Mixed Topics

How did your career pathway lead you to working at a health tech startup?

I’ve always had an interest in technology – in fact, it was part of the reason I chose gastroenterology. When I finished GI fellowship, I decided to stay in academics because of an opportunity to lead clinical innovation efforts at my institution’s patient safety institute. This role provided protected time to foster external and internal partnerships around technology. It also gave me an opportunity to pursue clinical research and administrative experiences. While I enjoyed all three paths, it became clear that health technology was my passion. While the opportunity to join a startup was largely serendipitous – I met the founder of the company after presenting at a digital medicine conference – it also happened as a result of the steps outlined in a subsequent question. Not long after learning about the company, I made the transition to part-time faculty/clinical status and full-time chief medical officer (CMO).

What do you do as CMO?

There is no one answer to this question. It will depend on a number of variables, especially the type of business (for example, diagnostic, drug, digital, direct care management, and so on), stage of company (for example, concept, seed, series A/B/C, public), and the existing background of company founders (for example, technical, clinical, operations, and so on). Generally speaking, the earlier the stage of the company, the more hats you’ll wear (though this also means more risk; more on that later). An early-stage company was appealing to me because it gave me an opportunity to apply many of the same critical-thinking and problem-solving skills in clinical medicine to a host of other challenges. For example, as a practicing gastroenterologist, I know the pain points in the delivery of GI care and the challenges that my patients encounter. I then ask how can I develop our technology and product platform to address these issues. Also understanding how value and quality are measured in GI practice makes it easier to convey the effect of the solutions that are built and prioritize their development. In my current role I contribute to the following areas:

• Clinical strategy and vision. This means understanding the clinical need the company is trying to address at a fundamental level and designing how the technology or solution can address that need in a meaningful way. This includes working directly with technology and product teams to create a roadmap for how the technology/solution will continue to drive impact.
• Clinical care leadership. If the company employs or works with health professionals in any capacity, this usually involves developing clinical protocols and providing clinical direction. 
• Clinical outcomes. This means being responsible for understanding and/or developing the metrics that will be used to demonstrate impact of the technology/solution. This includes designing clinical studies and being responsible for their execution.
• Stakeholder engagement. This means interfacing internally with nearly every aspect of the company and interacting externally with customers (usually medical peers and executives), investors, other companies, and key opinion leaders in the field.
• Regulatory. For companies pursuing Food and Drug Administration clearance or approval for their product, this entails developing a strategy and executing it.
• Research & development. This involves creating and executing a roadmap for integrating new technologies/ideas that generally complement the initial problem you are trying to solve.  

What do you enjoy most about working at a startup?

The variety of experience, the flexibility, the fast pace, the ability to work creatively, and the potential to make a large-scale impact are all aspects of the job that I enjoy. The ability to continue clinical practice is important to me and is a major plus. 
 

What do you find most challenging about working at a startup?

One of the biggest differences between a startup and a traditional clinical role is the degree of uncertainty that permeates the entire experience. It took some time for me to adjust to the relative volatility/risk associated with this type of work. Unlike an academic, administrative, or private practice job, things can change very quickly (as in a 24-hour period or less!). This can encompass a number of changes, such as funding, leadership, strategic direction, business model, and staffing, to name a few. What I’ve learned is that this doesn’t always mean changing for the worse, but it does mean things changing near constantly. Being mentally prepared to adapt quickly and frequently to big changes is part of the experience. 
 

What are the ways that GIs can get involved in startups?

Gastroenterologists have more opportunities than most physicians due to the diversity of conditions we treat and the large corresponding number of unmet needs we encounter. There is also the inherent innovation potential associated with new applications in endoscopy, diagnostics, and drug therapies. As a result, there are a number of ways to get involved:

• This often takes the form of “spinning out” research from an academic institution but can also be done successfully from private practice, particularly in the context of new devices/services. Another related option is to license your technology to a company, which offloads the operational aspects of running a business.
• Provide consulting/advisory support. Many early-stage companies cannot afford to hire a full-time physician, but they are open to consulting arrangements (and of course volunteer work). Don’t hesitate to directly contact companies that are interesting to you. These opportunities are possible even while in clinical training.
• Work part time or full time. The majority of startups are supportive of physicians continuing to practice clinically. This makes engaging in a part-time position financially feasible for both parties. Given the relatively high remuneration for gastroenterologists working clinically, a full-time position at a startup may require a financial tradeoff (that is, lower short-term salary for a potential larger long-term gain – note the emphasis on “potential”).  
• Invest in early-stage companies. Physicians can become angel investors for early-stage companies. Given the relatively time-intensive process of finding new opportunities and conducting due diligence, this often takes the form of pooling funds into angel networks that can distribute the execution of investments more efficiently. 

How would a fellow or early-career GI who is interested in startups pursue this career pathway?

The first step I recommend is self-reflection – what about the startup experience is interesting to you? Not all aspects appeal to everyone, and not all options provide the same opportunities. Spending time deciding which specific aspects of the startup experience appeal to you will make it easier to find the right opportunity. A concurrent step is to build expertise. This can take many forms, including traditional basic science or clinical research, but also includes implementation, evaluation/analysis, design, education, regulation, policy, and so on. The next step is to proactively meet people who are doing what you are interested in doing. Reach out to mentors, alumni, faculty, and friends. Conferences and social media are also great places to network. Other potential paths can include developing expertise in an allied functional area that can be later leveraged into a startup role (for example, experience at pharma, payer, regulatory, and so on). Many of these organizations have programs specifically geared toward physicians making a transition. In addition, another potential option is to seek additional education through an MBA where internships, recruitment programs, and robust alumni networks can be helpful in finding placement.

What if I want to learn more about the health technology startup experience?

The AGA Center for GI Innovation and Technology (CGIT) has a number of programs throughout the year, including the annual Tech Summit where you can learn about new companies, ideas, and technologies from like-minded individuals. I also invite you to reach out to me directly via Twitter, LinkedIn, or email with specific questions. As gastroenterologists, we are fortunate to work in a field full of innovation and new ideas. As a result, there are many meaningful career paths available to those interested in gastroenterology and technology. Whether providing direct clinical care with the latest endoscopic techniques or developing the next digital therapy, the opportunities for gastroenterologists will only continue to grow.

Dr. Mathews is chief medical officer at Vivante Health and assistant professor of medicine at Johns Hopkins Medicine in Baltimore. He is an officer at Vivante Health with stock options, but he reports having nothing else to disclose.

How did your career pathway lead you to working at a health tech startup?

I’ve always had an interest in technology – in fact, it was part of the reason I chose gastroenterology. When I finished GI fellowship, I decided to stay in academics because of an opportunity to lead clinical innovation efforts at my institution’s patient safety institute. This role provided protected time to foster external and internal partnerships around technology. It also gave me an opportunity to pursue clinical research and administrative experiences. While I enjoyed all three paths, it became clear that health technology was my passion. While the opportunity to join a startup was largely serendipitous – I met the founder of the company after presenting at a digital medicine conference – it also happened as a result of the steps outlined in a subsequent question. Not long after learning about the company, I made the transition to part-time faculty/clinical status and full-time chief medical officer (CMO).

What do you do as CMO?

There is no one answer to this question. It will depend on a number of variables, especially the type of business (for example, diagnostic, drug, digital, direct care management, and so on), stage of company (for example, concept, seed, series A/B/C, public), and the existing background of company founders (for example, technical, clinical, operations, and so on). Generally speaking, the earlier the stage of the company, the more hats you’ll wear (though this also means more risk; more on that later). An early-stage company was appealing to me because it gave me an opportunity to apply many of the same critical-thinking and problem-solving skills in clinical medicine to a host of other challenges. For example, as a practicing gastroenterologist, I know the pain points in the delivery of GI care and the challenges that my patients encounter. I then ask how can I develop our technology and product platform to address these issues. Also understanding how value and quality are measured in GI practice makes it easier to convey the effect of the solutions that are built and prioritize their development. In my current role I contribute to the following areas:

• Clinical strategy and vision. This means understanding the clinical need the company is trying to address at a fundamental level and designing how the technology or solution can address that need in a meaningful way. This includes working directly with technology and product teams to create a roadmap for how the technology/solution will continue to drive impact.
• Clinical care leadership. If the company employs or works with health professionals in any capacity, this usually involves developing clinical protocols and providing clinical direction. 
• Clinical outcomes. This means being responsible for understanding and/or developing the metrics that will be used to demonstrate impact of the technology/solution. This includes designing clinical studies and being responsible for their execution.
• Stakeholder engagement. This means interfacing internally with nearly every aspect of the company and interacting externally with customers (usually medical peers and executives), investors, other companies, and key opinion leaders in the field.
• Regulatory. For companies pursuing Food and Drug Administration clearance or approval for their product, this entails developing a strategy and executing it.
• Research & development. This involves creating and executing a roadmap for integrating new technologies/ideas that generally complement the initial problem you are trying to solve.  

What do you enjoy most about working at a startup?

The variety of experience, the flexibility, the fast pace, the ability to work creatively, and the potential to make a large-scale impact are all aspects of the job that I enjoy. The ability to continue clinical practice is important to me and is a major plus. 
 

What do you find most challenging about working at a startup?

One of the biggest differences between a startup and a traditional clinical role is the degree of uncertainty that permeates the entire experience. It took some time for me to adjust to the relative volatility/risk associated with this type of work. Unlike an academic, administrative, or private practice job, things can change very quickly (as in a 24-hour period or less!). This can encompass a number of changes, such as funding, leadership, strategic direction, business model, and staffing, to name a few. What I’ve learned is that this doesn’t always mean changing for the worse, but it does mean things changing near constantly. Being mentally prepared to adapt quickly and frequently to big changes is part of the experience. 
 

What are the ways that GIs can get involved in startups?

Gastroenterologists have more opportunities than most physicians due to the diversity of conditions we treat and the large corresponding number of unmet needs we encounter. There is also the inherent innovation potential associated with new applications in endoscopy, diagnostics, and drug therapies. As a result, there are a number of ways to get involved:

• This often takes the form of “spinning out” research from an academic institution but can also be done successfully from private practice, particularly in the context of new devices/services. Another related option is to license your technology to a company, which offloads the operational aspects of running a business.
• Provide consulting/advisory support. Many early-stage companies cannot afford to hire a full-time physician, but they are open to consulting arrangements (and of course volunteer work). Don’t hesitate to directly contact companies that are interesting to you. These opportunities are possible even while in clinical training.
• Work part time or full time. The majority of startups are supportive of physicians continuing to practice clinically. This makes engaging in a part-time position financially feasible for both parties. Given the relatively high remuneration for gastroenterologists working clinically, a full-time position at a startup may require a financial tradeoff (that is, lower short-term salary for a potential larger long-term gain – note the emphasis on “potential”).  
• Invest in early-stage companies. Physicians can become angel investors for early-stage companies. Given the relatively time-intensive process of finding new opportunities and conducting due diligence, this often takes the form of pooling funds into angel networks that can distribute the execution of investments more efficiently. 

How would a fellow or early-career GI who is interested in startups pursue this career pathway?

The first step I recommend is self-reflection – what about the startup experience is interesting to you? Not all aspects appeal to everyone, and not all options provide the same opportunities. Spending time deciding which specific aspects of the startup experience appeal to you will make it easier to find the right opportunity. A concurrent step is to build expertise. This can take many forms, including traditional basic science or clinical research, but also includes implementation, evaluation/analysis, design, education, regulation, policy, and so on. The next step is to proactively meet people who are doing what you are interested in doing. Reach out to mentors, alumni, faculty, and friends. Conferences and social media are also great places to network. Other potential paths can include developing expertise in an allied functional area that can be later leveraged into a startup role (for example, experience at pharma, payer, regulatory, and so on). Many of these organizations have programs specifically geared toward physicians making a transition. In addition, another potential option is to seek additional education through an MBA where internships, recruitment programs, and robust alumni networks can be helpful in finding placement.

What if I want to learn more about the health technology startup experience?

The AGA Center for GI Innovation and Technology (CGIT) has a number of programs throughout the year, including the annual Tech Summit where you can learn about new companies, ideas, and technologies from like-minded individuals. I also invite you to reach out to me directly via Twitter, LinkedIn, or email with specific questions. As gastroenterologists, we are fortunate to work in a field full of innovation and new ideas. As a result, there are many meaningful career paths available to those interested in gastroenterology and technology. Whether providing direct clinical care with the latest endoscopic techniques or developing the next digital therapy, the opportunities for gastroenterologists will only continue to grow.

Dr. Mathews is chief medical officer at Vivante Health and assistant professor of medicine at Johns Hopkins Medicine in Baltimore. He is an officer at Vivante Health with stock options, but he reports having nothing else to disclose.

How did your career pathway lead you to working at a health tech startup?

I’ve always had an interest in technology – in fact, it was part of the reason I chose gastroenterology. When I finished GI fellowship, I decided to stay in academics because of an opportunity to lead clinical innovation efforts at my institution’s patient safety institute. This role provided protected time to foster external and internal partnerships around technology. It also gave me an opportunity to pursue clinical research and administrative experiences. While I enjoyed all three paths, it became clear that health technology was my passion. While the opportunity to join a startup was largely serendipitous – I met the founder of the company after presenting at a digital medicine conference – it also happened as a result of the steps outlined in a subsequent question. Not long after learning about the company, I made the transition to part-time faculty/clinical status and full-time chief medical officer (CMO).

What do you do as CMO?

There is no one answer to this question. It will depend on a number of variables, especially the type of business (for example, diagnostic, drug, digital, direct care management, and so on), stage of company (for example, concept, seed, series A/B/C, public), and the existing background of company founders (for example, technical, clinical, operations, and so on). Generally speaking, the earlier the stage of the company, the more hats you’ll wear (though this also means more risk; more on that later). An early-stage company was appealing to me because it gave me an opportunity to apply many of the same critical-thinking and problem-solving skills in clinical medicine to a host of other challenges. For example, as a practicing gastroenterologist, I know the pain points in the delivery of GI care and the challenges that my patients encounter. I then ask how can I develop our technology and product platform to address these issues. Also understanding how value and quality are measured in GI practice makes it easier to convey the effect of the solutions that are built and prioritize their development. In my current role I contribute to the following areas:

• Clinical strategy and vision. This means understanding the clinical need the company is trying to address at a fundamental level and designing how the technology or solution can address that need in a meaningful way. This includes working directly with technology and product teams to create a roadmap for how the technology/solution will continue to drive impact.
• Clinical care leadership. If the company employs or works with health professionals in any capacity, this usually involves developing clinical protocols and providing clinical direction. 
• Clinical outcomes. This means being responsible for understanding and/or developing the metrics that will be used to demonstrate impact of the technology/solution. This includes designing clinical studies and being responsible for their execution.
• Stakeholder engagement. This means interfacing internally with nearly every aspect of the company and interacting externally with customers (usually medical peers and executives), investors, other companies, and key opinion leaders in the field.
• Regulatory. For companies pursuing Food and Drug Administration clearance or approval for their product, this entails developing a strategy and executing it.
• Research & development. This involves creating and executing a roadmap for integrating new technologies/ideas that generally complement the initial problem you are trying to solve.  

What do you enjoy most about working at a startup?

The variety of experience, the flexibility, the fast pace, the ability to work creatively, and the potential to make a large-scale impact are all aspects of the job that I enjoy. The ability to continue clinical practice is important to me and is a major plus. 
 

What do you find most challenging about working at a startup?

One of the biggest differences between a startup and a traditional clinical role is the degree of uncertainty that permeates the entire experience. It took some time for me to adjust to the relative volatility/risk associated with this type of work. Unlike an academic, administrative, or private practice job, things can change very quickly (as in a 24-hour period or less!). This can encompass a number of changes, such as funding, leadership, strategic direction, business model, and staffing, to name a few. What I’ve learned is that this doesn’t always mean changing for the worse, but it does mean things changing near constantly. Being mentally prepared to adapt quickly and frequently to big changes is part of the experience. 
 

What are the ways that GIs can get involved in startups?

Gastroenterologists have more opportunities than most physicians due to the diversity of conditions we treat and the large corresponding number of unmet needs we encounter. There is also the inherent innovation potential associated with new applications in endoscopy, diagnostics, and drug therapies. As a result, there are a number of ways to get involved:

• This often takes the form of “spinning out” research from an academic institution but can also be done successfully from private practice, particularly in the context of new devices/services. Another related option is to license your technology to a company, which offloads the operational aspects of running a business.
• Provide consulting/advisory support. Many early-stage companies cannot afford to hire a full-time physician, but they are open to consulting arrangements (and of course volunteer work). Don’t hesitate to directly contact companies that are interesting to you. These opportunities are possible even while in clinical training.
• Work part time or full time. The majority of startups are supportive of physicians continuing to practice clinically. This makes engaging in a part-time position financially feasible for both parties. Given the relatively high remuneration for gastroenterologists working clinically, a full-time position at a startup may require a financial tradeoff (that is, lower short-term salary for a potential larger long-term gain – note the emphasis on “potential”).  
• Invest in early-stage companies. Physicians can become angel investors for early-stage companies. Given the relatively time-intensive process of finding new opportunities and conducting due diligence, this often takes the form of pooling funds into angel networks that can distribute the execution of investments more efficiently. 

How would a fellow or early-career GI who is interested in startups pursue this career pathway?

The first step I recommend is self-reflection – what about the startup experience is interesting to you? Not all aspects appeal to everyone, and not all options provide the same opportunities. Spending time deciding which specific aspects of the startup experience appeal to you will make it easier to find the right opportunity. A concurrent step is to build expertise. This can take many forms, including traditional basic science or clinical research, but also includes implementation, evaluation/analysis, design, education, regulation, policy, and so on. The next step is to proactively meet people who are doing what you are interested in doing. Reach out to mentors, alumni, faculty, and friends. Conferences and social media are also great places to network. Other potential paths can include developing expertise in an allied functional area that can be later leveraged into a startup role (for example, experience at pharma, payer, regulatory, and so on). Many of these organizations have programs specifically geared toward physicians making a transition. In addition, another potential option is to seek additional education through an MBA where internships, recruitment programs, and robust alumni networks can be helpful in finding placement.

What if I want to learn more about the health technology startup experience?

The AGA Center for GI Innovation and Technology (CGIT) has a number of programs throughout the year, including the annual Tech Summit where you can learn about new companies, ideas, and technologies from like-minded individuals. I also invite you to reach out to me directly via Twitter, LinkedIn, or email with specific questions. As gastroenterologists, we are fortunate to work in a field full of innovation and new ideas. As a result, there are many meaningful career paths available to those interested in gastroenterology and technology. Whether providing direct clinical care with the latest endoscopic techniques or developing the next digital therapy, the opportunities for gastroenterologists will only continue to grow.

Dr. Mathews is chief medical officer at Vivante Health and assistant professor of medicine at Johns Hopkins Medicine in Baltimore. He is an officer at Vivante Health with stock options, but he reports having nothing else to disclose.

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

Sex should be removed as a legal designation on the public part of birth certificates, the American Medical Association said June 15.

Requiring the designation can lead to discrimination and unnecessary burden on individuals whose current gender identity does not align with their designation at birth when they register for school or sports, adopt, get married, or request personal records.

A person’s sex designation at birth would still be submitted to the U.S. Standard Certificate of Live Birth for medical, public health, and statistical use only, report authors note.

Willie Underwood III, MD, MSc, author of Board Report 15, explained in reference committee testimony that a standard certificate of live birth is critical for uniformly collecting and processing data, but birth certificates are issued by the government to individuals.
 

Ten states allow gender-neutral designation

According to the report, 48 states (Tennessee and Ohio are the exceptions) and the District of Columbia allow people to amend their sex designation on their birth certificate to reflect their gender identities, but only 10 states allow for a gender-neutral designation, usually “X,” on birth certificates. The U.S. Department of State does not currently offer an option for a gender-neutral designation on U.S. passports.

“Assigning sex using binary variables in the public portion of the birth certificate fails to recognize the medical spectrum of gender identity,” Dr. Underwood said, and it can be used to discriminate.

Jeremy Toler, MD, a delegate from GLMA: Health Professionals Advancing LGBTQ Equality, testified that there is precedent for information to be removed from the public portion of the birth certificates. And much data is collected for each live birth that doesn’t show up on individuals’ birth certificates, he noted.

Dr. Toler said transgender, gender nonbinary, and individuals with differences in sex development can be placed at a disadvantage by the sex label on the birth certificate.

“We unfortunately still live in a world where it is unsafe in many cases for one’s gender to vary from the sex assigned at birth,” Dr. Toler said.

Not having this data on the widely used form will reduce unnecessary reliance on sex as a stand-in for gender, he said, and would “serve as an equalizer” since policies differ by state.

Robert Jackson, MD, an alternate delegate from the American Academy of Cosmetic Surgery, spoke against the measure.

“We as physicians need to report things accurately,” Dr. Jackson said. “All through medical school, residency, and specialty training we were supposed to delegate all of the physical findings of the patient we’re taking care of. I think when the child is born, they do have physical characteristics either male or female, and I think that probably should be on the public record. That’s just my personal opinion.”

Sarah Mae Smith, MD, delegate from California, speaking on behalf of the Women Physicians Section, said removing the sex designation is important for moving toward gender equity.

“We need to recognize [that] gender is not a binary but a spectrum,” she said. “Obligating our patients to jump through numerous administrative hoops to identify as who they are based on a sex assigned at birth primarily on genitalia is not only unnecessary but actively deleterious to their health.”
 

Race was once public on birth certificates

She noted that the report mentions that previously, information on the race of a person’s parents was included on the public portion of the birth certificate and that information was recognized to facilitate discrimination.

“Thankfully, a change was made to obviate at least that avenue for discriminatory practices,” she said. “Now, likewise, the information on sex assigned at birth is being used to undermine the rights of our transgender, intersex, and nonbinary patients.”

Arlene Seid, MD, MPH, an alternate delegate from the American Association of Public Health Physicians, said the resolution protects the aggregate data “without the discrimination associated with the individual data.”

Sex no longer has a role to play in the jobs people do, she noted, and the designation shouldn’t have to be evaluated for something like a job interview.

“Our society doesn’t need it on an individual basis for most of what occurs in public life,” Dr. Seid said.

Dr. Underwood, Dr. Toler, Dr. Jackson, Dr. Smith, and Dr. Seid declared no relevant financial relationships.

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

People may be absorbing and ingesting potentially toxic chemicals from their cosmetic products, a new study suggests.

Researchers found high fluorine levels in most of the waterproof mascara, liquid lipsticks, and foundations they tested, indicating the probable presence of what’s known as PFAS – per- and polyfluoroalkyl substances. Many of these chemicals were not included on the product labels, making it difficult for consumers to consciously avoid them.

Environmental Science & Technology

“This study is very helpful for elucidating the PFAS content of different types of cosmetics in the U.S. and Canadian markets,” said Elsie Sunderland, PhD, an environmental scientist who was not involved with the study.

“Previously, all the data had been collected in Europe, and this study shows we are dealing with similar problems in the North American marketplace,” said Dr. Sunderland, a professor of environmental chemistry at the Harvard School of Public Health, Boston.

PFAS are a class of chemicals used in a variety of consumer products, such as nonstick cookware, stain-resistant carpeting, and water-repellent clothing, according to the Centers for Disease Control and Prevention. They are added to cosmetics to make the products more durable and spreadable, researchers said in the study.

“[PFAS] are added to change the properties of surfaces, to make them nonstick or resistant to stay in water or oils,” said study coauthor Tom Bruton, PhD, senior scientist at the Green Science Policy Institute in Berkeley, Calif. “The concerning thing about cosmetics is that these are products that you’re applying to your skin and face every day, so there’s the skin absorption route that’s of concern, but also incidental ingestion of cosmetics is also a concern as well.”

The CDC says some of the potential health effects of PFAS exposure includes increased cholesterol levels, increased risk of kidney and testicular cancer, changes in liver enzymes, decreased vaccine response in children, and a higher risk of high blood pressure or preeclampsia in pregnant women.

JackF/iStock/Getty Images

“PFAS are a large class of chemicals. In humans, exposure to some of these chemicals has been associated with impaired immune function, certain cancers, increased risks of diabetes, obesity and endocrine disruption,” Dr. Sunderland said. “They appear to be harmful to every major organ system in the human body.”

For the current study, published online in Environmental Science & Technology Letters, Dr. Bruton and colleagues purchased 231 cosmetic products in the United States and Canada from retailers such as Ulta Beauty, Sephora, Target, and Bed Bath & Beyond. They then screened them for fluorine.Three-quarters of waterproof mascara samples contained high fluorine concentrations, as did nearly two-thirds of foundations and liquid lipsticks, and more than half of the eye and lip products tested.

The authors found that different categories of makeup tended to have higher or lower fluorine concentrations. “High fluorine levels were found in products commonly advertised as ‘wear-resistant’ to water and oils or ‘long-lasting,’ including foundations, liquid lipsticks, and waterproof mascaras,” Dr. Bruton and colleagues wrote.

When they further analyzed a subset of 29 products to determine what types of chemicals were present, they found that each cosmetic product contained at least 4 PFAS, with one product containing 13.The PFAS substances found included some that break down into other chemicals that are known to be highly toxic and environmentally harmful.

“It’s concerning that some of the products we tested appear to be intentionally using PFAS, but not listing those ingredients on the label,” Dr. Bruton said. “I do think that it is helpful for consumers to read labels, but beyond that, there’s not a lot of ways that consumers themselves can solve this problem. ... We think that the industry needs to be more proactive about moving away from this group of chemicals.”

Dr. Sunderland said a resource people can use when trying to avoid PFAS is the Environmental Working Group, a nonprofit organization that maintains an extensive database of cosmetics and personal care products.

“At this point, there is very little regulatory activity related to PFAS in cosmetics,” Dr. Sunderland said. “The best thing to happen now would be for consumers to indicate that they prefer products without PFAS and to demand better transparency in product ingredient lists.”

A similar study done in 2018 by the Danish Environmental Protection Agency found high levels of PFAS in nearly one-third of the cosmetics products it tested.

People can also be exposed to PFAS by eating or drinking contaminated food or water and through food packaging. Dr. Sunderland said some wild foods like seafood are known to accumulate these compounds in the environment.

“There are examples of contaminated biosolids leading to accumulation of PFAS in vegetables and milk,” Dr. Sunderland explained. “Food packaging is another concern because it can also result in PFAS accumulation in the foods we eat.”

Although it’s difficult to avoid PFAS altogether, the CDC suggests lowering exposure rates by avoiding contaminated water and food. If you’re not sure if your water is contaminated, you should ask your local or state health and environmental quality departments for fish or water advisories in your area.

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

People may be absorbing and ingesting potentially toxic chemicals from their cosmetic products, a new study suggests.

Researchers found high fluorine levels in most of the waterproof mascara, liquid lipsticks, and foundations they tested, indicating the probable presence of what’s known as PFAS – per- and polyfluoroalkyl substances. Many of these chemicals were not included on the product labels, making it difficult for consumers to consciously avoid them.

Environmental Science & Technology

“This study is very helpful for elucidating the PFAS content of different types of cosmetics in the U.S. and Canadian markets,” said Elsie Sunderland, PhD, an environmental scientist who was not involved with the study.

“Previously, all the data had been collected in Europe, and this study shows we are dealing with similar problems in the North American marketplace,” said Dr. Sunderland, a professor of environmental chemistry at the Harvard School of Public Health, Boston.

PFAS are a class of chemicals used in a variety of consumer products, such as nonstick cookware, stain-resistant carpeting, and water-repellent clothing, according to the Centers for Disease Control and Prevention. They are added to cosmetics to make the products more durable and spreadable, researchers said in the study.

“[PFAS] are added to change the properties of surfaces, to make them nonstick or resistant to stay in water or oils,” said study coauthor Tom Bruton, PhD, senior scientist at the Green Science Policy Institute in Berkeley, Calif. “The concerning thing about cosmetics is that these are products that you’re applying to your skin and face every day, so there’s the skin absorption route that’s of concern, but also incidental ingestion of cosmetics is also a concern as well.”

The CDC says some of the potential health effects of PFAS exposure includes increased cholesterol levels, increased risk of kidney and testicular cancer, changes in liver enzymes, decreased vaccine response in children, and a higher risk of high blood pressure or preeclampsia in pregnant women.

JackF/iStock/Getty Images

“PFAS are a large class of chemicals. In humans, exposure to some of these chemicals has been associated with impaired immune function, certain cancers, increased risks of diabetes, obesity and endocrine disruption,” Dr. Sunderland said. “They appear to be harmful to every major organ system in the human body.”

For the current study, published online in Environmental Science & Technology Letters, Dr. Bruton and colleagues purchased 231 cosmetic products in the United States and Canada from retailers such as Ulta Beauty, Sephora, Target, and Bed Bath & Beyond. They then screened them for fluorine.Three-quarters of waterproof mascara samples contained high fluorine concentrations, as did nearly two-thirds of foundations and liquid lipsticks, and more than half of the eye and lip products tested.

The authors found that different categories of makeup tended to have higher or lower fluorine concentrations. “High fluorine levels were found in products commonly advertised as ‘wear-resistant’ to water and oils or ‘long-lasting,’ including foundations, liquid lipsticks, and waterproof mascaras,” Dr. Bruton and colleagues wrote.

When they further analyzed a subset of 29 products to determine what types of chemicals were present, they found that each cosmetic product contained at least 4 PFAS, with one product containing 13.The PFAS substances found included some that break down into other chemicals that are known to be highly toxic and environmentally harmful.

“It’s concerning that some of the products we tested appear to be intentionally using PFAS, but not listing those ingredients on the label,” Dr. Bruton said. “I do think that it is helpful for consumers to read labels, but beyond that, there’s not a lot of ways that consumers themselves can solve this problem. ... We think that the industry needs to be more proactive about moving away from this group of chemicals.”

Dr. Sunderland said a resource people can use when trying to avoid PFAS is the Environmental Working Group, a nonprofit organization that maintains an extensive database of cosmetics and personal care products.

“At this point, there is very little regulatory activity related to PFAS in cosmetics,” Dr. Sunderland said. “The best thing to happen now would be for consumers to indicate that they prefer products without PFAS and to demand better transparency in product ingredient lists.”

A similar study done in 2018 by the Danish Environmental Protection Agency found high levels of PFAS in nearly one-third of the cosmetics products it tested.

People can also be exposed to PFAS by eating or drinking contaminated food or water and through food packaging. Dr. Sunderland said some wild foods like seafood are known to accumulate these compounds in the environment.

“There are examples of contaminated biosolids leading to accumulation of PFAS in vegetables and milk,” Dr. Sunderland explained. “Food packaging is another concern because it can also result in PFAS accumulation in the foods we eat.”

Although it’s difficult to avoid PFAS altogether, the CDC suggests lowering exposure rates by avoiding contaminated water and food. If you’re not sure if your water is contaminated, you should ask your local or state health and environmental quality departments for fish or water advisories in your area.

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

People may be absorbing and ingesting potentially toxic chemicals from their cosmetic products, a new study suggests.

Researchers found high fluorine levels in most of the waterproof mascara, liquid lipsticks, and foundations they tested, indicating the probable presence of what’s known as PFAS – per- and polyfluoroalkyl substances. Many of these chemicals were not included on the product labels, making it difficult for consumers to consciously avoid them.

Environmental Science & Technology

“This study is very helpful for elucidating the PFAS content of different types of cosmetics in the U.S. and Canadian markets,” said Elsie Sunderland, PhD, an environmental scientist who was not involved with the study.

“Previously, all the data had been collected in Europe, and this study shows we are dealing with similar problems in the North American marketplace,” said Dr. Sunderland, a professor of environmental chemistry at the Harvard School of Public Health, Boston.

PFAS are a class of chemicals used in a variety of consumer products, such as nonstick cookware, stain-resistant carpeting, and water-repellent clothing, according to the Centers for Disease Control and Prevention. They are added to cosmetics to make the products more durable and spreadable, researchers said in the study.

“[PFAS] are added to change the properties of surfaces, to make them nonstick or resistant to stay in water or oils,” said study coauthor Tom Bruton, PhD, senior scientist at the Green Science Policy Institute in Berkeley, Calif. “The concerning thing about cosmetics is that these are products that you’re applying to your skin and face every day, so there’s the skin absorption route that’s of concern, but also incidental ingestion of cosmetics is also a concern as well.”

The CDC says some of the potential health effects of PFAS exposure includes increased cholesterol levels, increased risk of kidney and testicular cancer, changes in liver enzymes, decreased vaccine response in children, and a higher risk of high blood pressure or preeclampsia in pregnant women.

JackF/iStock/Getty Images

“PFAS are a large class of chemicals. In humans, exposure to some of these chemicals has been associated with impaired immune function, certain cancers, increased risks of diabetes, obesity and endocrine disruption,” Dr. Sunderland said. “They appear to be harmful to every major organ system in the human body.”

For the current study, published online in Environmental Science & Technology Letters, Dr. Bruton and colleagues purchased 231 cosmetic products in the United States and Canada from retailers such as Ulta Beauty, Sephora, Target, and Bed Bath & Beyond. They then screened them for fluorine.Three-quarters of waterproof mascara samples contained high fluorine concentrations, as did nearly two-thirds of foundations and liquid lipsticks, and more than half of the eye and lip products tested.

The authors found that different categories of makeup tended to have higher or lower fluorine concentrations. “High fluorine levels were found in products commonly advertised as ‘wear-resistant’ to water and oils or ‘long-lasting,’ including foundations, liquid lipsticks, and waterproof mascaras,” Dr. Bruton and colleagues wrote.

When they further analyzed a subset of 29 products to determine what types of chemicals were present, they found that each cosmetic product contained at least 4 PFAS, with one product containing 13.The PFAS substances found included some that break down into other chemicals that are known to be highly toxic and environmentally harmful.

“It’s concerning that some of the products we tested appear to be intentionally using PFAS, but not listing those ingredients on the label,” Dr. Bruton said. “I do think that it is helpful for consumers to read labels, but beyond that, there’s not a lot of ways that consumers themselves can solve this problem. ... We think that the industry needs to be more proactive about moving away from this group of chemicals.”

Dr. Sunderland said a resource people can use when trying to avoid PFAS is the Environmental Working Group, a nonprofit organization that maintains an extensive database of cosmetics and personal care products.

“At this point, there is very little regulatory activity related to PFAS in cosmetics,” Dr. Sunderland said. “The best thing to happen now would be for consumers to indicate that they prefer products without PFAS and to demand better transparency in product ingredient lists.”

A similar study done in 2018 by the Danish Environmental Protection Agency found high levels of PFAS in nearly one-third of the cosmetics products it tested.

People can also be exposed to PFAS by eating or drinking contaminated food or water and through food packaging. Dr. Sunderland said some wild foods like seafood are known to accumulate these compounds in the environment.

“There are examples of contaminated biosolids leading to accumulation of PFAS in vegetables and milk,” Dr. Sunderland explained. “Food packaging is another concern because it can also result in PFAS accumulation in the foods we eat.”

Although it’s difficult to avoid PFAS altogether, the CDC suggests lowering exposure rates by avoiding contaminated water and food. If you’re not sure if your water is contaminated, you should ask your local or state health and environmental quality departments for fish or water advisories in your area.

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

Advances in photobiomodulation have propelled the use of therapeutic applications in a variety of medical specialties, according to Juanita J. Anders, PhD.

During the annual conference of the American Society for Laser Medicine and Surgery, Dr. Anders, professor of anatomy, physiology, and genetics at the Uniformed Services University of the Health Sciences, Bethesda, Md., defined photobiomodulation (PBM) as the mechanism by which nonionizing optical radiation in the visible and near-infrared spectral range is absorbed by endogenous chromophores to elicit photophysical and photochemical events at various biological scales. Photobiomodulation therapy (PBMT) involves the use of light sources including lasers, LEDs, and broadband light, that emit visible and/or near-infrared light to cause physiological changes in cells and tissues and result in therapeutic benefits.

In dermatology, LED light therapy devices are commonly used for PBMT in wavelengths that range from blue (415 nm) and red (633 nm) to near infrared (830 nm). “Often, when PBMT is referred to by dermatologists it’s called LED therapy or LED light therapy,” Dr. Anders noted. “Some people are under the impression that this is different from PBMT. But remember: It’s not the device that’s producing the photons that is clinically relevant, but it’s the photons themselves. In both cases, the same radiances and fluence ranges are being used and the mechanisms are the same, so it’s all PBMT.”

The therapy is used to treat a wide variety of medical and aesthetic disorders including acne vulgaris, psoriasis, burns, and wound healing. It has also been used in conjunction with surgical aesthetic and resurfacing procedures and has been reported to reduce erythema, edema, bruising, and days to healing. It’s been shown that PBMT stimulates fibroblast proliferation, collagen synthesis, and extracellular matrix resulting in lifting and tightening lax skin.

According to Dr. Anders, French dermatologists Linda Fouque, MD, and Michele Pelletier, MD, performed a series of in vivo and in vitro studies in which they tested the effects of yellow and red light for skin rejuvenation when used individually or in combination. “They found that fibroblasts and keratinocytes in vitro had great improvement in their morphology both with the yellow and red light, but the best improvement was seen with combination therapy,” Dr. Anders said. “This held true in their work looking at epidermal and dermal markers in the skin, where they found the best up-regulation in protein synthesis of such markers as collagens and fibronectin were produced when a combination wavelength light was used.”

Oral mucositis and pain

PBMT is also being used to treat oral mucositis (OM), a common adverse response to chemotherapy and/or radiation therapy, which causes pain, difficulty in swallowing and eating, and oral ulceration, and often interrupts the course of treatments. Authors of a recently published review on the risks and benefits of PBMT concluded that there is consistent evidence from a small number of high-quality studies that PBMT can help prevent the development of cancer therapy–induced OM, reduce pain intensity, as well as promote healing, and enhance patient quality of life.

“They also cautioned that, due to the limited long-term follow-up of patients, there is still concern for the potential long-term risks of PBMT in cancer cell mutation and amplification,” Dr. Anders said. “They advised that PBMT should be used carefully when the irradiation beam is in the direction of the tumor zone.”

Using PBMT for modulation of pain is another area of active research. Based on work from the laboratory of Dr. Anders and others, there are two methods to modulate pain. The first is to target tissue at irradiances below 100 mW/cm².

“In my laboratory, based on in vivo preclinical animal models of neuropathic pain, we used a 980-nm wavelength laser at 43.25 mW/cm² transcutaneously delivered to the level of the nerve for 20 seconds,” said Dr. Anders, who is a past president of the ASLMS. “Essentially, we found that the pain was modulated by reducing sensitivity to mechanical stimulation and also by causing an anti-inflammatory shift in microglial and macrophage phenotype in the dorsal root ganglion and spinal cord of affected segments.”

The second way to modulate pain, she continued, is to target tissue at irradiances above 250 mW/cm². She and her colleagues have conducted in vitro and in vivo studies, which indicate that treatment with an irradiance/fluence rate at 270 mW/cm² or higher at the nerve can rapidly block pain transmission.

“In vitro, we found that if we used an 810-nm wavelength light at 300 mW/cm², we got a disruption of microtubules in the DRG neurons in culture, specifically the small neurons, the nociceptive fibers, but we did not affect the proprioceptive fibers unless we increased the length of the treatment,” she said. “We essentially found the same thing in vivo in a rodent model of neuropathic pain.”

In a pilot study, Dr. Anders and coauthors examined the efficacy of laser irradiation of the dorsal root ganglion of the second lumbar spinal nerve for patients with chronic back pain.

They found that PBMT effectively reduced back pain equal to the effects of lidocaine.

Based on these two irradiation approaches of targeting tissue, Dr. Anders recommends that a combination therapy be used to modulate neuropathic pain going forward. “This approach would involve the initial use of a high-irradiance treatment [at least 250 mW/cm²] at the nerve to block the pain transmission,” she said. “That treatment would be followed by a series of low-irradiance treatments [10-100 mW/cm²] along the course of the involved nerve to alter chronic pathology and inflammation.”
 

Potential applications in neurology

Dr. Anders also discussed research efforts under way involving transcranial PBMT: the delivery of near-infrared light through the tissues of the scalp and skull to targeted brain regions to treat neurologic injuries and disorders. “There have been some exciting results in preclinical animal work and in small clinical pilot work that show that there could be possible beneficial effects in Parkinson’s disease, Alzheimer’s disease, depression, and improvement in cognition and memory after a brain injury, such as a TBI,” she said.

“Initially, though, there were a lot of questions about whether you could really deliver light to the brain through the scalp. In my laboratory, we used slices of nonfixed brain and found that the sulci within the human brain act as light-wave guides. We used an 808-nm near-infrared wavelength of light, so that the light could penetrate more deeply.” Using nonfixed cadaver heads, where the light was applied at the scalp surface, Dr. Anders and colleagues were able to measure photons down to the depth of 4 cm. “It’s generally agreed now, though, that it’s to a maximum depth of 2.5-3 cm that enough photons are delivered that would cause a beneficial therapeutic effect,” she said.

Dr. Anders disclosed that she has received equipment from LiteCure, grant funding from the Department of Defense, and that she holds advisory board roles with LiteCure and Neurothera. She has also served in leadership roles for the Optical Society and holds intellectual property rights for the Henry M. Jackson Foundation for the Advancement of Military Medicine.

[email protected]

Advances in photobiomodulation have propelled the use of therapeutic applications in a variety of medical specialties, according to Juanita J. Anders, PhD.

During the annual conference of the American Society for Laser Medicine and Surgery, Dr. Anders, professor of anatomy, physiology, and genetics at the Uniformed Services University of the Health Sciences, Bethesda, Md., defined photobiomodulation (PBM) as the mechanism by which nonionizing optical radiation in the visible and near-infrared spectral range is absorbed by endogenous chromophores to elicit photophysical and photochemical events at various biological scales. Photobiomodulation therapy (PBMT) involves the use of light sources including lasers, LEDs, and broadband light, that emit visible and/or near-infrared light to cause physiological changes in cells and tissues and result in therapeutic benefits.

In dermatology, LED light therapy devices are commonly used for PBMT in wavelengths that range from blue (415 nm) and red (633 nm) to near infrared (830 nm). “Often, when PBMT is referred to by dermatologists it’s called LED therapy or LED light therapy,” Dr. Anders noted. “Some people are under the impression that this is different from PBMT. But remember: It’s not the device that’s producing the photons that is clinically relevant, but it’s the photons themselves. In both cases, the same radiances and fluence ranges are being used and the mechanisms are the same, so it’s all PBMT.”

The therapy is used to treat a wide variety of medical and aesthetic disorders including acne vulgaris, psoriasis, burns, and wound healing. It has also been used in conjunction with surgical aesthetic and resurfacing procedures and has been reported to reduce erythema, edema, bruising, and days to healing. It’s been shown that PBMT stimulates fibroblast proliferation, collagen synthesis, and extracellular matrix resulting in lifting and tightening lax skin.

According to Dr. Anders, French dermatologists Linda Fouque, MD, and Michele Pelletier, MD, performed a series of in vivo and in vitro studies in which they tested the effects of yellow and red light for skin rejuvenation when used individually or in combination. “They found that fibroblasts and keratinocytes in vitro had great improvement in their morphology both with the yellow and red light, but the best improvement was seen with combination therapy,” Dr. Anders said. “This held true in their work looking at epidermal and dermal markers in the skin, where they found the best up-regulation in protein synthesis of such markers as collagens and fibronectin were produced when a combination wavelength light was used.”

Oral mucositis and pain

PBMT is also being used to treat oral mucositis (OM), a common adverse response to chemotherapy and/or radiation therapy, which causes pain, difficulty in swallowing and eating, and oral ulceration, and often interrupts the course of treatments. Authors of a recently published review on the risks and benefits of PBMT concluded that there is consistent evidence from a small number of high-quality studies that PBMT can help prevent the development of cancer therapy–induced OM, reduce pain intensity, as well as promote healing, and enhance patient quality of life.

“They also cautioned that, due to the limited long-term follow-up of patients, there is still concern for the potential long-term risks of PBMT in cancer cell mutation and amplification,” Dr. Anders said. “They advised that PBMT should be used carefully when the irradiation beam is in the direction of the tumor zone.”

Using PBMT for modulation of pain is another area of active research. Based on work from the laboratory of Dr. Anders and others, there are two methods to modulate pain. The first is to target tissue at irradiances below 100 mW/cm².

“In my laboratory, based on in vivo preclinical animal models of neuropathic pain, we used a 980-nm wavelength laser at 43.25 mW/cm² transcutaneously delivered to the level of the nerve for 20 seconds,” said Dr. Anders, who is a past president of the ASLMS. “Essentially, we found that the pain was modulated by reducing sensitivity to mechanical stimulation and also by causing an anti-inflammatory shift in microglial and macrophage phenotype in the dorsal root ganglion and spinal cord of affected segments.”

The second way to modulate pain, she continued, is to target tissue at irradiances above 250 mW/cm². She and her colleagues have conducted in vitro and in vivo studies, which indicate that treatment with an irradiance/fluence rate at 270 mW/cm² or higher at the nerve can rapidly block pain transmission.

“In vitro, we found that if we used an 810-nm wavelength light at 300 mW/cm², we got a disruption of microtubules in the DRG neurons in culture, specifically the small neurons, the nociceptive fibers, but we did not affect the proprioceptive fibers unless we increased the length of the treatment,” she said. “We essentially found the same thing in vivo in a rodent model of neuropathic pain.”

In a pilot study, Dr. Anders and coauthors examined the efficacy of laser irradiation of the dorsal root ganglion of the second lumbar spinal nerve for patients with chronic back pain.

They found that PBMT effectively reduced back pain equal to the effects of lidocaine.

Based on these two irradiation approaches of targeting tissue, Dr. Anders recommends that a combination therapy be used to modulate neuropathic pain going forward. “This approach would involve the initial use of a high-irradiance treatment [at least 250 mW/cm²] at the nerve to block the pain transmission,” she said. “That treatment would be followed by a series of low-irradiance treatments [10-100 mW/cm²] along the course of the involved nerve to alter chronic pathology and inflammation.”
 

Potential applications in neurology

Dr. Anders also discussed research efforts under way involving transcranial PBMT: the delivery of near-infrared light through the tissues of the scalp and skull to targeted brain regions to treat neurologic injuries and disorders. “There have been some exciting results in preclinical animal work and in small clinical pilot work that show that there could be possible beneficial effects in Parkinson’s disease, Alzheimer’s disease, depression, and improvement in cognition and memory after a brain injury, such as a TBI,” she said.

“Initially, though, there were a lot of questions about whether you could really deliver light to the brain through the scalp. In my laboratory, we used slices of nonfixed brain and found that the sulci within the human brain act as light-wave guides. We used an 808-nm near-infrared wavelength of light, so that the light could penetrate more deeply.” Using nonfixed cadaver heads, where the light was applied at the scalp surface, Dr. Anders and colleagues were able to measure photons down to the depth of 4 cm. “It’s generally agreed now, though, that it’s to a maximum depth of 2.5-3 cm that enough photons are delivered that would cause a beneficial therapeutic effect,” she said.

Dr. Anders disclosed that she has received equipment from LiteCure, grant funding from the Department of Defense, and that she holds advisory board roles with LiteCure and Neurothera. She has also served in leadership roles for the Optical Society and holds intellectual property rights for the Henry M. Jackson Foundation for the Advancement of Military Medicine.

[email protected]

Advances in photobiomodulation have propelled the use of therapeutic applications in a variety of medical specialties, according to Juanita J. Anders, PhD.

During the annual conference of the American Society for Laser Medicine and Surgery, Dr. Anders, professor of anatomy, physiology, and genetics at the Uniformed Services University of the Health Sciences, Bethesda, Md., defined photobiomodulation (PBM) as the mechanism by which nonionizing optical radiation in the visible and near-infrared spectral range is absorbed by endogenous chromophores to elicit photophysical and photochemical events at various biological scales. Photobiomodulation therapy (PBMT) involves the use of light sources including lasers, LEDs, and broadband light, that emit visible and/or near-infrared light to cause physiological changes in cells and tissues and result in therapeutic benefits.

In dermatology, LED light therapy devices are commonly used for PBMT in wavelengths that range from blue (415 nm) and red (633 nm) to near infrared (830 nm). “Often, when PBMT is referred to by dermatologists it’s called LED therapy or LED light therapy,” Dr. Anders noted. “Some people are under the impression that this is different from PBMT. But remember: It’s not the device that’s producing the photons that is clinically relevant, but it’s the photons themselves. In both cases, the same radiances and fluence ranges are being used and the mechanisms are the same, so it’s all PBMT.”

The therapy is used to treat a wide variety of medical and aesthetic disorders including acne vulgaris, psoriasis, burns, and wound healing. It has also been used in conjunction with surgical aesthetic and resurfacing procedures and has been reported to reduce erythema, edema, bruising, and days to healing. It’s been shown that PBMT stimulates fibroblast proliferation, collagen synthesis, and extracellular matrix resulting in lifting and tightening lax skin.

According to Dr. Anders, French dermatologists Linda Fouque, MD, and Michele Pelletier, MD, performed a series of in vivo and in vitro studies in which they tested the effects of yellow and red light for skin rejuvenation when used individually or in combination. “They found that fibroblasts and keratinocytes in vitro had great improvement in their morphology both with the yellow and red light, but the best improvement was seen with combination therapy,” Dr. Anders said. “This held true in their work looking at epidermal and dermal markers in the skin, where they found the best up-regulation in protein synthesis of such markers as collagens and fibronectin were produced when a combination wavelength light was used.”

Oral mucositis and pain

PBMT is also being used to treat oral mucositis (OM), a common adverse response to chemotherapy and/or radiation therapy, which causes pain, difficulty in swallowing and eating, and oral ulceration, and often interrupts the course of treatments. Authors of a recently published review on the risks and benefits of PBMT concluded that there is consistent evidence from a small number of high-quality studies that PBMT can help prevent the development of cancer therapy–induced OM, reduce pain intensity, as well as promote healing, and enhance patient quality of life.

“They also cautioned that, due to the limited long-term follow-up of patients, there is still concern for the potential long-term risks of PBMT in cancer cell mutation and amplification,” Dr. Anders said. “They advised that PBMT should be used carefully when the irradiation beam is in the direction of the tumor zone.”

Using PBMT for modulation of pain is another area of active research. Based on work from the laboratory of Dr. Anders and others, there are two methods to modulate pain. The first is to target tissue at irradiances below 100 mW/cm².

“In my laboratory, based on in vivo preclinical animal models of neuropathic pain, we used a 980-nm wavelength laser at 43.25 mW/cm² transcutaneously delivered to the level of the nerve for 20 seconds,” said Dr. Anders, who is a past president of the ASLMS. “Essentially, we found that the pain was modulated by reducing sensitivity to mechanical stimulation and also by causing an anti-inflammatory shift in microglial and macrophage phenotype in the dorsal root ganglion and spinal cord of affected segments.”

The second way to modulate pain, she continued, is to target tissue at irradiances above 250 mW/cm². She and her colleagues have conducted in vitro and in vivo studies, which indicate that treatment with an irradiance/fluence rate at 270 mW/cm² or higher at the nerve can rapidly block pain transmission.

“In vitro, we found that if we used an 810-nm wavelength light at 300 mW/cm², we got a disruption of microtubules in the DRG neurons in culture, specifically the small neurons, the nociceptive fibers, but we did not affect the proprioceptive fibers unless we increased the length of the treatment,” she said. “We essentially found the same thing in vivo in a rodent model of neuropathic pain.”

In a pilot study, Dr. Anders and coauthors examined the efficacy of laser irradiation of the dorsal root ganglion of the second lumbar spinal nerve for patients with chronic back pain.

They found that PBMT effectively reduced back pain equal to the effects of lidocaine.

Based on these two irradiation approaches of targeting tissue, Dr. Anders recommends that a combination therapy be used to modulate neuropathic pain going forward. “This approach would involve the initial use of a high-irradiance treatment [at least 250 mW/cm²] at the nerve to block the pain transmission,” she said. “That treatment would be followed by a series of low-irradiance treatments [10-100 mW/cm²] along the course of the involved nerve to alter chronic pathology and inflammation.”
 

Potential applications in neurology

Dr. Anders also discussed research efforts under way involving transcranial PBMT: the delivery of near-infrared light through the tissues of the scalp and skull to targeted brain regions to treat neurologic injuries and disorders. “There have been some exciting results in preclinical animal work and in small clinical pilot work that show that there could be possible beneficial effects in Parkinson’s disease, Alzheimer’s disease, depression, and improvement in cognition and memory after a brain injury, such as a TBI,” she said.

“Initially, though, there were a lot of questions about whether you could really deliver light to the brain through the scalp. In my laboratory, we used slices of nonfixed brain and found that the sulci within the human brain act as light-wave guides. We used an 808-nm near-infrared wavelength of light, so that the light could penetrate more deeply.” Using nonfixed cadaver heads, where the light was applied at the scalp surface, Dr. Anders and colleagues were able to measure photons down to the depth of 4 cm. “It’s generally agreed now, though, that it’s to a maximum depth of 2.5-3 cm that enough photons are delivered that would cause a beneficial therapeutic effect,” she said.

Dr. Anders disclosed that she has received equipment from LiteCure, grant funding from the Department of Defense, and that she holds advisory board roles with LiteCure and Neurothera. She has also served in leadership roles for the Optical Society and holds intellectual property rights for the Henry M. Jackson Foundation for the Advancement of Military Medicine.

[email protected]

Last month we converged virtually for our annual conference, SHM Converge – the second time since the start of the coronavirus pandemic. We are thankful for innovations and advancements in technology that have allowed the world, including SHM, to continue connecting us all together. And yet, 18 months in, having forged new roads, experienced unique and life-changing events, we long for the in-person human connection that allows us to share a common experience. At a time of imperatives in our world – a global pandemic, systemic racism, and deep geopolitical divides – more than ever, we need to converge. Isolation only festers, deepening our divisions and conflicts.

In high school, I read Robert Frost’s poem “The Road Not Taken” and clung to the notion of diverging roads and choosing the road less traveled. Like most young people, my years since reading the poem were filled with attempts at forging new paths and experiencing great things – and yet, always feeling unaccomplished. Was Oscar Wilde right when he wrote: “Life imitates Art far more than Art imitates Life?” After all, these past 18 months, we have shared in the traumas of our times, and still, we remain isolated and alone. Our diverse experiences have been real, both tragic and heroic, from east to west, city to country, black to white, and red to blue.

At SHM, it’s time to converge and face the great challenges of our lifetime. A deadly pandemic continues to rage around the world, bringing unprecedented human suffering and loss of lives. In its wake, this pandemic also laid bare the ugly face of systemic racism, brought our deepest divisions to the surface – all threatening the very fabric of our society. This pandemic has been a stress test for health care systems, revealing our vulnerabilities and expanding the chasm of care between urban and rural communities, all in turn worsening our growing health disparities. This moment needs convergence to rekindle connection and solidarity.

Scholars do not interpret “The Road Not Taken” as a recommendation to take the road less traveled. Instead, it is a suggestion that the diverging roads lead to a common place having been “worn about the same” as they “equally lay.” It is true that our roads are unique and shape our lives, but so, too, does the destination and common place our roads lead us to. At that common place, during these taxing times, SHM enables hospitalists to tackle these great challenges.

For over 2 decades of dynamic changes in health care, SHM has been the workshop where hospitalists converged to sharpen clinical skills, improve quality and safety, develop acute care models inside and outside of hospitals, advocate for better health policy and blaze new trails. Though the issues evolved, and new ones emerge, today is no different.

Indeed, this is an historic time. This weighted moment meets us at the crossroads. A moment that demands synergy, cooperation, and creativity. A dynamic change to health care policy, advances in care innovation, renewed prioritization of public health, and rich national discourse on our social fabric; hospitalists are essential to every one of those conversations. SHM has evolved to meet our growing needs, equipping hospitalists with tools to engage at every level, and most importantly, enabled us to find our common place.

Where do we go now? I suggest we continue to take the roads not taken and at the destination, build the map of tomorrow, together.

Dr. Siy is division medical director, hospital specialties, in the departments of hospital medicine and community senior and palliative care at HealthPartners in Bloomington, Minn. He is the new president of SHM.

Last month we converged virtually for our annual conference, SHM Converge – the second time since the start of the coronavirus pandemic. We are thankful for innovations and advancements in technology that have allowed the world, including SHM, to continue connecting us all together. And yet, 18 months in, having forged new roads, experienced unique and life-changing events, we long for the in-person human connection that allows us to share a common experience. At a time of imperatives in our world – a global pandemic, systemic racism, and deep geopolitical divides – more than ever, we need to converge. Isolation only festers, deepening our divisions and conflicts.

In high school, I read Robert Frost’s poem “The Road Not Taken” and clung to the notion of diverging roads and choosing the road less traveled. Like most young people, my years since reading the poem were filled with attempts at forging new paths and experiencing great things – and yet, always feeling unaccomplished. Was Oscar Wilde right when he wrote: “Life imitates Art far more than Art imitates Life?” After all, these past 18 months, we have shared in the traumas of our times, and still, we remain isolated and alone. Our diverse experiences have been real, both tragic and heroic, from east to west, city to country, black to white, and red to blue.

At SHM, it’s time to converge and face the great challenges of our lifetime. A deadly pandemic continues to rage around the world, bringing unprecedented human suffering and loss of lives. In its wake, this pandemic also laid bare the ugly face of systemic racism, brought our deepest divisions to the surface – all threatening the very fabric of our society. This pandemic has been a stress test for health care systems, revealing our vulnerabilities and expanding the chasm of care between urban and rural communities, all in turn worsening our growing health disparities. This moment needs convergence to rekindle connection and solidarity.

Scholars do not interpret “The Road Not Taken” as a recommendation to take the road less traveled. Instead, it is a suggestion that the diverging roads lead to a common place having been “worn about the same” as they “equally lay.” It is true that our roads are unique and shape our lives, but so, too, does the destination and common place our roads lead us to. At that common place, during these taxing times, SHM enables hospitalists to tackle these great challenges.

For over 2 decades of dynamic changes in health care, SHM has been the workshop where hospitalists converged to sharpen clinical skills, improve quality and safety, develop acute care models inside and outside of hospitals, advocate for better health policy and blaze new trails. Though the issues evolved, and new ones emerge, today is no different.

Indeed, this is an historic time. This weighted moment meets us at the crossroads. A moment that demands synergy, cooperation, and creativity. A dynamic change to health care policy, advances in care innovation, renewed prioritization of public health, and rich national discourse on our social fabric; hospitalists are essential to every one of those conversations. SHM has evolved to meet our growing needs, equipping hospitalists with tools to engage at every level, and most importantly, enabled us to find our common place.

Where do we go now? I suggest we continue to take the roads not taken and at the destination, build the map of tomorrow, together.

Dr. Siy is division medical director, hospital specialties, in the departments of hospital medicine and community senior and palliative care at HealthPartners in Bloomington, Minn. He is the new president of SHM.

Last month we converged virtually for our annual conference, SHM Converge – the second time since the start of the coronavirus pandemic. We are thankful for innovations and advancements in technology that have allowed the world, including SHM, to continue connecting us all together. And yet, 18 months in, having forged new roads, experienced unique and life-changing events, we long for the in-person human connection that allows us to share a common experience. At a time of imperatives in our world – a global pandemic, systemic racism, and deep geopolitical divides – more than ever, we need to converge. Isolation only festers, deepening our divisions and conflicts.

In high school, I read Robert Frost’s poem “The Road Not Taken” and clung to the notion of diverging roads and choosing the road less traveled. Like most young people, my years since reading the poem were filled with attempts at forging new paths and experiencing great things – and yet, always feeling unaccomplished. Was Oscar Wilde right when he wrote: “Life imitates Art far more than Art imitates Life?” After all, these past 18 months, we have shared in the traumas of our times, and still, we remain isolated and alone. Our diverse experiences have been real, both tragic and heroic, from east to west, city to country, black to white, and red to blue.

At SHM, it’s time to converge and face the great challenges of our lifetime. A deadly pandemic continues to rage around the world, bringing unprecedented human suffering and loss of lives. In its wake, this pandemic also laid bare the ugly face of systemic racism, brought our deepest divisions to the surface – all threatening the very fabric of our society. This pandemic has been a stress test for health care systems, revealing our vulnerabilities and expanding the chasm of care between urban and rural communities, all in turn worsening our growing health disparities. This moment needs convergence to rekindle connection and solidarity.

Scholars do not interpret “The Road Not Taken” as a recommendation to take the road less traveled. Instead, it is a suggestion that the diverging roads lead to a common place having been “worn about the same” as they “equally lay.” It is true that our roads are unique and shape our lives, but so, too, does the destination and common place our roads lead us to. At that common place, during these taxing times, SHM enables hospitalists to tackle these great challenges.

For over 2 decades of dynamic changes in health care, SHM has been the workshop where hospitalists converged to sharpen clinical skills, improve quality and safety, develop acute care models inside and outside of hospitals, advocate for better health policy and blaze new trails. Though the issues evolved, and new ones emerge, today is no different.

Indeed, this is an historic time. This weighted moment meets us at the crossroads. A moment that demands synergy, cooperation, and creativity. A dynamic change to health care policy, advances in care innovation, renewed prioritization of public health, and rich national discourse on our social fabric; hospitalists are essential to every one of those conversations. SHM has evolved to meet our growing needs, equipping hospitalists with tools to engage at every level, and most importantly, enabled us to find our common place.

Where do we go now? I suggest we continue to take the roads not taken and at the destination, build the map of tomorrow, together.

Dr. Siy is division medical director, hospital specialties, in the departments of hospital medicine and community senior and palliative care at HealthPartners in Bloomington, Minn. He is the new president of SHM.

Clinical scenario

An 83-year-old man is admitted with a hemiplegic cerebrovascular accident. He is found to have dysphagia, and a nasogastric feeding tube is placed. Over the next several days, his strength begins to recover, and he tolerates his tube feeding well. Discharge to a skilled nursing facility (SNF) for subacute rehabilitation is planned. His swallowing is showing signs of recovery; it has not recovered adequately but is expected to continue to improve such that he is predicted to be independent of tube feeding within 7-14 days. None of the facilities in the region are willing to admit a patient with a nasal feeding tube, despite the anticipated short duration. The patient is medically ready for discharge but is refusing the feeding gastrostomy. “Why would I want a hole in my stomach, if I’m only going to need it for 1-2 weeks and this tube in my nose is working fine and is comfortable?” he pleads with tears in his eyes.

Feeding dysphagic patients after stroke

Dysphagia, potentially leading to aspiration and/or pneumonia, is a common sequela of stroke – up to half of hospitalized patients are affected.¹ When oral intake is contraindicated, patients are often fed by nasogastric tube (NGT) or by surgically or endoscopically placed gastrostomy tube (GT). Without good justification based on outcomes, NGTs are traditionally used when the need for feeding is thought to be short term (<4 weeks) and GTs are used for long term (>4 weeks). However, in 2005, a large multicenter randomized control trial found that the majority of stroke patients with dysphagia that would resolve had resolution within 2-3 weeks. Moreover, outcomes were equivalent or better for patients fed with an NGT versus GT.

The authors concluded by recommending feeding via NGT for 2-3 weeks, after which conversion to GT can be considered if dysphagia persists.¹ Notably, the recommendation allows consideration, and no evidence-based guideline requires or recommends GT be placed based on duration of tube feed dependence. Currently, while nutrition and neurology authorities have adopted these recommendations,^2,3 many authors have noted poor adherence to this guideline, and many find that the median period between stroke and GT placement is 7 days rather than the recommended minimum of 14.^4,5,6 While ignorance can partially explain the lack of widespread compliance,⁶ the policies of posthospital facilities are another culprit. Increasingly, and for a variety of reasons unsupported by the literature, SNFs refuse NGT and require GT.^4,7,8,9

Ethical considerations

The four principles of medical ethics – autonomy, beneficence, nonmaleficence, and justice – can guide clinicians, patients, and family members in decision-making. In our case, by withholding needed and desired treatment (discharge to and treatment by a rehabilitation facility) the patient is being coerced to undergo a procedure he does not want, and clinicians participate in denying him autonomy. Further, given that the evidence, national guidelines, and in fact federal regulations indicate that his preferences are congruent with best practices, pressuring him to accept gastrostomy placement runs afoul of the principles of beneficence and nonmaleficence. Though the mechanism is unclear, early gastrostomy (<14-21 days) is associated with increased risk of death, worse functional outcomes, and a lower rate of return to oral feeding, as well as a significant procedure-specific complication rate.^1,10 By insisting on gastrostomy, we neither act in this patient’s best interests nor “do no harm.”

However, the medical system is complex. The clinician at the bedside can evaluate this scenario, review the national guidelines, discuss the procedure and risks with the patient and family, and conclude that the patient should be discharged with a nasal feeding tube. Nevertheless, if no facility is willing to accept him without a gastrostomy, our decision-making model – previously limited to our patient’s best interests alone – is forced to change. Despite our misgivings, we often conclude that the harm done by an early gastrostomy is outweighed by the harm of remaining unnecessarily in the acute hospital setting. We further worry about other patients lingering in the emergency department for lack of an inpatient bed and the possible – though unknowable – harm done to them.
 

Looking forward

It is an unfortunate fact that medical decision-making must often include factors unrelated to the patient’s best interests, with financial considerations and structural barriers frequently driving deviation from ideal care. Providers and patients navigate these decisions to their best abilities, making compromises when forced. However, with education and professional activism, providers can advocate for the elimination of barriers to providing medically sound and ethically appropriate care. In our experience, delay of gastrostomy placement, until discharge is imminent and planning for postdischarge care is initiated, has resulted in a decrease by half the fraction of patients with tracheostomies who had gastrostomies placed prior to discharge.¹¹ With aggressive outreach and education, we now have nursing homes willing to accept patients with NGTs.

Criteria for admission to discharge facilities can drive medical decision-making that is unethical and unsupported by evidence. Continued efforts to eliminate barriers to appropriate and ethical care have been successful and are encouraged.
 

Dr. Cowan is administrative chief resident in the department of surgery at Columbia University Irving Medical Center, New York. Dr. Seres is professor of medicine in the Institute of Human Nutrition and associate clinical ethicist at Columbia University Irving Medical Center. The authors have no conflicts of interest to disclose.

References

1. Dennis MS et al. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72.

2. Powers W. et al. Stroke. 2018 Mar;49(3):e46-e110.

3. Burgos R et al. Clin Nutr. 2018 Feb;37(1):354-96.

4. Wilmskoetter J et al. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2694-700.

5. George BP et al. Stroke. 2017 Feb;48(2):420-7.

6. Fessler TA. et al. Surg Endosc. 2019 Dec;33(12):4089-97.

7. Burgermaster M et al. Nutr Clin Pract. 2016 Jun;31(3):342-8.

8. Moran C and O’Mahoney S. Curr Opin Gastroenterol. 2015 Mar;31(2):137-42.

9. Gomes CA et al. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008096.

10. Joundi RA et al. Neurology. 2018 Feb 13;90(7):e544-52.

11. Bothra A et al. J Parenter Enteral Nutr. 2018 Feb;42(2):491.

Clinical scenario

An 83-year-old man is admitted with a hemiplegic cerebrovascular accident. He is found to have dysphagia, and a nasogastric feeding tube is placed. Over the next several days, his strength begins to recover, and he tolerates his tube feeding well. Discharge to a skilled nursing facility (SNF) for subacute rehabilitation is planned. His swallowing is showing signs of recovery; it has not recovered adequately but is expected to continue to improve such that he is predicted to be independent of tube feeding within 7-14 days. None of the facilities in the region are willing to admit a patient with a nasal feeding tube, despite the anticipated short duration. The patient is medically ready for discharge but is refusing the feeding gastrostomy. “Why would I want a hole in my stomach, if I’m only going to need it for 1-2 weeks and this tube in my nose is working fine and is comfortable?” he pleads with tears in his eyes.

Feeding dysphagic patients after stroke

Dysphagia, potentially leading to aspiration and/or pneumonia, is a common sequela of stroke – up to half of hospitalized patients are affected.¹ When oral intake is contraindicated, patients are often fed by nasogastric tube (NGT) or by surgically or endoscopically placed gastrostomy tube (GT). Without good justification based on outcomes, NGTs are traditionally used when the need for feeding is thought to be short term (<4 weeks) and GTs are used for long term (>4 weeks). However, in 2005, a large multicenter randomized control trial found that the majority of stroke patients with dysphagia that would resolve had resolution within 2-3 weeks. Moreover, outcomes were equivalent or better for patients fed with an NGT versus GT.

The authors concluded by recommending feeding via NGT for 2-3 weeks, after which conversion to GT can be considered if dysphagia persists.¹ Notably, the recommendation allows consideration, and no evidence-based guideline requires or recommends GT be placed based on duration of tube feed dependence. Currently, while nutrition and neurology authorities have adopted these recommendations,^2,3 many authors have noted poor adherence to this guideline, and many find that the median period between stroke and GT placement is 7 days rather than the recommended minimum of 14.^4,5,6 While ignorance can partially explain the lack of widespread compliance,⁶ the policies of posthospital facilities are another culprit. Increasingly, and for a variety of reasons unsupported by the literature, SNFs refuse NGT and require GT.^4,7,8,9

Ethical considerations

The four principles of medical ethics – autonomy, beneficence, nonmaleficence, and justice – can guide clinicians, patients, and family members in decision-making. In our case, by withholding needed and desired treatment (discharge to and treatment by a rehabilitation facility) the patient is being coerced to undergo a procedure he does not want, and clinicians participate in denying him autonomy. Further, given that the evidence, national guidelines, and in fact federal regulations indicate that his preferences are congruent with best practices, pressuring him to accept gastrostomy placement runs afoul of the principles of beneficence and nonmaleficence. Though the mechanism is unclear, early gastrostomy (<14-21 days) is associated with increased risk of death, worse functional outcomes, and a lower rate of return to oral feeding, as well as a significant procedure-specific complication rate.^1,10 By insisting on gastrostomy, we neither act in this patient’s best interests nor “do no harm.”

However, the medical system is complex. The clinician at the bedside can evaluate this scenario, review the national guidelines, discuss the procedure and risks with the patient and family, and conclude that the patient should be discharged with a nasal feeding tube. Nevertheless, if no facility is willing to accept him without a gastrostomy, our decision-making model – previously limited to our patient’s best interests alone – is forced to change. Despite our misgivings, we often conclude that the harm done by an early gastrostomy is outweighed by the harm of remaining unnecessarily in the acute hospital setting. We further worry about other patients lingering in the emergency department for lack of an inpatient bed and the possible – though unknowable – harm done to them.
 

Looking forward

It is an unfortunate fact that medical decision-making must often include factors unrelated to the patient’s best interests, with financial considerations and structural barriers frequently driving deviation from ideal care. Providers and patients navigate these decisions to their best abilities, making compromises when forced. However, with education and professional activism, providers can advocate for the elimination of barriers to providing medically sound and ethically appropriate care. In our experience, delay of gastrostomy placement, until discharge is imminent and planning for postdischarge care is initiated, has resulted in a decrease by half the fraction of patients with tracheostomies who had gastrostomies placed prior to discharge.¹¹ With aggressive outreach and education, we now have nursing homes willing to accept patients with NGTs.

Criteria for admission to discharge facilities can drive medical decision-making that is unethical and unsupported by evidence. Continued efforts to eliminate barriers to appropriate and ethical care have been successful and are encouraged.
 

Dr. Cowan is administrative chief resident in the department of surgery at Columbia University Irving Medical Center, New York. Dr. Seres is professor of medicine in the Institute of Human Nutrition and associate clinical ethicist at Columbia University Irving Medical Center. The authors have no conflicts of interest to disclose.

References

1. Dennis MS et al. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72.

2. Powers W. et al. Stroke. 2018 Mar;49(3):e46-e110.

3. Burgos R et al. Clin Nutr. 2018 Feb;37(1):354-96.

4. Wilmskoetter J et al. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2694-700.

5. George BP et al. Stroke. 2017 Feb;48(2):420-7.

6. Fessler TA. et al. Surg Endosc. 2019 Dec;33(12):4089-97.

7. Burgermaster M et al. Nutr Clin Pract. 2016 Jun;31(3):342-8.

8. Moran C and O’Mahoney S. Curr Opin Gastroenterol. 2015 Mar;31(2):137-42.

9. Gomes CA et al. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008096.

10. Joundi RA et al. Neurology. 2018 Feb 13;90(7):e544-52.

11. Bothra A et al. J Parenter Enteral Nutr. 2018 Feb;42(2):491.

Clinical scenario

An 83-year-old man is admitted with a hemiplegic cerebrovascular accident. He is found to have dysphagia, and a nasogastric feeding tube is placed. Over the next several days, his strength begins to recover, and he tolerates his tube feeding well. Discharge to a skilled nursing facility (SNF) for subacute rehabilitation is planned. His swallowing is showing signs of recovery; it has not recovered adequately but is expected to continue to improve such that he is predicted to be independent of tube feeding within 7-14 days. None of the facilities in the region are willing to admit a patient with a nasal feeding tube, despite the anticipated short duration. The patient is medically ready for discharge but is refusing the feeding gastrostomy. “Why would I want a hole in my stomach, if I’m only going to need it for 1-2 weeks and this tube in my nose is working fine and is comfortable?” he pleads with tears in his eyes.

Feeding dysphagic patients after stroke

Dysphagia, potentially leading to aspiration and/or pneumonia, is a common sequela of stroke – up to half of hospitalized patients are affected.¹ When oral intake is contraindicated, patients are often fed by nasogastric tube (NGT) or by surgically or endoscopically placed gastrostomy tube (GT). Without good justification based on outcomes, NGTs are traditionally used when the need for feeding is thought to be short term (<4 weeks) and GTs are used for long term (>4 weeks). However, in 2005, a large multicenter randomized control trial found that the majority of stroke patients with dysphagia that would resolve had resolution within 2-3 weeks. Moreover, outcomes were equivalent or better for patients fed with an NGT versus GT.

The authors concluded by recommending feeding via NGT for 2-3 weeks, after which conversion to GT can be considered if dysphagia persists.¹ Notably, the recommendation allows consideration, and no evidence-based guideline requires or recommends GT be placed based on duration of tube feed dependence. Currently, while nutrition and neurology authorities have adopted these recommendations,^2,3 many authors have noted poor adherence to this guideline, and many find that the median period between stroke and GT placement is 7 days rather than the recommended minimum of 14.^4,5,6 While ignorance can partially explain the lack of widespread compliance,⁶ the policies of posthospital facilities are another culprit. Increasingly, and for a variety of reasons unsupported by the literature, SNFs refuse NGT and require GT.^4,7,8,9

Ethical considerations

The four principles of medical ethics – autonomy, beneficence, nonmaleficence, and justice – can guide clinicians, patients, and family members in decision-making. In our case, by withholding needed and desired treatment (discharge to and treatment by a rehabilitation facility) the patient is being coerced to undergo a procedure he does not want, and clinicians participate in denying him autonomy. Further, given that the evidence, national guidelines, and in fact federal regulations indicate that his preferences are congruent with best practices, pressuring him to accept gastrostomy placement runs afoul of the principles of beneficence and nonmaleficence. Though the mechanism is unclear, early gastrostomy (<14-21 days) is associated with increased risk of death, worse functional outcomes, and a lower rate of return to oral feeding, as well as a significant procedure-specific complication rate.^1,10 By insisting on gastrostomy, we neither act in this patient’s best interests nor “do no harm.”

However, the medical system is complex. The clinician at the bedside can evaluate this scenario, review the national guidelines, discuss the procedure and risks with the patient and family, and conclude that the patient should be discharged with a nasal feeding tube. Nevertheless, if no facility is willing to accept him without a gastrostomy, our decision-making model – previously limited to our patient’s best interests alone – is forced to change. Despite our misgivings, we often conclude that the harm done by an early gastrostomy is outweighed by the harm of remaining unnecessarily in the acute hospital setting. We further worry about other patients lingering in the emergency department for lack of an inpatient bed and the possible – though unknowable – harm done to them.
 

Looking forward

It is an unfortunate fact that medical decision-making must often include factors unrelated to the patient’s best interests, with financial considerations and structural barriers frequently driving deviation from ideal care. Providers and patients navigate these decisions to their best abilities, making compromises when forced. However, with education and professional activism, providers can advocate for the elimination of barriers to providing medically sound and ethically appropriate care. In our experience, delay of gastrostomy placement, until discharge is imminent and planning for postdischarge care is initiated, has resulted in a decrease by half the fraction of patients with tracheostomies who had gastrostomies placed prior to discharge.¹¹ With aggressive outreach and education, we now have nursing homes willing to accept patients with NGTs.

Criteria for admission to discharge facilities can drive medical decision-making that is unethical and unsupported by evidence. Continued efforts to eliminate barriers to appropriate and ethical care have been successful and are encouraged.
 

Dr. Cowan is administrative chief resident in the department of surgery at Columbia University Irving Medical Center, New York. Dr. Seres is professor of medicine in the Institute of Human Nutrition and associate clinical ethicist at Columbia University Irving Medical Center. The authors have no conflicts of interest to disclose.

References

1. Dennis MS et al. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72.

2. Powers W. et al. Stroke. 2018 Mar;49(3):e46-e110.

3. Burgos R et al. Clin Nutr. 2018 Feb;37(1):354-96.

4. Wilmskoetter J et al. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2694-700.

5. George BP et al. Stroke. 2017 Feb;48(2):420-7.

6. Fessler TA. et al. Surg Endosc. 2019 Dec;33(12):4089-97.

7. Burgermaster M et al. Nutr Clin Pract. 2016 Jun;31(3):342-8.

8. Moran C and O’Mahoney S. Curr Opin Gastroenterol. 2015 Mar;31(2):137-42.

9. Gomes CA et al. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008096.

10. Joundi RA et al. Neurology. 2018 Feb 13;90(7):e544-52.

11. Bothra A et al. J Parenter Enteral Nutr. 2018 Feb;42(2):491.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

A third dose of a COVID-19 vaccine can boost antibody levels in people who previously received a solid organ transplant and had an unsatisfactory response to their first two mRNA shots, according to data from a newly published 30-patient case series.

All of those with low titers before the third dose had high titers after receiving the additional shot, but only about 33% of those with negative initial responses had detectable antibodies after the third dose, according to the paper, published in Annals of Internal Medicine.

Researchers at Johns Hopkins, Baltimore, who keep a COVID-19 vaccine registry, perform antibody tests on all registry subjects and inform them of their results. Registry participants were asked to inform the research team if they received a third dose, and, the research team tracked the immune responses of those who did.

The participants in this case series had low antibody levels and received a third dose of the vaccine on their own between March 20 and May 10 of 2021.
 

Third dose results

In this cases series – thought to be the first to look at third vaccine shots in this type of patient group – all six of those who had low antibody titers before the third dose had high-positive titers after the third dose.

Of the 24 individuals who had negative antibody titers before the third dose, just 6 had high titers after the third dose.

Two of the participants had low-positive titers, and 16 were negative.

“Several of those boosted very nicely into ranges seen, using these assays, in healthy persons,” said William Werbel, MD, a fellow in infectious disease at Johns Hopkins Medicine, Baltimore, who helped lead the study. Those with negative levels, even if they responded, tended to have lower titers, he said.

“The benefits at least from an antibody perspective were not the same for everybody and so this is obviously something that needs to be considered when thinking about selecting patients” for a COVID-19 prevention strategy, he said.

Reactions to the vaccine were low to moderate, such as some arm pain and fatigue.

“Showing that something is safe in that special, vulnerable population is important,” Dr. Werbel said. “We’re all wanting to make sure that we’re doing no harm.”

Dr. Werbel noted that there was no pattern in the small series based on the organ transplanted or in the vaccines used. As their third shot, 15 of the patients received the Johnson & Johnson vaccine; 9 received Moderna; and 6 received Pfizer-BioNTech.
 

Welcome news, but larger studies needed

“To think that a third dose could confer protection for a significant number of people is of course extremely welcome news,” said Christian Larsen, MD, DPhil, professor of surgery in the transplantation division at Emory University, Atlanta, who was not involved in the study. “It’s the easiest conceivable next intervention.”

He added, “We just want studies to confirm that – larger studies.”

Dr. Werbel stressed the importance of looking at third doses in these patients in a more controlled fashion in a randomized trial, to more carefully monitor safety and how patients fare when starting with one type of vaccine and switching to another, for example.

Richard Wender, MD, chair of family medicine and community health at the University of Pennsylvania, Philadelphia, said the findings are a reminder that there is still a lot that is unknown about COVID-19 and vaccination.

“We still don’t know who will or will not benefit from a third dose,” he said. “And our knowledge is evolving.  For example, a recent study suggested that people with previous infection and who are vaccinated may have better and longer protection than people with vaccination alone. We’re still learning.”

He added that specialists, not primary care clinicians, should be relied upon to respond to this emerging vaccination data. Primary care doctors are very busy in other ways – such as in getting children caught up on vaccinations and helping adults return to managing their chronic diseases, Dr. Wender noted.

“Their focus needs to be on helping to overcome hesitancy, mistrust, lack of information, or antivaccination sentiment to help more people feel comfortable being vaccinated – this is a lot of work and needs constant focus. In short, primary care clinicians need to focus chiefly on the unvaccinated,” he said.

“Monitoring immunization recommendations for unique at-risk populations should be the chief responsibility of teams providing subspecialty care, [such as for] transplant patients, people with chronic kidney disease, cancer patients, and people with other chronic illnesses.  This will allow primary care clinicians to tackle their many complex jobs.”
 

Possible solutions for those with low antibody responses

Dr. Larsen said that those with ongoing low antibody responses might still have other immune responses, such as a T-cell response. Such patients also could consider changing their vaccine type, he said.

“At the more significant intervention level, there may be circumstances where one could change the immunosuppressive drugs in a controlled way that might allow a better response,” suggested Dr. Larsen. “That’s obviously going to be something that requires a lot more thought and careful study.”

Dr. Werbel said that other options might need to be considered for those having no response following a third dose. One possibility is trying a vaccine with an adjuvant, such as the Novavax version, which might be more widely available soon.

“If you’re given a third dose of a very immunogenic vaccine – something that should work – and you just have no antibody development, it seems relatively unlikely that doing the same thing again is going to help you from that perspective, and for all we know might expose you to more risk,” Dr. Werbel noted.
 

Participant details

None of the 30 patients were thought to have ever had COVID-19. On average, patients had received their transplant 4.5 years before their original vaccination. In 25 patients, maintenance immunosuppression included tacrolimus or cyclosporine along with mycophenolate. Corticosteroids were also used for 24 patients, sirolimus was used for one patient, and belatacept was used for another patient.

Fifty-seven percent of patients had received the Pfizer/BioNTech vaccine originally, and 43% the Moderna vaccine. Most of the patients were kidney recipients, with two heart, three liver, one lung, one pancreas and one kidney-pancreas.

Dr. Werbel, Dr. Wender, and Dr. Larsen reported no relevant disclosures.

Among the studies we review in this Update are a follow-up of the US Women’s Health Initiative clinical trials and a large observational study from the United Kingdom, which exlore the impact of different hormone therapies (HTs) on breast cancer risk. We look at the interesting patterns found by authors of a study in Canada that analyzed predictors of unnecessary bilateral salpingo-oophorectomy. In addition, we review a study that investigates whether hormone therapy can be effective, alone or adjunctively, in peri- and postmenopausal women with depression. Finally, Dr. Chrisandra Shufelt and Dr. JoAnn Manson summarize highlights from the recent American Heart Association’s scientific statement on the menopause transition and increasing risk factors for cardiovascular disease, and how this period can be viewed as an opportunity to encourage healthy, cardiovascular risk–reducing behaviors.

Studies clarify menopausal HT’s impact on breast cancer risk

Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of menopausal hormone therapy with breast cancer incidence and mortality during long-term follow-up of the Women’s Health Initiative randomized clinical trials. JAMA. 2020;324:369-380. doi: 10.1001/jama.2020.9482.

Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of breast cancer: nested case-control studies using the QResearch and CPRD databases. BMJ. 2020;371:m3873. doi: 10.1136/bmj.m3873.

For many menopausal women, the most worrisome concern related to the use of HT is that it might increase breast cancer risk. In the summer and fall of 2020, 2 important articles were published that addressed how the use of menopausal HT impacts the risk of breast cancer.

The Women’s Health Initiative (WHI) represents the largest and longest-term randomized trial assessing the health impacts of systemic HT. A 2013 WHI report found that with a median of 13 years’ cumulative follow-up, estrogen-only HT (ET) reduced the risk for breast cancer while estrogen-progestin therapy (EPT) increased the risk.¹ In a July 2020 issue of JAMA, WHI investigators analyzed longer-term data (cumulative median follow-up >20 years), which allowed assessment of whether these trends (breast cancer incidence) persisted and if they led to changes in mortality from breast cancer.²

WHI data on breast cancer risk trends in ET vs EPT users

In the ET trial, in which Chlebowski and colleagues studied 10,739 women with prior hysterectomy, 238 versus 296 new cases of breast cancer were diagnosed in women in the ET versus placebo groups, respectively (annualized incidence, 0.30% [ET] vs 0.37% [placebo]; hazard ratio [HR], 0.78; P = .005). ET also was associated with significantly lower mortality from breast cancer: 30 versus 46 deaths (annualized mortality, 0.031% [ET] vs 0.046% [placebo]; HR, 0.60; P = 0.04).

In the EPT trial, which included 16,608 participants with an intact uterus, EPT compared with placebo was associated with significantly elevated risk for incident breast cancer: 584 versus 447 new cases, respectively (annualized incidence, 0.45% [EPT] vs 0.36% [placebo]; HR, 1.28; P<.001). However, mortality from breast cancer was similar in the EPT and placebo groups: 71 and 53 deaths (annualized mortality, 0.045% [EPT] and 0.035% [placebo]; HR, 1.35; P = .11).²

For women with previous hysterectomy who are considering initiating or continuing ET for treatment of bothersome menopausal symptoms, the breast cancer mortality benefit documented in this long-term WHI analysis could, as editorialists point out, “tip the scales” in favor of ET.³ Furthermore, the mortality benefit raises the possibility that ET could be evaluated as a risk-reduction strategy for selected high-risk menopausal women who have undergone hysterectomy. Although tamoxifen and aromatase inhibitors are approved for breast cancer chemoprophylaxis in high-risk menopausal women, these agents have not been found to lower breast cancer mortality.²

UK data analysis and risk for breast cancer in HT users

In an October 2020 issue of BMJ, Vinogradova and colleagues described their analysis of 2 primary care databases in the United Kingdom that in aggregate included roughly 99,000 women with breast cancer diagnosed between 1998 and 2018 (age range, 50–79; mean age at diagnosis, 63; >95% White); these were matched with more than 450,000 women without breast cancer (controls).⁴ Analyses were adjusted for smoking, body mass index (BMI), ethnicity, and mammography.

In this study, ever-use of EPT was associated with an adjusted odds ratio (OR) for breast cancer of 1.26 (95% confidence interval [CI], 1.24–1.29), while ET had an OR of 1.06 (95% CI, 1.03–1.10). In women aged 50 to 59 who used EPT for 5 years or more, 15 additional breast cancers were diagnosed per 10,000 woman-years; for ET users, the attributable risk was 3. Although risk rose with longer HT duration, this trend was less evident with ET than EPT.

In addition, the increased risk associated with ET use was less pronounced in women with a BMI greater than 30 kg/m². Among EPT users, risks were similar with the progestins medroxyprogesterone acetate (MPA), norethindrone (NET), and levonorgestrel (LNG). Likewise, risks were similar regardless of estrogen dose and route of administration (that is, oral vs transdermal). Vaginal estrogen was not associated with a higher or lower risk for breast cancer. Among past users of ET or EPT (with MPA), no increased risk was noted 5 years or more after stopping HT. For users of EPT (with NET or LNG), risks diminished 5 years or more after stopping HT but remained modestly elevated compared with risk in never-users.⁴

In this large observational UK study, ET was associated with minimally elevated risk for breast cancer, while in the WHI study, ET reduced the risk for breast cancer. For EPT, the excess risk in both studies was identical. As the authors note, mean BMI in the UK study participants was slightly lower than that in the WHI participants, a distinction that might explain the differing findings with ET use.

Continue to: Frequency of nonindicated BSO at the time of hysterectomy in pre- and perimenopausal women...

Frequency of nonindicated BSO at the time of hysterectomy in pre- and perimenopausal women

Wong J, Murji A, Sunderji Z, et al. Unnecessary bilateral salpingo-oophorectomy at the time of hysterectomy and potential for ovarian preservation. Menopause. 2020;28:8-11. doi: 10.1097/GME.0000000000001652.

While prevention of ovarian cancer is an important benefit of bilateral salpingo-oophorectomy (BSO), performing a BSO at the time of hysterectomy in pre- or perimenopausal patients not only will induce surgical menopause but also is associated with significantly increased overall mortality and an increased risk of mortality due to cardiovascular disease in patients younger than age 45.^5,6 Earlier BSO also has been associated with diabetes, accelerated bone density loss, sexual dysfunction, mood disorders, and decreased cognitive function.⁷

BSO at hysterectomy: How many procedures are not indicated?

To evaluate the prevalence and predictors of unnecessary BSO at the time of hysterectomy, Wong and colleagues conducted a multicenter retrospective review of hysterectomy procedures completed at 6 Canadian hospitals.⁸ Criteria for unnecessary BSO included age younger than 51 years; benign preoperative diagnosis (other than endometriosis, premenstrual dysphoric disorder, and gender dysphoria); and absence of endometriosis and pelvic adhesions.

A total of 2,656 hysterectomies were performed by 75 surgeons (28 fellowship trained and 47 generalists) across 3 community and 3 tertiary care hospitals between 2016 and 2018. At the time of hysterectomy, 749 patients (28%) underwent BSO. Of these, 509 women (68%) had at least 1 indication for concurrent BSO based on preoperative diagnosis.

Key study findings. Concurrent BSO procedures performed at academic hospitals were more likely to have a preoperative indication compared with BSO performed at community sites (70% vs 63%; OR, 1.42; 95% CI, 1.02–1.97; P = .04). BSO was more likely to be indicated when performed by fellowship-trained surgeons compared with surgeries performed by generalist surgeons (75% vs 63%; OR, 1.76; 95% CI, 1.26–2.44, P = .001). BSO procedures performed with vaginal hysterectomy were less likely to be indicated (3 of 20, 15%) when compared with open hysterectomy (74 of 154, 48%) and laparoscopic hysterectomy (432 of 575, 75%).

Of the patients who lacked a preoperative indication for concomitant BSO, 105 of 239 (43.9%) were younger than age 51. Overall, 8% (59 of 749) of patients in the study cohort had an unnecessary BSO based on a combination of preoperative diagnosis, age younger than age 51, and intraoperative factors including absence of endometriosis and adhesions.

Continue to: HT for menopausal depression: Which patients may benefit?

HT for menopausal depression: Which patients may benefit?

Dwyer JB, Aftab A, Radhakrishnan R, et al; APA Council of Research Task Force on Novel Biomarkers and Treatments. Hormonal treatments for major depressive disorder: state of the art. Am J Psychiatry. 2020;177:686- 705. doi:10.1176/appi.ajp.2020.19080848.

The cumulative lifetime prevalence of major depression in US women is 21%.9 An increased risk of mood symptoms and major depressive disorder occurs with the cessation of ovarian hormone production during menopause. In a review of both physiology and clinical studies, an American Psychiatric Association task force found support for several hormone-related strategies for treating depression and highlighted the rapidly advancing, but mixed, findings in this field.¹⁰

Clinical trials that examined mood in peri- and postmenopausal women treated with HT have produced mixed results for a variety of reasons, including differences in psychiatric symptomatology across studies and differences in treatment timing in relation to menopause onset.

HT effectiveness for depression depends on menopausal status

Five studies included in a meta-analysis by Rubinow and colleagues examined the use of ET and EPT as antidepressant monotherapy in peri- or postmenopausal women with major depression.¹¹ Of the 3 higher-quality studies, 2 conducted in perimenopausal women demonstrated the antidepressant efficacy of transdermal estrogen patches compared with placebo. The third study included a mixed population of both peri- and postmenopausal women, and it found that increased estradiol levels (spontaneously occurring or due to ET) were associated with improvement in depression in perimenopausal women but not in postmenopausal women.¹¹

ET also has been investigated as a potential adjunctive treatment to selective serotonin reuptake inhibitors (SSRIs). In a retrospective analysis of a multicenter randomized controlled trial of fluoxetine in patients with depression, women who received ET and fluoxetine demonstrated a greater improvement than those who received fluoxetine monotherapy.¹² One small study that prospectively assessed ET in combination with an antidepressant in postmenopausal women demonstrated no benefit of ET in treating depression.¹³ Another small trial found that while combining transdermal ET with an SSRI accelerated symptom improvement, by the end of the 10-week study, treatment efficacy in the HT plus SSRI group was no greater than that observed in the SSRI-only group.¹⁴

Nineteen studies included in the metaanalysis by Rubinow and colleagues, which examined mood after ET or EPT treatment in nondepressed women, found little evidence of benefit, particularly in women without other physical symptoms of menopause.¹¹

The Kronos Early Estrogen Prevention Study (KEEPS) followed 661 women who received either oral estrogen plus progesterone, transdermal estrogen plus progesterone, or placebo over 4 years.¹⁵ Women with clinical depression were excluded from the study; however, women with mild to moderate mood symptoms who were being treated with an antidepressant were included. Improvements in depressive symptoms and anxiety were observed only in the oral estrogen plus progesterone group compared with the placebo group.¹⁵

In a study of 172 euthymic peri- and postmenopausal women treated for 12 months with transdermal estrogen plus oral progesterone, investigators found that, unlike postmenopausal women and those in the late perimenopausal transition, only women in the early perimenopausal transition had a lower risk of developing depressive symptoms.¹⁶

Bottom line

This complex literature suggests that ET/HT interventions are most likely to be successful when implemented early in the menopausal transition. The clearest indication for the use of HT is for perimenopausal women experiencing depression who are also experiencing menopausal symptoms (for example, bothersome hot flashes). There is little evidence that the use of ET/HT in late perimenopausal or postmenopausal women effectively treats depression; accordingly, HT is not recommended for the treatment of mood disorders in this population. The more ambiguous cases are those of perimenopausal women who are depressed but do not have classic vasomotor symptoms; some evidence supports the antidepressant efficacy of HT in this setting.¹¹ Although some studies suggest that HT can be effective in preventing depression in perimenopausal women, more evidence is needed.¹⁶

 

The menopause transition: A key period for strategizing CVD risk factor reduction

---

Chrisandra L. Shufelt, MD, MS, NCMP

Dr. Shufelt is Associate Director of the Barbra
Streisand Women’s Heart Center, Smidt
Heart Institute, Cedars-Sinai Medical Center,
Los Angeles, California.

JoAnn E. Manson, MD, DrPH, NCMP

Dr. Manson is Professor of Medicine and the
Michael and Lee Bell Professor of Women’s
Health at Harvard Medical School; Professor
in the Department of Epidemiology, Harvard
T.H. Chan School of Public Health; and Chief
of the Division of Preventive Medicine
at Brigham and Women’s Hospital, Boston,
Massachusetts.

The authors report no financial relationships relevant to this article. Dr. Manson is a coauthor of the AHA Scientific Statement discussed in this article.

In the United States, nearly one-half of a woman’s life, on average, will be lived after menopause. For women with natural menopause, the menopause transition (MT) can begin 2 to 7 years before and may extend 1 year past the final menstrual period, which occurs at an average age of 51 years. For women with surgical menopause, the MT occurs abruptly with the sudden loss of endogenous ovarian hormones. Both types of transitions mark a critical time period when reproduction and endogenous sex hormone levels diminish and when cardiovascular disease (CVD) risk factors begin to rise.

The 2020 American Heart Association (AHA) scientific statement, “Menopause transition and cardiovascular disease risk: Implications for timing of early prevention,” highlights the MT as a window of opportunity for CVD prevention.¹

CVD risk factors associated with ovarian aging

In the AHA scientific statement, data from several longitudinal women’s health studies were used to identify which CVD risk factor changes during the MT are related to ovarian aging as opposed to chronologic aging. Independent of aging, those associated with reproductive or ovarian aging included an increase in serum total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B. Changes in high-density lipoprotein cholesterol (HDL-C) particles and function also occur during the MT, which may explain why higher HDL-C levels during the MT and the postmenopausal years are not as cardioprotective as during the premenopausal period.

Changes in body composition and adipose tissue distribution also are associated with ovarian aging, with reduction in muscle mass and lean body mass and an increase in abdominal/visceral fat and subcutaneous adipose tissue. Although these body composition changes reflect ovarian aging, midlife weight gain is more closely related to chronologic aging.

The risk of the metabolic syndrome constellation of risk factors was found to be more closely associated with ovarian aging, whereas changes in blood pressure, insulin, and glucose individually tracked more closely with chronologic aging. Additionally, the AHA statement notes the research that identified several symptoms during the MT—including vasomotor symptoms, sleep disturbance, and depression—as being associated with more adverse CVD risk factor status and with subclinical measures of atherosclerosis. Additional research on the mechanistic basis for these associations is needed.

Chronologic age and type of menopause

Notably, a woman’s age and type of menopause matter with respect to CVD risk. Higher CVD risk is seen in women with premature onset (age < 40 years) or early onset (age < 45 years) of menopause and in women undergoing surgical menopause (bilateral oophorectomy) before age 45. In general, menopausal hormone therapy (HT) is recommended for women with premature or early menopause, whether natural or surgical, with continuation through at least the average age of natural menopause. In other women, although not recommended for the express purpose of CVD prevention, menopausal HT is appropriate for the treatment of bothersome vasomotor or other menopausal symptoms, especially when therapy is started before age 60 or within 10 years of menopause among women who are not at elevated risk of CVD.

While the AHA statement suggests that some women who begin estrogen early in menopause may experience reduced coronary heart disease risk, major research gaps remain with regard to HT dose, formulation, route of delivery, and recommended duration of treatment.

An opportunity to promote healthy lifestyle behaviors

Translating the AHA’s first-of-its-kind scientific statement into clinical practice requires recognition and awareness of the MT as a unique phase in a woman’s life associated with myriad changes in CVD risk factors. The statement underscores that the MT is an important time to target behavioral changes to promote CVD risk reduction, including lifestyle modifications in the AHA’s Life’s Simple 7 components (increased physical activity, smoking cessation, healthy diet, avoidance of weight gain) as well as vigilant control of blood pressure, cholesterol, and glucose levels. The MT is truly a window of opportunity for reinvigorated efforts to lower women’s CVD risk. ●

Reference

1. El Khoudary SR, Aggarwal B, Beckie TM, et al; American Heart Association Prevention Science Committee of the Council on Epidemiology and Prevention; and Council on Cardiovascular and Stroke Nursing. Menopause transition and cardiovascular disease risk: implications for timing of early prevention: a scientific statement from the American Heart Association. Circulation. 2020;142:e506-e532. doi: 10.1161/CIR.000000000000912.

Among the studies we review in this Update are a follow-up of the US Women’s Health Initiative clinical trials and a large observational study from the United Kingdom, which exlore the impact of different hormone therapies (HTs) on breast cancer risk. We look at the interesting patterns found by authors of a study in Canada that analyzed predictors of unnecessary bilateral salpingo-oophorectomy. In addition, we review a study that investigates whether hormone therapy can be effective, alone or adjunctively, in peri- and postmenopausal women with depression. Finally, Dr. Chrisandra Shufelt and Dr. JoAnn Manson summarize highlights from the recent American Heart Association’s scientific statement on the menopause transition and increasing risk factors for cardiovascular disease, and how this period can be viewed as an opportunity to encourage healthy, cardiovascular risk–reducing behaviors.

Studies clarify menopausal HT’s impact on breast cancer risk

Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of menopausal hormone therapy with breast cancer incidence and mortality during long-term follow-up of the Women’s Health Initiative randomized clinical trials. JAMA. 2020;324:369-380. doi: 10.1001/jama.2020.9482.

Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of breast cancer: nested case-control studies using the QResearch and CPRD databases. BMJ. 2020;371:m3873. doi: 10.1136/bmj.m3873.

For many menopausal women, the most worrisome concern related to the use of HT is that it might increase breast cancer risk. In the summer and fall of 2020, 2 important articles were published that addressed how the use of menopausal HT impacts the risk of breast cancer.

The Women’s Health Initiative (WHI) represents the largest and longest-term randomized trial assessing the health impacts of systemic HT. A 2013 WHI report found that with a median of 13 years’ cumulative follow-up, estrogen-only HT (ET) reduced the risk for breast cancer while estrogen-progestin therapy (EPT) increased the risk.¹ In a July 2020 issue of JAMA, WHI investigators analyzed longer-term data (cumulative median follow-up >20 years), which allowed assessment of whether these trends (breast cancer incidence) persisted and if they led to changes in mortality from breast cancer.²

WHI data on breast cancer risk trends in ET vs EPT users

In the ET trial, in which Chlebowski and colleagues studied 10,739 women with prior hysterectomy, 238 versus 296 new cases of breast cancer were diagnosed in women in the ET versus placebo groups, respectively (annualized incidence, 0.30% [ET] vs 0.37% [placebo]; hazard ratio [HR], 0.78; P = .005). ET also was associated with significantly lower mortality from breast cancer: 30 versus 46 deaths (annualized mortality, 0.031% [ET] vs 0.046% [placebo]; HR, 0.60; P = 0.04).

In the EPT trial, which included 16,608 participants with an intact uterus, EPT compared with placebo was associated with significantly elevated risk for incident breast cancer: 584 versus 447 new cases, respectively (annualized incidence, 0.45% [EPT] vs 0.36% [placebo]; HR, 1.28; P<.001). However, mortality from breast cancer was similar in the EPT and placebo groups: 71 and 53 deaths (annualized mortality, 0.045% [EPT] and 0.035% [placebo]; HR, 1.35; P = .11).²

For women with previous hysterectomy who are considering initiating or continuing ET for treatment of bothersome menopausal symptoms, the breast cancer mortality benefit documented in this long-term WHI analysis could, as editorialists point out, “tip the scales” in favor of ET.³ Furthermore, the mortality benefit raises the possibility that ET could be evaluated as a risk-reduction strategy for selected high-risk menopausal women who have undergone hysterectomy. Although tamoxifen and aromatase inhibitors are approved for breast cancer chemoprophylaxis in high-risk menopausal women, these agents have not been found to lower breast cancer mortality.²

UK data analysis and risk for breast cancer in HT users

In an October 2020 issue of BMJ, Vinogradova and colleagues described their analysis of 2 primary care databases in the United Kingdom that in aggregate included roughly 99,000 women with breast cancer diagnosed between 1998 and 2018 (age range, 50–79; mean age at diagnosis, 63; >95% White); these were matched with more than 450,000 women without breast cancer (controls).⁴ Analyses were adjusted for smoking, body mass index (BMI), ethnicity, and mammography.

In this study, ever-use of EPT was associated with an adjusted odds ratio (OR) for breast cancer of 1.26 (95% confidence interval [CI], 1.24–1.29), while ET had an OR of 1.06 (95% CI, 1.03–1.10). In women aged 50 to 59 who used EPT for 5 years or more, 15 additional breast cancers were diagnosed per 10,000 woman-years; for ET users, the attributable risk was 3. Although risk rose with longer HT duration, this trend was less evident with ET than EPT.

In addition, the increased risk associated with ET use was less pronounced in women with a BMI greater than 30 kg/m². Among EPT users, risks were similar with the progestins medroxyprogesterone acetate (MPA), norethindrone (NET), and levonorgestrel (LNG). Likewise, risks were similar regardless of estrogen dose and route of administration (that is, oral vs transdermal). Vaginal estrogen was not associated with a higher or lower risk for breast cancer. Among past users of ET or EPT (with MPA), no increased risk was noted 5 years or more after stopping HT. For users of EPT (with NET or LNG), risks diminished 5 years or more after stopping HT but remained modestly elevated compared with risk in never-users.⁴

In this large observational UK study, ET was associated with minimally elevated risk for breast cancer, while in the WHI study, ET reduced the risk for breast cancer. For EPT, the excess risk in both studies was identical. As the authors note, mean BMI in the UK study participants was slightly lower than that in the WHI participants, a distinction that might explain the differing findings with ET use.

Continue to: Frequency of nonindicated BSO at the time of hysterectomy in pre- and perimenopausal women...

Frequency of nonindicated BSO at the time of hysterectomy in pre- and perimenopausal women

Wong J, Murji A, Sunderji Z, et al. Unnecessary bilateral salpingo-oophorectomy at the time of hysterectomy and potential for ovarian preservation. Menopause. 2020;28:8-11. doi: 10.1097/GME.0000000000001652.

While prevention of ovarian cancer is an important benefit of bilateral salpingo-oophorectomy (BSO), performing a BSO at the time of hysterectomy in pre- or perimenopausal patients not only will induce surgical menopause but also is associated with significantly increased overall mortality and an increased risk of mortality due to cardiovascular disease in patients younger than age 45.^5,6 Earlier BSO also has been associated with diabetes, accelerated bone density loss, sexual dysfunction, mood disorders, and decreased cognitive function.⁷

BSO at hysterectomy: How many procedures are not indicated?

To evaluate the prevalence and predictors of unnecessary BSO at the time of hysterectomy, Wong and colleagues conducted a multicenter retrospective review of hysterectomy procedures completed at 6 Canadian hospitals.⁸ Criteria for unnecessary BSO included age younger than 51 years; benign preoperative diagnosis (other than endometriosis, premenstrual dysphoric disorder, and gender dysphoria); and absence of endometriosis and pelvic adhesions.

A total of 2,656 hysterectomies were performed by 75 surgeons (28 fellowship trained and 47 generalists) across 3 community and 3 tertiary care hospitals between 2016 and 2018. At the time of hysterectomy, 749 patients (28%) underwent BSO. Of these, 509 women (68%) had at least 1 indication for concurrent BSO based on preoperative diagnosis.

Key study findings. Concurrent BSO procedures performed at academic hospitals were more likely to have a preoperative indication compared with BSO performed at community sites (70% vs 63%; OR, 1.42; 95% CI, 1.02–1.97; P = .04). BSO was more likely to be indicated when performed by fellowship-trained surgeons compared with surgeries performed by generalist surgeons (75% vs 63%; OR, 1.76; 95% CI, 1.26–2.44, P = .001). BSO procedures performed with vaginal hysterectomy were less likely to be indicated (3 of 20, 15%) when compared with open hysterectomy (74 of 154, 48%) and laparoscopic hysterectomy (432 of 575, 75%).

Of the patients who lacked a preoperative indication for concomitant BSO, 105 of 239 (43.9%) were younger than age 51. Overall, 8% (59 of 749) of patients in the study cohort had an unnecessary BSO based on a combination of preoperative diagnosis, age younger than age 51, and intraoperative factors including absence of endometriosis and adhesions.

Continue to: HT for menopausal depression: Which patients may benefit?

HT for menopausal depression: Which patients may benefit?

Dwyer JB, Aftab A, Radhakrishnan R, et al; APA Council of Research Task Force on Novel Biomarkers and Treatments. Hormonal treatments for major depressive disorder: state of the art. Am J Psychiatry. 2020;177:686- 705. doi:10.1176/appi.ajp.2020.19080848.

The cumulative lifetime prevalence of major depression in US women is 21%.9 An increased risk of mood symptoms and major depressive disorder occurs with the cessation of ovarian hormone production during menopause. In a review of both physiology and clinical studies, an American Psychiatric Association task force found support for several hormone-related strategies for treating depression and highlighted the rapidly advancing, but mixed, findings in this field.¹⁰

Clinical trials that examined mood in peri- and postmenopausal women treated with HT have produced mixed results for a variety of reasons, including differences in psychiatric symptomatology across studies and differences in treatment timing in relation to menopause onset.

HT effectiveness for depression depends on menopausal status

Five studies included in a meta-analysis by Rubinow and colleagues examined the use of ET and EPT as antidepressant monotherapy in peri- or postmenopausal women with major depression.¹¹ Of the 3 higher-quality studies, 2 conducted in perimenopausal women demonstrated the antidepressant efficacy of transdermal estrogen patches compared with placebo. The third study included a mixed population of both peri- and postmenopausal women, and it found that increased estradiol levels (spontaneously occurring or due to ET) were associated with improvement in depression in perimenopausal women but not in postmenopausal women.¹¹

ET also has been investigated as a potential adjunctive treatment to selective serotonin reuptake inhibitors (SSRIs). In a retrospective analysis of a multicenter randomized controlled trial of fluoxetine in patients with depression, women who received ET and fluoxetine demonstrated a greater improvement than those who received fluoxetine monotherapy.¹² One small study that prospectively assessed ET in combination with an antidepressant in postmenopausal women demonstrated no benefit of ET in treating depression.¹³ Another small trial found that while combining transdermal ET with an SSRI accelerated symptom improvement, by the end of the 10-week study, treatment efficacy in the HT plus SSRI group was no greater than that observed in the SSRI-only group.¹⁴

Nineteen studies included in the metaanalysis by Rubinow and colleagues, which examined mood after ET or EPT treatment in nondepressed women, found little evidence of benefit, particularly in women without other physical symptoms of menopause.¹¹

The Kronos Early Estrogen Prevention Study (KEEPS) followed 661 women who received either oral estrogen plus progesterone, transdermal estrogen plus progesterone, or placebo over 4 years.¹⁵ Women with clinical depression were excluded from the study; however, women with mild to moderate mood symptoms who were being treated with an antidepressant were included. Improvements in depressive symptoms and anxiety were observed only in the oral estrogen plus progesterone group compared with the placebo group.¹⁵

In a study of 172 euthymic peri- and postmenopausal women treated for 12 months with transdermal estrogen plus oral progesterone, investigators found that, unlike postmenopausal women and those in the late perimenopausal transition, only women in the early perimenopausal transition had a lower risk of developing depressive symptoms.¹⁶

Bottom line

This complex literature suggests that ET/HT interventions are most likely to be successful when implemented early in the menopausal transition. The clearest indication for the use of HT is for perimenopausal women experiencing depression who are also experiencing menopausal symptoms (for example, bothersome hot flashes). There is little evidence that the use of ET/HT in late perimenopausal or postmenopausal women effectively treats depression; accordingly, HT is not recommended for the treatment of mood disorders in this population. The more ambiguous cases are those of perimenopausal women who are depressed but do not have classic vasomotor symptoms; some evidence supports the antidepressant efficacy of HT in this setting.¹¹ Although some studies suggest that HT can be effective in preventing depression in perimenopausal women, more evidence is needed.¹⁶

 

The menopause transition: A key period for strategizing CVD risk factor reduction

---

Chrisandra L. Shufelt, MD, MS, NCMP

Dr. Shufelt is Associate Director of the Barbra
Streisand Women’s Heart Center, Smidt
Heart Institute, Cedars-Sinai Medical Center,
Los Angeles, California.

JoAnn E. Manson, MD, DrPH, NCMP

Dr. Manson is Professor of Medicine and the
Michael and Lee Bell Professor of Women’s
Health at Harvard Medical School; Professor
in the Department of Epidemiology, Harvard
T.H. Chan School of Public Health; and Chief
of the Division of Preventive Medicine
at Brigham and Women’s Hospital, Boston,
Massachusetts.

The authors report no financial relationships relevant to this article. Dr. Manson is a coauthor of the AHA Scientific Statement discussed in this article.

In the United States, nearly one-half of a woman’s life, on average, will be lived after menopause. For women with natural menopause, the menopause transition (MT) can begin 2 to 7 years before and may extend 1 year past the final menstrual period, which occurs at an average age of 51 years. For women with surgical menopause, the MT occurs abruptly with the sudden loss of endogenous ovarian hormones. Both types of transitions mark a critical time period when reproduction and endogenous sex hormone levels diminish and when cardiovascular disease (CVD) risk factors begin to rise.

The 2020 American Heart Association (AHA) scientific statement, “Menopause transition and cardiovascular disease risk: Implications for timing of early prevention,” highlights the MT as a window of opportunity for CVD prevention.¹

CVD risk factors associated with ovarian aging

In the AHA scientific statement, data from several longitudinal women’s health studies were used to identify which CVD risk factor changes during the MT are related to ovarian aging as opposed to chronologic aging. Independent of aging, those associated with reproductive or ovarian aging included an increase in serum total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B. Changes in high-density lipoprotein cholesterol (HDL-C) particles and function also occur during the MT, which may explain why higher HDL-C levels during the MT and the postmenopausal years are not as cardioprotective as during the premenopausal period.

Changes in body composition and adipose tissue distribution also are associated with ovarian aging, with reduction in muscle mass and lean body mass and an increase in abdominal/visceral fat and subcutaneous adipose tissue. Although these body composition changes reflect ovarian aging, midlife weight gain is more closely related to chronologic aging.

The risk of the metabolic syndrome constellation of risk factors was found to be more closely associated with ovarian aging, whereas changes in blood pressure, insulin, and glucose individually tracked more closely with chronologic aging. Additionally, the AHA statement notes the research that identified several symptoms during the MT—including vasomotor symptoms, sleep disturbance, and depression—as being associated with more adverse CVD risk factor status and with subclinical measures of atherosclerosis. Additional research on the mechanistic basis for these associations is needed.

Chronologic age and type of menopause

Notably, a woman’s age and type of menopause matter with respect to CVD risk. Higher CVD risk is seen in women with premature onset (age < 40 years) or early onset (age < 45 years) of menopause and in women undergoing surgical menopause (bilateral oophorectomy) before age 45. In general, menopausal hormone therapy (HT) is recommended for women with premature or early menopause, whether natural or surgical, with continuation through at least the average age of natural menopause. In other women, although not recommended for the express purpose of CVD prevention, menopausal HT is appropriate for the treatment of bothersome vasomotor or other menopausal symptoms, especially when therapy is started before age 60 or within 10 years of menopause among women who are not at elevated risk of CVD.

While the AHA statement suggests that some women who begin estrogen early in menopause may experience reduced coronary heart disease risk, major research gaps remain with regard to HT dose, formulation, route of delivery, and recommended duration of treatment.

An opportunity to promote healthy lifestyle behaviors

Translating the AHA’s first-of-its-kind scientific statement into clinical practice requires recognition and awareness of the MT as a unique phase in a woman’s life associated with myriad changes in CVD risk factors. The statement underscores that the MT is an important time to target behavioral changes to promote CVD risk reduction, including lifestyle modifications in the AHA’s Life’s Simple 7 components (increased physical activity, smoking cessation, healthy diet, avoidance of weight gain) as well as vigilant control of blood pressure, cholesterol, and glucose levels. The MT is truly a window of opportunity for reinvigorated efforts to lower women’s CVD risk. ●

Reference

1. El Khoudary SR, Aggarwal B, Beckie TM, et al; American Heart Association Prevention Science Committee of the Council on Epidemiology and Prevention; and Council on Cardiovascular and Stroke Nursing. Menopause transition and cardiovascular disease risk: implications for timing of early prevention: a scientific statement from the American Heart Association. Circulation. 2020;142:e506-e532. doi: 10.1161/CIR.000000000000912.

Among the studies we review in this Update are a follow-up of the US Women’s Health Initiative clinical trials and a large observational study from the United Kingdom, which exlore the impact of different hormone therapies (HTs) on breast cancer risk. We look at the interesting patterns found by authors of a study in Canada that analyzed predictors of unnecessary bilateral salpingo-oophorectomy. In addition, we review a study that investigates whether hormone therapy can be effective, alone or adjunctively, in peri- and postmenopausal women with depression. Finally, Dr. Chrisandra Shufelt and Dr. JoAnn Manson summarize highlights from the recent American Heart Association’s scientific statement on the menopause transition and increasing risk factors for cardiovascular disease, and how this period can be viewed as an opportunity to encourage healthy, cardiovascular risk–reducing behaviors.

Studies clarify menopausal HT’s impact on breast cancer risk

Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of menopausal hormone therapy with breast cancer incidence and mortality during long-term follow-up of the Women’s Health Initiative randomized clinical trials. JAMA. 2020;324:369-380. doi: 10.1001/jama.2020.9482.

Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of breast cancer: nested case-control studies using the QResearch and CPRD databases. BMJ. 2020;371:m3873. doi: 10.1136/bmj.m3873.

For many menopausal women, the most worrisome concern related to the use of HT is that it might increase breast cancer risk. In the summer and fall of 2020, 2 important articles were published that addressed how the use of menopausal HT impacts the risk of breast cancer.

The Women’s Health Initiative (WHI) represents the largest and longest-term randomized trial assessing the health impacts of systemic HT. A 2013 WHI report found that with a median of 13 years’ cumulative follow-up, estrogen-only HT (ET) reduced the risk for breast cancer while estrogen-progestin therapy (EPT) increased the risk.¹ In a July 2020 issue of JAMA, WHI investigators analyzed longer-term data (cumulative median follow-up >20 years), which allowed assessment of whether these trends (breast cancer incidence) persisted and if they led to changes in mortality from breast cancer.²

WHI data on breast cancer risk trends in ET vs EPT users

In the ET trial, in which Chlebowski and colleagues studied 10,739 women with prior hysterectomy, 238 versus 296 new cases of breast cancer were diagnosed in women in the ET versus placebo groups, respectively (annualized incidence, 0.30% [ET] vs 0.37% [placebo]; hazard ratio [HR], 0.78; P = .005). ET also was associated with significantly lower mortality from breast cancer: 30 versus 46 deaths (annualized mortality, 0.031% [ET] vs 0.046% [placebo]; HR, 0.60; P = 0.04).

In the EPT trial, which included 16,608 participants with an intact uterus, EPT compared with placebo was associated with significantly elevated risk for incident breast cancer: 584 versus 447 new cases, respectively (annualized incidence, 0.45% [EPT] vs 0.36% [placebo]; HR, 1.28; P<.001). However, mortality from breast cancer was similar in the EPT and placebo groups: 71 and 53 deaths (annualized mortality, 0.045% [EPT] and 0.035% [placebo]; HR, 1.35; P = .11).²

For women with previous hysterectomy who are considering initiating or continuing ET for treatment of bothersome menopausal symptoms, the breast cancer mortality benefit documented in this long-term WHI analysis could, as editorialists point out, “tip the scales” in favor of ET.³ Furthermore, the mortality benefit raises the possibility that ET could be evaluated as a risk-reduction strategy for selected high-risk menopausal women who have undergone hysterectomy. Although tamoxifen and aromatase inhibitors are approved for breast cancer chemoprophylaxis in high-risk menopausal women, these agents have not been found to lower breast cancer mortality.²

UK data analysis and risk for breast cancer in HT users

In an October 2020 issue of BMJ, Vinogradova and colleagues described their analysis of 2 primary care databases in the United Kingdom that in aggregate included roughly 99,000 women with breast cancer diagnosed between 1998 and 2018 (age range, 50–79; mean age at diagnosis, 63; >95% White); these were matched with more than 450,000 women without breast cancer (controls).⁴ Analyses were adjusted for smoking, body mass index (BMI), ethnicity, and mammography.

In this study, ever-use of EPT was associated with an adjusted odds ratio (OR) for breast cancer of 1.26 (95% confidence interval [CI], 1.24–1.29), while ET had an OR of 1.06 (95% CI, 1.03–1.10). In women aged 50 to 59 who used EPT for 5 years or more, 15 additional breast cancers were diagnosed per 10,000 woman-years; for ET users, the attributable risk was 3. Although risk rose with longer HT duration, this trend was less evident with ET than EPT.

In addition, the increased risk associated with ET use was less pronounced in women with a BMI greater than 30 kg/m². Among EPT users, risks were similar with the progestins medroxyprogesterone acetate (MPA), norethindrone (NET), and levonorgestrel (LNG). Likewise, risks were similar regardless of estrogen dose and route of administration (that is, oral vs transdermal). Vaginal estrogen was not associated with a higher or lower risk for breast cancer. Among past users of ET or EPT (with MPA), no increased risk was noted 5 years or more after stopping HT. For users of EPT (with NET or LNG), risks diminished 5 years or more after stopping HT but remained modestly elevated compared with risk in never-users.⁴

In this large observational UK study, ET was associated with minimally elevated risk for breast cancer, while in the WHI study, ET reduced the risk for breast cancer. For EPT, the excess risk in both studies was identical. As the authors note, mean BMI in the UK study participants was slightly lower than that in the WHI participants, a distinction that might explain the differing findings with ET use.

Continue to: Frequency of nonindicated BSO at the time of hysterectomy in pre- and perimenopausal women...

Frequency of nonindicated BSO at the time of hysterectomy in pre- and perimenopausal women

Wong J, Murji A, Sunderji Z, et al. Unnecessary bilateral salpingo-oophorectomy at the time of hysterectomy and potential for ovarian preservation. Menopause. 2020;28:8-11. doi: 10.1097/GME.0000000000001652.

While prevention of ovarian cancer is an important benefit of bilateral salpingo-oophorectomy (BSO), performing a BSO at the time of hysterectomy in pre- or perimenopausal patients not only will induce surgical menopause but also is associated with significantly increased overall mortality and an increased risk of mortality due to cardiovascular disease in patients younger than age 45.^5,6 Earlier BSO also has been associated with diabetes, accelerated bone density loss, sexual dysfunction, mood disorders, and decreased cognitive function.⁷

BSO at hysterectomy: How many procedures are not indicated?

To evaluate the prevalence and predictors of unnecessary BSO at the time of hysterectomy, Wong and colleagues conducted a multicenter retrospective review of hysterectomy procedures completed at 6 Canadian hospitals.⁸ Criteria for unnecessary BSO included age younger than 51 years; benign preoperative diagnosis (other than endometriosis, premenstrual dysphoric disorder, and gender dysphoria); and absence of endometriosis and pelvic adhesions.

A total of 2,656 hysterectomies were performed by 75 surgeons (28 fellowship trained and 47 generalists) across 3 community and 3 tertiary care hospitals between 2016 and 2018. At the time of hysterectomy, 749 patients (28%) underwent BSO. Of these, 509 women (68%) had at least 1 indication for concurrent BSO based on preoperative diagnosis.

Key study findings. Concurrent BSO procedures performed at academic hospitals were more likely to have a preoperative indication compared with BSO performed at community sites (70% vs 63%; OR, 1.42; 95% CI, 1.02–1.97; P = .04). BSO was more likely to be indicated when performed by fellowship-trained surgeons compared with surgeries performed by generalist surgeons (75% vs 63%; OR, 1.76; 95% CI, 1.26–2.44, P = .001). BSO procedures performed with vaginal hysterectomy were less likely to be indicated (3 of 20, 15%) when compared with open hysterectomy (74 of 154, 48%) and laparoscopic hysterectomy (432 of 575, 75%).

Of the patients who lacked a preoperative indication for concomitant BSO, 105 of 239 (43.9%) were younger than age 51. Overall, 8% (59 of 749) of patients in the study cohort had an unnecessary BSO based on a combination of preoperative diagnosis, age younger than age 51, and intraoperative factors including absence of endometriosis and adhesions.

Continue to: HT for menopausal depression: Which patients may benefit?

HT for menopausal depression: Which patients may benefit?

Dwyer JB, Aftab A, Radhakrishnan R, et al; APA Council of Research Task Force on Novel Biomarkers and Treatments. Hormonal treatments for major depressive disorder: state of the art. Am J Psychiatry. 2020;177:686- 705. doi:10.1176/appi.ajp.2020.19080848.

The cumulative lifetime prevalence of major depression in US women is 21%.9 An increased risk of mood symptoms and major depressive disorder occurs with the cessation of ovarian hormone production during menopause. In a review of both physiology and clinical studies, an American Psychiatric Association task force found support for several hormone-related strategies for treating depression and highlighted the rapidly advancing, but mixed, findings in this field.¹⁰

Clinical trials that examined mood in peri- and postmenopausal women treated with HT have produced mixed results for a variety of reasons, including differences in psychiatric symptomatology across studies and differences in treatment timing in relation to menopause onset.

HT effectiveness for depression depends on menopausal status

Five studies included in a meta-analysis by Rubinow and colleagues examined the use of ET and EPT as antidepressant monotherapy in peri- or postmenopausal women with major depression.¹¹ Of the 3 higher-quality studies, 2 conducted in perimenopausal women demonstrated the antidepressant efficacy of transdermal estrogen patches compared with placebo. The third study included a mixed population of both peri- and postmenopausal women, and it found that increased estradiol levels (spontaneously occurring or due to ET) were associated with improvement in depression in perimenopausal women but not in postmenopausal women.¹¹

ET also has been investigated as a potential adjunctive treatment to selective serotonin reuptake inhibitors (SSRIs). In a retrospective analysis of a multicenter randomized controlled trial of fluoxetine in patients with depression, women who received ET and fluoxetine demonstrated a greater improvement than those who received fluoxetine monotherapy.¹² One small study that prospectively assessed ET in combination with an antidepressant in postmenopausal women demonstrated no benefit of ET in treating depression.¹³ Another small trial found that while combining transdermal ET with an SSRI accelerated symptom improvement, by the end of the 10-week study, treatment efficacy in the HT plus SSRI group was no greater than that observed in the SSRI-only group.¹⁴

Nineteen studies included in the metaanalysis by Rubinow and colleagues, which examined mood after ET or EPT treatment in nondepressed women, found little evidence of benefit, particularly in women without other physical symptoms of menopause.¹¹

The Kronos Early Estrogen Prevention Study (KEEPS) followed 661 women who received either oral estrogen plus progesterone, transdermal estrogen plus progesterone, or placebo over 4 years.¹⁵ Women with clinical depression were excluded from the study; however, women with mild to moderate mood symptoms who were being treated with an antidepressant were included. Improvements in depressive symptoms and anxiety were observed only in the oral estrogen plus progesterone group compared with the placebo group.¹⁵

In a study of 172 euthymic peri- and postmenopausal women treated for 12 months with transdermal estrogen plus oral progesterone, investigators found that, unlike postmenopausal women and those in the late perimenopausal transition, only women in the early perimenopausal transition had a lower risk of developing depressive symptoms.¹⁶

Bottom line

This complex literature suggests that ET/HT interventions are most likely to be successful when implemented early in the menopausal transition. The clearest indication for the use of HT is for perimenopausal women experiencing depression who are also experiencing menopausal symptoms (for example, bothersome hot flashes). There is little evidence that the use of ET/HT in late perimenopausal or postmenopausal women effectively treats depression; accordingly, HT is not recommended for the treatment of mood disorders in this population. The more ambiguous cases are those of perimenopausal women who are depressed but do not have classic vasomotor symptoms; some evidence supports the antidepressant efficacy of HT in this setting.¹¹ Although some studies suggest that HT can be effective in preventing depression in perimenopausal women, more evidence is needed.¹⁶

 

The menopause transition: A key period for strategizing CVD risk factor reduction

---

Chrisandra L. Shufelt, MD, MS, NCMP

Dr. Shufelt is Associate Director of the Barbra
Streisand Women’s Heart Center, Smidt
Heart Institute, Cedars-Sinai Medical Center,
Los Angeles, California.

JoAnn E. Manson, MD, DrPH, NCMP

Dr. Manson is Professor of Medicine and the
Michael and Lee Bell Professor of Women’s
Health at Harvard Medical School; Professor
in the Department of Epidemiology, Harvard
T.H. Chan School of Public Health; and Chief
of the Division of Preventive Medicine
at Brigham and Women’s Hospital, Boston,
Massachusetts.

The authors report no financial relationships relevant to this article. Dr. Manson is a coauthor of the AHA Scientific Statement discussed in this article.

In the United States, nearly one-half of a woman’s life, on average, will be lived after menopause. For women with natural menopause, the menopause transition (MT) can begin 2 to 7 years before and may extend 1 year past the final menstrual period, which occurs at an average age of 51 years. For women with surgical menopause, the MT occurs abruptly with the sudden loss of endogenous ovarian hormones. Both types of transitions mark a critical time period when reproduction and endogenous sex hormone levels diminish and when cardiovascular disease (CVD) risk factors begin to rise.

The 2020 American Heart Association (AHA) scientific statement, “Menopause transition and cardiovascular disease risk: Implications for timing of early prevention,” highlights the MT as a window of opportunity for CVD prevention.¹

CVD risk factors associated with ovarian aging

In the AHA scientific statement, data from several longitudinal women’s health studies were used to identify which CVD risk factor changes during the MT are related to ovarian aging as opposed to chronologic aging. Independent of aging, those associated with reproductive or ovarian aging included an increase in serum total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B. Changes in high-density lipoprotein cholesterol (HDL-C) particles and function also occur during the MT, which may explain why higher HDL-C levels during the MT and the postmenopausal years are not as cardioprotective as during the premenopausal period.

Changes in body composition and adipose tissue distribution also are associated with ovarian aging, with reduction in muscle mass and lean body mass and an increase in abdominal/visceral fat and subcutaneous adipose tissue. Although these body composition changes reflect ovarian aging, midlife weight gain is more closely related to chronologic aging.

The risk of the metabolic syndrome constellation of risk factors was found to be more closely associated with ovarian aging, whereas changes in blood pressure, insulin, and glucose individually tracked more closely with chronologic aging. Additionally, the AHA statement notes the research that identified several symptoms during the MT—including vasomotor symptoms, sleep disturbance, and depression—as being associated with more adverse CVD risk factor status and with subclinical measures of atherosclerosis. Additional research on the mechanistic basis for these associations is needed.

Chronologic age and type of menopause

Notably, a woman’s age and type of menopause matter with respect to CVD risk. Higher CVD risk is seen in women with premature onset (age < 40 years) or early onset (age < 45 years) of menopause and in women undergoing surgical menopause (bilateral oophorectomy) before age 45. In general, menopausal hormone therapy (HT) is recommended for women with premature or early menopause, whether natural or surgical, with continuation through at least the average age of natural menopause. In other women, although not recommended for the express purpose of CVD prevention, menopausal HT is appropriate for the treatment of bothersome vasomotor or other menopausal symptoms, especially when therapy is started before age 60 or within 10 years of menopause among women who are not at elevated risk of CVD.

While the AHA statement suggests that some women who begin estrogen early in menopause may experience reduced coronary heart disease risk, major research gaps remain with regard to HT dose, formulation, route of delivery, and recommended duration of treatment.

An opportunity to promote healthy lifestyle behaviors

Translating the AHA’s first-of-its-kind scientific statement into clinical practice requires recognition and awareness of the MT as a unique phase in a woman’s life associated with myriad changes in CVD risk factors. The statement underscores that the MT is an important time to target behavioral changes to promote CVD risk reduction, including lifestyle modifications in the AHA’s Life’s Simple 7 components (increased physical activity, smoking cessation, healthy diet, avoidance of weight gain) as well as vigilant control of blood pressure, cholesterol, and glucose levels. The MT is truly a window of opportunity for reinvigorated efforts to lower women’s CVD risk. ●

Reference

1. El Khoudary SR, Aggarwal B, Beckie TM, et al; American Heart Association Prevention Science Committee of the Council on Epidemiology and Prevention; and Council on Cardiovascular and Stroke Nursing. Menopause transition and cardiovascular disease risk: implications for timing of early prevention: a scientific statement from the American Heart Association. Circulation. 2020;142:e506-e532. doi: 10.1161/CIR.000000000000912.

Each clinician has had to develop his or her individual approach and follow their institutional guidance regarding counseling and managing all of their patients’ expectations in this quickly changing climate of vaccination availability and recommendations. For pregnant women specifically, who are at increased risk for severe SARS-COV-2 disease,¹ the availability of varied types of vaccines for COVID-19 is promising, but with limited data available to discuss safety for the mother and the baby, what is the best discussion to guide decision making? OBG Management reached out to several experts, who share here what they do in their practices.

Addressing an uncharted front in the war on COVID-19

Ashley S. Roman, MD, MPH

In December 2020, the US Food and Drug Administration (FDA)’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.² Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.³ Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.⁴ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^5,6

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• the presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes
• potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• the ability to take precautions (social distancing, wearing a mask, etc).

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

Continue to: Benefits outweigh the risks, for now...

Benefits outweigh the risks, for now

Ashley S. Coggins, MD, and Jeanne S. Sheffield, MD

Vaccines have been a lifesaving public health measure since 1000 CE, when the Chinese first used smallpox inoculations to induce immunity.⁷ Work by pioneers such as Edward Jenner, Louis Pasteur, and Maurice Hilleman has averted countless millions of vaccine-preventable illnesses and deaths, and vaccines have become a routine part of health maintenance throughout the human life cycle.

Pregnant patients who receive vaccines often have an added benefit of protection provided to their infants through passive transfer of antibodies. Several vaccine platforms have been utilized in pregnancy with well-documented improvements in maternal and obstetric outcomes as well as improved neonatal outcomes in the first several months of life.

Risks of COVID-19 in pregnancy

The COVID-19 pandemic placed a spotlight on medically at-risk groups. Pregnant women are 3 times more likely to require admission to the intensive care unit, have increased requirement for extracorporeal membrane oxygenation treatment, and are up to 70% more likely to die than nonpregnant peers— and this risk increases with the presence of additional comorbidities.

In the case of COVID-19, vaccination trials that have shaped worldwide clinical practice unfortunately followed the historical trend of excluding pregnant patients from participation. This has required clinicians to guide their patients through the decision of whether or not to accept vaccination without having the same reassurances regarding safety and effectiveness afforded to their nonpregnant counterparts. With more than 86,000 pregnant women infected with COVID-19 through April 19, 2021, this lack of information regarding vaccine safety in pregnancy is a significant public health gap.⁸

COVID-19 vaccines

The current COVID-19 vaccines approved for use in the United States under an Emergency Use Authorization issued by the FDA are nonreplicating and thus cannot cause infection in the mother or fetus. These are the Pfizer-BioNTech mRNA vaccine, the Moderna mRNA-1273 vaccine, and the Janssen Biotech Inc. monovalent vaccine. Furthermore, in animal studies that included the Pfizer-BioNTech, Moderna, or Janssen COVID-19 vaccines, no fetal, embryonal, female reproductive, or postnatal development safety concerns were demonstrated.

As of April 19, 2021, 94,335 pregnant women had received a COVID-19 vaccination, and 4,622 of these enrolled in the Centers for Disease Control and Prevention (CDC)’s V-safe Vaccine Pregnancy Registry.⁹ The data reported noted no unexpected pregnancy or infant outcomes related to COVID-19 vaccination in pregnancy. Adverse effects of the vaccine were similar to those in nonpregnant cohorts. Additionally, emerging data suggest passage of immunity to neonates, with maternal antibodies demonstrated in cord blood at time of delivery as well as in breast milk.¹⁰ To date, these data mainly have come from women immunized with the Moderna and Pfizer-BioNTech mRNA vaccines.

Counseling pregnant patients

Our counseling aligns with that of the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC’s Advisory Committee on Immunization Practices. These organizations advise that COVID-19 vaccination should not be withheld from pregnant patients or patients who want to become pregnant. In pregnant patients with comorbidities that place them at higher risk for severe COVID-19 infection, all available formulations of the COVID-19 vaccination should be strongly considered. As evidence for vaccination safety continues to emerge, patients should continue to discuss their individual needs for vaccination in a shared decision-making format with their obstetric providers.

Each clinician has had to develop his or her individual approach and follow their institutional guidance regarding counseling and managing all of their patients’ expectations in this quickly changing climate of vaccination availability and recommendations. For pregnant women specifically, who are at increased risk for severe SARS-COV-2 disease,¹ the availability of varied types of vaccines for COVID-19 is promising, but with limited data available to discuss safety for the mother and the baby, what is the best discussion to guide decision making? OBG Management reached out to several experts, who share here what they do in their practices.

Addressing an uncharted front in the war on COVID-19

Ashley S. Roman, MD, MPH

In December 2020, the US Food and Drug Administration (FDA)’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.² Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.³ Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.⁴ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^5,6

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• the presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes
• potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• the ability to take precautions (social distancing, wearing a mask, etc).

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

Continue to: Benefits outweigh the risks, for now...

Benefits outweigh the risks, for now

Ashley S. Coggins, MD, and Jeanne S. Sheffield, MD

Vaccines have been a lifesaving public health measure since 1000 CE, when the Chinese first used smallpox inoculations to induce immunity.⁷ Work by pioneers such as Edward Jenner, Louis Pasteur, and Maurice Hilleman has averted countless millions of vaccine-preventable illnesses and deaths, and vaccines have become a routine part of health maintenance throughout the human life cycle.

Pregnant patients who receive vaccines often have an added benefit of protection provided to their infants through passive transfer of antibodies. Several vaccine platforms have been utilized in pregnancy with well-documented improvements in maternal and obstetric outcomes as well as improved neonatal outcomes in the first several months of life.

Risks of COVID-19 in pregnancy

The COVID-19 pandemic placed a spotlight on medically at-risk groups. Pregnant women are 3 times more likely to require admission to the intensive care unit, have increased requirement for extracorporeal membrane oxygenation treatment, and are up to 70% more likely to die than nonpregnant peers— and this risk increases with the presence of additional comorbidities.

In the case of COVID-19, vaccination trials that have shaped worldwide clinical practice unfortunately followed the historical trend of excluding pregnant patients from participation. This has required clinicians to guide their patients through the decision of whether or not to accept vaccination without having the same reassurances regarding safety and effectiveness afforded to their nonpregnant counterparts. With more than 86,000 pregnant women infected with COVID-19 through April 19, 2021, this lack of information regarding vaccine safety in pregnancy is a significant public health gap.⁸

COVID-19 vaccines

The current COVID-19 vaccines approved for use in the United States under an Emergency Use Authorization issued by the FDA are nonreplicating and thus cannot cause infection in the mother or fetus. These are the Pfizer-BioNTech mRNA vaccine, the Moderna mRNA-1273 vaccine, and the Janssen Biotech Inc. monovalent vaccine. Furthermore, in animal studies that included the Pfizer-BioNTech, Moderna, or Janssen COVID-19 vaccines, no fetal, embryonal, female reproductive, or postnatal development safety concerns were demonstrated.

As of April 19, 2021, 94,335 pregnant women had received a COVID-19 vaccination, and 4,622 of these enrolled in the Centers for Disease Control and Prevention (CDC)’s V-safe Vaccine Pregnancy Registry.⁹ The data reported noted no unexpected pregnancy or infant outcomes related to COVID-19 vaccination in pregnancy. Adverse effects of the vaccine were similar to those in nonpregnant cohorts. Additionally, emerging data suggest passage of immunity to neonates, with maternal antibodies demonstrated in cord blood at time of delivery as well as in breast milk.¹⁰ To date, these data mainly have come from women immunized with the Moderna and Pfizer-BioNTech mRNA vaccines.

Counseling pregnant patients

Our counseling aligns with that of the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC’s Advisory Committee on Immunization Practices. These organizations advise that COVID-19 vaccination should not be withheld from pregnant patients or patients who want to become pregnant. In pregnant patients with comorbidities that place them at higher risk for severe COVID-19 infection, all available formulations of the COVID-19 vaccination should be strongly considered. As evidence for vaccination safety continues to emerge, patients should continue to discuss their individual needs for vaccination in a shared decision-making format with their obstetric providers.

Each clinician has had to develop his or her individual approach and follow their institutional guidance regarding counseling and managing all of their patients’ expectations in this quickly changing climate of vaccination availability and recommendations. For pregnant women specifically, who are at increased risk for severe SARS-COV-2 disease,¹ the availability of varied types of vaccines for COVID-19 is promising, but with limited data available to discuss safety for the mother and the baby, what is the best discussion to guide decision making? OBG Management reached out to several experts, who share here what they do in their practices.

Addressing an uncharted front in the war on COVID-19

Ashley S. Roman, MD, MPH

In December 2020, the US Food and Drug Administration (FDA)’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.² Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.³ Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.⁴ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^5,6

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• the presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes
• potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• the ability to take precautions (social distancing, wearing a mask, etc).

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

Continue to: Benefits outweigh the risks, for now...

Benefits outweigh the risks, for now

Ashley S. Coggins, MD, and Jeanne S. Sheffield, MD

Vaccines have been a lifesaving public health measure since 1000 CE, when the Chinese first used smallpox inoculations to induce immunity.⁷ Work by pioneers such as Edward Jenner, Louis Pasteur, and Maurice Hilleman has averted countless millions of vaccine-preventable illnesses and deaths, and vaccines have become a routine part of health maintenance throughout the human life cycle.

Pregnant patients who receive vaccines often have an added benefit of protection provided to their infants through passive transfer of antibodies. Several vaccine platforms have been utilized in pregnancy with well-documented improvements in maternal and obstetric outcomes as well as improved neonatal outcomes in the first several months of life.

Risks of COVID-19 in pregnancy

The COVID-19 pandemic placed a spotlight on medically at-risk groups. Pregnant women are 3 times more likely to require admission to the intensive care unit, have increased requirement for extracorporeal membrane oxygenation treatment, and are up to 70% more likely to die than nonpregnant peers— and this risk increases with the presence of additional comorbidities.

In the case of COVID-19, vaccination trials that have shaped worldwide clinical practice unfortunately followed the historical trend of excluding pregnant patients from participation. This has required clinicians to guide their patients through the decision of whether or not to accept vaccination without having the same reassurances regarding safety and effectiveness afforded to their nonpregnant counterparts. With more than 86,000 pregnant women infected with COVID-19 through April 19, 2021, this lack of information regarding vaccine safety in pregnancy is a significant public health gap.⁸

COVID-19 vaccines

The current COVID-19 vaccines approved for use in the United States under an Emergency Use Authorization issued by the FDA are nonreplicating and thus cannot cause infection in the mother or fetus. These are the Pfizer-BioNTech mRNA vaccine, the Moderna mRNA-1273 vaccine, and the Janssen Biotech Inc. monovalent vaccine. Furthermore, in animal studies that included the Pfizer-BioNTech, Moderna, or Janssen COVID-19 vaccines, no fetal, embryonal, female reproductive, or postnatal development safety concerns were demonstrated.

As of April 19, 2021, 94,335 pregnant women had received a COVID-19 vaccination, and 4,622 of these enrolled in the Centers for Disease Control and Prevention (CDC)’s V-safe Vaccine Pregnancy Registry.⁹ The data reported noted no unexpected pregnancy or infant outcomes related to COVID-19 vaccination in pregnancy. Adverse effects of the vaccine were similar to those in nonpregnant cohorts. Additionally, emerging data suggest passage of immunity to neonates, with maternal antibodies demonstrated in cord blood at time of delivery as well as in breast milk.¹⁰ To date, these data mainly have come from women immunized with the Moderna and Pfizer-BioNTech mRNA vaccines.

Counseling pregnant patients

Our counseling aligns with that of the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC’s Advisory Committee on Immunization Practices. These organizations advise that COVID-19 vaccination should not be withheld from pregnant patients or patients who want to become pregnant. In pregnant patients with comorbidities that place them at higher risk for severe COVID-19 infection, all available formulations of the COVID-19 vaccination should be strongly considered. As evidence for vaccination safety continues to emerge, patients should continue to discuss their individual needs for vaccination in a shared decision-making format with their obstetric providers.

Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

PxHere

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at [email protected].

Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

PxHere

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at [email protected].

Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

PxHere

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at [email protected].