. Chen D et al. N Engl J Med. 2023;388:240-50.

12. de Vries ALC et al. Pediatrics. 2014 Oct;134(4):696-70.

13. Allen LR et al. Clin Pract Pediatr Psychol. 2019. doi: 10.1037/cpp0000288.

14. Tordoff DM et al. JAMA Netw Open. 2022 Feb 1;5(2):e220978.

15. Olson-Kennedy J et al. JAMA Pediatr. 2018;172(5):431-6.

16. Tang A et al. Ann Plast Surg. 2022 May;88(4 Suppl):S325-31

17. Johns MM et al. Morb Mortal Wkly Rep. 2019 Jan 25;68(3):67-71.

18. Turban JL et al. JAMA. 2021;325(22):2251-2.

Medical student loans top hundreds of thousands of dollars, so it’s understandable that physicians may want to select a specialty that pays well.

But overwhelmingly, the physicians this news organization spoke to said they chose a specialty they were passionate about rather than focusing on going where more money was. Moreover, most advised young doctors to follow their hearts rather than their wallets.

“There is no question that many young kids immediately think about money when deciding to pursue medicine, but the thought of a big paycheck will never sustain someone long enough to get them here,” says Sergio Alvarez, MD, a board-certified plastic surgeon based in Miami, Fla., and the CEO and medical director of Mia Aesthetics, which has several national locations.

“Getting into medicine is a long game, and there are many hurdles along the way that only the dedicated overcome,” says Dr. Alvarez.

Unfortunately, he says it may be late in that long game before some realize that the pay rate for certain specialties isn’t commensurate with the immense workload and responsibility they require.

“The short of it is that to become a happy doctor, medicine really needs to be a calling: a passion! There are far easier things to do to make money.”

Here is what physicians said about choosing between love or money.
 

The lowest-paying subspecialty in a low-paying specialty

Sophia Yen, MD, MPH, cofounder and CEO of Pandia Health, a women-founded, doctor-led birth control delivery service in Sunnyvale, Calif., and clinical associate professor at Stanford (Calif.) University, says you should pursue a specialty because you love the work.

“I chose the lowest-paying subspecialty (adolescent medicine) of a low-paying specialty (pediatrics), but I’d do it all again because I love the patient population – I love what I do.”

Dr. Yen says she chose adolescent medicine because she loves doing “outpatient gynecology” without going through the surgical training of a full ob.gyn. “I love the target population of young adults because you can talk to the patient versus in pediatrics, where you often talk to the parent. With young adults you can catch things – for example, teach a young person about consent, alcohol, marijuana’s effects on the growing brain, prevent unplanned pregnancies and sexually transmitted infections, instill healthy eating, and more.

“Do I wish that I got paid as much as a surgeon?” Dr. Yen says yes. “I hope that someday society will realize the time spent preventing future disease is worth it and pay us accordingly.”

Unfortunately, she says, since the health care system makes more money if you get pregnant, need a cardiac bypass, or need gastric surgery, those who deliver babies or do surgery get paid more than someone who prevents the need for those services.
 

Money doesn’t buy happiness

Stella Bard, MD, a rheumatologist in McKinney, Tex., says she eats, lives, and breathes rheumatology. “I never regret the decision of choosing this specialty for a single second,” says Dr. Bard. “I feel like it’s a rewarding experience with every single patient encounter.” Dr. Bard notes that money is no guarantee of happiness and that she feels blessed to wake up every morning doing what she loves.

Career or calling?

For Dr. Alvarez, inspiration came when watching his father help change people’s lives. “I saw how impactful a doctor is during a person’s most desperate moments, and that was enough to make medicine my life’s passion at the age of 10.”

He says once you’re in medical school, choosing a specialty is far easier than you think. “Each specialty requires a certain personality or specific characteristics, and some will call to you while others simply won’t.”

“For me, plastics was about finesse, art, and life-changing surgeries that affected people from kids to adults and involved every aspect of the human body. Changing someone’s outward appearance has a profoundly positive impact on their confidence and self-esteem, making plastic surgery a genuinely transformative experience.”

Patricia Celan, MD, a postgraduate psychiatry resident in Canada, also chose psychiatry for the love of the field. “I enjoy helping vulnerable people and exploring what makes a person tick, the source of their difficulties, and how to help people counteract and overcome the difficult cards they’ve been dealt in life.”

She says it’s incredibly rewarding to watch someone turn their life around from severe mental illness, especially those who have been victimized and traumatized, and learn to trust people again.

“I could have made more money in a higher-paying specialty, yes, but I’m not sure I would have felt as fulfilled as psychiatry can make me feel.”

Dr. Celan says everyone has their calling, and some lucky people find their deepest passion in higher-paying specialties. “My calling is psychiatry, and I am at peace with this no matter the money.”
 

For the love of surgery

“In my experience, most people don’t choose their specialty based on money,” says Nicole Aaronson, MD, MBA, an otolaryngologist and board-certified in the subspecialty of pediatric otolaryngology, an attending surgeon at Nemours Children’s Health of Delaware and clinical associate professor of otolaryngology and pediatrics at Sidney Kimmel Medical College, Philadelphia.

“The first decision point in medical school is usually figuring out if you are a surgery person or a medicine person. I knew very early that I wanted to be a surgeon and wanted to spend time in the OR fixing problems with my hands.”

Part of what attracted Dr. Aaronson to otolaryngology was the variety of conditions managed within the specialty, from head and neck cancer to voice problems to sleep disorders to sinus disease. “I chose my subspecialty because I enjoy working with children and making an impact that will help them live their best possible lives.”

She says a relatively simple surgery like placing ear tubes may help a child’s hearing and allow them to be more successful in school, opening up a new world of opportunities for the child’s future.

“While I don’t think most people choose their specialty based on prospective compensation, I do think all physicians want to be compensated fairly for their time, effort, and level of training,” says Dr. Aaronson.
 

Choosing a specialty for the money can lead to burnout and dissatisfaction

“For me, the decision to pursue gastroenterology went beyond financial considerations,” says Saurabh Sethi, MD, MPH, a gastroenterologist specializing in hepatology and interventional endoscopy. “While financial stability is undoubtedly important, no doctor enters this field solely for the love of money. The primary driving force for most medical professionals, myself included, is the passion to help people and make a positive difference in their lives.”

Dr. Sethi says the gratification that comes from providing quality care and witnessing patients’ improved well-being is priceless. Moreover, he believes that selecting a specialty based solely on financial gain is likely to lead to burnout and greater dissatisfaction over time.

“By following my love for gut health and prioritizing patient care, I have found a sense of fulfillment and purpose in my career. It has been a rewarding journey, and I’m grateful for the opportunity to contribute to the well-being of my patients through my expertise in gastroenterology.”
 

Key takeaways: Love or money?

Multiple factors influence doctors’ specialty choices, including genuine love for the work and the future of the specialty. Others include job prospects, hands-on experience they receive, mentors, childhood dreams, parental expectations, complexity of cases, the lifestyle of each specialty, including office hours worked, on-call requirements, and autonomy.

Physicians also mentioned other factors they considered when choosing their specialty:

• Personal interest.
• Intellectual stimulation.
• Work-life balance.
• Patient populations.
• Future opportunities.
• Desire to make a difference.
• Passion.
• Financial stability.
• Being personally fulfilled.

Overwhelmingly, doctors say to pick a specialty you can envision yourself loving 40 years from now and you won’t go wrong.

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

Medical student loans top hundreds of thousands of dollars, so it’s understandable that physicians may want to select a specialty that pays well.

But overwhelmingly, the physicians this news organization spoke to said they chose a specialty they were passionate about rather than focusing on going where more money was. Moreover, most advised young doctors to follow their hearts rather than their wallets.

“There is no question that many young kids immediately think about money when deciding to pursue medicine, but the thought of a big paycheck will never sustain someone long enough to get them here,” says Sergio Alvarez, MD, a board-certified plastic surgeon based in Miami, Fla., and the CEO and medical director of Mia Aesthetics, which has several national locations.

“Getting into medicine is a long game, and there are many hurdles along the way that only the dedicated overcome,” says Dr. Alvarez.

Unfortunately, he says it may be late in that long game before some realize that the pay rate for certain specialties isn’t commensurate with the immense workload and responsibility they require.

“The short of it is that to become a happy doctor, medicine really needs to be a calling: a passion! There are far easier things to do to make money.”

Here is what physicians said about choosing between love or money.
 

The lowest-paying subspecialty in a low-paying specialty

Sophia Yen, MD, MPH, cofounder and CEO of Pandia Health, a women-founded, doctor-led birth control delivery service in Sunnyvale, Calif., and clinical associate professor at Stanford (Calif.) University, says you should pursue a specialty because you love the work.

“I chose the lowest-paying subspecialty (adolescent medicine) of a low-paying specialty (pediatrics), but I’d do it all again because I love the patient population – I love what I do.”

Dr. Yen says she chose adolescent medicine because she loves doing “outpatient gynecology” without going through the surgical training of a full ob.gyn. “I love the target population of young adults because you can talk to the patient versus in pediatrics, where you often talk to the parent. With young adults you can catch things – for example, teach a young person about consent, alcohol, marijuana’s effects on the growing brain, prevent unplanned pregnancies and sexually transmitted infections, instill healthy eating, and more.

“Do I wish that I got paid as much as a surgeon?” Dr. Yen says yes. “I hope that someday society will realize the time spent preventing future disease is worth it and pay us accordingly.”

Unfortunately, she says, since the health care system makes more money if you get pregnant, need a cardiac bypass, or need gastric surgery, those who deliver babies or do surgery get paid more than someone who prevents the need for those services.
 

Money doesn’t buy happiness

Stella Bard, MD, a rheumatologist in McKinney, Tex., says she eats, lives, and breathes rheumatology. “I never regret the decision of choosing this specialty for a single second,” says Dr. Bard. “I feel like it’s a rewarding experience with every single patient encounter.” Dr. Bard notes that money is no guarantee of happiness and that she feels blessed to wake up every morning doing what she loves.

Career or calling?

For Dr. Alvarez, inspiration came when watching his father help change people’s lives. “I saw how impactful a doctor is during a person’s most desperate moments, and that was enough to make medicine my life’s passion at the age of 10.”

He says once you’re in medical school, choosing a specialty is far easier than you think. “Each specialty requires a certain personality or specific characteristics, and some will call to you while others simply won’t.”

“For me, plastics was about finesse, art, and life-changing surgeries that affected people from kids to adults and involved every aspect of the human body. Changing someone’s outward appearance has a profoundly positive impact on their confidence and self-esteem, making plastic surgery a genuinely transformative experience.”

Patricia Celan, MD, a postgraduate psychiatry resident in Canada, also chose psychiatry for the love of the field. “I enjoy helping vulnerable people and exploring what makes a person tick, the source of their difficulties, and how to help people counteract and overcome the difficult cards they’ve been dealt in life.”

She says it’s incredibly rewarding to watch someone turn their life around from severe mental illness, especially those who have been victimized and traumatized, and learn to trust people again.

“I could have made more money in a higher-paying specialty, yes, but I’m not sure I would have felt as fulfilled as psychiatry can make me feel.”

Dr. Celan says everyone has their calling, and some lucky people find their deepest passion in higher-paying specialties. “My calling is psychiatry, and I am at peace with this no matter the money.”
 

For the love of surgery

“In my experience, most people don’t choose their specialty based on money,” says Nicole Aaronson, MD, MBA, an otolaryngologist and board-certified in the subspecialty of pediatric otolaryngology, an attending surgeon at Nemours Children’s Health of Delaware and clinical associate professor of otolaryngology and pediatrics at Sidney Kimmel Medical College, Philadelphia.

“The first decision point in medical school is usually figuring out if you are a surgery person or a medicine person. I knew very early that I wanted to be a surgeon and wanted to spend time in the OR fixing problems with my hands.”

Part of what attracted Dr. Aaronson to otolaryngology was the variety of conditions managed within the specialty, from head and neck cancer to voice problems to sleep disorders to sinus disease. “I chose my subspecialty because I enjoy working with children and making an impact that will help them live their best possible lives.”

She says a relatively simple surgery like placing ear tubes may help a child’s hearing and allow them to be more successful in school, opening up a new world of opportunities for the child’s future.

“While I don’t think most people choose their specialty based on prospective compensation, I do think all physicians want to be compensated fairly for their time, effort, and level of training,” says Dr. Aaronson.
 

Choosing a specialty for the money can lead to burnout and dissatisfaction

“For me, the decision to pursue gastroenterology went beyond financial considerations,” says Saurabh Sethi, MD, MPH, a gastroenterologist specializing in hepatology and interventional endoscopy. “While financial stability is undoubtedly important, no doctor enters this field solely for the love of money. The primary driving force for most medical professionals, myself included, is the passion to help people and make a positive difference in their lives.”

Dr. Sethi says the gratification that comes from providing quality care and witnessing patients’ improved well-being is priceless. Moreover, he believes that selecting a specialty based solely on financial gain is likely to lead to burnout and greater dissatisfaction over time.

“By following my love for gut health and prioritizing patient care, I have found a sense of fulfillment and purpose in my career. It has been a rewarding journey, and I’m grateful for the opportunity to contribute to the well-being of my patients through my expertise in gastroenterology.”
 

Key takeaways: Love or money?

Multiple factors influence doctors’ specialty choices, including genuine love for the work and the future of the specialty. Others include job prospects, hands-on experience they receive, mentors, childhood dreams, parental expectations, complexity of cases, the lifestyle of each specialty, including office hours worked, on-call requirements, and autonomy.

Physicians also mentioned other factors they considered when choosing their specialty:

• Personal interest.
• Intellectual stimulation.
• Work-life balance.
• Patient populations.
• Future opportunities.
• Desire to make a difference.
• Passion.
• Financial stability.
• Being personally fulfilled.

Overwhelmingly, doctors say to pick a specialty you can envision yourself loving 40 years from now and you won’t go wrong.

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

Medical student loans top hundreds of thousands of dollars, so it’s understandable that physicians may want to select a specialty that pays well.

But overwhelmingly, the physicians this news organization spoke to said they chose a specialty they were passionate about rather than focusing on going where more money was. Moreover, most advised young doctors to follow their hearts rather than their wallets.

“There is no question that many young kids immediately think about money when deciding to pursue medicine, but the thought of a big paycheck will never sustain someone long enough to get them here,” says Sergio Alvarez, MD, a board-certified plastic surgeon based in Miami, Fla., and the CEO and medical director of Mia Aesthetics, which has several national locations.

“Getting into medicine is a long game, and there are many hurdles along the way that only the dedicated overcome,” says Dr. Alvarez.

Unfortunately, he says it may be late in that long game before some realize that the pay rate for certain specialties isn’t commensurate with the immense workload and responsibility they require.

“The short of it is that to become a happy doctor, medicine really needs to be a calling: a passion! There are far easier things to do to make money.”

Here is what physicians said about choosing between love or money.
 

The lowest-paying subspecialty in a low-paying specialty

Sophia Yen, MD, MPH, cofounder and CEO of Pandia Health, a women-founded, doctor-led birth control delivery service in Sunnyvale, Calif., and clinical associate professor at Stanford (Calif.) University, says you should pursue a specialty because you love the work.

“I chose the lowest-paying subspecialty (adolescent medicine) of a low-paying specialty (pediatrics), but I’d do it all again because I love the patient population – I love what I do.”

Dr. Yen says she chose adolescent medicine because she loves doing “outpatient gynecology” without going through the surgical training of a full ob.gyn. “I love the target population of young adults because you can talk to the patient versus in pediatrics, where you often talk to the parent. With young adults you can catch things – for example, teach a young person about consent, alcohol, marijuana’s effects on the growing brain, prevent unplanned pregnancies and sexually transmitted infections, instill healthy eating, and more.

“Do I wish that I got paid as much as a surgeon?” Dr. Yen says yes. “I hope that someday society will realize the time spent preventing future disease is worth it and pay us accordingly.”

Unfortunately, she says, since the health care system makes more money if you get pregnant, need a cardiac bypass, or need gastric surgery, those who deliver babies or do surgery get paid more than someone who prevents the need for those services.
 

Money doesn’t buy happiness

Stella Bard, MD, a rheumatologist in McKinney, Tex., says she eats, lives, and breathes rheumatology. “I never regret the decision of choosing this specialty for a single second,” says Dr. Bard. “I feel like it’s a rewarding experience with every single patient encounter.” Dr. Bard notes that money is no guarantee of happiness and that she feels blessed to wake up every morning doing what she loves.

Career or calling?

For Dr. Alvarez, inspiration came when watching his father help change people’s lives. “I saw how impactful a doctor is during a person’s most desperate moments, and that was enough to make medicine my life’s passion at the age of 10.”

He says once you’re in medical school, choosing a specialty is far easier than you think. “Each specialty requires a certain personality or specific characteristics, and some will call to you while others simply won’t.”

“For me, plastics was about finesse, art, and life-changing surgeries that affected people from kids to adults and involved every aspect of the human body. Changing someone’s outward appearance has a profoundly positive impact on their confidence and self-esteem, making plastic surgery a genuinely transformative experience.”

Patricia Celan, MD, a postgraduate psychiatry resident in Canada, also chose psychiatry for the love of the field. “I enjoy helping vulnerable people and exploring what makes a person tick, the source of their difficulties, and how to help people counteract and overcome the difficult cards they’ve been dealt in life.”

She says it’s incredibly rewarding to watch someone turn their life around from severe mental illness, especially those who have been victimized and traumatized, and learn to trust people again.

“I could have made more money in a higher-paying specialty, yes, but I’m not sure I would have felt as fulfilled as psychiatry can make me feel.”

Dr. Celan says everyone has their calling, and some lucky people find their deepest passion in higher-paying specialties. “My calling is psychiatry, and I am at peace with this no matter the money.”
 

For the love of surgery

“In my experience, most people don’t choose their specialty based on money,” says Nicole Aaronson, MD, MBA, an otolaryngologist and board-certified in the subspecialty of pediatric otolaryngology, an attending surgeon at Nemours Children’s Health of Delaware and clinical associate professor of otolaryngology and pediatrics at Sidney Kimmel Medical College, Philadelphia.

“The first decision point in medical school is usually figuring out if you are a surgery person or a medicine person. I knew very early that I wanted to be a surgeon and wanted to spend time in the OR fixing problems with my hands.”

Part of what attracted Dr. Aaronson to otolaryngology was the variety of conditions managed within the specialty, from head and neck cancer to voice problems to sleep disorders to sinus disease. “I chose my subspecialty because I enjoy working with children and making an impact that will help them live their best possible lives.”

She says a relatively simple surgery like placing ear tubes may help a child’s hearing and allow them to be more successful in school, opening up a new world of opportunities for the child’s future.

“While I don’t think most people choose their specialty based on prospective compensation, I do think all physicians want to be compensated fairly for their time, effort, and level of training,” says Dr. Aaronson.
 

Choosing a specialty for the money can lead to burnout and dissatisfaction

“For me, the decision to pursue gastroenterology went beyond financial considerations,” says Saurabh Sethi, MD, MPH, a gastroenterologist specializing in hepatology and interventional endoscopy. “While financial stability is undoubtedly important, no doctor enters this field solely for the love of money. The primary driving force for most medical professionals, myself included, is the passion to help people and make a positive difference in their lives.”

Dr. Sethi says the gratification that comes from providing quality care and witnessing patients’ improved well-being is priceless. Moreover, he believes that selecting a specialty based solely on financial gain is likely to lead to burnout and greater dissatisfaction over time.

“By following my love for gut health and prioritizing patient care, I have found a sense of fulfillment and purpose in my career. It has been a rewarding journey, and I’m grateful for the opportunity to contribute to the well-being of my patients through my expertise in gastroenterology.”
 

Key takeaways: Love or money?

Multiple factors influence doctors’ specialty choices, including genuine love for the work and the future of the specialty. Others include job prospects, hands-on experience they receive, mentors, childhood dreams, parental expectations, complexity of cases, the lifestyle of each specialty, including office hours worked, on-call requirements, and autonomy.

Physicians also mentioned other factors they considered when choosing their specialty:

• Personal interest.
• Intellectual stimulation.
• Work-life balance.
• Patient populations.
• Future opportunities.
• Desire to make a difference.
• Passion.
• Financial stability.
• Being personally fulfilled.

Overwhelmingly, doctors say to pick a specialty you can envision yourself loving 40 years from now and you won’t go wrong.

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

Micronized oral progesterone might decrease night sweats and improve sleep in perimenopausal women, according to new research.

In a randomized, placebo-controlled trial of about 180 women with vasomotor symptoms (VMS), women who received progesterone perceived a significantly greater decrease in night sweats (P = .023) and improved sleep quality (P = .005), compared with controls. VMS score did not differ significantly by treatment group, however.

“Women who have menstruated within the last year, who are waking twice or more times a week with night sweats and bothered by sleep disturbances would benefit from taking oral micronized progesterone 300 mg at bedtime,” principal investigator Jerilynn C. Prior, MD, professor of endocrinology at the University of British Columbia in Vancouver, British Columbia, Canada, said in an interview.

The study was published online in Scientific Reports.
 

A neglected group?

The best management for symptoms in perimenopause is an often-neglected topic of research, said Dr. Prior. Yet perimenopause is often associated with significant symptoms for women, including heavy menstrual bleeding, sore breasts, mood swings, night sweats, and insomnia – all when many women are at the peak of their careers.

Dr. Prior herself had a difficult perimenopause. “I began having cyclic night sweats, clustered around flow, when I was still having regular menstrual cycles, plus breast tenderness and sleep problems,” she said. “I knew from my research and my own experience that my estrogen levels were very high. Higher estrogen levels are not suppressible by exogenous estrogen, so it made no sense to me to ask my family doctor for a prescription for estrogen – or hormone replacement therapy, as it was then called. However, medroxyprogesterone acetate had been reported to be effective for menopausal hot flushes. I tried it, and it helped my night sweats and hot flushes but not my sleep. When oral micronized progesterone became available, I switched to that.”

In the current study, which was performed at the UBC Centre for Menstrual Cycle and Ovulation Research, the investigators studied 189 community-dwelling women from across Canada who were aged 35-58 years, had menstruated in the past year, and were bothered by daytime flushes or night sweats at least twice per week.

Participants were randomly assigned to receive either 300 mg of oral micronized progesterone or placebo at bedtime for 3 months. They recorded VMS number and intensity while awake and asleep each day. Some women participated remotely by web conference, telephone, or email. The experimental medicine was delivered to these participants by courier. The primary outcome was VMS score during the 3rd month.

Most (87%) participants were White, and about 57% had a college degree. The population’s average body mass index was 26.7, and 66.7% of participants were in late perimenopause.

The mean baseline VMS score among the women was 12.2. The average frequency of VMS per 24-hour day was 4.9. Average VMS intensity was 2.3 on a scale of 0-4. VMS scores decreased over time in both treatment groups.

At month 3, the VMS score was 5.5 in the progesterone group and 7.1 in the placebo group. The difference between groups was not statistically significant.

Compared with controls, however, women in the progesterone group perceived a significantly greater decrease in night sweats and improved sleep quality. Progesterone also was associated with significantly decreased perception of physical and emotional interference with their daily activities, compared with placebo (P = .017). Moreover, progesterone did not increase depression.

There were no serious adverse events.

“I hope that when women who look young and are still menstruating in their late 30s to early 50s go to the doctor and ask for help with night sweats and sleep problems, they will be told about this trial and offered progesterone therapy. I also hope they won’t be told, ‘You are too young,’ or ‘You are not in menopause,’ with the inference that the issue is all in their minds,” said Dr. Prior.
 

Useful dosing information

Mitchell S. Kramer, MD, chair of obstetrics and gynecology at Huntington (N.Y.) Hospital Northwell Health, said in a comment that “progesterone has been used for quite a while. I’ve been treating menopausal and perimenopausal hormonal disturbances and VMS for many years, and progesterone has been a real staple of treatment for these symptoms, especially in perimenopausal patients who are not good candidates for estrogen or who won’t accept treatment with estrogen. It’s actually nice to see a study that addresses this issue in a randomized controlled fashion and that confirms the efficacy of progesterone.”

The most helpful aspect of the study is the dosing information, Dr. Kramer added. “They recommend a 300-mg dose of oral micronized progesterone, which is much higher than I normally use. I may start to prescribe the higher dose and perhaps get a better or more complete response. There were no adverse events reported in this study, so the higher dose was enlightening to me,” he said.

Perimenopause is a time that is challenging to manage, said Michelle Jacobson, MD, of the department of obstetrics and gynecology at the University of Toronto, and obstetrician-gynecologist at Women’s College and Mount Sinai Hospitals in Toronto.

“There are so many nuances to the management. Women are suffering oftentimes from classic menopausal symptoms. There are fluctuating levels of estrogen, sometimes high. Sometimes there are complications of bleeding. There is the potential need for contraception because they are still menstruating,” she said in an interview.

“It’s important to specifically study this group of women with their own unique needs. Dr. Prior is a longtime proponent of using progesterone therapy, and kudos to her for doing this study in perimenopausal women, which is a group that is probably underrepresented in the menopause management literature,” she said.

Dr. Prior and Dr. Kramer reported no relevant financial relationships. Dr. Jacobson reported financial relationships with Astellas, AbbVie, Bayer, BioSyent, Duchesnay, Eisai, Lupin, Organon, Pfizer, and Searchlight.

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

Micronized oral progesterone might decrease night sweats and improve sleep in perimenopausal women, according to new research.

In a randomized, placebo-controlled trial of about 180 women with vasomotor symptoms (VMS), women who received progesterone perceived a significantly greater decrease in night sweats (P = .023) and improved sleep quality (P = .005), compared with controls. VMS score did not differ significantly by treatment group, however.

“Women who have menstruated within the last year, who are waking twice or more times a week with night sweats and bothered by sleep disturbances would benefit from taking oral micronized progesterone 300 mg at bedtime,” principal investigator Jerilynn C. Prior, MD, professor of endocrinology at the University of British Columbia in Vancouver, British Columbia, Canada, said in an interview.

The study was published online in Scientific Reports.
 

A neglected group?

The best management for symptoms in perimenopause is an often-neglected topic of research, said Dr. Prior. Yet perimenopause is often associated with significant symptoms for women, including heavy menstrual bleeding, sore breasts, mood swings, night sweats, and insomnia – all when many women are at the peak of their careers.

Dr. Prior herself had a difficult perimenopause. “I began having cyclic night sweats, clustered around flow, when I was still having regular menstrual cycles, plus breast tenderness and sleep problems,” she said. “I knew from my research and my own experience that my estrogen levels were very high. Higher estrogen levels are not suppressible by exogenous estrogen, so it made no sense to me to ask my family doctor for a prescription for estrogen – or hormone replacement therapy, as it was then called. However, medroxyprogesterone acetate had been reported to be effective for menopausal hot flushes. I tried it, and it helped my night sweats and hot flushes but not my sleep. When oral micronized progesterone became available, I switched to that.”

In the current study, which was performed at the UBC Centre for Menstrual Cycle and Ovulation Research, the investigators studied 189 community-dwelling women from across Canada who were aged 35-58 years, had menstruated in the past year, and were bothered by daytime flushes or night sweats at least twice per week.

Participants were randomly assigned to receive either 300 mg of oral micronized progesterone or placebo at bedtime for 3 months. They recorded VMS number and intensity while awake and asleep each day. Some women participated remotely by web conference, telephone, or email. The experimental medicine was delivered to these participants by courier. The primary outcome was VMS score during the 3rd month.

Most (87%) participants were White, and about 57% had a college degree. The population’s average body mass index was 26.7, and 66.7% of participants were in late perimenopause.

The mean baseline VMS score among the women was 12.2. The average frequency of VMS per 24-hour day was 4.9. Average VMS intensity was 2.3 on a scale of 0-4. VMS scores decreased over time in both treatment groups.

At month 3, the VMS score was 5.5 in the progesterone group and 7.1 in the placebo group. The difference between groups was not statistically significant.

Compared with controls, however, women in the progesterone group perceived a significantly greater decrease in night sweats and improved sleep quality. Progesterone also was associated with significantly decreased perception of physical and emotional interference with their daily activities, compared with placebo (P = .017). Moreover, progesterone did not increase depression.

There were no serious adverse events.

“I hope that when women who look young and are still menstruating in their late 30s to early 50s go to the doctor and ask for help with night sweats and sleep problems, they will be told about this trial and offered progesterone therapy. I also hope they won’t be told, ‘You are too young,’ or ‘You are not in menopause,’ with the inference that the issue is all in their minds,” said Dr. Prior.
 

Useful dosing information

Mitchell S. Kramer, MD, chair of obstetrics and gynecology at Huntington (N.Y.) Hospital Northwell Health, said in a comment that “progesterone has been used for quite a while. I’ve been treating menopausal and perimenopausal hormonal disturbances and VMS for many years, and progesterone has been a real staple of treatment for these symptoms, especially in perimenopausal patients who are not good candidates for estrogen or who won’t accept treatment with estrogen. It’s actually nice to see a study that addresses this issue in a randomized controlled fashion and that confirms the efficacy of progesterone.”

The most helpful aspect of the study is the dosing information, Dr. Kramer added. “They recommend a 300-mg dose of oral micronized progesterone, which is much higher than I normally use. I may start to prescribe the higher dose and perhaps get a better or more complete response. There were no adverse events reported in this study, so the higher dose was enlightening to me,” he said.

Perimenopause is a time that is challenging to manage, said Michelle Jacobson, MD, of the department of obstetrics and gynecology at the University of Toronto, and obstetrician-gynecologist at Women’s College and Mount Sinai Hospitals in Toronto.

“There are so many nuances to the management. Women are suffering oftentimes from classic menopausal symptoms. There are fluctuating levels of estrogen, sometimes high. Sometimes there are complications of bleeding. There is the potential need for contraception because they are still menstruating,” she said in an interview.

“It’s important to specifically study this group of women with their own unique needs. Dr. Prior is a longtime proponent of using progesterone therapy, and kudos to her for doing this study in perimenopausal women, which is a group that is probably underrepresented in the menopause management literature,” she said.

Dr. Prior and Dr. Kramer reported no relevant financial relationships. Dr. Jacobson reported financial relationships with Astellas, AbbVie, Bayer, BioSyent, Duchesnay, Eisai, Lupin, Organon, Pfizer, and Searchlight.

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

Micronized oral progesterone might decrease night sweats and improve sleep in perimenopausal women, according to new research.

In a randomized, placebo-controlled trial of about 180 women with vasomotor symptoms (VMS), women who received progesterone perceived a significantly greater decrease in night sweats (P = .023) and improved sleep quality (P = .005), compared with controls. VMS score did not differ significantly by treatment group, however.

“Women who have menstruated within the last year, who are waking twice or more times a week with night sweats and bothered by sleep disturbances would benefit from taking oral micronized progesterone 300 mg at bedtime,” principal investigator Jerilynn C. Prior, MD, professor of endocrinology at the University of British Columbia in Vancouver, British Columbia, Canada, said in an interview.

The study was published online in Scientific Reports.
 

A neglected group?

The best management for symptoms in perimenopause is an often-neglected topic of research, said Dr. Prior. Yet perimenopause is often associated with significant symptoms for women, including heavy menstrual bleeding, sore breasts, mood swings, night sweats, and insomnia – all when many women are at the peak of their careers.

Dr. Prior herself had a difficult perimenopause. “I began having cyclic night sweats, clustered around flow, when I was still having regular menstrual cycles, plus breast tenderness and sleep problems,” she said. “I knew from my research and my own experience that my estrogen levels were very high. Higher estrogen levels are not suppressible by exogenous estrogen, so it made no sense to me to ask my family doctor for a prescription for estrogen – or hormone replacement therapy, as it was then called. However, medroxyprogesterone acetate had been reported to be effective for menopausal hot flushes. I tried it, and it helped my night sweats and hot flushes but not my sleep. When oral micronized progesterone became available, I switched to that.”

In the current study, which was performed at the UBC Centre for Menstrual Cycle and Ovulation Research, the investigators studied 189 community-dwelling women from across Canada who were aged 35-58 years, had menstruated in the past year, and were bothered by daytime flushes or night sweats at least twice per week.

Participants were randomly assigned to receive either 300 mg of oral micronized progesterone or placebo at bedtime for 3 months. They recorded VMS number and intensity while awake and asleep each day. Some women participated remotely by web conference, telephone, or email. The experimental medicine was delivered to these participants by courier. The primary outcome was VMS score during the 3rd month.

Most (87%) participants were White, and about 57% had a college degree. The population’s average body mass index was 26.7, and 66.7% of participants were in late perimenopause.

The mean baseline VMS score among the women was 12.2. The average frequency of VMS per 24-hour day was 4.9. Average VMS intensity was 2.3 on a scale of 0-4. VMS scores decreased over time in both treatment groups.

At month 3, the VMS score was 5.5 in the progesterone group and 7.1 in the placebo group. The difference between groups was not statistically significant.

Compared with controls, however, women in the progesterone group perceived a significantly greater decrease in night sweats and improved sleep quality. Progesterone also was associated with significantly decreased perception of physical and emotional interference with their daily activities, compared with placebo (P = .017). Moreover, progesterone did not increase depression.

There were no serious adverse events.

“I hope that when women who look young and are still menstruating in their late 30s to early 50s go to the doctor and ask for help with night sweats and sleep problems, they will be told about this trial and offered progesterone therapy. I also hope they won’t be told, ‘You are too young,’ or ‘You are not in menopause,’ with the inference that the issue is all in their minds,” said Dr. Prior.
 

Useful dosing information

Mitchell S. Kramer, MD, chair of obstetrics and gynecology at Huntington (N.Y.) Hospital Northwell Health, said in a comment that “progesterone has been used for quite a while. I’ve been treating menopausal and perimenopausal hormonal disturbances and VMS for many years, and progesterone has been a real staple of treatment for these symptoms, especially in perimenopausal patients who are not good candidates for estrogen or who won’t accept treatment with estrogen. It’s actually nice to see a study that addresses this issue in a randomized controlled fashion and that confirms the efficacy of progesterone.”

The most helpful aspect of the study is the dosing information, Dr. Kramer added. “They recommend a 300-mg dose of oral micronized progesterone, which is much higher than I normally use. I may start to prescribe the higher dose and perhaps get a better or more complete response. There were no adverse events reported in this study, so the higher dose was enlightening to me,” he said.

Perimenopause is a time that is challenging to manage, said Michelle Jacobson, MD, of the department of obstetrics and gynecology at the University of Toronto, and obstetrician-gynecologist at Women’s College and Mount Sinai Hospitals in Toronto.

“There are so many nuances to the management. Women are suffering oftentimes from classic menopausal symptoms. There are fluctuating levels of estrogen, sometimes high. Sometimes there are complications of bleeding. There is the potential need for contraception because they are still menstruating,” she said in an interview.

“It’s important to specifically study this group of women with their own unique needs. Dr. Prior is a longtime proponent of using progesterone therapy, and kudos to her for doing this study in perimenopausal women, which is a group that is probably underrepresented in the menopause management literature,” she said.

Dr. Prior and Dr. Kramer reported no relevant financial relationships. Dr. Jacobson reported financial relationships with Astellas, AbbVie, Bayer, BioSyent, Duchesnay, Eisai, Lupin, Organon, Pfizer, and Searchlight.

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

ILLUSTRATION © IRYNA INSHYNA/SHUTTERSTOCK

Patient satisfaction questionnaires were developed in the 1980s as part of the movement to better understand the patient’s experience and their perspective of the quality of care. In 1985, the Press Ganey survey—now the most widely used method to assess patient satisfaction—was developed by 2 professors in anthropology and sociology-statistics at Notre Dame. Initially intended for inpatient admissions, the survey was validated based on a few thousand survey results.¹ Given the strong interest in improving patient satisfaction at the time, it became widely adopted and quickly expanded into outpatient encounters and ambulatory surgery settings.

Although other surveys have been developed,² the Press Ganey survey is the most commonly used assessment tool for patient satisfaction metrics in the United States, with approximately 50% of all hospitals and more than 41,000 health care organizations using its services.^3,4 The survey consists of 6 domains related to satisfaction with:

1. the care provider

2. the nurse or assistant

3. personal issues

4. overall assessment

5. access

6. moving through the visit. 

Survey items are scored using a 5-point Likert scale, with scores ranging from “very poor” (a score of 1) to “very good” (a score of 5). According to the company, because this format is balanced and parallel (unlike a “poor” to “excellent” format), responses can be quantified and used statistically without violating methodologic assumptions. Also, variability in patients’ responses with this format allows for the identification of opportunities to improve, unlike “yes/no” response formats.¹ There are limitations to this design, however, which can impact data quality,⁵ as we will see.

While the distribution process varies by institution, there is an algorithm laid out by Press Ganey for administering surveys to patients in their preferred language after outpatient visits. Based on recent research into Press Ganey response rates, the typical response rate is estimated to be 16% to 19%.⁶ Although this low response rate is typical of survey data, it inherently introduces the risk of responder bias—meaning results may be skewed by patients who represent the extremes of satisfaction or dissatisfaction.

Adoption of the survey as we move toward value-based care

More recently, patients’ satisfaction with their health care has received increased attention as we move to a patient-centered care model and as health care reimbursement models shift toward value-based care. Current trends in health care policy statements include the importance of raising the standard of care and shifting from a “fee-for-service” to a “pay-for-performance” reimbursement model.^7,8 As a result, hospitals are establishing systems to measure “performance” that are not nationally standardized or extensively studied with objective measures. The changing standard of health care expectations in the United States is a topic of much public debate.⁹ And as expectations and new standards are defined, the impact of implementing novel measures of performance should be evaluated prior to widespread adoption and utilization.

Patient satisfaction also has been identified as a driver for hospital finances through loyalty, described as the “likelihood to return to that system for future medical services.”^10,11 This measure has contributed to policy changes that reinforce prioritization of patient satisfaction. For example, the Affordable Care Act tied Medicare reimbursement and patient satisfaction together in the Hospital Value-Based Purchasing Program. This program uses measures of clinical processes, efficiency, outcomes, and patient experiences to calculate a total score that results in hospital reimbursement and incentives,¹² which creates a direct pathway from patient experience to reimbursement—underscoring hospitals’ desire for ongoing assessment of patient satisfaction.

Continue to: Gender, race, and age bias...

Gender, race, and age bias

Although the rationale behind gathering patient input is important, recent data suggest that patient satisfaction surveys are subject to inherent biases.^6,13,14 These biases tend to negatively impact women and non-White physicians, adding to the systemic discrimination against women and physicians of color that already exists in health care.

In a single-site retrospective study performed in 2018 by Rogo-Gupta et al, female gynecologists were found to be 47% less likely to receive top patient satisfaction scores than their male counterparts owing to their gender alone, suggesting that gender bias may impact the results of patient satisfaction questionnaires.¹³ The authors encouraged that the results of patient satisfaction surveys be interpreted with great caution until the impact on female physicians is better understood.

A multi-center study by the same group (Rogo-Gupta et al) assessed the same construct across 5 different geographically diverse institutions.¹⁵ This study confirmed that female gynecologists were less likely to receive a top satisfaction score from their patients (19% lower odds when compared with male gynecologists). They also studied the effects of other patient demographics, including age, race/ethnicity, and race concordance. Older patients (aged ≥63 years) had an over-3-fold increase in odds of providing a top satisfaction score than younger patients. Additionally, Asian physicians had significantly lower odds of receiving a top satisfaction score when compared with White physicians, while Asian patients had significantly lower odds of providing a top satisfaction score when compared with White patients. Lastly, in most cases, when underrepresented-in-medicine patients saw an underrepresented-in-medicine physician (race concordance), there was a significant increase in odds of receiving a top satisfaction score. Asian race concordance, however, actually resulted in a lower likelihood of receiving a top satisfaction score.¹⁵

Literature from other specialties supports these findings. These results are consistent with emerging data from other medical specialties that also suggest that Press Ganey survey data are subject to inherent biases. For example, data from emergency medicine literature have shown discrepancies between patient satisfaction for providers at tertiary inner-city institutions versus those in affluent suburban populations,¹⁶ and that worse mortality is actually correlated with better patient satisfaction scores, and vice versa.¹⁷

Another study by Sotto-Santiago in 2019 assessed patient satisfaction scores in multiple specialties at a single institution where quality-related financial incentives were offered based on this metric. They found a significant difference in patient satisfaction scores between underrepresented and White physicians, which suggests a potential bias among patients and institutional practices—ultimately leading to pay inequities through differences in financial incentives.¹⁸

Percentile differences reveal small gaps in satisfaction ratings

When examining the difference between raw Press Ganey patient satisfaction data and the percentiles associated with these scores, an interesting finding arises. Looking at the 2023 multicenter study by Rogo-Gupta et al, the difference in the top raw scores between male and female gynecologists appears to be small (3.3%).¹⁵ However, in 2020, the difference in top scores separating the top (75th) and bottom (25th) percentile quartiles of physicians was also small, at only 6.9%.

Considering the percentiles, if a provider who scores in the 25th percentile is compared with a colleague who scores in the 75th percentile, they may think the reported satisfaction score differences were quite large. This may potentially invoke feelings of decreased self-worth, negatively impact their professional identity or overall well-being, and they may seek (or be told to seek) improvement opportunities. Now imagine the provider in question realizes the difference between the 25th percentile and 75th percentile is actually only 6.9%. This information may completely change how the results are interpreted and acted upon by administrators. This is further changed with the understanding that 3.3% of the difference may be due to gender alone, narrowing the gap even further. Providers would become understandably frustrated if measures of success such as reimbursement, financial bonus or incentives, promotion, or advancement are linked to these results. It violates the value of fairness and does not offer an equitable starting point.

Evolution of the data distribution. Another consideration, as noted by Robert C. Lloyd, PhD, one of the statisticians who helped develop the percentile statistical analysis mapping in 1985, is that it was based on a classic bell-shaped distribution of patient satisfaction survey scores.¹⁹ Because hospitals, medical groups, and physicians have been working these past 20 years to achieve higher Press Ganey scores, the data no longer have a bell-shaped distribution. Rather, there are significant clusters of raw scores at the high end with a very narrow response range. When these data are mapped to the percentile spectrum, they are highly inaccurate.¹⁹

Impact of sample size. According to Press Ganey, a minimum of 30 survey responses collected over the designated time period is necessary to draw meaningful conclusions of the data for a specific individual, program, or hospital. Despite this requirement to achieve statistical significance, Sullivan and DeLucia found that the firm often provides comparative data about hospital departments and individual physicians based on a smaller sample size that may create an unacceptably large margin of error.²⁰ Sullivan, for example, said his department may only have 8 to 10 Press Ganey survey responses per month and yet still receives monthly reports from the company analyzing the data. Because of the small sample size, 1 month his department ranked in the 1st percentile and 2 months later it ranked in the 99th percentile.²⁰

The effect of a high ceiling rate. A psychometrics report for the Press Ganey survey is available from the vendor that provides vague assessments of reliability and validity based on 2,762 surveys from 12 practices across 10 states. This report describes a 12-question version of the survey with “no problems encountered” with missingness and response variability. The report further states that the Press Ganey survey demonstrates construct, convergent, divergent, and predictive validities, and high reliability; however, these data are not made available.¹

In response to this report, Presson et al analyzed more than 34,000 surveys from one institution to evaluate the reliability and validity of the Press Ganey survey.21 Overall, the survey demonstrated suitable psychometric properties for most metrics. However, Presson et al noted a significantly high ceiling rate of 29.3% for the total score, which ranged from 55.4% to 84.1% across items.²¹ (Ceiling rates are considered substantial if they occur more than 20% of the time.) Ultimately, a high ceiling rate reduces the power to discriminate between patients who have high satisfaction (everyone is “happy”) with those who are just slightly less than happy, but not dissatisfied. This data quality metric can impact the reliability and validity of a survey—and substantial ceiling rates can notably impact percentile rankings of scores within an institution, offering a possible explanation for the small percentage change between the top and bottom percentiles.

Continue to: Other issues with surveys...

Other issues with surveys

In addition to the limitations associated with percentile groupings, survey data are always subject to nonresponse bias, and small sample size can lead to nonsignificant results. Skewed responses also can make it difficult to identify true outlying providers who may need remediation or may be offering a superior patient experience. Satisfaction surveys also lack an assessment of objective data and instead assess how patients perceive and feel, which introduces subjectivity to the results.

Additionally, focusing on improving patient experience ratings can incentivize unnecessary or inappropriate care (ie, overprescribing of narcotics, prescribing antibiotics when not indicated, or ordering testing that may not change management). Some physicians even state that they are not getting the type of feedback that they are asking for and that the survey is not asking the right questions to elicit patient input that is meaningful to their practice. Lastly, the incorporation of trainees and advanced practice providers in the patient care experience leads to the assessment of an alternative provider being included in the ultimate score and may not be representative of that physician.

Patients’ perception and survey results. In some circumstances, the patient’s understanding of their medical situation may affect their responses. Some may argue that patients may mistake a physician’s confidence for competence, when in reality these two entities are mutually exclusive. In a randomized controlled trial, researchers from Mount Sinai School of Medicine and Columbia University Medical Center surveyed inner-city women with newly diagnosed and surgically treated early-stage breast cancer for their perceived quality of care and the process of getting care, including referrals, test results, and treatments. They compared the responses with patient records to determine the actual quality of care. Of the 374 women who received treatment for early-stage breast cancer, 55% said they received “excellent care,” but most—88%—actually got care that was in line with the best current treatment guidelines. Interestingly, the study found African American women were less likely to report excellent care than White or Hispanic women, less likely to trust their doctor, and more likely to say they experienced bias during the process. However, there was no difference in actual quality of care received in any group.²²

You can’t improve what you can’t control. Ultimately, while many providers think patient satisfaction survey results may help inform some aspects of their practice, they cannot improve what they cannot control. For example, the multicenter study by Rogo-Gupta et al found that older patients (≥63 years) have more than a 3-fold increase in odds of giving a top satisfaction score than younger patients (≤33 years), independent of other aspects of the care experience.15 Additionally, they found that older physicians (≥56 years) had a significant increase in odds of receiving a top satisfaction score when compared with physicians who were younger than 55 years old.¹⁵ Given that physicians clearly cannot control their own age or the age of their patients, the negative impacts of these biases need to be addressed and remedied at a systems level.

Why might these biases exist?

While we cannot completely understand all of the possible explanations for these biases, it is important to emphasize the long-standing prejudice and discrimination against women and people of color in our society and how this has impacted our behavior. While strides have been made, there clearly still seems to be a difference between what we say and how our biases impact our behavior. Women are still tougher on women in professional evaluations in other fields as well²³; it is not unique to medicine. While workplace improvements are slowly changing, women still face inequities. The more research we publish to describe it, the more we hope the conversation continues, allowing us to reduce the impact of bias on our sense of self-worth and identity related to our careers, narrow the pay gap, and see women advance at the same rate as male counterparts. Considerable transformation is crucial to prevent further workforce attrition.

With regard to the lower scores provided by Asian patients, studies suggest that cultural response bias, rather than true differences in quality of care, may account for these discrepancies. Previous literature has found that Asian patients are more likely to select midpoints, rather than extremes, when completing Likert-type studies²⁴ and are not more likely to change medical providers than other race/ethnicities, indicating that lower ratings may not necessarily imply greater dissatisfaction with care.²⁵

Far-reaching effects on finances, income, well-being, job satisfaction, etc.

Depending on how the results are distributed and used, the effects of patient satisfaction surveys can extend well beyond the original intentions. At some institutions, income for physicians is directly tied to their Press Ganey satisfaction scores, which could have profound implications for female and Asian physicians,^13,15 who would be paid less—resulting in a wider pay gap than already exists.¹⁸

When negative and not constructive, patient evaluations can contribute to physician burnout and a loss of productive members of the workforce.²⁶ This is especially important in obstetrics and gynecology, where physicians are most likely to experience burnout due to multiple factors such as high-risk medical conditions, pressures of the electronic medical record (EMR), the medicolegal environment, and difficulty balancing patient expectations for autonomy with professional judgement.²⁷ Burnout also disproportionately affects women and younger physicians, which is especially concerning given that, in 2017, approximately one-third of practicing obstetrician/gynecologists were women, while that same year more than 80% of trainees matching into the field were women.²⁸ In one survey sent to members of a prominent medical society, 20% of the medical professionals who responded said they have had their employment threatened by low patient satisfaction scores, 78% reported that patient satisfaction surveys moderately or severely affected their job satisfaction, and 28% stated they had considered quitting their job or leaving the medical profession.²⁹Another related effect is the association between malpractice proceedings and a lack of satisfaction with perceived quality of physician-patient communication.³⁰ This may be an important determinant of malpractice lawsuits, and ensuring high patient satisfaction may be a form of defensive medicine.

Continue to: Controlling the narrative for the future: Proposed strategies...

Controlling the narrative for the future: Proposed strategies

The rapid, widespread adoption of the Press Ganey survey across specialties, clinical care settings, and geographic areas may have been largely due to the ease and operational benefits for hospitals rather than after rigorous study and validation. For example, repeated use of a specific measurement tool may facilitate comparison across areas within a hospital but also across institutions, which can help assess performance at a national level. Hospitals also may have a financial incentive to work with a single third-party or vendor instead of using multiple options across multiple vendors. However, the impact of adoption of novel measures of performance should be evaluated prior to widespread adoption and utilization.

A similar example of an emergence of a technological advancement that has changed the field of medicine and how we provide care is the EMR. Epic is now the most commonly used medical record system and holds the market share of the industry, covering 78% of patients in the United States.³¹ While there are certainly many potential benefits of a common EMR, such as ease of information sharing and standardization of formatting, opportunities are identified in real time and require product adjustment. For example, modifications have been made to accurately represent gender outside of the previously used dichotomous options. Diagnoses such as cervical cancer screening can now be used even if the patient gender is listed as male.

Similarly, the Press Ganey and other patient satisfaction questionnaires should be evaluated and modified to address existing societal biases. The World Health Organization estimates that it will take 300 years to fix gender inequality,³² but we have an opportunity now to control the narrative and improve patient feedback.

Future research avenues

Ultimately, there is a need to further explore currently available methods of evaluating clinical encounters to better understand the inherent biases and limitations. We hope this review will encourage other physicians to examine their specialties and hospitals and require similar analyses from vendors of such satisfaction rating products prior to using them. At the very least, health systems should be willing to partner with vendors and physicians on an ongoing basis to better understand the biases involved in these survey results and make modifications as needed. Patients also obtain information from and contribute to self-reported, publicly available websites; therefore, additional exploration into a nationalized standard for assessing patient satisfaction also may serve as an opportunity to standardize the information patients evaluate.³³ Further assessment of the potential financial and emotional impact of using the currently available patient-reported surveys on female physicians, Asian physicians, young physicians, and physicians who see young patients is needed. It is time to put pressure on a broken patient satisfaction system and improve on a national level to avoid undue negative consequences on our physicians. Use of patient satisfaction survey data should be limited until we all understand and account for the biases that are evident. ●

ILLUSTRATION © IRYNA INSHYNA/SHUTTERSTOCK

Patient satisfaction questionnaires were developed in the 1980s as part of the movement to better understand the patient’s experience and their perspective of the quality of care. In 1985, the Press Ganey survey—now the most widely used method to assess patient satisfaction—was developed by 2 professors in anthropology and sociology-statistics at Notre Dame. Initially intended for inpatient admissions, the survey was validated based on a few thousand survey results.¹ Given the strong interest in improving patient satisfaction at the time, it became widely adopted and quickly expanded into outpatient encounters and ambulatory surgery settings.

Although other surveys have been developed,² the Press Ganey survey is the most commonly used assessment tool for patient satisfaction metrics in the United States, with approximately 50% of all hospitals and more than 41,000 health care organizations using its services.^3,4 The survey consists of 6 domains related to satisfaction with:

1. the care provider

2. the nurse or assistant

3. personal issues

4. overall assessment

5. access

6. moving through the visit. 

Survey items are scored using a 5-point Likert scale, with scores ranging from “very poor” (a score of 1) to “very good” (a score of 5). According to the company, because this format is balanced and parallel (unlike a “poor” to “excellent” format), responses can be quantified and used statistically without violating methodologic assumptions. Also, variability in patients’ responses with this format allows for the identification of opportunities to improve, unlike “yes/no” response formats.¹ There are limitations to this design, however, which can impact data quality,⁵ as we will see.

While the distribution process varies by institution, there is an algorithm laid out by Press Ganey for administering surveys to patients in their preferred language after outpatient visits. Based on recent research into Press Ganey response rates, the typical response rate is estimated to be 16% to 19%.⁶ Although this low response rate is typical of survey data, it inherently introduces the risk of responder bias—meaning results may be skewed by patients who represent the extremes of satisfaction or dissatisfaction.

Adoption of the survey as we move toward value-based care

More recently, patients’ satisfaction with their health care has received increased attention as we move to a patient-centered care model and as health care reimbursement models shift toward value-based care. Current trends in health care policy statements include the importance of raising the standard of care and shifting from a “fee-for-service” to a “pay-for-performance” reimbursement model.^7,8 As a result, hospitals are establishing systems to measure “performance” that are not nationally standardized or extensively studied with objective measures. The changing standard of health care expectations in the United States is a topic of much public debate.⁹ And as expectations and new standards are defined, the impact of implementing novel measures of performance should be evaluated prior to widespread adoption and utilization.

Patient satisfaction also has been identified as a driver for hospital finances through loyalty, described as the “likelihood to return to that system for future medical services.”^10,11 This measure has contributed to policy changes that reinforce prioritization of patient satisfaction. For example, the Affordable Care Act tied Medicare reimbursement and patient satisfaction together in the Hospital Value-Based Purchasing Program. This program uses measures of clinical processes, efficiency, outcomes, and patient experiences to calculate a total score that results in hospital reimbursement and incentives,¹² which creates a direct pathway from patient experience to reimbursement—underscoring hospitals’ desire for ongoing assessment of patient satisfaction.

Continue to: Gender, race, and age bias...

Gender, race, and age bias

Although the rationale behind gathering patient input is important, recent data suggest that patient satisfaction surveys are subject to inherent biases.^6,13,14 These biases tend to negatively impact women and non-White physicians, adding to the systemic discrimination against women and physicians of color that already exists in health care.

In a single-site retrospective study performed in 2018 by Rogo-Gupta et al, female gynecologists were found to be 47% less likely to receive top patient satisfaction scores than their male counterparts owing to their gender alone, suggesting that gender bias may impact the results of patient satisfaction questionnaires.¹³ The authors encouraged that the results of patient satisfaction surveys be interpreted with great caution until the impact on female physicians is better understood.

A multi-center study by the same group (Rogo-Gupta et al) assessed the same construct across 5 different geographically diverse institutions.¹⁵ This study confirmed that female gynecologists were less likely to receive a top satisfaction score from their patients (19% lower odds when compared with male gynecologists). They also studied the effects of other patient demographics, including age, race/ethnicity, and race concordance. Older patients (aged ≥63 years) had an over-3-fold increase in odds of providing a top satisfaction score than younger patients. Additionally, Asian physicians had significantly lower odds of receiving a top satisfaction score when compared with White physicians, while Asian patients had significantly lower odds of providing a top satisfaction score when compared with White patients. Lastly, in most cases, when underrepresented-in-medicine patients saw an underrepresented-in-medicine physician (race concordance), there was a significant increase in odds of receiving a top satisfaction score. Asian race concordance, however, actually resulted in a lower likelihood of receiving a top satisfaction score.¹⁵

Literature from other specialties supports these findings. These results are consistent with emerging data from other medical specialties that also suggest that Press Ganey survey data are subject to inherent biases. For example, data from emergency medicine literature have shown discrepancies between patient satisfaction for providers at tertiary inner-city institutions versus those in affluent suburban populations,¹⁶ and that worse mortality is actually correlated with better patient satisfaction scores, and vice versa.¹⁷

Another study by Sotto-Santiago in 2019 assessed patient satisfaction scores in multiple specialties at a single institution where quality-related financial incentives were offered based on this metric. They found a significant difference in patient satisfaction scores between underrepresented and White physicians, which suggests a potential bias among patients and institutional practices—ultimately leading to pay inequities through differences in financial incentives.¹⁸

Percentile differences reveal small gaps in satisfaction ratings

When examining the difference between raw Press Ganey patient satisfaction data and the percentiles associated with these scores, an interesting finding arises. Looking at the 2023 multicenter study by Rogo-Gupta et al, the difference in the top raw scores between male and female gynecologists appears to be small (3.3%).¹⁵ However, in 2020, the difference in top scores separating the top (75th) and bottom (25th) percentile quartiles of physicians was also small, at only 6.9%.

Considering the percentiles, if a provider who scores in the 25th percentile is compared with a colleague who scores in the 75th percentile, they may think the reported satisfaction score differences were quite large. This may potentially invoke feelings of decreased self-worth, negatively impact their professional identity or overall well-being, and they may seek (or be told to seek) improvement opportunities. Now imagine the provider in question realizes the difference between the 25th percentile and 75th percentile is actually only 6.9%. This information may completely change how the results are interpreted and acted upon by administrators. This is further changed with the understanding that 3.3% of the difference may be due to gender alone, narrowing the gap even further. Providers would become understandably frustrated if measures of success such as reimbursement, financial bonus or incentives, promotion, or advancement are linked to these results. It violates the value of fairness and does not offer an equitable starting point.

Evolution of the data distribution. Another consideration, as noted by Robert C. Lloyd, PhD, one of the statisticians who helped develop the percentile statistical analysis mapping in 1985, is that it was based on a classic bell-shaped distribution of patient satisfaction survey scores.¹⁹ Because hospitals, medical groups, and physicians have been working these past 20 years to achieve higher Press Ganey scores, the data no longer have a bell-shaped distribution. Rather, there are significant clusters of raw scores at the high end with a very narrow response range. When these data are mapped to the percentile spectrum, they are highly inaccurate.¹⁹

Impact of sample size. According to Press Ganey, a minimum of 30 survey responses collected over the designated time period is necessary to draw meaningful conclusions of the data for a specific individual, program, or hospital. Despite this requirement to achieve statistical significance, Sullivan and DeLucia found that the firm often provides comparative data about hospital departments and individual physicians based on a smaller sample size that may create an unacceptably large margin of error.²⁰ Sullivan, for example, said his department may only have 8 to 10 Press Ganey survey responses per month and yet still receives monthly reports from the company analyzing the data. Because of the small sample size, 1 month his department ranked in the 1st percentile and 2 months later it ranked in the 99th percentile.²⁰

The effect of a high ceiling rate. A psychometrics report for the Press Ganey survey is available from the vendor that provides vague assessments of reliability and validity based on 2,762 surveys from 12 practices across 10 states. This report describes a 12-question version of the survey with “no problems encountered” with missingness and response variability. The report further states that the Press Ganey survey demonstrates construct, convergent, divergent, and predictive validities, and high reliability; however, these data are not made available.¹

In response to this report, Presson et al analyzed more than 34,000 surveys from one institution to evaluate the reliability and validity of the Press Ganey survey.21 Overall, the survey demonstrated suitable psychometric properties for most metrics. However, Presson et al noted a significantly high ceiling rate of 29.3% for the total score, which ranged from 55.4% to 84.1% across items.²¹ (Ceiling rates are considered substantial if they occur more than 20% of the time.) Ultimately, a high ceiling rate reduces the power to discriminate between patients who have high satisfaction (everyone is “happy”) with those who are just slightly less than happy, but not dissatisfied. This data quality metric can impact the reliability and validity of a survey—and substantial ceiling rates can notably impact percentile rankings of scores within an institution, offering a possible explanation for the small percentage change between the top and bottom percentiles.

Continue to: Other issues with surveys...

Other issues with surveys

In addition to the limitations associated with percentile groupings, survey data are always subject to nonresponse bias, and small sample size can lead to nonsignificant results. Skewed responses also can make it difficult to identify true outlying providers who may need remediation or may be offering a superior patient experience. Satisfaction surveys also lack an assessment of objective data and instead assess how patients perceive and feel, which introduces subjectivity to the results.

Additionally, focusing on improving patient experience ratings can incentivize unnecessary or inappropriate care (ie, overprescribing of narcotics, prescribing antibiotics when not indicated, or ordering testing that may not change management). Some physicians even state that they are not getting the type of feedback that they are asking for and that the survey is not asking the right questions to elicit patient input that is meaningful to their practice. Lastly, the incorporation of trainees and advanced practice providers in the patient care experience leads to the assessment of an alternative provider being included in the ultimate score and may not be representative of that physician.

Patients’ perception and survey results. In some circumstances, the patient’s understanding of their medical situation may affect their responses. Some may argue that patients may mistake a physician’s confidence for competence, when in reality these two entities are mutually exclusive. In a randomized controlled trial, researchers from Mount Sinai School of Medicine and Columbia University Medical Center surveyed inner-city women with newly diagnosed and surgically treated early-stage breast cancer for their perceived quality of care and the process of getting care, including referrals, test results, and treatments. They compared the responses with patient records to determine the actual quality of care. Of the 374 women who received treatment for early-stage breast cancer, 55% said they received “excellent care,” but most—88%—actually got care that was in line with the best current treatment guidelines. Interestingly, the study found African American women were less likely to report excellent care than White or Hispanic women, less likely to trust their doctor, and more likely to say they experienced bias during the process. However, there was no difference in actual quality of care received in any group.²²

You can’t improve what you can’t control. Ultimately, while many providers think patient satisfaction survey results may help inform some aspects of their practice, they cannot improve what they cannot control. For example, the multicenter study by Rogo-Gupta et al found that older patients (≥63 years) have more than a 3-fold increase in odds of giving a top satisfaction score than younger patients (≤33 years), independent of other aspects of the care experience.15 Additionally, they found that older physicians (≥56 years) had a significant increase in odds of receiving a top satisfaction score when compared with physicians who were younger than 55 years old.¹⁵ Given that physicians clearly cannot control their own age or the age of their patients, the negative impacts of these biases need to be addressed and remedied at a systems level.

Why might these biases exist?

While we cannot completely understand all of the possible explanations for these biases, it is important to emphasize the long-standing prejudice and discrimination against women and people of color in our society and how this has impacted our behavior. While strides have been made, there clearly still seems to be a difference between what we say and how our biases impact our behavior. Women are still tougher on women in professional evaluations in other fields as well²³; it is not unique to medicine. While workplace improvements are slowly changing, women still face inequities. The more research we publish to describe it, the more we hope the conversation continues, allowing us to reduce the impact of bias on our sense of self-worth and identity related to our careers, narrow the pay gap, and see women advance at the same rate as male counterparts. Considerable transformation is crucial to prevent further workforce attrition.

With regard to the lower scores provided by Asian patients, studies suggest that cultural response bias, rather than true differences in quality of care, may account for these discrepancies. Previous literature has found that Asian patients are more likely to select midpoints, rather than extremes, when completing Likert-type studies²⁴ and are not more likely to change medical providers than other race/ethnicities, indicating that lower ratings may not necessarily imply greater dissatisfaction with care.²⁵

Far-reaching effects on finances, income, well-being, job satisfaction, etc.

Depending on how the results are distributed and used, the effects of patient satisfaction surveys can extend well beyond the original intentions. At some institutions, income for physicians is directly tied to their Press Ganey satisfaction scores, which could have profound implications for female and Asian physicians,^13,15 who would be paid less—resulting in a wider pay gap than already exists.¹⁸

When negative and not constructive, patient evaluations can contribute to physician burnout and a loss of productive members of the workforce.²⁶ This is especially important in obstetrics and gynecology, where physicians are most likely to experience burnout due to multiple factors such as high-risk medical conditions, pressures of the electronic medical record (EMR), the medicolegal environment, and difficulty balancing patient expectations for autonomy with professional judgement.²⁷ Burnout also disproportionately affects women and younger physicians, which is especially concerning given that, in 2017, approximately one-third of practicing obstetrician/gynecologists were women, while that same year more than 80% of trainees matching into the field were women.²⁸ In one survey sent to members of a prominent medical society, 20% of the medical professionals who responded said they have had their employment threatened by low patient satisfaction scores, 78% reported that patient satisfaction surveys moderately or severely affected their job satisfaction, and 28% stated they had considered quitting their job or leaving the medical profession.²⁹Another related effect is the association between malpractice proceedings and a lack of satisfaction with perceived quality of physician-patient communication.³⁰ This may be an important determinant of malpractice lawsuits, and ensuring high patient satisfaction may be a form of defensive medicine.

Continue to: Controlling the narrative for the future: Proposed strategies...

Controlling the narrative for the future: Proposed strategies

The rapid, widespread adoption of the Press Ganey survey across specialties, clinical care settings, and geographic areas may have been largely due to the ease and operational benefits for hospitals rather than after rigorous study and validation. For example, repeated use of a specific measurement tool may facilitate comparison across areas within a hospital but also across institutions, which can help assess performance at a national level. Hospitals also may have a financial incentive to work with a single third-party or vendor instead of using multiple options across multiple vendors. However, the impact of adoption of novel measures of performance should be evaluated prior to widespread adoption and utilization.

A similar example of an emergence of a technological advancement that has changed the field of medicine and how we provide care is the EMR. Epic is now the most commonly used medical record system and holds the market share of the industry, covering 78% of patients in the United States.³¹ While there are certainly many potential benefits of a common EMR, such as ease of information sharing and standardization of formatting, opportunities are identified in real time and require product adjustment. For example, modifications have been made to accurately represent gender outside of the previously used dichotomous options. Diagnoses such as cervical cancer screening can now be used even if the patient gender is listed as male.

Similarly, the Press Ganey and other patient satisfaction questionnaires should be evaluated and modified to address existing societal biases. The World Health Organization estimates that it will take 300 years to fix gender inequality,³² but we have an opportunity now to control the narrative and improve patient feedback.

Future research avenues

Ultimately, there is a need to further explore currently available methods of evaluating clinical encounters to better understand the inherent biases and limitations. We hope this review will encourage other physicians to examine their specialties and hospitals and require similar analyses from vendors of such satisfaction rating products prior to using them. At the very least, health systems should be willing to partner with vendors and physicians on an ongoing basis to better understand the biases involved in these survey results and make modifications as needed. Patients also obtain information from and contribute to self-reported, publicly available websites; therefore, additional exploration into a nationalized standard for assessing patient satisfaction also may serve as an opportunity to standardize the information patients evaluate.³³ Further assessment of the potential financial and emotional impact of using the currently available patient-reported surveys on female physicians, Asian physicians, young physicians, and physicians who see young patients is needed. It is time to put pressure on a broken patient satisfaction system and improve on a national level to avoid undue negative consequences on our physicians. Use of patient satisfaction survey data should be limited until we all understand and account for the biases that are evident. ●

ILLUSTRATION © IRYNA INSHYNA/SHUTTERSTOCK

Patient satisfaction questionnaires were developed in the 1980s as part of the movement to better understand the patient’s experience and their perspective of the quality of care. In 1985, the Press Ganey survey—now the most widely used method to assess patient satisfaction—was developed by 2 professors in anthropology and sociology-statistics at Notre Dame. Initially intended for inpatient admissions, the survey was validated based on a few thousand survey results.¹ Given the strong interest in improving patient satisfaction at the time, it became widely adopted and quickly expanded into outpatient encounters and ambulatory surgery settings.

Although other surveys have been developed,² the Press Ganey survey is the most commonly used assessment tool for patient satisfaction metrics in the United States, with approximately 50% of all hospitals and more than 41,000 health care organizations using its services.^3,4 The survey consists of 6 domains related to satisfaction with:

1. the care provider

2. the nurse or assistant

3. personal issues

4. overall assessment

5. access

6. moving through the visit. 

Survey items are scored using a 5-point Likert scale, with scores ranging from “very poor” (a score of 1) to “very good” (a score of 5). According to the company, because this format is balanced and parallel (unlike a “poor” to “excellent” format), responses can be quantified and used statistically without violating methodologic assumptions. Also, variability in patients’ responses with this format allows for the identification of opportunities to improve, unlike “yes/no” response formats.¹ There are limitations to this design, however, which can impact data quality,⁵ as we will see.

While the distribution process varies by institution, there is an algorithm laid out by Press Ganey for administering surveys to patients in their preferred language after outpatient visits. Based on recent research into Press Ganey response rates, the typical response rate is estimated to be 16% to 19%.⁶ Although this low response rate is typical of survey data, it inherently introduces the risk of responder bias—meaning results may be skewed by patients who represent the extremes of satisfaction or dissatisfaction.

Adoption of the survey as we move toward value-based care

More recently, patients’ satisfaction with their health care has received increased attention as we move to a patient-centered care model and as health care reimbursement models shift toward value-based care. Current trends in health care policy statements include the importance of raising the standard of care and shifting from a “fee-for-service” to a “pay-for-performance” reimbursement model.^7,8 As a result, hospitals are establishing systems to measure “performance” that are not nationally standardized or extensively studied with objective measures. The changing standard of health care expectations in the United States is a topic of much public debate.⁹ And as expectations and new standards are defined, the impact of implementing novel measures of performance should be evaluated prior to widespread adoption and utilization.

Patient satisfaction also has been identified as a driver for hospital finances through loyalty, described as the “likelihood to return to that system for future medical services.”^10,11 This measure has contributed to policy changes that reinforce prioritization of patient satisfaction. For example, the Affordable Care Act tied Medicare reimbursement and patient satisfaction together in the Hospital Value-Based Purchasing Program. This program uses measures of clinical processes, efficiency, outcomes, and patient experiences to calculate a total score that results in hospital reimbursement and incentives,¹² which creates a direct pathway from patient experience to reimbursement—underscoring hospitals’ desire for ongoing assessment of patient satisfaction.

Continue to: Gender, race, and age bias...

Gender, race, and age bias

Although the rationale behind gathering patient input is important, recent data suggest that patient satisfaction surveys are subject to inherent biases.^6,13,14 These biases tend to negatively impact women and non-White physicians, adding to the systemic discrimination against women and physicians of color that already exists in health care.

In a single-site retrospective study performed in 2018 by Rogo-Gupta et al, female gynecologists were found to be 47% less likely to receive top patient satisfaction scores than their male counterparts owing to their gender alone, suggesting that gender bias may impact the results of patient satisfaction questionnaires.¹³ The authors encouraged that the results of patient satisfaction surveys be interpreted with great caution until the impact on female physicians is better understood.

A multi-center study by the same group (Rogo-Gupta et al) assessed the same construct across 5 different geographically diverse institutions.¹⁵ This study confirmed that female gynecologists were less likely to receive a top satisfaction score from their patients (19% lower odds when compared with male gynecologists). They also studied the effects of other patient demographics, including age, race/ethnicity, and race concordance. Older patients (aged ≥63 years) had an over-3-fold increase in odds of providing a top satisfaction score than younger patients. Additionally, Asian physicians had significantly lower odds of receiving a top satisfaction score when compared with White physicians, while Asian patients had significantly lower odds of providing a top satisfaction score when compared with White patients. Lastly, in most cases, when underrepresented-in-medicine patients saw an underrepresented-in-medicine physician (race concordance), there was a significant increase in odds of receiving a top satisfaction score. Asian race concordance, however, actually resulted in a lower likelihood of receiving a top satisfaction score.¹⁵

Literature from other specialties supports these findings. These results are consistent with emerging data from other medical specialties that also suggest that Press Ganey survey data are subject to inherent biases. For example, data from emergency medicine literature have shown discrepancies between patient satisfaction for providers at tertiary inner-city institutions versus those in affluent suburban populations,¹⁶ and that worse mortality is actually correlated with better patient satisfaction scores, and vice versa.¹⁷

Another study by Sotto-Santiago in 2019 assessed patient satisfaction scores in multiple specialties at a single institution where quality-related financial incentives were offered based on this metric. They found a significant difference in patient satisfaction scores between underrepresented and White physicians, which suggests a potential bias among patients and institutional practices—ultimately leading to pay inequities through differences in financial incentives.¹⁸

Percentile differences reveal small gaps in satisfaction ratings

When examining the difference between raw Press Ganey patient satisfaction data and the percentiles associated with these scores, an interesting finding arises. Looking at the 2023 multicenter study by Rogo-Gupta et al, the difference in the top raw scores between male and female gynecologists appears to be small (3.3%).¹⁵ However, in 2020, the difference in top scores separating the top (75th) and bottom (25th) percentile quartiles of physicians was also small, at only 6.9%.

Considering the percentiles, if a provider who scores in the 25th percentile is compared with a colleague who scores in the 75th percentile, they may think the reported satisfaction score differences were quite large. This may potentially invoke feelings of decreased self-worth, negatively impact their professional identity or overall well-being, and they may seek (or be told to seek) improvement opportunities. Now imagine the provider in question realizes the difference between the 25th percentile and 75th percentile is actually only 6.9%. This information may completely change how the results are interpreted and acted upon by administrators. This is further changed with the understanding that 3.3% of the difference may be due to gender alone, narrowing the gap even further. Providers would become understandably frustrated if measures of success such as reimbursement, financial bonus or incentives, promotion, or advancement are linked to these results. It violates the value of fairness and does not offer an equitable starting point.

Evolution of the data distribution. Another consideration, as noted by Robert C. Lloyd, PhD, one of the statisticians who helped develop the percentile statistical analysis mapping in 1985, is that it was based on a classic bell-shaped distribution of patient satisfaction survey scores.¹⁹ Because hospitals, medical groups, and physicians have been working these past 20 years to achieve higher Press Ganey scores, the data no longer have a bell-shaped distribution. Rather, there are significant clusters of raw scores at the high end with a very narrow response range. When these data are mapped to the percentile spectrum, they are highly inaccurate.¹⁹

Impact of sample size. According to Press Ganey, a minimum of 30 survey responses collected over the designated time period is necessary to draw meaningful conclusions of the data for a specific individual, program, or hospital. Despite this requirement to achieve statistical significance, Sullivan and DeLucia found that the firm often provides comparative data about hospital departments and individual physicians based on a smaller sample size that may create an unacceptably large margin of error.²⁰ Sullivan, for example, said his department may only have 8 to 10 Press Ganey survey responses per month and yet still receives monthly reports from the company analyzing the data. Because of the small sample size, 1 month his department ranked in the 1st percentile and 2 months later it ranked in the 99th percentile.²⁰

The effect of a high ceiling rate. A psychometrics report for the Press Ganey survey is available from the vendor that provides vague assessments of reliability and validity based on 2,762 surveys from 12 practices across 10 states. This report describes a 12-question version of the survey with “no problems encountered” with missingness and response variability. The report further states that the Press Ganey survey demonstrates construct, convergent, divergent, and predictive validities, and high reliability; however, these data are not made available.¹

In response to this report, Presson et al analyzed more than 34,000 surveys from one institution to evaluate the reliability and validity of the Press Ganey survey.21 Overall, the survey demonstrated suitable psychometric properties for most metrics. However, Presson et al noted a significantly high ceiling rate of 29.3% for the total score, which ranged from 55.4% to 84.1% across items.²¹ (Ceiling rates are considered substantial if they occur more than 20% of the time.) Ultimately, a high ceiling rate reduces the power to discriminate between patients who have high satisfaction (everyone is “happy”) with those who are just slightly less than happy, but not dissatisfied. This data quality metric can impact the reliability and validity of a survey—and substantial ceiling rates can notably impact percentile rankings of scores within an institution, offering a possible explanation for the small percentage change between the top and bottom percentiles.

Continue to: Other issues with surveys...

Other issues with surveys

In addition to the limitations associated with percentile groupings, survey data are always subject to nonresponse bias, and small sample size can lead to nonsignificant results. Skewed responses also can make it difficult to identify true outlying providers who may need remediation or may be offering a superior patient experience. Satisfaction surveys also lack an assessment of objective data and instead assess how patients perceive and feel, which introduces subjectivity to the results.

Additionally, focusing on improving patient experience ratings can incentivize unnecessary or inappropriate care (ie, overprescribing of narcotics, prescribing antibiotics when not indicated, or ordering testing that may not change management). Some physicians even state that they are not getting the type of feedback that they are asking for and that the survey is not asking the right questions to elicit patient input that is meaningful to their practice. Lastly, the incorporation of trainees and advanced practice providers in the patient care experience leads to the assessment of an alternative provider being included in the ultimate score and may not be representative of that physician.

Patients’ perception and survey results. In some circumstances, the patient’s understanding of their medical situation may affect their responses. Some may argue that patients may mistake a physician’s confidence for competence, when in reality these two entities are mutually exclusive. In a randomized controlled trial, researchers from Mount Sinai School of Medicine and Columbia University Medical Center surveyed inner-city women with newly diagnosed and surgically treated early-stage breast cancer for their perceived quality of care and the process of getting care, including referrals, test results, and treatments. They compared the responses with patient records to determine the actual quality of care. Of the 374 women who received treatment for early-stage breast cancer, 55% said they received “excellent care,” but most—88%—actually got care that was in line with the best current treatment guidelines. Interestingly, the study found African American women were less likely to report excellent care than White or Hispanic women, less likely to trust their doctor, and more likely to say they experienced bias during the process. However, there was no difference in actual quality of care received in any group.²²

You can’t improve what you can’t control. Ultimately, while many providers think patient satisfaction survey results may help inform some aspects of their practice, they cannot improve what they cannot control. For example, the multicenter study by Rogo-Gupta et al found that older patients (≥63 years) have more than a 3-fold increase in odds of giving a top satisfaction score than younger patients (≤33 years), independent of other aspects of the care experience.15 Additionally, they found that older physicians (≥56 years) had a significant increase in odds of receiving a top satisfaction score when compared with physicians who were younger than 55 years old.¹⁵ Given that physicians clearly cannot control their own age or the age of their patients, the negative impacts of these biases need to be addressed and remedied at a systems level.

Why might these biases exist?

While we cannot completely understand all of the possible explanations for these biases, it is important to emphasize the long-standing prejudice and discrimination against women and people of color in our society and how this has impacted our behavior. While strides have been made, there clearly still seems to be a difference between what we say and how our biases impact our behavior. Women are still tougher on women in professional evaluations in other fields as well²³; it is not unique to medicine. While workplace improvements are slowly changing, women still face inequities. The more research we publish to describe it, the more we hope the conversation continues, allowing us to reduce the impact of bias on our sense of self-worth and identity related to our careers, narrow the pay gap, and see women advance at the same rate as male counterparts. Considerable transformation is crucial to prevent further workforce attrition.

With regard to the lower scores provided by Asian patients, studies suggest that cultural response bias, rather than true differences in quality of care, may account for these discrepancies. Previous literature has found that Asian patients are more likely to select midpoints, rather than extremes, when completing Likert-type studies²⁴ and are not more likely to change medical providers than other race/ethnicities, indicating that lower ratings may not necessarily imply greater dissatisfaction with care.²⁵

Far-reaching effects on finances, income, well-being, job satisfaction, etc.

Depending on how the results are distributed and used, the effects of patient satisfaction surveys can extend well beyond the original intentions. At some institutions, income for physicians is directly tied to their Press Ganey satisfaction scores, which could have profound implications for female and Asian physicians,^13,15 who would be paid less—resulting in a wider pay gap than already exists.¹⁸

When negative and not constructive, patient evaluations can contribute to physician burnout and a loss of productive members of the workforce.²⁶ This is especially important in obstetrics and gynecology, where physicians are most likely to experience burnout due to multiple factors such as high-risk medical conditions, pressures of the electronic medical record (EMR), the medicolegal environment, and difficulty balancing patient expectations for autonomy with professional judgement.²⁷ Burnout also disproportionately affects women and younger physicians, which is especially concerning given that, in 2017, approximately one-third of practicing obstetrician/gynecologists were women, while that same year more than 80% of trainees matching into the field were women.²⁸ In one survey sent to members of a prominent medical society, 20% of the medical professionals who responded said they have had their employment threatened by low patient satisfaction scores, 78% reported that patient satisfaction surveys moderately or severely affected their job satisfaction, and 28% stated they had considered quitting their job or leaving the medical profession.²⁹Another related effect is the association between malpractice proceedings and a lack of satisfaction with perceived quality of physician-patient communication.³⁰ This may be an important determinant of malpractice lawsuits, and ensuring high patient satisfaction may be a form of defensive medicine.

Continue to: Controlling the narrative for the future: Proposed strategies...

Controlling the narrative for the future: Proposed strategies

The rapid, widespread adoption of the Press Ganey survey across specialties, clinical care settings, and geographic areas may have been largely due to the ease and operational benefits for hospitals rather than after rigorous study and validation. For example, repeated use of a specific measurement tool may facilitate comparison across areas within a hospital but also across institutions, which can help assess performance at a national level. Hospitals also may have a financial incentive to work with a single third-party or vendor instead of using multiple options across multiple vendors. However, the impact of adoption of novel measures of performance should be evaluated prior to widespread adoption and utilization.

A similar example of an emergence of a technological advancement that has changed the field of medicine and how we provide care is the EMR. Epic is now the most commonly used medical record system and holds the market share of the industry, covering 78% of patients in the United States.³¹ While there are certainly many potential benefits of a common EMR, such as ease of information sharing and standardization of formatting, opportunities are identified in real time and require product adjustment. For example, modifications have been made to accurately represent gender outside of the previously used dichotomous options. Diagnoses such as cervical cancer screening can now be used even if the patient gender is listed as male.

Similarly, the Press Ganey and other patient satisfaction questionnaires should be evaluated and modified to address existing societal biases. The World Health Organization estimates that it will take 300 years to fix gender inequality,³² but we have an opportunity now to control the narrative and improve patient feedback.

Future research avenues

Ultimately, there is a need to further explore currently available methods of evaluating clinical encounters to better understand the inherent biases and limitations. We hope this review will encourage other physicians to examine their specialties and hospitals and require similar analyses from vendors of such satisfaction rating products prior to using them. At the very least, health systems should be willing to partner with vendors and physicians on an ongoing basis to better understand the biases involved in these survey results and make modifications as needed. Patients also obtain information from and contribute to self-reported, publicly available websites; therefore, additional exploration into a nationalized standard for assessing patient satisfaction also may serve as an opportunity to standardize the information patients evaluate.³³ Further assessment of the potential financial and emotional impact of using the currently available patient-reported surveys on female physicians, Asian physicians, young physicians, and physicians who see young patients is needed. It is time to put pressure on a broken patient satisfaction system and improve on a national level to avoid undue negative consequences on our physicians. Use of patient satisfaction survey data should be limited until we all understand and account for the biases that are evident. ●

This year’s menopause Update highlights a highly effective nonhormonal medication that recently received approval by the US Food and Drug Administration (FDA) for the treatment of bothersome menopausal vasomotor symptoms. In addition, the Update provides guidance regarding how ObGyns should respond when an endometrial biopsy for postmenopausal bleeding reveals proliferative changes.

Breakthrough in women’s health: A new nonhormone therapy for vasomotor symptoms

Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate-to-severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;dgad058. doi:10.1210/clinem/dgad058.
 

Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023;401:1091-1102. doi:10.1016/S0140-6736(23)00085-5.

A new oral nonestrogen-containing medication for relief of moderate to severe hot flashes, fezolinetant (Veozah) 45 mg daily, has been approved by the FDA and was expected to be available by the end of May 2023. Fezolinetant is a selective neurokinin 3 (NK3) receptor antagonistthat offers a targeted nonhormonal approach to menopausal vasomotor symptoms (VMS), and it is the first in its class to make it to market.

The decline in estrogen at menopause appears to result in increased signaling at kisspeptin/neurokinin B/dynorphin (KNDy) neurons in the thermoregulatory center within the hypothalamus with resultant increases in hot flashes.^1,2 Fezolinetant works by binding to and blocking the activities of the NK3 receptor.^3-5

Key study findings

Selective NK3 receptor antagonists, including fezolinetant, effectively reduce the frequency and severity of VMS comparable to that of hormone therapy (HT). Two phase 3 clinical trials, Skylight 1 and 2, confirmed the efficacy and safety of fezolinetant 45 mg in treating VMS,^6,7 and an additional 52-week placebo-controlled study, Skylight 4, confirmed long-term safety.⁸ Onset of action occurs within a week. Reported adverse events occurred in 1% to 2% of healthy menopausal women participating in clinical trials; these included headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminase levels.^6-9

The published phase 2 trials⁹ and the international randomized controlled trial (RCT) 12-week studies, Skylight 1 and 2,^6,7 found that once-daily 30-mg and 45-mg doses of fezolinetant significantly reduced VMS frequency and severity at 12 weeks among women aged 40 to 60 years who reported an average of 7 moderate to severe VMS/day; the reduction in reported VMS was sustained at 40 weeks. Phase 3 data from Skylight 1 and 2 demonstrated fezolinetant’s efficacy in reducing the frequency and severity of VMS and provided information on the safety profile of fezolinetant compared with placebo over 12 weeks and a noncontrolled extension for an additional 40 weeks.^6,7

Oral fezolinetant was associated with improved quality of life, including reduced VMS-related interference with daily life.¹⁰ Johnson and colleagues, reporting for Skylight 2, found VMS frequency and severity improvement by week 1, which achieved statistical significance at weeks 4 and 12, with this improvement maintained through week 52.⁶ A 64.3% reduction in mean daily VMS from baseline was seen at 12 weeks for fezolinetant 45 mg compared with a 45.4% reduction for placebo. VMS severity significantly decreased compared with placebo at 4 and 12 weeks.⁶

Serious treatment-emergent adverse events were infrequent, reported by 2%, 1%, and 0% of those receiving fezolinetant 30 mg, fezolinetant 45 mg, and placebo.⁶ Increases in levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were noted and were described as asymptomatic, isolated, intermittent, or transient, and these levels returned to baseline during treatment or after discontinuation.⁶

Of the 5 participants taking fezolinetant in Skyline 1 with ALT or AST levels greater than 3 times the upper limit of normal in the 12-week randomized trial, levels returned to normal range while continuing treatment in 2 participants, with treatment interruption in 2, and with discontinuation in 1. No new safety signals were seen in the 40-week extension trial.⁶

Continue to: Endometrial and bone safety...

Endometrial and bone safety

Results from Skylight 4, a phase 3, randomized, double-blind, 52-week safety study, provided additional evidence that confirmed the longer-term safety of fezolinetant over a 52-week treatment period.⁸

Endometrial safety was assessed in postmenopausal women with normal baseline endometrium (n = 599).⁸ For fezolinetant 45 mg, 1 of 203 participants had endometrial hyperplasia (EH) (0.5%; upper limit of one-sided 95% confidence interval [CI], 2.3%); no cases of EH were noted in the placebo (0 of 186) or fezolinetant 30-mg (0 of 210) groups. The incidence of EH or malignancy in fezolinetant-treated participants was within prespecified limits, as assessed by blinded, centrally read endometrial biopsies. Endometrial malignancy occurred in 1 of 210 in the fezolinetant 30-mg group (0.5%; 95% CI, 2.2%) with no cases in the other groups, thus meeting FDA requirements for endometrial safety.⁸

In addition, no significant differences were noted in change from baseline endometrial thickness on transvaginal ultrasonography between fezolinetant-treated and placebo groups. Likewise, no loss of bone density was found on dual-energy x-ray absorptiometry (DEXA) scans or trabecular bone scores.⁸

Liver safety

Although no cases of severe liver injury were noted, elevations in serum transaminase concentrations greater than 3 times the upper limit of normal were observed in the clinical trials. In Skylight 4, liver enzyme elevations more than 3 times the upper limit of normal occurred in 6 of 583 participants taking placebo, 8 of 590 taking fezolinetant 30 mg, and 12 of 589 taking fezolinetant 45 mg.⁸

The prescribing information for fezolinetant includes a warning for elevated hepatic transaminases: Fezolinetant should not be started if baseline serum transaminase concentration is equal to or exceeds 2 times the upper limit of normal. Liver tests should be obtained at baseline and repeated every 3 months for the first 9 months and then if symptoms suggest liver injury.^11,12

Unmet need for nonhormone treatment of VMS

Vasomotor symptoms affect up to 80% of women, with approximately 25% bothersome enough to warrant treatment. Vasomotor symptoms persist for a median of 7 years, with duration and severity differing by race and ethnicity. Black, Hispanic, and possibly Native American women experience the highest burden of VMS.² Although VMS, including hot flashes, night sweats, and mood and sleep disturbances, often are considered an annoyance to those with mild symptoms, moderate to severe VMS impact women’s lives, including functioning at home or work, affecting relationships, and decreasing perceived quality of life, and they have been associated with workplace absenteeism and increased health care costs, both direct from medical care and testing and indirect costs from lost work.^13-15

Women with 7 or more daily moderate to severe VMS (defined as with sweating or affecting function) reported interference with sleep (94%), concentration (84%), mood (85%), energy (77%), and sexual activity (61%).¹⁶ Moderately to severely bothersome VMS have been associated with impaired psychological and general well-being, affecting work performance.¹⁷ Based on a Mayo Clinic workplace survey, Faubion and colleagues estimated an annual loss of $1.8 billion in the United States for menopause-related missed work and a $28 billion loss when medical expenses were added.¹⁵

Menopausal HT has been the primary treatment for VMS and has been shown to reduce the frequency and severity of hot flashes, with additional benefits on sleep, mood, fatigue, bone loss and reduction of fracture, and genitourinary syndrome of menopause (GSM), and with potential improvement in cardiovascular health with decreased type 2 diabetes.^18,19 For healthy women with early menopause and no contraindications, HT has been recommended until at least the age of natural menopause, as observational data suggest that HT prevents osteoporosis, cardiovascular disease, neurodegenerative changes, and sexual dysfunction for these women.^19,20 Similarly, for healthy women younger than age 60 or within 10 years of menopause, initiating HT has been shown to be safe and effective in treating bothersome VMS and preventing osteoporotic fractures and genitourinary changes.^19,21

Most systemic HT formulations are inexpensive (for example, available as generics), with multiple dosing and formulations available for use alone or combined as oral, transdermal, or vaginal therapies. Despite the fear that arose for clinicians and women from the initial 2002 findings of the Women’s Health Initiative regarding increased risk of breast cancer, stroke, venous thrombosis, cardiovascular disease, and dementia, major medical societies agree that when initiated at or soon after menopause, HT is a safe and effective therapy to relieve VMS, protect against bone loss, and treat genitourinary changes.^19,21

Many women, however, cannot take HT, including those with estrogen-sensitive cancers, such as breast or uterine cancers; prior cardiovascular disease, stroke, or venous thrombotic events; severe endometriosis; or migraine headaches with visual auras.² In addition, many symptomatic menopausal women without health contraindications choose not to take HT.² Until now, the only FDA-approved VMS nonhormone therapy has been a low-dose 7.5-mg paroxetine salt. Unfortunately, this formulation, along with the off-label use of other antidepressants (selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors), gabapentinoids, oxybutynin, and clonidine, are substantially less effective than HT in treating moderate to severe VMS.

Bottom line

A substantial unmet need remains for effective therapy for moderate to severe VMS for women who cannot or choose not to take menopausal HT to relieve VMS.^2,16 Effective, safe nonhormone treatment options such as the new NK3 receptor antagonist fezolinetant will address this clinically important need.

One concern is that the cost of developing and bringing to market the first of a new type of medication will be passed on to consumers, which may put it out of the price range for the many women who need it. However, the development and FDA approval of fezolinetant as the first NK3 receptor antagonist to treat menopausal VMS is potentially a practice changer. It provides a novel, effective, and safe FDA-approved nonhormonal treatment for menopausal women with moderate to severe VMS, particularly for women who cannot or will not take hormone therapy.

Continue to: When endometrial biopsy for postmenopausal bleeding reveals proliferative changes, how should we respond?...

Abraham C. Proliferative endometrium in menopause: to treat or not to treat? Obstet Gynecol. 2023;141:265-267. doi:10.1097/AOG.0000000000005054.

The following case represents a common scenario for ObGyns.

CASE Patient with proliferative endometrial changes

A menopausal patient with a body mass index (BMI) > 30 kg/m² presents with uterine bleeding. She does not use systemic menopausal hormone therapy. Endometrial biopsy indicates proliferative changes.

When endometrial biopsy performed for bleeding reveals proliferative changes in menopausal women, we traditionally have responded by reassuring the patient that the findings are benign and advising that she should let us know if future spotting or bleeding occurs.

However, a recent review by Abraham published in Obstetrics and Gynecology details the implications of proliferative endometrial changes in menopausal patients, advising that treatment, as well as monitoring, may be appropriate.²²

Endometrial changes and what they suggest

In premenopausal women, proliferative endometrial changes are physiologic and result from ovarian estrogen production early in each cycle, during what is called the proliferative (referring to the endometrium) or follicular (referring to the dominant follicle that synthesizes estrogen) phase. In menopausal women who are not using HT, however, proliferative endometrial changes, with orderly uniform glands seen on histologic evaluation, reflect aromatization of androgens by adipose and other tissues into estrogen.

The next step on the continuum to hyperplasia (benign or atypical) after proliferative endometrium is disordered proliferative endometrium. At this stage, histologic evaluation reveals scattered cystic and dilated glands that have a normal gland-to-stroma ratio with a low gland density overall and without any atypia. Randomly distributed glands may have tubal metaplasia or fibrin thrombi associated with microinfarcts, often presenting with irregular bleeding. This is a noncancerous change that occurs with excess estrogen (endogenous or exogenous).²³

Progestins reverse endometrial hyperplasia by activating progesterone receptors, which leads to stromal decidualization with thinning of the endometrium. They have a pronounced effect on the histologic appearance of the endometrium. By contrast, endometrial intraepithelial neoplasia (EIN, previously known as endometrial hyperplasiawith atypia) shows underlying molecular mutations and histologic alterations and represents a sharp transition to true neoplasia, which greatly increases the risk of endometrioid endometrial adenocarcinoma.²⁴

For decades, we have been aware that if women diagnosed with endometrial hyperplasia are not treated with progestational therapy, their future risk of endometrial cancer is elevated. More recently, we also recognize that menopausal women found to have proliferative endometrial changes, if not treated, have an increased risk of endometrial cancer.

In a retrospective cohort study of almost 300 menopausal women who were not treated after endometrial biopsy revealed proliferative changes, investigators followed participants for an average of 11 years.²⁵ These women had a mean BMI of 34 kg/m². During follow-up, almost 12% of these women were diagnosed with endometrial hyperplasia or cancer. This incidence of endometrial neoplasia was some 4 times higher than for women initially found to have atrophic endometrial changes.²⁵

Progestin treatment

Oral progestin therapy with follow-up endometrial biopsy constitutes traditional management for endometrial hyperplasia. Such therapy minimizes the likelihood that hyperplasia will progress to endometrial cancer.

We now recognize that the convenience, as well as the high endometrial progestin levels achieved, with levonorgestrel-releasing intrauterine devices (LNG-IUDs) have advantages over oral progestin therapy in treating endometrial hyperplasia. Indeed, a recent US report found that among women with EIN managed medically, use of progestin-releasing IUDs has grown from 7.7% in 2008 to 35.6% in 2020.²⁶

Although both oral and intrauterine progestin are highly effective in treating simple hyperplasia, progestin IUDs are substantially more effective than oral progestins in treating EIN.²⁷ Progestin concentrations in the endometrium have been shown to be 100-fold higher after LNG-IUD placement compared with oral progestin use.²² In addition, adverse effects, including bloating, unpleasant mood changes, and increased appetite, are more common with oral than intrauterine progestin therapy.²⁸

Unfortunately, data from randomized trials addressing progestational treatment of proliferative endometrium in menopausal women are not available to support the treatment of proliferative endometrium with either oral progestins or the LNG-IUD.²²

Role of ultrasonography

Another concern is relying on a finding of thin endometrial thickness on vaginal ultrasonography. In a simulated retrospective cohort study, use of transvaginal ultrasonography to determine the appropriateness of a biopsy was found not to be sufficiently accurate or racially equitable with regard to Black women.²⁹ In simulated data, transvaginal ultrasonography missed almost 5 times more cases of endometrial cancer among Black women compared with White women due to higher fibroid prevalence and nonendometrioid histologic type malignancies in Black women.²⁹

Assessing risk

If proliferative endometrium is found, Abraham suggests assessing risk using²²:

• age
• comorbidities (including obesity)
• endometrial echo thickness on vaginal ultrasonography.

Consider the patient’s risk and tolerance of recurrent bleeding as well as her tolerance for progestational adverse effects if medical therapy is chosen. Discussion about next steps should include reviewing the histologic findings with the patient and discussing the difference in risk of progression to endometrial cancer of a finding of proliferative endometrium compared with a histologic finding of endometrial hyperplasia.

Using this patient-centered approach, observation over time with follow-up endometrial biopsies remains a management option. Although some women may tolerate micronized progesterone over synthetic progestins, there is concern that it may be less effective in suppressing the endometrium than synthetic progestins.³⁰ Accordingly, synthetic progestins represent first-line options in this setting^.

In her review, Abraham suggests that when endometrial biopsy reveals proliferative changes in a menopausal woman, we should initiate progestin treatment and perform surveillance endometrial sampling every 3 to 6 months. If such sampling reveals benign but not proliferative endometrium, progestin therapy can be stopped and endometrial biopsy repeated if bleeding recurs.²² ●

This year’s menopause Update highlights a highly effective nonhormonal medication that recently received approval by the US Food and Drug Administration (FDA) for the treatment of bothersome menopausal vasomotor symptoms. In addition, the Update provides guidance regarding how ObGyns should respond when an endometrial biopsy for postmenopausal bleeding reveals proliferative changes.

Breakthrough in women’s health: A new nonhormone therapy for vasomotor symptoms

Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate-to-severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;dgad058. doi:10.1210/clinem/dgad058.
 

Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023;401:1091-1102. doi:10.1016/S0140-6736(23)00085-5.

A new oral nonestrogen-containing medication for relief of moderate to severe hot flashes, fezolinetant (Veozah) 45 mg daily, has been approved by the FDA and was expected to be available by the end of May 2023. Fezolinetant is a selective neurokinin 3 (NK3) receptor antagonistthat offers a targeted nonhormonal approach to menopausal vasomotor symptoms (VMS), and it is the first in its class to make it to market.

The decline in estrogen at menopause appears to result in increased signaling at kisspeptin/neurokinin B/dynorphin (KNDy) neurons in the thermoregulatory center within the hypothalamus with resultant increases in hot flashes.^1,2 Fezolinetant works by binding to and blocking the activities of the NK3 receptor.^3-5

Key study findings

Selective NK3 receptor antagonists, including fezolinetant, effectively reduce the frequency and severity of VMS comparable to that of hormone therapy (HT). Two phase 3 clinical trials, Skylight 1 and 2, confirmed the efficacy and safety of fezolinetant 45 mg in treating VMS,^6,7 and an additional 52-week placebo-controlled study, Skylight 4, confirmed long-term safety.⁸ Onset of action occurs within a week. Reported adverse events occurred in 1% to 2% of healthy menopausal women participating in clinical trials; these included headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminase levels.^6-9

The published phase 2 trials⁹ and the international randomized controlled trial (RCT) 12-week studies, Skylight 1 and 2,^6,7 found that once-daily 30-mg and 45-mg doses of fezolinetant significantly reduced VMS frequency and severity at 12 weeks among women aged 40 to 60 years who reported an average of 7 moderate to severe VMS/day; the reduction in reported VMS was sustained at 40 weeks. Phase 3 data from Skylight 1 and 2 demonstrated fezolinetant’s efficacy in reducing the frequency and severity of VMS and provided information on the safety profile of fezolinetant compared with placebo over 12 weeks and a noncontrolled extension for an additional 40 weeks.^6,7

Oral fezolinetant was associated with improved quality of life, including reduced VMS-related interference with daily life.¹⁰ Johnson and colleagues, reporting for Skylight 2, found VMS frequency and severity improvement by week 1, which achieved statistical significance at weeks 4 and 12, with this improvement maintained through week 52.⁶ A 64.3% reduction in mean daily VMS from baseline was seen at 12 weeks for fezolinetant 45 mg compared with a 45.4% reduction for placebo. VMS severity significantly decreased compared with placebo at 4 and 12 weeks.⁶

Serious treatment-emergent adverse events were infrequent, reported by 2%, 1%, and 0% of those receiving fezolinetant 30 mg, fezolinetant 45 mg, and placebo.⁶ Increases in levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were noted and were described as asymptomatic, isolated, intermittent, or transient, and these levels returned to baseline during treatment or after discontinuation.⁶

Of the 5 participants taking fezolinetant in Skyline 1 with ALT or AST levels greater than 3 times the upper limit of normal in the 12-week randomized trial, levels returned to normal range while continuing treatment in 2 participants, with treatment interruption in 2, and with discontinuation in 1. No new safety signals were seen in the 40-week extension trial.⁶

Continue to: Endometrial and bone safety...

Endometrial and bone safety

Results from Skylight 4, a phase 3, randomized, double-blind, 52-week safety study, provided additional evidence that confirmed the longer-term safety of fezolinetant over a 52-week treatment period.⁸

Endometrial safety was assessed in postmenopausal women with normal baseline endometrium (n = 599).⁸ For fezolinetant 45 mg, 1 of 203 participants had endometrial hyperplasia (EH) (0.5%; upper limit of one-sided 95% confidence interval [CI], 2.3%); no cases of EH were noted in the placebo (0 of 186) or fezolinetant 30-mg (0 of 210) groups. The incidence of EH or malignancy in fezolinetant-treated participants was within prespecified limits, as assessed by blinded, centrally read endometrial biopsies. Endometrial malignancy occurred in 1 of 210 in the fezolinetant 30-mg group (0.5%; 95% CI, 2.2%) with no cases in the other groups, thus meeting FDA requirements for endometrial safety.⁸

In addition, no significant differences were noted in change from baseline endometrial thickness on transvaginal ultrasonography between fezolinetant-treated and placebo groups. Likewise, no loss of bone density was found on dual-energy x-ray absorptiometry (DEXA) scans or trabecular bone scores.⁸

Liver safety

Although no cases of severe liver injury were noted, elevations in serum transaminase concentrations greater than 3 times the upper limit of normal were observed in the clinical trials. In Skylight 4, liver enzyme elevations more than 3 times the upper limit of normal occurred in 6 of 583 participants taking placebo, 8 of 590 taking fezolinetant 30 mg, and 12 of 589 taking fezolinetant 45 mg.⁸

The prescribing information for fezolinetant includes a warning for elevated hepatic transaminases: Fezolinetant should not be started if baseline serum transaminase concentration is equal to or exceeds 2 times the upper limit of normal. Liver tests should be obtained at baseline and repeated every 3 months for the first 9 months and then if symptoms suggest liver injury.^11,12

Unmet need for nonhormone treatment of VMS

Vasomotor symptoms affect up to 80% of women, with approximately 25% bothersome enough to warrant treatment. Vasomotor symptoms persist for a median of 7 years, with duration and severity differing by race and ethnicity. Black, Hispanic, and possibly Native American women experience the highest burden of VMS.² Although VMS, including hot flashes, night sweats, and mood and sleep disturbances, often are considered an annoyance to those with mild symptoms, moderate to severe VMS impact women’s lives, including functioning at home or work, affecting relationships, and decreasing perceived quality of life, and they have been associated with workplace absenteeism and increased health care costs, both direct from medical care and testing and indirect costs from lost work.^13-15

Women with 7 or more daily moderate to severe VMS (defined as with sweating or affecting function) reported interference with sleep (94%), concentration (84%), mood (85%), energy (77%), and sexual activity (61%).¹⁶ Moderately to severely bothersome VMS have been associated with impaired psychological and general well-being, affecting work performance.¹⁷ Based on a Mayo Clinic workplace survey, Faubion and colleagues estimated an annual loss of $1.8 billion in the United States for menopause-related missed work and a $28 billion loss when medical expenses were added.¹⁵

Menopausal HT has been the primary treatment for VMS and has been shown to reduce the frequency and severity of hot flashes, with additional benefits on sleep, mood, fatigue, bone loss and reduction of fracture, and genitourinary syndrome of menopause (GSM), and with potential improvement in cardiovascular health with decreased type 2 diabetes.^18,19 For healthy women with early menopause and no contraindications, HT has been recommended until at least the age of natural menopause, as observational data suggest that HT prevents osteoporosis, cardiovascular disease, neurodegenerative changes, and sexual dysfunction for these women.^19,20 Similarly, for healthy women younger than age 60 or within 10 years of menopause, initiating HT has been shown to be safe and effective in treating bothersome VMS and preventing osteoporotic fractures and genitourinary changes.^19,21

Most systemic HT formulations are inexpensive (for example, available as generics), with multiple dosing and formulations available for use alone or combined as oral, transdermal, or vaginal therapies. Despite the fear that arose for clinicians and women from the initial 2002 findings of the Women’s Health Initiative regarding increased risk of breast cancer, stroke, venous thrombosis, cardiovascular disease, and dementia, major medical societies agree that when initiated at or soon after menopause, HT is a safe and effective therapy to relieve VMS, protect against bone loss, and treat genitourinary changes.^19,21

Many women, however, cannot take HT, including those with estrogen-sensitive cancers, such as breast or uterine cancers; prior cardiovascular disease, stroke, or venous thrombotic events; severe endometriosis; or migraine headaches with visual auras.² In addition, many symptomatic menopausal women without health contraindications choose not to take HT.² Until now, the only FDA-approved VMS nonhormone therapy has been a low-dose 7.5-mg paroxetine salt. Unfortunately, this formulation, along with the off-label use of other antidepressants (selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors), gabapentinoids, oxybutynin, and clonidine, are substantially less effective than HT in treating moderate to severe VMS.

Bottom line

A substantial unmet need remains for effective therapy for moderate to severe VMS for women who cannot or choose not to take menopausal HT to relieve VMS.^2,16 Effective, safe nonhormone treatment options such as the new NK3 receptor antagonist fezolinetant will address this clinically important need.

One concern is that the cost of developing and bringing to market the first of a new type of medication will be passed on to consumers, which may put it out of the price range for the many women who need it. However, the development and FDA approval of fezolinetant as the first NK3 receptor antagonist to treat menopausal VMS is potentially a practice changer. It provides a novel, effective, and safe FDA-approved nonhormonal treatment for menopausal women with moderate to severe VMS, particularly for women who cannot or will not take hormone therapy.

Continue to: When endometrial biopsy for postmenopausal bleeding reveals proliferative changes, how should we respond?...

Abraham C. Proliferative endometrium in menopause: to treat or not to treat? Obstet Gynecol. 2023;141:265-267. doi:10.1097/AOG.0000000000005054.

The following case represents a common scenario for ObGyns.

CASE Patient with proliferative endometrial changes

A menopausal patient with a body mass index (BMI) > 30 kg/m² presents with uterine bleeding. She does not use systemic menopausal hormone therapy. Endometrial biopsy indicates proliferative changes.

When endometrial biopsy performed for bleeding reveals proliferative changes in menopausal women, we traditionally have responded by reassuring the patient that the findings are benign and advising that she should let us know if future spotting or bleeding occurs.

However, a recent review by Abraham published in Obstetrics and Gynecology details the implications of proliferative endometrial changes in menopausal patients, advising that treatment, as well as monitoring, may be appropriate.²²

Endometrial changes and what they suggest

In premenopausal women, proliferative endometrial changes are physiologic and result from ovarian estrogen production early in each cycle, during what is called the proliferative (referring to the endometrium) or follicular (referring to the dominant follicle that synthesizes estrogen) phase. In menopausal women who are not using HT, however, proliferative endometrial changes, with orderly uniform glands seen on histologic evaluation, reflect aromatization of androgens by adipose and other tissues into estrogen.

The next step on the continuum to hyperplasia (benign or atypical) after proliferative endometrium is disordered proliferative endometrium. At this stage, histologic evaluation reveals scattered cystic and dilated glands that have a normal gland-to-stroma ratio with a low gland density overall and without any atypia. Randomly distributed glands may have tubal metaplasia or fibrin thrombi associated with microinfarcts, often presenting with irregular bleeding. This is a noncancerous change that occurs with excess estrogen (endogenous or exogenous).²³

Progestins reverse endometrial hyperplasia by activating progesterone receptors, which leads to stromal decidualization with thinning of the endometrium. They have a pronounced effect on the histologic appearance of the endometrium. By contrast, endometrial intraepithelial neoplasia (EIN, previously known as endometrial hyperplasiawith atypia) shows underlying molecular mutations and histologic alterations and represents a sharp transition to true neoplasia, which greatly increases the risk of endometrioid endometrial adenocarcinoma.²⁴

For decades, we have been aware that if women diagnosed with endometrial hyperplasia are not treated with progestational therapy, their future risk of endometrial cancer is elevated. More recently, we also recognize that menopausal women found to have proliferative endometrial changes, if not treated, have an increased risk of endometrial cancer.

In a retrospective cohort study of almost 300 menopausal women who were not treated after endometrial biopsy revealed proliferative changes, investigators followed participants for an average of 11 years.²⁵ These women had a mean BMI of 34 kg/m². During follow-up, almost 12% of these women were diagnosed with endometrial hyperplasia or cancer. This incidence of endometrial neoplasia was some 4 times higher than for women initially found to have atrophic endometrial changes.²⁵

Progestin treatment

Oral progestin therapy with follow-up endometrial biopsy constitutes traditional management for endometrial hyperplasia. Such therapy minimizes the likelihood that hyperplasia will progress to endometrial cancer.

We now recognize that the convenience, as well as the high endometrial progestin levels achieved, with levonorgestrel-releasing intrauterine devices (LNG-IUDs) have advantages over oral progestin therapy in treating endometrial hyperplasia. Indeed, a recent US report found that among women with EIN managed medically, use of progestin-releasing IUDs has grown from 7.7% in 2008 to 35.6% in 2020.²⁶

Although both oral and intrauterine progestin are highly effective in treating simple hyperplasia, progestin IUDs are substantially more effective than oral progestins in treating EIN.²⁷ Progestin concentrations in the endometrium have been shown to be 100-fold higher after LNG-IUD placement compared with oral progestin use.²² In addition, adverse effects, including bloating, unpleasant mood changes, and increased appetite, are more common with oral than intrauterine progestin therapy.²⁸

Unfortunately, data from randomized trials addressing progestational treatment of proliferative endometrium in menopausal women are not available to support the treatment of proliferative endometrium with either oral progestins or the LNG-IUD.²²

Role of ultrasonography

Another concern is relying on a finding of thin endometrial thickness on vaginal ultrasonography. In a simulated retrospective cohort study, use of transvaginal ultrasonography to determine the appropriateness of a biopsy was found not to be sufficiently accurate or racially equitable with regard to Black women.²⁹ In simulated data, transvaginal ultrasonography missed almost 5 times more cases of endometrial cancer among Black women compared with White women due to higher fibroid prevalence and nonendometrioid histologic type malignancies in Black women.²⁹

Assessing risk

If proliferative endometrium is found, Abraham suggests assessing risk using²²:

• age
• comorbidities (including obesity)
• endometrial echo thickness on vaginal ultrasonography.

Consider the patient’s risk and tolerance of recurrent bleeding as well as her tolerance for progestational adverse effects if medical therapy is chosen. Discussion about next steps should include reviewing the histologic findings with the patient and discussing the difference in risk of progression to endometrial cancer of a finding of proliferative endometrium compared with a histologic finding of endometrial hyperplasia.

Using this patient-centered approach, observation over time with follow-up endometrial biopsies remains a management option. Although some women may tolerate micronized progesterone over synthetic progestins, there is concern that it may be less effective in suppressing the endometrium than synthetic progestins.³⁰ Accordingly, synthetic progestins represent first-line options in this setting^.

In her review, Abraham suggests that when endometrial biopsy reveals proliferative changes in a menopausal woman, we should initiate progestin treatment and perform surveillance endometrial sampling every 3 to 6 months. If such sampling reveals benign but not proliferative endometrium, progestin therapy can be stopped and endometrial biopsy repeated if bleeding recurs.²² ●

This year’s menopause Update highlights a highly effective nonhormonal medication that recently received approval by the US Food and Drug Administration (FDA) for the treatment of bothersome menopausal vasomotor symptoms. In addition, the Update provides guidance regarding how ObGyns should respond when an endometrial biopsy for postmenopausal bleeding reveals proliferative changes.

Breakthrough in women’s health: A new nonhormone therapy for vasomotor symptoms

Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate-to-severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;dgad058. doi:10.1210/clinem/dgad058.
 

Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023;401:1091-1102. doi:10.1016/S0140-6736(23)00085-5.

A new oral nonestrogen-containing medication for relief of moderate to severe hot flashes, fezolinetant (Veozah) 45 mg daily, has been approved by the FDA and was expected to be available by the end of May 2023. Fezolinetant is a selective neurokinin 3 (NK3) receptor antagonistthat offers a targeted nonhormonal approach to menopausal vasomotor symptoms (VMS), and it is the first in its class to make it to market.

The decline in estrogen at menopause appears to result in increased signaling at kisspeptin/neurokinin B/dynorphin (KNDy) neurons in the thermoregulatory center within the hypothalamus with resultant increases in hot flashes.^1,2 Fezolinetant works by binding to and blocking the activities of the NK3 receptor.^3-5

Key study findings

Selective NK3 receptor antagonists, including fezolinetant, effectively reduce the frequency and severity of VMS comparable to that of hormone therapy (HT). Two phase 3 clinical trials, Skylight 1 and 2, confirmed the efficacy and safety of fezolinetant 45 mg in treating VMS,^6,7 and an additional 52-week placebo-controlled study, Skylight 4, confirmed long-term safety.⁸ Onset of action occurs within a week. Reported adverse events occurred in 1% to 2% of healthy menopausal women participating in clinical trials; these included headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminase levels.^6-9

The published phase 2 trials⁹ and the international randomized controlled trial (RCT) 12-week studies, Skylight 1 and 2,^6,7 found that once-daily 30-mg and 45-mg doses of fezolinetant significantly reduced VMS frequency and severity at 12 weeks among women aged 40 to 60 years who reported an average of 7 moderate to severe VMS/day; the reduction in reported VMS was sustained at 40 weeks. Phase 3 data from Skylight 1 and 2 demonstrated fezolinetant’s efficacy in reducing the frequency and severity of VMS and provided information on the safety profile of fezolinetant compared with placebo over 12 weeks and a noncontrolled extension for an additional 40 weeks.^6,7

Oral fezolinetant was associated with improved quality of life, including reduced VMS-related interference with daily life.¹⁰ Johnson and colleagues, reporting for Skylight 2, found VMS frequency and severity improvement by week 1, which achieved statistical significance at weeks 4 and 12, with this improvement maintained through week 52.⁶ A 64.3% reduction in mean daily VMS from baseline was seen at 12 weeks for fezolinetant 45 mg compared with a 45.4% reduction for placebo. VMS severity significantly decreased compared with placebo at 4 and 12 weeks.⁶

Serious treatment-emergent adverse events were infrequent, reported by 2%, 1%, and 0% of those receiving fezolinetant 30 mg, fezolinetant 45 mg, and placebo.⁶ Increases in levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were noted and were described as asymptomatic, isolated, intermittent, or transient, and these levels returned to baseline during treatment or after discontinuation.⁶

Of the 5 participants taking fezolinetant in Skyline 1 with ALT or AST levels greater than 3 times the upper limit of normal in the 12-week randomized trial, levels returned to normal range while continuing treatment in 2 participants, with treatment interruption in 2, and with discontinuation in 1. No new safety signals were seen in the 40-week extension trial.⁶

Continue to: Endometrial and bone safety...

Endometrial and bone safety

Results from Skylight 4, a phase 3, randomized, double-blind, 52-week safety study, provided additional evidence that confirmed the longer-term safety of fezolinetant over a 52-week treatment period.⁸

Endometrial safety was assessed in postmenopausal women with normal baseline endometrium (n = 599).⁸ For fezolinetant 45 mg, 1 of 203 participants had endometrial hyperplasia (EH) (0.5%; upper limit of one-sided 95% confidence interval [CI], 2.3%); no cases of EH were noted in the placebo (0 of 186) or fezolinetant 30-mg (0 of 210) groups. The incidence of EH or malignancy in fezolinetant-treated participants was within prespecified limits, as assessed by blinded, centrally read endometrial biopsies. Endometrial malignancy occurred in 1 of 210 in the fezolinetant 30-mg group (0.5%; 95% CI, 2.2%) with no cases in the other groups, thus meeting FDA requirements for endometrial safety.⁸

In addition, no significant differences were noted in change from baseline endometrial thickness on transvaginal ultrasonography between fezolinetant-treated and placebo groups. Likewise, no loss of bone density was found on dual-energy x-ray absorptiometry (DEXA) scans or trabecular bone scores.⁸

Liver safety

Although no cases of severe liver injury were noted, elevations in serum transaminase concentrations greater than 3 times the upper limit of normal were observed in the clinical trials. In Skylight 4, liver enzyme elevations more than 3 times the upper limit of normal occurred in 6 of 583 participants taking placebo, 8 of 590 taking fezolinetant 30 mg, and 12 of 589 taking fezolinetant 45 mg.⁸

The prescribing information for fezolinetant includes a warning for elevated hepatic transaminases: Fezolinetant should not be started if baseline serum transaminase concentration is equal to or exceeds 2 times the upper limit of normal. Liver tests should be obtained at baseline and repeated every 3 months for the first 9 months and then if symptoms suggest liver injury.^11,12

Unmet need for nonhormone treatment of VMS

Vasomotor symptoms affect up to 80% of women, with approximately 25% bothersome enough to warrant treatment. Vasomotor symptoms persist for a median of 7 years, with duration and severity differing by race and ethnicity. Black, Hispanic, and possibly Native American women experience the highest burden of VMS.² Although VMS, including hot flashes, night sweats, and mood and sleep disturbances, often are considered an annoyance to those with mild symptoms, moderate to severe VMS impact women’s lives, including functioning at home or work, affecting relationships, and decreasing perceived quality of life, and they have been associated with workplace absenteeism and increased health care costs, both direct from medical care and testing and indirect costs from lost work.^13-15

Women with 7 or more daily moderate to severe VMS (defined as with sweating or affecting function) reported interference with sleep (94%), concentration (84%), mood (85%), energy (77%), and sexual activity (61%).¹⁶ Moderately to severely bothersome VMS have been associated with impaired psychological and general well-being, affecting work performance.¹⁷ Based on a Mayo Clinic workplace survey, Faubion and colleagues estimated an annual loss of $1.8 billion in the United States for menopause-related missed work and a $28 billion loss when medical expenses were added.¹⁵

Menopausal HT has been the primary treatment for VMS and has been shown to reduce the frequency and severity of hot flashes, with additional benefits on sleep, mood, fatigue, bone loss and reduction of fracture, and genitourinary syndrome of menopause (GSM), and with potential improvement in cardiovascular health with decreased type 2 diabetes.^18,19 For healthy women with early menopause and no contraindications, HT has been recommended until at least the age of natural menopause, as observational data suggest that HT prevents osteoporosis, cardiovascular disease, neurodegenerative changes, and sexual dysfunction for these women.^19,20 Similarly, for healthy women younger than age 60 or within 10 years of menopause, initiating HT has been shown to be safe and effective in treating bothersome VMS and preventing osteoporotic fractures and genitourinary changes.^19,21

Most systemic HT formulations are inexpensive (for example, available as generics), with multiple dosing and formulations available for use alone or combined as oral, transdermal, or vaginal therapies. Despite the fear that arose for clinicians and women from the initial 2002 findings of the Women’s Health Initiative regarding increased risk of breast cancer, stroke, venous thrombosis, cardiovascular disease, and dementia, major medical societies agree that when initiated at or soon after menopause, HT is a safe and effective therapy to relieve VMS, protect against bone loss, and treat genitourinary changes.^19,21

Many women, however, cannot take HT, including those with estrogen-sensitive cancers, such as breast or uterine cancers; prior cardiovascular disease, stroke, or venous thrombotic events; severe endometriosis; or migraine headaches with visual auras.² In addition, many symptomatic menopausal women without health contraindications choose not to take HT.² Until now, the only FDA-approved VMS nonhormone therapy has been a low-dose 7.5-mg paroxetine salt. Unfortunately, this formulation, along with the off-label use of other antidepressants (selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors), gabapentinoids, oxybutynin, and clonidine, are substantially less effective than HT in treating moderate to severe VMS.

Bottom line

A substantial unmet need remains for effective therapy for moderate to severe VMS for women who cannot or choose not to take menopausal HT to relieve VMS.^2,16 Effective, safe nonhormone treatment options such as the new NK3 receptor antagonist fezolinetant will address this clinically important need.

One concern is that the cost of developing and bringing to market the first of a new type of medication will be passed on to consumers, which may put it out of the price range for the many women who need it. However, the development and FDA approval of fezolinetant as the first NK3 receptor antagonist to treat menopausal VMS is potentially a practice changer. It provides a novel, effective, and safe FDA-approved nonhormonal treatment for menopausal women with moderate to severe VMS, particularly for women who cannot or will not take hormone therapy.

Continue to: When endometrial biopsy for postmenopausal bleeding reveals proliferative changes, how should we respond?...

Abraham C. Proliferative endometrium in menopause: to treat or not to treat? Obstet Gynecol. 2023;141:265-267. doi:10.1097/AOG.0000000000005054.

The following case represents a common scenario for ObGyns.

CASE Patient with proliferative endometrial changes

A menopausal patient with a body mass index (BMI) > 30 kg/m² presents with uterine bleeding. She does not use systemic menopausal hormone therapy. Endometrial biopsy indicates proliferative changes.

When endometrial biopsy performed for bleeding reveals proliferative changes in menopausal women, we traditionally have responded by reassuring the patient that the findings are benign and advising that she should let us know if future spotting or bleeding occurs.

However, a recent review by Abraham published in Obstetrics and Gynecology details the implications of proliferative endometrial changes in menopausal patients, advising that treatment, as well as monitoring, may be appropriate.²²

Endometrial changes and what they suggest

In premenopausal women, proliferative endometrial changes are physiologic and result from ovarian estrogen production early in each cycle, during what is called the proliferative (referring to the endometrium) or follicular (referring to the dominant follicle that synthesizes estrogen) phase. In menopausal women who are not using HT, however, proliferative endometrial changes, with orderly uniform glands seen on histologic evaluation, reflect aromatization of androgens by adipose and other tissues into estrogen.

The next step on the continuum to hyperplasia (benign or atypical) after proliferative endometrium is disordered proliferative endometrium. At this stage, histologic evaluation reveals scattered cystic and dilated glands that have a normal gland-to-stroma ratio with a low gland density overall and without any atypia. Randomly distributed glands may have tubal metaplasia or fibrin thrombi associated with microinfarcts, often presenting with irregular bleeding. This is a noncancerous change that occurs with excess estrogen (endogenous or exogenous).²³

Progestins reverse endometrial hyperplasia by activating progesterone receptors, which leads to stromal decidualization with thinning of the endometrium. They have a pronounced effect on the histologic appearance of the endometrium. By contrast, endometrial intraepithelial neoplasia (EIN, previously known as endometrial hyperplasiawith atypia) shows underlying molecular mutations and histologic alterations and represents a sharp transition to true neoplasia, which greatly increases the risk of endometrioid endometrial adenocarcinoma.²⁴

For decades, we have been aware that if women diagnosed with endometrial hyperplasia are not treated with progestational therapy, their future risk of endometrial cancer is elevated. More recently, we also recognize that menopausal women found to have proliferative endometrial changes, if not treated, have an increased risk of endometrial cancer.

In a retrospective cohort study of almost 300 menopausal women who were not treated after endometrial biopsy revealed proliferative changes, investigators followed participants for an average of 11 years.²⁵ These women had a mean BMI of 34 kg/m². During follow-up, almost 12% of these women were diagnosed with endometrial hyperplasia or cancer. This incidence of endometrial neoplasia was some 4 times higher than for women initially found to have atrophic endometrial changes.²⁵

Progestin treatment

Oral progestin therapy with follow-up endometrial biopsy constitutes traditional management for endometrial hyperplasia. Such therapy minimizes the likelihood that hyperplasia will progress to endometrial cancer.

We now recognize that the convenience, as well as the high endometrial progestin levels achieved, with levonorgestrel-releasing intrauterine devices (LNG-IUDs) have advantages over oral progestin therapy in treating endometrial hyperplasia. Indeed, a recent US report found that among women with EIN managed medically, use of progestin-releasing IUDs has grown from 7.7% in 2008 to 35.6% in 2020.²⁶

Although both oral and intrauterine progestin are highly effective in treating simple hyperplasia, progestin IUDs are substantially more effective than oral progestins in treating EIN.²⁷ Progestin concentrations in the endometrium have been shown to be 100-fold higher after LNG-IUD placement compared with oral progestin use.²² In addition, adverse effects, including bloating, unpleasant mood changes, and increased appetite, are more common with oral than intrauterine progestin therapy.²⁸

Unfortunately, data from randomized trials addressing progestational treatment of proliferative endometrium in menopausal women are not available to support the treatment of proliferative endometrium with either oral progestins or the LNG-IUD.²²

Role of ultrasonography

Another concern is relying on a finding of thin endometrial thickness on vaginal ultrasonography. In a simulated retrospective cohort study, use of transvaginal ultrasonography to determine the appropriateness of a biopsy was found not to be sufficiently accurate or racially equitable with regard to Black women.²⁹ In simulated data, transvaginal ultrasonography missed almost 5 times more cases of endometrial cancer among Black women compared with White women due to higher fibroid prevalence and nonendometrioid histologic type malignancies in Black women.²⁹

Assessing risk

If proliferative endometrium is found, Abraham suggests assessing risk using²²:

• age
• comorbidities (including obesity)
• endometrial echo thickness on vaginal ultrasonography.

Consider the patient’s risk and tolerance of recurrent bleeding as well as her tolerance for progestational adverse effects if medical therapy is chosen. Discussion about next steps should include reviewing the histologic findings with the patient and discussing the difference in risk of progression to endometrial cancer of a finding of proliferative endometrium compared with a histologic finding of endometrial hyperplasia.

Using this patient-centered approach, observation over time with follow-up endometrial biopsies remains a management option. Although some women may tolerate micronized progesterone over synthetic progestins, there is concern that it may be less effective in suppressing the endometrium than synthetic progestins.³⁰ Accordingly, synthetic progestins represent first-line options in this setting^.

In her review, Abraham suggests that when endometrial biopsy reveals proliferative changes in a menopausal woman, we should initiate progestin treatment and perform surveillance endometrial sampling every 3 to 6 months. If such sampling reveals benign but not proliferative endometrium, progestin therapy can be stopped and endometrial biopsy repeated if bleeding recurs.²² ●

The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.

Fertility CARE

The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded – ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.

The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.

CARE Fertility

I spoke with the past president of The Society for Assisted Reproductive Technology (SART.org), Kevin Doody, MD, HCLD, to discuss current IVF treatment options for couples that may decrease their financial burden, particularly by applying a novel approach – called INVOcell – that involves using the woman’s vagina as the embryo “incubator.” Dr. Doody is director of CARE Fertility in Bedford, Tex., and clinical professor at UT Southwestern Medical Center, Dallas.
 

How does limiting the dosage of gonadotropins in IVF cycles, known as “minimal stimulation,” affect pregnancy outcomes?

IVF medications are often costly, so it is logical to try and minimize expenses by using them judiciously. “Minimal stimulation” generally is not the best approach, as having more eggs usually leads to better pregnancy rates. High egg yield increases short-term success and provides additional embryos for future attempts.

However, extremely high gonadotropin doses do not necessarily yield more eggs or successful pregnancies. The dose response to gonadotropins follows a sigmoid curve, and typically doses beyond 225-300 IU per day do not offer additional benefits, except for women with an elevated body weight. Yet, some physicians continue to use higher doses in women with low ovarian reserve, which is often not beneficial and can add unnecessary costs.
 

Is “natural cycle” IVF cost-effective with acceptable pregnancy success rates?

Although the first-ever IVF baby was conceived through a natural cycle, this approach has very low success rates. Even with advancements in IVF laboratory technologies, the outcomes of natural cycle IVF have remained disappointingly low and are generally considered unacceptable.

Are there other cost-saving alternatives for IVF that still maintain reasonable success rates?

Some patients can undergo a more simplified ovarian stimulation protocol that reduces the number of monitoring visits, thus reducing costs. In couples without a severe male factor, the application and additional expense of intracytoplasmic sperm injection (ICSI) is unnecessary. Pre-implantation genetic testing for embryo aneuploidy, another “add-on” procedure, has specific indications and medical evidence does not support its use in all patient cycles.

How can the cost of a standard IVF cycle be reduced, especially in areas without mandated infertility insurance coverage?

Addressing this issue involves considering principles of justice in medical ethics, which emphasize equal health care access for all individuals. Infertility is a medical condition and IVF is expensive, so lack of insurance coverage often restricts access. Our clinic offers a more affordable option called “effortless IVF” using an intravaginal culture system (INVOcell), which minimizes the monitoring process while maintaining satisfactory success rates and reducing the risks associated with ovarian hyperstimulation syndrome.

What is INVOcell, and how successful is it in terms of live birth rates?

INVOcell is an innovative approach to IVF, where an intravaginal culture system is used as an “embryo incubator whereby freshly harvested eggs along with sperm are immediately added to a small chamber device that is placed in the woman’s vagina for up to 5 days to allow for fertilization and embryo development.” The woman, typically, has no discomfort from the device. For appropriately selected patients, the literature has shown live birth rates are comparable to those achieved using conventional laboratory incubation systems.

As an early participant in INVOcell research, can you share insights on the ideal candidates for this procedure and any contraindications?

The INVOcell system is best suited for straightforward cases. It is not recommended for severe male factor infertility requiring ICSI, since this will delay application of the chamber device and increase cost. Further, cases involving preimplantation genetic testing are not recommended because the embryos may not develop synchronously within the device to the embryo stage needed for a biopsy.

What training is required for embryologists and physicians to use INVOcell?

Embryologists require training for a few hours to learn the basics of INVOcell. They must master loading eggs into and retrieving embryos from the device. Practicing on discarded eggs and embryos, embryologists can accelerate the acquisition of the proper technique needed for INVOcell. Physicians find the training easier; they mainly need to learn the correct placement and removal of the device in the vagina.
 

Is INVOcell gaining acceptance among patients and IVF centers?

Acceptance varies. In our practice, INVOcell has largely replaced superovulation and intrauterine insemination treatments. However, some clinics still need to determine how this tool fits within their practice.

Have IVF success rates plateaued as affordable options increase?

IVF success rates grew substantially in the 1980s and 1990s, fostered by improved embryo culture systems and higher numbers of embryos transferred, the latter at the expense of a multiple gestation. While the rate of improvement has slowed, coinciding with the increasing use of single embryo transfer, advancements in IVF continue toward the goal of improving the singleton live birth rate per IVF cycle. There is still room for enhancement in success rates alongside cost reduction. Continued innovation is needed, especially for patients with challenging underlying biological issues.

Can you provide insight into the next potential breakthrough in IVF that may reduce costs, be less invasive, and maintain optimal pregnancy rates?

I am very excited about recent breakthroughs in in vitro maturation (IVM) of oocytes. The bottleneck in IVF clinics (and significant expense) primarily relates to the need to stimulate the ovaries to get mature and competent eggs. The technology of IVM has existed for decades but has yet to be fully embraced by clinics because of the poor competency of oocytes matured in the laboratory.

Immature eggs resume meiosis immediately upon removal from the ovary. Nuclear maturation of eggs in the lab is easy. In fact, it happens too quickly, thereby not allowing for the maturation of the egg cytoplasm. This has previously led to poor development of embryos following fertilization and low success rates.

Recently, a new laboratory strategy has resulted in a significant improvement in success. This improved culture system uses a peptide that prevents the resumption of meiosis for the initial culture time frame. Substances, including follicle stimulating hormone, can be added to the media to promote oocyte cytoplasmic maturation. Following this, the eggs are placed in a media without the meiosis inhibitor to allow for nuclear maturation. This results in a significantly higher proportion of competent mature eggs.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.

Fertility CARE

The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded – ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.

The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.

CARE Fertility

I spoke with the past president of The Society for Assisted Reproductive Technology (SART.org), Kevin Doody, MD, HCLD, to discuss current IVF treatment options for couples that may decrease their financial burden, particularly by applying a novel approach – called INVOcell – that involves using the woman’s vagina as the embryo “incubator.” Dr. Doody is director of CARE Fertility in Bedford, Tex., and clinical professor at UT Southwestern Medical Center, Dallas.
 

How does limiting the dosage of gonadotropins in IVF cycles, known as “minimal stimulation,” affect pregnancy outcomes?

IVF medications are often costly, so it is logical to try and minimize expenses by using them judiciously. “Minimal stimulation” generally is not the best approach, as having more eggs usually leads to better pregnancy rates. High egg yield increases short-term success and provides additional embryos for future attempts.

However, extremely high gonadotropin doses do not necessarily yield more eggs or successful pregnancies. The dose response to gonadotropins follows a sigmoid curve, and typically doses beyond 225-300 IU per day do not offer additional benefits, except for women with an elevated body weight. Yet, some physicians continue to use higher doses in women with low ovarian reserve, which is often not beneficial and can add unnecessary costs.
 

Is “natural cycle” IVF cost-effective with acceptable pregnancy success rates?

Although the first-ever IVF baby was conceived through a natural cycle, this approach has very low success rates. Even with advancements in IVF laboratory technologies, the outcomes of natural cycle IVF have remained disappointingly low and are generally considered unacceptable.

Are there other cost-saving alternatives for IVF that still maintain reasonable success rates?

Some patients can undergo a more simplified ovarian stimulation protocol that reduces the number of monitoring visits, thus reducing costs. In couples without a severe male factor, the application and additional expense of intracytoplasmic sperm injection (ICSI) is unnecessary. Pre-implantation genetic testing for embryo aneuploidy, another “add-on” procedure, has specific indications and medical evidence does not support its use in all patient cycles.

How can the cost of a standard IVF cycle be reduced, especially in areas without mandated infertility insurance coverage?

Addressing this issue involves considering principles of justice in medical ethics, which emphasize equal health care access for all individuals. Infertility is a medical condition and IVF is expensive, so lack of insurance coverage often restricts access. Our clinic offers a more affordable option called “effortless IVF” using an intravaginal culture system (INVOcell), which minimizes the monitoring process while maintaining satisfactory success rates and reducing the risks associated with ovarian hyperstimulation syndrome.

What is INVOcell, and how successful is it in terms of live birth rates?

INVOcell is an innovative approach to IVF, where an intravaginal culture system is used as an “embryo incubator whereby freshly harvested eggs along with sperm are immediately added to a small chamber device that is placed in the woman’s vagina for up to 5 days to allow for fertilization and embryo development.” The woman, typically, has no discomfort from the device. For appropriately selected patients, the literature has shown live birth rates are comparable to those achieved using conventional laboratory incubation systems.

As an early participant in INVOcell research, can you share insights on the ideal candidates for this procedure and any contraindications?

The INVOcell system is best suited for straightforward cases. It is not recommended for severe male factor infertility requiring ICSI, since this will delay application of the chamber device and increase cost. Further, cases involving preimplantation genetic testing are not recommended because the embryos may not develop synchronously within the device to the embryo stage needed for a biopsy.

What training is required for embryologists and physicians to use INVOcell?

Embryologists require training for a few hours to learn the basics of INVOcell. They must master loading eggs into and retrieving embryos from the device. Practicing on discarded eggs and embryos, embryologists can accelerate the acquisition of the proper technique needed for INVOcell. Physicians find the training easier; they mainly need to learn the correct placement and removal of the device in the vagina.
 

Is INVOcell gaining acceptance among patients and IVF centers?

Acceptance varies. In our practice, INVOcell has largely replaced superovulation and intrauterine insemination treatments. However, some clinics still need to determine how this tool fits within their practice.

Have IVF success rates plateaued as affordable options increase?

IVF success rates grew substantially in the 1980s and 1990s, fostered by improved embryo culture systems and higher numbers of embryos transferred, the latter at the expense of a multiple gestation. While the rate of improvement has slowed, coinciding with the increasing use of single embryo transfer, advancements in IVF continue toward the goal of improving the singleton live birth rate per IVF cycle. There is still room for enhancement in success rates alongside cost reduction. Continued innovation is needed, especially for patients with challenging underlying biological issues.

Can you provide insight into the next potential breakthrough in IVF that may reduce costs, be less invasive, and maintain optimal pregnancy rates?

I am very excited about recent breakthroughs in in vitro maturation (IVM) of oocytes. The bottleneck in IVF clinics (and significant expense) primarily relates to the need to stimulate the ovaries to get mature and competent eggs. The technology of IVM has existed for decades but has yet to be fully embraced by clinics because of the poor competency of oocytes matured in the laboratory.

Immature eggs resume meiosis immediately upon removal from the ovary. Nuclear maturation of eggs in the lab is easy. In fact, it happens too quickly, thereby not allowing for the maturation of the egg cytoplasm. This has previously led to poor development of embryos following fertilization and low success rates.

Recently, a new laboratory strategy has resulted in a significant improvement in success. This improved culture system uses a peptide that prevents the resumption of meiosis for the initial culture time frame. Substances, including follicle stimulating hormone, can be added to the media to promote oocyte cytoplasmic maturation. Following this, the eggs are placed in a media without the meiosis inhibitor to allow for nuclear maturation. This results in a significantly higher proportion of competent mature eggs.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.

Fertility CARE

The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded – ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.

The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.

CARE Fertility

I spoke with the past president of The Society for Assisted Reproductive Technology (SART.org), Kevin Doody, MD, HCLD, to discuss current IVF treatment options for couples that may decrease their financial burden, particularly by applying a novel approach – called INVOcell – that involves using the woman’s vagina as the embryo “incubator.” Dr. Doody is director of CARE Fertility in Bedford, Tex., and clinical professor at UT Southwestern Medical Center, Dallas.
 

How does limiting the dosage of gonadotropins in IVF cycles, known as “minimal stimulation,” affect pregnancy outcomes?

IVF medications are often costly, so it is logical to try and minimize expenses by using them judiciously. “Minimal stimulation” generally is not the best approach, as having more eggs usually leads to better pregnancy rates. High egg yield increases short-term success and provides additional embryos for future attempts.

However, extremely high gonadotropin doses do not necessarily yield more eggs or successful pregnancies. The dose response to gonadotropins follows a sigmoid curve, and typically doses beyond 225-300 IU per day do not offer additional benefits, except for women with an elevated body weight. Yet, some physicians continue to use higher doses in women with low ovarian reserve, which is often not beneficial and can add unnecessary costs.
 

Is “natural cycle” IVF cost-effective with acceptable pregnancy success rates?

Although the first-ever IVF baby was conceived through a natural cycle, this approach has very low success rates. Even with advancements in IVF laboratory technologies, the outcomes of natural cycle IVF have remained disappointingly low and are generally considered unacceptable.

Are there other cost-saving alternatives for IVF that still maintain reasonable success rates?

Some patients can undergo a more simplified ovarian stimulation protocol that reduces the number of monitoring visits, thus reducing costs. In couples without a severe male factor, the application and additional expense of intracytoplasmic sperm injection (ICSI) is unnecessary. Pre-implantation genetic testing for embryo aneuploidy, another “add-on” procedure, has specific indications and medical evidence does not support its use in all patient cycles.

How can the cost of a standard IVF cycle be reduced, especially in areas without mandated infertility insurance coverage?

Addressing this issue involves considering principles of justice in medical ethics, which emphasize equal health care access for all individuals. Infertility is a medical condition and IVF is expensive, so lack of insurance coverage often restricts access. Our clinic offers a more affordable option called “effortless IVF” using an intravaginal culture system (INVOcell), which minimizes the monitoring process while maintaining satisfactory success rates and reducing the risks associated with ovarian hyperstimulation syndrome.

What is INVOcell, and how successful is it in terms of live birth rates?

INVOcell is an innovative approach to IVF, where an intravaginal culture system is used as an “embryo incubator whereby freshly harvested eggs along with sperm are immediately added to a small chamber device that is placed in the woman’s vagina for up to 5 days to allow for fertilization and embryo development.” The woman, typically, has no discomfort from the device. For appropriately selected patients, the literature has shown live birth rates are comparable to those achieved using conventional laboratory incubation systems.

As an early participant in INVOcell research, can you share insights on the ideal candidates for this procedure and any contraindications?

The INVOcell system is best suited for straightforward cases. It is not recommended for severe male factor infertility requiring ICSI, since this will delay application of the chamber device and increase cost. Further, cases involving preimplantation genetic testing are not recommended because the embryos may not develop synchronously within the device to the embryo stage needed for a biopsy.

What training is required for embryologists and physicians to use INVOcell?

Embryologists require training for a few hours to learn the basics of INVOcell. They must master loading eggs into and retrieving embryos from the device. Practicing on discarded eggs and embryos, embryologists can accelerate the acquisition of the proper technique needed for INVOcell. Physicians find the training easier; they mainly need to learn the correct placement and removal of the device in the vagina.
 

Is INVOcell gaining acceptance among patients and IVF centers?

Acceptance varies. In our practice, INVOcell has largely replaced superovulation and intrauterine insemination treatments. However, some clinics still need to determine how this tool fits within their practice.

Have IVF success rates plateaued as affordable options increase?

IVF success rates grew substantially in the 1980s and 1990s, fostered by improved embryo culture systems and higher numbers of embryos transferred, the latter at the expense of a multiple gestation. While the rate of improvement has slowed, coinciding with the increasing use of single embryo transfer, advancements in IVF continue toward the goal of improving the singleton live birth rate per IVF cycle. There is still room for enhancement in success rates alongside cost reduction. Continued innovation is needed, especially for patients with challenging underlying biological issues.

Can you provide insight into the next potential breakthrough in IVF that may reduce costs, be less invasive, and maintain optimal pregnancy rates?

I am very excited about recent breakthroughs in in vitro maturation (IVM) of oocytes. The bottleneck in IVF clinics (and significant expense) primarily relates to the need to stimulate the ovaries to get mature and competent eggs. The technology of IVM has existed for decades but has yet to be fully embraced by clinics because of the poor competency of oocytes matured in the laboratory.

Immature eggs resume meiosis immediately upon removal from the ovary. Nuclear maturation of eggs in the lab is easy. In fact, it happens too quickly, thereby not allowing for the maturation of the egg cytoplasm. This has previously led to poor development of embryos following fertilization and low success rates.

Recently, a new laboratory strategy has resulted in a significant improvement in success. This improved culture system uses a peptide that prevents the resumption of meiosis for the initial culture time frame. Substances, including follicle stimulating hormone, can be added to the media to promote oocyte cytoplasmic maturation. Following this, the eggs are placed in a media without the meiosis inhibitor to allow for nuclear maturation. This results in a significantly higher proportion of competent mature eggs.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Feelings of inadequacy, in terms of skills and expectations in an ever-changing system, are common emotions that many doctors have experienced since the start of the pandemic.

COVID-19 imposed challenges on health care professionals and systems by forcing changes in how doctors organize themselves professionally as well as in their relationships with patients and in their expectations (realistic or not) of their roles. The situation was bound to generate high rates of frustration and discomfort among younger and older physicians. It was compounded by a generational transition of the profession, which was accelerated by the virus. It was not managed by the decision-makers and was painful for doctors and patients.

Impostor syndrome (IS) is a psychological construct characterized by the persistent belief that one’s success is undeserved, rather than stemming from personal effort, skill, and ability. The phenomenon is common among medics for various reasons, including professional burnout. Recent studies have helped to better define the extent and characteristic features of the syndrome, as well as efforts to combat it.
 

Doctors and burnout

Although occupational burnout among physicians is a systemic issue primarily attributable to problems in the practice environment, professional norms and aspects of medical culture often contribute to the distress that individual physicians experience.

These dimensions have been well characterized and include suggestions that physicians should be impervious to normal human limitations (that is, superhuman), that work should always come first, and that seeking help is a sign of weakness. In aggregate, these attitudes lead many physicians to engage in unhealthy levels of self-sacrifice, manifested by excessive work hours, anxiety about missing something that would benefit their patients, and prioritizing work over personal health. These factors are familiar to many hospital-based and family physicians.
 

The impostor phenomenon

The impostor phenomenon (IP) is a psychological experience of intellectual and professional fraud. Individuals who suffer from it believe that others have inflated perceptions of the individual’s abilities and fear being judged. This fear persists despite continual proof of the individual’s successes. These people ignore praise, are highly self-critical, and attribute their successes to external factors, such as luck, hard work, or receiving help from others, rather than to qualities such as skill, intelligence, or ability.

IP is common among men and women. Some studies suggest it may be more prevalent among women. Studies across industries suggest that the phenomenon is associated with personal consequences (for example, low emotional well-being, problems with work-life integration, anxiety, depression, suicide) and professional consequences (for example, impaired job performance, occupational burnout). Studies involving U.S. medical students have revealed that more than one in four medical students experience IP and that those who experience it are at higher risk for burnout.
 

Surveying IS

IS, which is not a formal psychiatric diagnosis, is defined as having feelings of uncertainty, inadequacy, and being undeserving of one’s achievements despite evidence to the contrary. There are five subtypes of IS:

• Perfectionist: insecurity related to self-imposed, unachievable goals
• Expert: feeling inadequate from lacking sufficient knowledge
• Superperson: assuming excessive workloads just to feel okay among peers
• Natural genius: experiencing shame when it takes effort to develop a skill
• Soloist: believing that requesting help is a sign of weakness

Risk factors

Studies suggest that IS is a problem early in the physician training process. There is limited information on IS among physicians in practice.

Because transitions represent a risk factor for IP, the frequent rotation between clerkships and being a “perpetual novice” during medical school training may contribute to the high prevalence. Qualitative studies suggest that, once in practice, other professional experiences (for example, unfavorable patient outcomes, patient complaints, rejection of grants or manuscripts, and poor teaching evaluations or patient satisfaction scores) may contribute to IP.
 

Impact on doctors

Several methods have been used to classify how much the phenomenon interferes with a person’s life. The Clance Impostor Phenomenon Scale is a 20-item scale that asks respondents to indicate how well each item characterizes their experience on a 5-point scale. Options range from “not at all” to “very true.” The sum of responses to the individual items is used to create an aggregate score (IP score). The higher the score, the more frequently and seriously IP interferes with a person’s life.

A simplified version of the IP score was used in a study of 3,237 U.S. doctors that investigated the association between IS and burnout among doctors and to compare their rates of IS with those of other professionals.

Mean IP scores were higher for female physicians than for male physicians (mean, 10.91 vs. 9.12; P < .001). Scores decreased with age and were lower among those who were married or widowed.

With respect to professional characteristics, IP scores were greater among those in academic practice or who worked in the Veterans Affairs medical system and decreased with years in practice.

The highest IP scores were among pediatric subspecialists, general pediatricians, and emergency medicine physicians. Scores were lowest among ophthalmologists, radiologists, and orthopedic surgeons. IP has been independently associated with the risk of burnout and low professional fulfillment.
 

Lessening the impact

An article commenting on the study highlighted the following expert practice strategies that doctors can use to reduce the impact of IS in their professional life.

• Review and celebrate feats that have led to your professional role.
• Share concerns with trusted colleagues who can validate your accomplishments and normalize your feelings by reporting their own struggles with IS.
• Combat perfectionism by accepting that it is okay to be good enough when meeting the challenges of a demanding profession.
• Exercise self-compassion as an alternative to relying on an external locus of self-worth.
• Understand that IS may be common, especially during transitions, such as when entering medical school, graduate medical training, or starting a new career.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Feelings of inadequacy, in terms of skills and expectations in an ever-changing system, are common emotions that many doctors have experienced since the start of the pandemic.

COVID-19 imposed challenges on health care professionals and systems by forcing changes in how doctors organize themselves professionally as well as in their relationships with patients and in their expectations (realistic or not) of their roles. The situation was bound to generate high rates of frustration and discomfort among younger and older physicians. It was compounded by a generational transition of the profession, which was accelerated by the virus. It was not managed by the decision-makers and was painful for doctors and patients.

Impostor syndrome (IS) is a psychological construct characterized by the persistent belief that one’s success is undeserved, rather than stemming from personal effort, skill, and ability. The phenomenon is common among medics for various reasons, including professional burnout. Recent studies have helped to better define the extent and characteristic features of the syndrome, as well as efforts to combat it.
 

Doctors and burnout

Although occupational burnout among physicians is a systemic issue primarily attributable to problems in the practice environment, professional norms and aspects of medical culture often contribute to the distress that individual physicians experience.

These dimensions have been well characterized and include suggestions that physicians should be impervious to normal human limitations (that is, superhuman), that work should always come first, and that seeking help is a sign of weakness. In aggregate, these attitudes lead many physicians to engage in unhealthy levels of self-sacrifice, manifested by excessive work hours, anxiety about missing something that would benefit their patients, and prioritizing work over personal health. These factors are familiar to many hospital-based and family physicians.
 

The impostor phenomenon

The impostor phenomenon (IP) is a psychological experience of intellectual and professional fraud. Individuals who suffer from it believe that others have inflated perceptions of the individual’s abilities and fear being judged. This fear persists despite continual proof of the individual’s successes. These people ignore praise, are highly self-critical, and attribute their successes to external factors, such as luck, hard work, or receiving help from others, rather than to qualities such as skill, intelligence, or ability.

IP is common among men and women. Some studies suggest it may be more prevalent among women. Studies across industries suggest that the phenomenon is associated with personal consequences (for example, low emotional well-being, problems with work-life integration, anxiety, depression, suicide) and professional consequences (for example, impaired job performance, occupational burnout). Studies involving U.S. medical students have revealed that more than one in four medical students experience IP and that those who experience it are at higher risk for burnout.
 

Surveying IS

IS, which is not a formal psychiatric diagnosis, is defined as having feelings of uncertainty, inadequacy, and being undeserving of one’s achievements despite evidence to the contrary. There are five subtypes of IS:

• Perfectionist: insecurity related to self-imposed, unachievable goals
• Expert: feeling inadequate from lacking sufficient knowledge
• Superperson: assuming excessive workloads just to feel okay among peers
• Natural genius: experiencing shame when it takes effort to develop a skill
• Soloist: believing that requesting help is a sign of weakness

Risk factors

Studies suggest that IS is a problem early in the physician training process. There is limited information on IS among physicians in practice.

Because transitions represent a risk factor for IP, the frequent rotation between clerkships and being a “perpetual novice” during medical school training may contribute to the high prevalence. Qualitative studies suggest that, once in practice, other professional experiences (for example, unfavorable patient outcomes, patient complaints, rejection of grants or manuscripts, and poor teaching evaluations or patient satisfaction scores) may contribute to IP.
 

Impact on doctors

Several methods have been used to classify how much the phenomenon interferes with a person’s life. The Clance Impostor Phenomenon Scale is a 20-item scale that asks respondents to indicate how well each item characterizes their experience on a 5-point scale. Options range from “not at all” to “very true.” The sum of responses to the individual items is used to create an aggregate score (IP score). The higher the score, the more frequently and seriously IP interferes with a person’s life.

A simplified version of the IP score was used in a study of 3,237 U.S. doctors that investigated the association between IS and burnout among doctors and to compare their rates of IS with those of other professionals.

Mean IP scores were higher for female physicians than for male physicians (mean, 10.91 vs. 9.12; P < .001). Scores decreased with age and were lower among those who were married or widowed.

With respect to professional characteristics, IP scores were greater among those in academic practice or who worked in the Veterans Affairs medical system and decreased with years in practice.

The highest IP scores were among pediatric subspecialists, general pediatricians, and emergency medicine physicians. Scores were lowest among ophthalmologists, radiologists, and orthopedic surgeons. IP has been independently associated with the risk of burnout and low professional fulfillment.
 

Lessening the impact

An article commenting on the study highlighted the following expert practice strategies that doctors can use to reduce the impact of IS in their professional life.

• Review and celebrate feats that have led to your professional role.
• Share concerns with trusted colleagues who can validate your accomplishments and normalize your feelings by reporting their own struggles with IS.
• Combat perfectionism by accepting that it is okay to be good enough when meeting the challenges of a demanding profession.
• Exercise self-compassion as an alternative to relying on an external locus of self-worth.
• Understand that IS may be common, especially during transitions, such as when entering medical school, graduate medical training, or starting a new career.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Feelings of inadequacy, in terms of skills and expectations in an ever-changing system, are common emotions that many doctors have experienced since the start of the pandemic.

COVID-19 imposed challenges on health care professionals and systems by forcing changes in how doctors organize themselves professionally as well as in their relationships with patients and in their expectations (realistic or not) of their roles. The situation was bound to generate high rates of frustration and discomfort among younger and older physicians. It was compounded by a generational transition of the profession, which was accelerated by the virus. It was not managed by the decision-makers and was painful for doctors and patients.

Impostor syndrome (IS) is a psychological construct characterized by the persistent belief that one’s success is undeserved, rather than stemming from personal effort, skill, and ability. The phenomenon is common among medics for various reasons, including professional burnout. Recent studies have helped to better define the extent and characteristic features of the syndrome, as well as efforts to combat it.
 

Doctors and burnout

Although occupational burnout among physicians is a systemic issue primarily attributable to problems in the practice environment, professional norms and aspects of medical culture often contribute to the distress that individual physicians experience.

These dimensions have been well characterized and include suggestions that physicians should be impervious to normal human limitations (that is, superhuman), that work should always come first, and that seeking help is a sign of weakness. In aggregate, these attitudes lead many physicians to engage in unhealthy levels of self-sacrifice, manifested by excessive work hours, anxiety about missing something that would benefit their patients, and prioritizing work over personal health. These factors are familiar to many hospital-based and family physicians.
 

The impostor phenomenon

The impostor phenomenon (IP) is a psychological experience of intellectual and professional fraud. Individuals who suffer from it believe that others have inflated perceptions of the individual’s abilities and fear being judged. This fear persists despite continual proof of the individual’s successes. These people ignore praise, are highly self-critical, and attribute their successes to external factors, such as luck, hard work, or receiving help from others, rather than to qualities such as skill, intelligence, or ability.

IP is common among men and women. Some studies suggest it may be more prevalent among women. Studies across industries suggest that the phenomenon is associated with personal consequences (for example, low emotional well-being, problems with work-life integration, anxiety, depression, suicide) and professional consequences (for example, impaired job performance, occupational burnout). Studies involving U.S. medical students have revealed that more than one in four medical students experience IP and that those who experience it are at higher risk for burnout.
 

Surveying IS

IS, which is not a formal psychiatric diagnosis, is defined as having feelings of uncertainty, inadequacy, and being undeserving of one’s achievements despite evidence to the contrary. There are five subtypes of IS:

• Perfectionist: insecurity related to self-imposed, unachievable goals
• Expert: feeling inadequate from lacking sufficient knowledge
• Superperson: assuming excessive workloads just to feel okay among peers
• Natural genius: experiencing shame when it takes effort to develop a skill
• Soloist: believing that requesting help is a sign of weakness

Risk factors

Studies suggest that IS is a problem early in the physician training process. There is limited information on IS among physicians in practice.

Because transitions represent a risk factor for IP, the frequent rotation between clerkships and being a “perpetual novice” during medical school training may contribute to the high prevalence. Qualitative studies suggest that, once in practice, other professional experiences (for example, unfavorable patient outcomes, patient complaints, rejection of grants or manuscripts, and poor teaching evaluations or patient satisfaction scores) may contribute to IP.
 

Impact on doctors

Several methods have been used to classify how much the phenomenon interferes with a person’s life. The Clance Impostor Phenomenon Scale is a 20-item scale that asks respondents to indicate how well each item characterizes their experience on a 5-point scale. Options range from “not at all” to “very true.” The sum of responses to the individual items is used to create an aggregate score (IP score). The higher the score, the more frequently and seriously IP interferes with a person’s life.

A simplified version of the IP score was used in a study of 3,237 U.S. doctors that investigated the association between IS and burnout among doctors and to compare their rates of IS with those of other professionals.

Mean IP scores were higher for female physicians than for male physicians (mean, 10.91 vs. 9.12; P < .001). Scores decreased with age and were lower among those who were married or widowed.

With respect to professional characteristics, IP scores were greater among those in academic practice or who worked in the Veterans Affairs medical system and decreased with years in practice.

The highest IP scores were among pediatric subspecialists, general pediatricians, and emergency medicine physicians. Scores were lowest among ophthalmologists, radiologists, and orthopedic surgeons. IP has been independently associated with the risk of burnout and low professional fulfillment.
 

Lessening the impact

An article commenting on the study highlighted the following expert practice strategies that doctors can use to reduce the impact of IS in their professional life.

• Review and celebrate feats that have led to your professional role.
• Share concerns with trusted colleagues who can validate your accomplishments and normalize your feelings by reporting their own struggles with IS.
• Combat perfectionism by accepting that it is okay to be good enough when meeting the challenges of a demanding profession.
• Exercise self-compassion as an alternative to relying on an external locus of self-worth.
• Understand that IS may be common, especially during transitions, such as when entering medical school, graduate medical training, or starting a new career.

This article was translated from Univadis Italy. A version appeared on Medscape.com.