Women's Health

People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.

Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one  unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.

To find out how physicians can provide more compassionate, effective care for this group, this news organization spoke with K. Ashley Brandt, DO, gender-affirming surgeon and obstetrician/gynecologist in West Reading, Penn. This interview has been edited for length and clarity.

Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?

Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.

The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.

What can clinics and clinicians do to create a safe and welcoming environment?

Dr. Brandt: It starts with educating office staff about terminology and gender identities.

A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.

There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room.  A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.

Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?

Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.

It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.

Do you think that many physicians are educated about the care of underserved populations such as transgender patients?

Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.

However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.

But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.

What should physicians keep in mind when treating patients who identify as transgender?

Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.

Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.

What are your top health concerns for these patients and how do you address them?

Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.

Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.

Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.

Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?

Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.

Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?

Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.

People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.

Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.

Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.

Do you have any strategies on how to make the appointment more successful in addressing those issues?

Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.

If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.

That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.

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

People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.

Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one  unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.

To find out how physicians can provide more compassionate, effective care for this group, this news organization spoke with K. Ashley Brandt, DO, gender-affirming surgeon and obstetrician/gynecologist in West Reading, Penn. This interview has been edited for length and clarity.

Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?

Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.

The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.

What can clinics and clinicians do to create a safe and welcoming environment?

Dr. Brandt: It starts with educating office staff about terminology and gender identities.

A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.

There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room.  A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.

Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?

Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.

It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.

Do you think that many physicians are educated about the care of underserved populations such as transgender patients?

Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.

However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.

But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.

What should physicians keep in mind when treating patients who identify as transgender?

Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.

Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.

What are your top health concerns for these patients and how do you address them?

Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.

Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.

Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.

Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?

Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.

Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?

Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.

People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.

Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.

Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.

Do you have any strategies on how to make the appointment more successful in addressing those issues?

Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.

If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.

That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.

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

People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.

Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one  unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.

To find out how physicians can provide more compassionate, effective care for this group, this news organization spoke with K. Ashley Brandt, DO, gender-affirming surgeon and obstetrician/gynecologist in West Reading, Penn. This interview has been edited for length and clarity.

Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?

Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.

The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.

What can clinics and clinicians do to create a safe and welcoming environment?

Dr. Brandt: It starts with educating office staff about terminology and gender identities.

A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.

There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room.  A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.

Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?

Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.

It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.

Do you think that many physicians are educated about the care of underserved populations such as transgender patients?

Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.

However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.

But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.

What should physicians keep in mind when treating patients who identify as transgender?

Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.

Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.

What are your top health concerns for these patients and how do you address them?

Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.

Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.

Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.

Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?

Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.

Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?

Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.

People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.

Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.

Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.

Do you have any strategies on how to make the appointment more successful in addressing those issues?

Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.

If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.

That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.

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

Incorporation of a nonintensive fitness intervention for women with obesity into a standard fertility treatment program could be cost effective, a new analysis finds.

Financial data for the Canadian Fit-for-Fertility program were presented March 20 at the annual meeting of the Endocrine Society by Matea Belan, PhD, of the division of endocrinology at the University of Sherbrooke (Que.).

Women with obesity and infertility are typically advised to lose 5%-10% of their body weight as first-line fertility treatment, as doing so has been shown to increase rates of ovulation and pregnancy. But most established fertility treatment programs don’t incorporate organized lifestyle modification interventions, Dr. Belan explained during a press briefing.

“Mostly they’re just given general advice, not resources. It’s up to the woman to seek help for lifestyle. Our idea is to give them access to intervention that’s integrated into the setting of a fertility clinic,” she said.

Primary results from the Fit-for-Fertility program, including significant weight loss and a 40% increased live birth rate at 18 months, compared with standard fertility treatment, were presented at ENDO 2019 and reported at the time by this news organization.

In the new analysis, the cost in Canadian dollars per additional newborn achieved with the Fit-for-Fertility program was similar to the willingness-to-pay for in vitro fertilization from a health system perspective.

The final goal, lead investigator Jean-Patrice Baillargeon, MD, said in an interview, “would be to convince stakeholders, and mainly the provincial government, to cover the costs of our lifestyle program. This would not be more costly than funding IVF, but [would provide] more long-term benefits for the whole family and the offspring.”

Chloe A. Zera, MD, said in an interview that she supports the idea in principle, but is concerned that, in the U.S. health care system, women don’t always have access to fertility and obesity treatments to begin with.

“There’s a huge equity issue. People with Medicaid don’t necessarily get coverage for IVF. ... Even many commercially insured people are paying out of pocket, which can be $10,000 to $15,000 for a cycle just for the medications, so the cost to patients on the individual level is huge,” said Dr. Zera, who is associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston.

She added: “I’m prolifestyle modification. I’m also proequity in health care delivery so I would want to make sure that the way it’s delivered incorporates that as a consideration. ... Is that money better spent on primary prevention of obesity and access to basic services and basic reproductive health care for everybody?”
 

Primary results: Improvements in overall and spontaneous pregnancy rates

The study included 130 women with infertility and a body mass index of at least 30 kg/m2 (mean, 40), of whom 65 were randomized to the Fit-for-Fitness program and 65 to standard fertility treatment that did not include a lifestyle intervention, although those women could consult professionals on their own. The women in the lifestyle intervention group had to stop medical fertility treatments for the first 6 months but could use them thereafter while the controls continued to use them throughout.

Based on motivational interviewing, the program focused on womens’ individual likes and dislikes, experiences, and perceived capacities, aiming to improve healthful habits gradually and with “low intensity” so as to maintain them in the long run.

The program combined individual sessions with a nutritionist and kinesiologist every 6 weeks and 12 mandatory group sessions. The women were asked to reduce their total caloric intake by about 500 calories/day but weren’t asked to change their diets. They were also advised to increase physical activity by about 150 minutes/week.

“We want to keep it sustainable in time, so they don’t have a relapse when they become pregnant, and to help the newborn and spouse too. It’s about improving and maintaining habits,” Dr. Belan explained during the briefing.

At 6 months, mean weight changes were –3.4% versus –0.89% for the intervention versus control groups (P = .003).

“What is important for women with obesity and infertility is to improve their lifestyle, both physical activity and nutrition, even if the weight loss is minimal,” noted Dr. Baillargeon, professor of medicine, health sciences research and physiology, also at the University of Sherbrooke.

A total of 46 intervention and 52 control patients finished the 18-month study. Pregnancies occurred in 61% of the intervention group versus 39% of the controls, while spontaneous pregnancies – among those not using medical fertility treatments – occurred in 33.3% versus 12.3% (P = .009).

The primary outcome, live births at 18 months, occurred in 51.0% of the intervention group versus 36.8% of controls, which wasn’t a statistically significant difference, but was “highly clinically significant,” Dr. Belan said.
 

Cost per additional newborn similar to IVF

Costs (in Canadian dollars) considered in the analysis included those related to the management of infertility, obesity, pregnancy, and childbirth. The incremental cost-effectiveness ratios, a standard cost-effectiveness measure, per live birth were $24,393 from a societal perspective, $12,633 for the health system, and $5,980 for the patient.

Because the $12,633 health system cost per additional newborn with the Fit-for-Fertility program is similar to the health system’s willingness-to-pay for IVF of up to $15,000, a lifestyle intervention could be considered cost-efficient compared with the standard of care, Dr. Belan said.

“We think that the Fit-for-Fertility program could be deemed cost effective and could represent an interesting alternative to the usual standard of care for women with obesity seeking fertility treatments,” she commented.

The Canadian Institutes of Health Research is funding a larger randomized, controlled trial of the program at six Canadian centers to validate these results.

Dr. Belan, Dr. Baillargeon, and Dr. Zera reported no relevant financial relationships.

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

Incorporation of a nonintensive fitness intervention for women with obesity into a standard fertility treatment program could be cost effective, a new analysis finds.

Financial data for the Canadian Fit-for-Fertility program were presented March 20 at the annual meeting of the Endocrine Society by Matea Belan, PhD, of the division of endocrinology at the University of Sherbrooke (Que.).

Women with obesity and infertility are typically advised to lose 5%-10% of their body weight as first-line fertility treatment, as doing so has been shown to increase rates of ovulation and pregnancy. But most established fertility treatment programs don’t incorporate organized lifestyle modification interventions, Dr. Belan explained during a press briefing.

“Mostly they’re just given general advice, not resources. It’s up to the woman to seek help for lifestyle. Our idea is to give them access to intervention that’s integrated into the setting of a fertility clinic,” she said.

Primary results from the Fit-for-Fertility program, including significant weight loss and a 40% increased live birth rate at 18 months, compared with standard fertility treatment, were presented at ENDO 2019 and reported at the time by this news organization.

In the new analysis, the cost in Canadian dollars per additional newborn achieved with the Fit-for-Fertility program was similar to the willingness-to-pay for in vitro fertilization from a health system perspective.

The final goal, lead investigator Jean-Patrice Baillargeon, MD, said in an interview, “would be to convince stakeholders, and mainly the provincial government, to cover the costs of our lifestyle program. This would not be more costly than funding IVF, but [would provide] more long-term benefits for the whole family and the offspring.”

Chloe A. Zera, MD, said in an interview that she supports the idea in principle, but is concerned that, in the U.S. health care system, women don’t always have access to fertility and obesity treatments to begin with.

“There’s a huge equity issue. People with Medicaid don’t necessarily get coverage for IVF. ... Even many commercially insured people are paying out of pocket, which can be $10,000 to $15,000 for a cycle just for the medications, so the cost to patients on the individual level is huge,” said Dr. Zera, who is associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston.

She added: “I’m prolifestyle modification. I’m also proequity in health care delivery so I would want to make sure that the way it’s delivered incorporates that as a consideration. ... Is that money better spent on primary prevention of obesity and access to basic services and basic reproductive health care for everybody?”
 

Primary results: Improvements in overall and spontaneous pregnancy rates

The study included 130 women with infertility and a body mass index of at least 30 kg/m2 (mean, 40), of whom 65 were randomized to the Fit-for-Fitness program and 65 to standard fertility treatment that did not include a lifestyle intervention, although those women could consult professionals on their own. The women in the lifestyle intervention group had to stop medical fertility treatments for the first 6 months but could use them thereafter while the controls continued to use them throughout.

Based on motivational interviewing, the program focused on womens’ individual likes and dislikes, experiences, and perceived capacities, aiming to improve healthful habits gradually and with “low intensity” so as to maintain them in the long run.

The program combined individual sessions with a nutritionist and kinesiologist every 6 weeks and 12 mandatory group sessions. The women were asked to reduce their total caloric intake by about 500 calories/day but weren’t asked to change their diets. They were also advised to increase physical activity by about 150 minutes/week.

“We want to keep it sustainable in time, so they don’t have a relapse when they become pregnant, and to help the newborn and spouse too. It’s about improving and maintaining habits,” Dr. Belan explained during the briefing.

At 6 months, mean weight changes were –3.4% versus –0.89% for the intervention versus control groups (P = .003).

“What is important for women with obesity and infertility is to improve their lifestyle, both physical activity and nutrition, even if the weight loss is minimal,” noted Dr. Baillargeon, professor of medicine, health sciences research and physiology, also at the University of Sherbrooke.

A total of 46 intervention and 52 control patients finished the 18-month study. Pregnancies occurred in 61% of the intervention group versus 39% of the controls, while spontaneous pregnancies – among those not using medical fertility treatments – occurred in 33.3% versus 12.3% (P = .009).

The primary outcome, live births at 18 months, occurred in 51.0% of the intervention group versus 36.8% of controls, which wasn’t a statistically significant difference, but was “highly clinically significant,” Dr. Belan said.
 

Cost per additional newborn similar to IVF

Costs (in Canadian dollars) considered in the analysis included those related to the management of infertility, obesity, pregnancy, and childbirth. The incremental cost-effectiveness ratios, a standard cost-effectiveness measure, per live birth were $24,393 from a societal perspective, $12,633 for the health system, and $5,980 for the patient.

Because the $12,633 health system cost per additional newborn with the Fit-for-Fertility program is similar to the health system’s willingness-to-pay for IVF of up to $15,000, a lifestyle intervention could be considered cost-efficient compared with the standard of care, Dr. Belan said.

“We think that the Fit-for-Fertility program could be deemed cost effective and could represent an interesting alternative to the usual standard of care for women with obesity seeking fertility treatments,” she commented.

The Canadian Institutes of Health Research is funding a larger randomized, controlled trial of the program at six Canadian centers to validate these results.

Dr. Belan, Dr. Baillargeon, and Dr. Zera reported no relevant financial relationships.

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

Incorporation of a nonintensive fitness intervention for women with obesity into a standard fertility treatment program could be cost effective, a new analysis finds.

Financial data for the Canadian Fit-for-Fertility program were presented March 20 at the annual meeting of the Endocrine Society by Matea Belan, PhD, of the division of endocrinology at the University of Sherbrooke (Que.).

Women with obesity and infertility are typically advised to lose 5%-10% of their body weight as first-line fertility treatment, as doing so has been shown to increase rates of ovulation and pregnancy. But most established fertility treatment programs don’t incorporate organized lifestyle modification interventions, Dr. Belan explained during a press briefing.

“Mostly they’re just given general advice, not resources. It’s up to the woman to seek help for lifestyle. Our idea is to give them access to intervention that’s integrated into the setting of a fertility clinic,” she said.

Primary results from the Fit-for-Fertility program, including significant weight loss and a 40% increased live birth rate at 18 months, compared with standard fertility treatment, were presented at ENDO 2019 and reported at the time by this news organization.

In the new analysis, the cost in Canadian dollars per additional newborn achieved with the Fit-for-Fertility program was similar to the willingness-to-pay for in vitro fertilization from a health system perspective.

The final goal, lead investigator Jean-Patrice Baillargeon, MD, said in an interview, “would be to convince stakeholders, and mainly the provincial government, to cover the costs of our lifestyle program. This would not be more costly than funding IVF, but [would provide] more long-term benefits for the whole family and the offspring.”

Chloe A. Zera, MD, said in an interview that she supports the idea in principle, but is concerned that, in the U.S. health care system, women don’t always have access to fertility and obesity treatments to begin with.

“There’s a huge equity issue. People with Medicaid don’t necessarily get coverage for IVF. ... Even many commercially insured people are paying out of pocket, which can be $10,000 to $15,000 for a cycle just for the medications, so the cost to patients on the individual level is huge,” said Dr. Zera, who is associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston.

She added: “I’m prolifestyle modification. I’m also proequity in health care delivery so I would want to make sure that the way it’s delivered incorporates that as a consideration. ... Is that money better spent on primary prevention of obesity and access to basic services and basic reproductive health care for everybody?”
 

Primary results: Improvements in overall and spontaneous pregnancy rates

The study included 130 women with infertility and a body mass index of at least 30 kg/m2 (mean, 40), of whom 65 were randomized to the Fit-for-Fitness program and 65 to standard fertility treatment that did not include a lifestyle intervention, although those women could consult professionals on their own. The women in the lifestyle intervention group had to stop medical fertility treatments for the first 6 months but could use them thereafter while the controls continued to use them throughout.

Based on motivational interviewing, the program focused on womens’ individual likes and dislikes, experiences, and perceived capacities, aiming to improve healthful habits gradually and with “low intensity” so as to maintain them in the long run.

The program combined individual sessions with a nutritionist and kinesiologist every 6 weeks and 12 mandatory group sessions. The women were asked to reduce their total caloric intake by about 500 calories/day but weren’t asked to change their diets. They were also advised to increase physical activity by about 150 minutes/week.

“We want to keep it sustainable in time, so they don’t have a relapse when they become pregnant, and to help the newborn and spouse too. It’s about improving and maintaining habits,” Dr. Belan explained during the briefing.

At 6 months, mean weight changes were –3.4% versus –0.89% for the intervention versus control groups (P = .003).

“What is important for women with obesity and infertility is to improve their lifestyle, both physical activity and nutrition, even if the weight loss is minimal,” noted Dr. Baillargeon, professor of medicine, health sciences research and physiology, also at the University of Sherbrooke.

A total of 46 intervention and 52 control patients finished the 18-month study. Pregnancies occurred in 61% of the intervention group versus 39% of the controls, while spontaneous pregnancies – among those not using medical fertility treatments – occurred in 33.3% versus 12.3% (P = .009).

The primary outcome, live births at 18 months, occurred in 51.0% of the intervention group versus 36.8% of controls, which wasn’t a statistically significant difference, but was “highly clinically significant,” Dr. Belan said.
 

Cost per additional newborn similar to IVF

Costs (in Canadian dollars) considered in the analysis included those related to the management of infertility, obesity, pregnancy, and childbirth. The incremental cost-effectiveness ratios, a standard cost-effectiveness measure, per live birth were $24,393 from a societal perspective, $12,633 for the health system, and $5,980 for the patient.

Because the $12,633 health system cost per additional newborn with the Fit-for-Fertility program is similar to the health system’s willingness-to-pay for IVF of up to $15,000, a lifestyle intervention could be considered cost-efficient compared with the standard of care, Dr. Belan said.

“We think that the Fit-for-Fertility program could be deemed cost effective and could represent an interesting alternative to the usual standard of care for women with obesity seeking fertility treatments,” she commented.

The Canadian Institutes of Health Research is funding a larger randomized, controlled trial of the program at six Canadian centers to validate these results.

Dr. Belan, Dr. Baillargeon, and Dr. Zera reported no relevant financial relationships.

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

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

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

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

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

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

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

Following a recent article in the Guardian, the Internet has erupted with tales of periods gone awry. The stress and loss of normalcy over the last year appears to have altered cycles and amplified the premenstrual syndrome (PMS) symptoms many women experience. And after the piece published, many responded on social media with the same sentiment: “So, it’s not just me?”

Women have experienced the loss of their period, excessive and prolonged bleeding, severe mood swings, and irritability, according to the Guardian article. London-based gynecologist Anita Mitra, MBChB, PhD, took an informal survey and found that 65% of 5,677 respondents had noticed a change in their menstrual cycle, the Guardian reported. Another survey, which was posted on medRxiv but hasn’t been peer reviewed yet, found 53% of the 749 respondents had noticed a change in their menstrual cycle, including increased cycle length.

“The pandemic in itself has made more stress for women,” said Karen Carlson, MD, obstetrician and gynecologist at Nebraska Medicine. There’s preliminary evidence that the cycling progesterone and estrogen experienced by reproductive age women actually offers a protective effect against COVID-19, which is good news. But Dr. Carlson said that because they are less likely than men and the elderly to become seriously ill, many women have taken on a lot of the additional responsibilities brought on by the pandemic. They often juggle homeschooling and elder care in addition to the ubiquitous stressors of isolation and concerns around personal health.

“Abnormal bleeding is the most common reason people present to the gynecologist,” Dr. Carlson said in an interview. But in recent months, Dr. Carlson said she’s seen a slight uptick in these issues, and there might have been even more women presenting to their physicians if the pandemic hadn’t also suppressed access to care.

Stress, or rather the cortisol it causes the body to produce, is the culprit for disrupted cycles. It can suppress pituitary hormones that stimulate ovulation. “Some women don’t feel right because they are stuck in the one phase of the cycle,” Dr. Carlson said. They may go months without a period and when they do eventually shed their uterine lining the bleeding goes on for a while.

Some irregularity in a person’s cycle is a normal response to stress and even likely, given the last year. However, bleeding for more than 2 weeks or irregularity for more than 3 months could point to something more serious like an infection or cancer, Dr. Carlson said. Getting a clear history so you know when you need to do blood and hormone workups is critical.
 

Anxiety and depression amplified

For some women it’s not bleeding that’s a problem, rather their PMS has become crippling. And some of their significant others have noticed drastic changes in their mood. In the Guardian article, one woman said she’d gone from feeling withdrawn during her period to being totally unreachable and experiencing intense anxiety.

Maureen Whelihan, MD, a gynecologist in Palm Beach, Fla., said that, for the majority of her patients under 39 years of age, these feelings aren’t a hormone issue, but a stress and neuroreceptor issue. She says she’s seen approximately a 30% increase in mood disorders since the start of the pandemic. Even though many of her patients are cycling relatively normally, their anxiety and depression have been amplified.

Caroline Gurvich, PhD, a neuroscientist at Monash University in Melbourne, attributes this to the loss of typical coping mechanisms. “Having changes to the support system and routine and things that would keep them mentally healthy can exacerbate PMS,” she said in an interview. Dr. Gurvich’s advice is to build routines into the pandemic lifestyle. Normal wake and sleep times, healthy eating, and practices that bring happiness can be “crucial to keeping those PMS systems as controlled as possible.”

Telehealth has made it much easier to access some patients struggling with PMS and offer them the medication or counseling they need, Dr. Carlson said. But that approach doesn’t work for everyone. “I feel like there are a lot of silent sufferers,” she said.

This is where screening practices like the Patient Health Questionnaire-9 are so critical, according to Dr. Whelihan, who screens every patient as part of their routine iPad check-in process. Even in a normal year, “I think one-third of gynecology is psychiatry,” she said in an interview. She finds many of the patients struggling with excessive PMS symptoms, both during the pandemic and before, benefit from a child-sized dose of antidepressant. This may allow them to get to a place where they can make impactful routine decisions about exercise or sleep, and then taper off the antidepressant.

It may also be important for clinicians to help patients make the initial connection between their worsening mood or cognitive function and their period. Knowing their feelings of stress, irritability, fogginess, or being withdrawn are linked to their hormone cycle and possibly worsened by the stress of the pandemic can be helpful, Dr. Gurvich said. “If they become conscious of how they are feeling it can be helpful for management of these stressful symptoms,” she said.

Following a recent article in the Guardian, the Internet has erupted with tales of periods gone awry. The stress and loss of normalcy over the last year appears to have altered cycles and amplified the premenstrual syndrome (PMS) symptoms many women experience. And after the piece published, many responded on social media with the same sentiment: “So, it’s not just me?”

Women have experienced the loss of their period, excessive and prolonged bleeding, severe mood swings, and irritability, according to the Guardian article. London-based gynecologist Anita Mitra, MBChB, PhD, took an informal survey and found that 65% of 5,677 respondents had noticed a change in their menstrual cycle, the Guardian reported. Another survey, which was posted on medRxiv but hasn’t been peer reviewed yet, found 53% of the 749 respondents had noticed a change in their menstrual cycle, including increased cycle length.

“The pandemic in itself has made more stress for women,” said Karen Carlson, MD, obstetrician and gynecologist at Nebraska Medicine. There’s preliminary evidence that the cycling progesterone and estrogen experienced by reproductive age women actually offers a protective effect against COVID-19, which is good news. But Dr. Carlson said that because they are less likely than men and the elderly to become seriously ill, many women have taken on a lot of the additional responsibilities brought on by the pandemic. They often juggle homeschooling and elder care in addition to the ubiquitous stressors of isolation and concerns around personal health.

“Abnormal bleeding is the most common reason people present to the gynecologist,” Dr. Carlson said in an interview. But in recent months, Dr. Carlson said she’s seen a slight uptick in these issues, and there might have been even more women presenting to their physicians if the pandemic hadn’t also suppressed access to care.

Stress, or rather the cortisol it causes the body to produce, is the culprit for disrupted cycles. It can suppress pituitary hormones that stimulate ovulation. “Some women don’t feel right because they are stuck in the one phase of the cycle,” Dr. Carlson said. They may go months without a period and when they do eventually shed their uterine lining the bleeding goes on for a while.

Some irregularity in a person’s cycle is a normal response to stress and even likely, given the last year. However, bleeding for more than 2 weeks or irregularity for more than 3 months could point to something more serious like an infection or cancer, Dr. Carlson said. Getting a clear history so you know when you need to do blood and hormone workups is critical.
 

Anxiety and depression amplified

For some women it’s not bleeding that’s a problem, rather their PMS has become crippling. And some of their significant others have noticed drastic changes in their mood. In the Guardian article, one woman said she’d gone from feeling withdrawn during her period to being totally unreachable and experiencing intense anxiety.

Maureen Whelihan, MD, a gynecologist in Palm Beach, Fla., said that, for the majority of her patients under 39 years of age, these feelings aren’t a hormone issue, but a stress and neuroreceptor issue. She says she’s seen approximately a 30% increase in mood disorders since the start of the pandemic. Even though many of her patients are cycling relatively normally, their anxiety and depression have been amplified.

Caroline Gurvich, PhD, a neuroscientist at Monash University in Melbourne, attributes this to the loss of typical coping mechanisms. “Having changes to the support system and routine and things that would keep them mentally healthy can exacerbate PMS,” she said in an interview. Dr. Gurvich’s advice is to build routines into the pandemic lifestyle. Normal wake and sleep times, healthy eating, and practices that bring happiness can be “crucial to keeping those PMS systems as controlled as possible.”

Telehealth has made it much easier to access some patients struggling with PMS and offer them the medication or counseling they need, Dr. Carlson said. But that approach doesn’t work for everyone. “I feel like there are a lot of silent sufferers,” she said.

This is where screening practices like the Patient Health Questionnaire-9 are so critical, according to Dr. Whelihan, who screens every patient as part of their routine iPad check-in process. Even in a normal year, “I think one-third of gynecology is psychiatry,” she said in an interview. She finds many of the patients struggling with excessive PMS symptoms, both during the pandemic and before, benefit from a child-sized dose of antidepressant. This may allow them to get to a place where they can make impactful routine decisions about exercise or sleep, and then taper off the antidepressant.

It may also be important for clinicians to help patients make the initial connection between their worsening mood or cognitive function and their period. Knowing their feelings of stress, irritability, fogginess, or being withdrawn are linked to their hormone cycle and possibly worsened by the stress of the pandemic can be helpful, Dr. Gurvich said. “If they become conscious of how they are feeling it can be helpful for management of these stressful symptoms,” she said.

Following a recent article in the Guardian, the Internet has erupted with tales of periods gone awry. The stress and loss of normalcy over the last year appears to have altered cycles and amplified the premenstrual syndrome (PMS) symptoms many women experience. And after the piece published, many responded on social media with the same sentiment: “So, it’s not just me?”

Women have experienced the loss of their period, excessive and prolonged bleeding, severe mood swings, and irritability, according to the Guardian article. London-based gynecologist Anita Mitra, MBChB, PhD, took an informal survey and found that 65% of 5,677 respondents had noticed a change in their menstrual cycle, the Guardian reported. Another survey, which was posted on medRxiv but hasn’t been peer reviewed yet, found 53% of the 749 respondents had noticed a change in their menstrual cycle, including increased cycle length.

“The pandemic in itself has made more stress for women,” said Karen Carlson, MD, obstetrician and gynecologist at Nebraska Medicine. There’s preliminary evidence that the cycling progesterone and estrogen experienced by reproductive age women actually offers a protective effect against COVID-19, which is good news. But Dr. Carlson said that because they are less likely than men and the elderly to become seriously ill, many women have taken on a lot of the additional responsibilities brought on by the pandemic. They often juggle homeschooling and elder care in addition to the ubiquitous stressors of isolation and concerns around personal health.

“Abnormal bleeding is the most common reason people present to the gynecologist,” Dr. Carlson said in an interview. But in recent months, Dr. Carlson said she’s seen a slight uptick in these issues, and there might have been even more women presenting to their physicians if the pandemic hadn’t also suppressed access to care.

Stress, or rather the cortisol it causes the body to produce, is the culprit for disrupted cycles. It can suppress pituitary hormones that stimulate ovulation. “Some women don’t feel right because they are stuck in the one phase of the cycle,” Dr. Carlson said. They may go months without a period and when they do eventually shed their uterine lining the bleeding goes on for a while.

Some irregularity in a person’s cycle is a normal response to stress and even likely, given the last year. However, bleeding for more than 2 weeks or irregularity for more than 3 months could point to something more serious like an infection or cancer, Dr. Carlson said. Getting a clear history so you know when you need to do blood and hormone workups is critical.
 

Anxiety and depression amplified

For some women it’s not bleeding that’s a problem, rather their PMS has become crippling. And some of their significant others have noticed drastic changes in their mood. In the Guardian article, one woman said she’d gone from feeling withdrawn during her period to being totally unreachable and experiencing intense anxiety.

Maureen Whelihan, MD, a gynecologist in Palm Beach, Fla., said that, for the majority of her patients under 39 years of age, these feelings aren’t a hormone issue, but a stress and neuroreceptor issue. She says she’s seen approximately a 30% increase in mood disorders since the start of the pandemic. Even though many of her patients are cycling relatively normally, their anxiety and depression have been amplified.

Caroline Gurvich, PhD, a neuroscientist at Monash University in Melbourne, attributes this to the loss of typical coping mechanisms. “Having changes to the support system and routine and things that would keep them mentally healthy can exacerbate PMS,” she said in an interview. Dr. Gurvich’s advice is to build routines into the pandemic lifestyle. Normal wake and sleep times, healthy eating, and practices that bring happiness can be “crucial to keeping those PMS systems as controlled as possible.”

Telehealth has made it much easier to access some patients struggling with PMS and offer them the medication or counseling they need, Dr. Carlson said. But that approach doesn’t work for everyone. “I feel like there are a lot of silent sufferers,” she said.

This is where screening practices like the Patient Health Questionnaire-9 are so critical, according to Dr. Whelihan, who screens every patient as part of their routine iPad check-in process. Even in a normal year, “I think one-third of gynecology is psychiatry,” she said in an interview. She finds many of the patients struggling with excessive PMS symptoms, both during the pandemic and before, benefit from a child-sized dose of antidepressant. This may allow them to get to a place where they can make impactful routine decisions about exercise or sleep, and then taper off the antidepressant.

It may also be important for clinicians to help patients make the initial connection between their worsening mood or cognitive function and their period. Knowing their feelings of stress, irritability, fogginess, or being withdrawn are linked to their hormone cycle and possibly worsened by the stress of the pandemic can be helpful, Dr. Gurvich said. “If they become conscious of how they are feeling it can be helpful for management of these stressful symptoms,” she said.

Six pregnancy-related complications increase a woman’s risk of developing risk factors for cardiovascular disease (CVD) and subsequently developing CVD, the American Heart Association says in a new scientific statement.

They are hypertensive disorders of pregnancy, preterm delivery, gestational diabetes, small-for-gestational-age (SGA) delivery, placental abruption (abruptio placentae), and pregnancy loss.

A history of any of these adverse pregnancy outcomes should prompt “more vigorous primordial prevention of CVD risk factors and primary prevention of CVD,” the writing group says.

“Adverse pregnancy outcomes are linked to women having hypertension, diabetes, abnormal cholesterol, and cardiovascular disease events, including heart attack and stroke, long after their pregnancies,” Nisha I. Parikh, MD, MPH, chair of the writing group, said in a news release.

Adverse pregnancy outcomes can be a “powerful window” into CVD prevention “if women and their health care professionals harness the knowledge and use it for health improvement,” said Dr. Parikh, associate professor of medicine in the cardiovascular division at the University of California, San Francisco.

The statement was published online March 29 in Circulation.

For the scientific statement, the writing group reviewed the latest scientific literature on adverse pregnancy outcomes and CVD risk. 

The evidence in the literature linking adverse pregnancy outcomes to later CVD is “consistent over many years and confirmed in nearly every study we examined,” Dr. Parikh said. Among their key findings:

• Gestational hypertension is associated with an increased risk of CVD later in life by 67% and the odds of stroke by 83%. Moderate and severe  is associated with a more than twofold increase in the risk for CVD.
• Gestational diabetes is associated with an increase in the risk for CVD by 68% and the risk of developing  after pregnancy by 10-fold.
• Preterm delivery (before 37 weeks) is associated with double the risk of developing CVD and is strongly associated with later heart disease, stroke, and CVD.
• Placental abruption is associated with an 82% increased risk for CVD.
• Stillbirth is associated with about double the risk for CVD.

“This statement should inform future prevention guidelines in terms of the important factors to consider for determining women’s risk for heart diseases and stroke,” Dr. Parikh added.

The statement emphasizes the importance of recognizing these adverse pregnancy outcomes when evaluating CVD risk in women but notes that their value in reclassifying CVD risk may not be established.

It highlights the importance of adopting a heart-healthy diet and increasing physical activity among women with any of these pregnancy-related complications, starting right after childbirth and continuing across the life span to decrease CVD risk.

Lactation and breastfeeding may lower a woman’s later cardiometabolic risk, the writing group notes.
 

‘Golden year of opportunity’

The statement highlights several opportunities to improve transition of care for women with adverse pregnancy outcomes and to implement strategies to reduce their long-term CVD risk.

One strategy is longer postpartum follow-up care, sometimes referred to as the “fourth trimester,” to screen for CVD risk factors and provide CVD prevention counseling.

Another strategy involves improving the transfer of health information between ob/gyns and primary care physicians to eliminate inconsistencies in electronic health record documentation, which should improve patient care.

A third strategy is obtaining a short and targeted health history for each woman to confirm if she has any of the six pregnancy-related complications.

“If a woman has had any of these adverse pregnancy outcomes, consider close blood pressure monitoring, type 2 diabetes and lipid screening, and more aggressive risk factor modification and CVD prevention recommendations,” Dr. Parikh advised.

“Our data [lend] support to the prior AHA recommendation that these important adverse pregnancy outcomes should be ‘risk enhancers’ to guide consideration for statin therapy aimed at CVD prevention in women,” Dr. Parikh added.

In a commentary in Circulation, Eliza C. Miller, MD, assistant professor of neurology at Columbia University, New York, notes that pregnancy and the postpartum period are a critical time window in a woman’s life to identify CVD risk and improve a woman’s health trajectory.

“The so-called ‘Golden Hour’ for conditions such as sepsis and acute stroke refers to a critical time window for early recognition and treatment, when we can change a patient’s clinical trajectory and prevent severe morbidity and mortality,” writes Dr. Miller.

“Pregnancy and the postpartum period can be considered a ‘Golden Year’ in a woman’s life, offering a rare opportunity for clinicians to identify young women at risk and work with them to improve their cardiovascular health trajectories,” she notes.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular and Stroke Nursing; and the Stroke Council.

The authors of the scientific statement have disclosed no relevant financial relationships. Dr. Miller received personal compensation from Finch McCranie and Argionis & Associates for expert testimony regarding maternal stroke; and personal compensation from Elsevier for editorial work on Handbook of Clinical Neurology, Vol. 171 and 172 (Neurology of Pregnancy).

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

Six pregnancy-related complications increase a woman’s risk of developing risk factors for cardiovascular disease (CVD) and subsequently developing CVD, the American Heart Association says in a new scientific statement.

They are hypertensive disorders of pregnancy, preterm delivery, gestational diabetes, small-for-gestational-age (SGA) delivery, placental abruption (abruptio placentae), and pregnancy loss.

A history of any of these adverse pregnancy outcomes should prompt “more vigorous primordial prevention of CVD risk factors and primary prevention of CVD,” the writing group says.

“Adverse pregnancy outcomes are linked to women having hypertension, diabetes, abnormal cholesterol, and cardiovascular disease events, including heart attack and stroke, long after their pregnancies,” Nisha I. Parikh, MD, MPH, chair of the writing group, said in a news release.

Adverse pregnancy outcomes can be a “powerful window” into CVD prevention “if women and their health care professionals harness the knowledge and use it for health improvement,” said Dr. Parikh, associate professor of medicine in the cardiovascular division at the University of California, San Francisco.

The statement was published online March 29 in Circulation.

For the scientific statement, the writing group reviewed the latest scientific literature on adverse pregnancy outcomes and CVD risk. 

The evidence in the literature linking adverse pregnancy outcomes to later CVD is “consistent over many years and confirmed in nearly every study we examined,” Dr. Parikh said. Among their key findings:

• Gestational hypertension is associated with an increased risk of CVD later in life by 67% and the odds of stroke by 83%. Moderate and severe  is associated with a more than twofold increase in the risk for CVD.
• Gestational diabetes is associated with an increase in the risk for CVD by 68% and the risk of developing  after pregnancy by 10-fold.
• Preterm delivery (before 37 weeks) is associated with double the risk of developing CVD and is strongly associated with later heart disease, stroke, and CVD.
• Placental abruption is associated with an 82% increased risk for CVD.
• Stillbirth is associated with about double the risk for CVD.

“This statement should inform future prevention guidelines in terms of the important factors to consider for determining women’s risk for heart diseases and stroke,” Dr. Parikh added.

The statement emphasizes the importance of recognizing these adverse pregnancy outcomes when evaluating CVD risk in women but notes that their value in reclassifying CVD risk may not be established.

It highlights the importance of adopting a heart-healthy diet and increasing physical activity among women with any of these pregnancy-related complications, starting right after childbirth and continuing across the life span to decrease CVD risk.

Lactation and breastfeeding may lower a woman’s later cardiometabolic risk, the writing group notes.
 

‘Golden year of opportunity’

The statement highlights several opportunities to improve transition of care for women with adverse pregnancy outcomes and to implement strategies to reduce their long-term CVD risk.

One strategy is longer postpartum follow-up care, sometimes referred to as the “fourth trimester,” to screen for CVD risk factors and provide CVD prevention counseling.

Another strategy involves improving the transfer of health information between ob/gyns and primary care physicians to eliminate inconsistencies in electronic health record documentation, which should improve patient care.

A third strategy is obtaining a short and targeted health history for each woman to confirm if she has any of the six pregnancy-related complications.

“If a woman has had any of these adverse pregnancy outcomes, consider close blood pressure monitoring, type 2 diabetes and lipid screening, and more aggressive risk factor modification and CVD prevention recommendations,” Dr. Parikh advised.

“Our data [lend] support to the prior AHA recommendation that these important adverse pregnancy outcomes should be ‘risk enhancers’ to guide consideration for statin therapy aimed at CVD prevention in women,” Dr. Parikh added.

In a commentary in Circulation, Eliza C. Miller, MD, assistant professor of neurology at Columbia University, New York, notes that pregnancy and the postpartum period are a critical time window in a woman’s life to identify CVD risk and improve a woman’s health trajectory.

“The so-called ‘Golden Hour’ for conditions such as sepsis and acute stroke refers to a critical time window for early recognition and treatment, when we can change a patient’s clinical trajectory and prevent severe morbidity and mortality,” writes Dr. Miller.

“Pregnancy and the postpartum period can be considered a ‘Golden Year’ in a woman’s life, offering a rare opportunity for clinicians to identify young women at risk and work with them to improve their cardiovascular health trajectories,” she notes.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular and Stroke Nursing; and the Stroke Council.

The authors of the scientific statement have disclosed no relevant financial relationships. Dr. Miller received personal compensation from Finch McCranie and Argionis & Associates for expert testimony regarding maternal stroke; and personal compensation from Elsevier for editorial work on Handbook of Clinical Neurology, Vol. 171 and 172 (Neurology of Pregnancy).

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

Six pregnancy-related complications increase a woman’s risk of developing risk factors for cardiovascular disease (CVD) and subsequently developing CVD, the American Heart Association says in a new scientific statement.

They are hypertensive disorders of pregnancy, preterm delivery, gestational diabetes, small-for-gestational-age (SGA) delivery, placental abruption (abruptio placentae), and pregnancy loss.

A history of any of these adverse pregnancy outcomes should prompt “more vigorous primordial prevention of CVD risk factors and primary prevention of CVD,” the writing group says.

“Adverse pregnancy outcomes are linked to women having hypertension, diabetes, abnormal cholesterol, and cardiovascular disease events, including heart attack and stroke, long after their pregnancies,” Nisha I. Parikh, MD, MPH, chair of the writing group, said in a news release.

Adverse pregnancy outcomes can be a “powerful window” into CVD prevention “if women and their health care professionals harness the knowledge and use it for health improvement,” said Dr. Parikh, associate professor of medicine in the cardiovascular division at the University of California, San Francisco.

The statement was published online March 29 in Circulation.

For the scientific statement, the writing group reviewed the latest scientific literature on adverse pregnancy outcomes and CVD risk. 

The evidence in the literature linking adverse pregnancy outcomes to later CVD is “consistent over many years and confirmed in nearly every study we examined,” Dr. Parikh said. Among their key findings:

• Gestational hypertension is associated with an increased risk of CVD later in life by 67% and the odds of stroke by 83%. Moderate and severe  is associated with a more than twofold increase in the risk for CVD.
• Gestational diabetes is associated with an increase in the risk for CVD by 68% and the risk of developing  after pregnancy by 10-fold.
• Preterm delivery (before 37 weeks) is associated with double the risk of developing CVD and is strongly associated with later heart disease, stroke, and CVD.
• Placental abruption is associated with an 82% increased risk for CVD.
• Stillbirth is associated with about double the risk for CVD.

“This statement should inform future prevention guidelines in terms of the important factors to consider for determining women’s risk for heart diseases and stroke,” Dr. Parikh added.

The statement emphasizes the importance of recognizing these adverse pregnancy outcomes when evaluating CVD risk in women but notes that their value in reclassifying CVD risk may not be established.

It highlights the importance of adopting a heart-healthy diet and increasing physical activity among women with any of these pregnancy-related complications, starting right after childbirth and continuing across the life span to decrease CVD risk.

Lactation and breastfeeding may lower a woman’s later cardiometabolic risk, the writing group notes.
 

‘Golden year of opportunity’

The statement highlights several opportunities to improve transition of care for women with adverse pregnancy outcomes and to implement strategies to reduce their long-term CVD risk.

One strategy is longer postpartum follow-up care, sometimes referred to as the “fourth trimester,” to screen for CVD risk factors and provide CVD prevention counseling.

Another strategy involves improving the transfer of health information between ob/gyns and primary care physicians to eliminate inconsistencies in electronic health record documentation, which should improve patient care.

A third strategy is obtaining a short and targeted health history for each woman to confirm if she has any of the six pregnancy-related complications.

“If a woman has had any of these adverse pregnancy outcomes, consider close blood pressure monitoring, type 2 diabetes and lipid screening, and more aggressive risk factor modification and CVD prevention recommendations,” Dr. Parikh advised.

“Our data [lend] support to the prior AHA recommendation that these important adverse pregnancy outcomes should be ‘risk enhancers’ to guide consideration for statin therapy aimed at CVD prevention in women,” Dr. Parikh added.

In a commentary in Circulation, Eliza C. Miller, MD, assistant professor of neurology at Columbia University, New York, notes that pregnancy and the postpartum period are a critical time window in a woman’s life to identify CVD risk and improve a woman’s health trajectory.

“The so-called ‘Golden Hour’ for conditions such as sepsis and acute stroke refers to a critical time window for early recognition and treatment, when we can change a patient’s clinical trajectory and prevent severe morbidity and mortality,” writes Dr. Miller.

“Pregnancy and the postpartum period can be considered a ‘Golden Year’ in a woman’s life, offering a rare opportunity for clinicians to identify young women at risk and work with them to improve their cardiovascular health trajectories,” she notes.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular and Stroke Nursing; and the Stroke Council.

The authors of the scientific statement have disclosed no relevant financial relationships. Dr. Miller received personal compensation from Finch McCranie and Argionis & Associates for expert testimony regarding maternal stroke; and personal compensation from Elsevier for editorial work on Handbook of Clinical Neurology, Vol. 171 and 172 (Neurology of Pregnancy).

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

Endometrial cancer patients should be screened for frailty before hysterectomies, and frail patients should be counseled thoroughly about their increased risk for poor outcomes, according to a review of 144,809 cases in the Nationwide Readmissions Database.

©Wavebreakmedia Ltd/thinkstockphotos.com

Overall, 1.8% of the women were frail according to the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator, which characterizes patients as frail or not based on diagnostic codes in a range of areas, including abnormal weight loss, dementia, urinary or fecal incontinence, difficulty walking, inadequate social support, and other matters.

Frailty was associated with an almost fourfold increased risk of intensive care after surgery; a more than twofold risk of inpatient mortality, and a 59% increased risk of something other than routine discharge to home. Frail patients were 33% more likely to be readmitted within 30 days and 21% more likely to be readmitted within 90 days, and they had a higher risk of dying on readmission. Hospital costs and lengths of stay were higher for frail women, according to the report, which was published online in Gynecologic Oncology.

The findings were adjusted for patient, hospital, and clinical factors, and the readmission outcomes were unchanged when limited to patients who had minimally invasive surgery.

Frailty is a well-known risk factor for poor surgical outcomes, so it “comes as little surprise” that it was associated with worse outcomes in hysterectomies for endometrial cancer. Even so, “frailty is oftentimes not screened for in oncology clinics” leading to “a large number of potentially unrecognized frail patients who are recommended to undergo surgery,” said investigators led by Tiffany Sia, MD, an obstetrics and gynecology resident at Columbia University, New York.

“We believe that each potential patient’s frailty status should be assessed during the preoperative period ... frail patients should be counseled regarding these risks in the perioperative setting,” Dr. Sia said in an interview.

“Researchers and clinicians have adopted the scoring instrument that corresponds best with the data they have available,” but “lack of a widely recognized gold standard or easily utilized diagnostic tool makes frailty rather difficult to formally assess in a clinical setting,” she said.

The investigators found a “surprisingly high rate” of frail patients (82%) who underwent total abdominal hysterectomies compared to less invasive options, with 16.5% undergoing extended procedures. The reason is unknown because stage, tumor grade, and histology – factors that likely influenced decision making – were not captured in the analysis.

However, almost half of the frail subjects were 70 years or older, and increasing age is associated with more aggressive tumor characteristics and worse prognosis.

The team said future research should integrate screening instruments into routine clinic workflow, but there have been a number of roadblocks. Current screening instruments are “cumbersome to use and difficult to implement ... as they typically require measurement of a frailty phenotype such as a timed up-and-go test or grip strength and require numerous patient surveys,” they added.

Proposed screening tools include the Frailty Index, Memorial Sloan Kettering–Frailty Index, Hopkins’ frailty indicator, and the Vulnerable Elders Survey, but no preferred method has emerged, and each scale captures different subpopulations of frailty and differs in its prognostic ability.

There was no external funding, and Dr. Sia didn’t have any disclosures.

aotto@mdedge.com

Endometrial cancer patients should be screened for frailty before hysterectomies, and frail patients should be counseled thoroughly about their increased risk for poor outcomes, according to a review of 144,809 cases in the Nationwide Readmissions Database.

©Wavebreakmedia Ltd/thinkstockphotos.com

Overall, 1.8% of the women were frail according to the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator, which characterizes patients as frail or not based on diagnostic codes in a range of areas, including abnormal weight loss, dementia, urinary or fecal incontinence, difficulty walking, inadequate social support, and other matters.

Frailty was associated with an almost fourfold increased risk of intensive care after surgery; a more than twofold risk of inpatient mortality, and a 59% increased risk of something other than routine discharge to home. Frail patients were 33% more likely to be readmitted within 30 days and 21% more likely to be readmitted within 90 days, and they had a higher risk of dying on readmission. Hospital costs and lengths of stay were higher for frail women, according to the report, which was published online in Gynecologic Oncology.

The findings were adjusted for patient, hospital, and clinical factors, and the readmission outcomes were unchanged when limited to patients who had minimally invasive surgery.

Frailty is a well-known risk factor for poor surgical outcomes, so it “comes as little surprise” that it was associated with worse outcomes in hysterectomies for endometrial cancer. Even so, “frailty is oftentimes not screened for in oncology clinics” leading to “a large number of potentially unrecognized frail patients who are recommended to undergo surgery,” said investigators led by Tiffany Sia, MD, an obstetrics and gynecology resident at Columbia University, New York.

“We believe that each potential patient’s frailty status should be assessed during the preoperative period ... frail patients should be counseled regarding these risks in the perioperative setting,” Dr. Sia said in an interview.

“Researchers and clinicians have adopted the scoring instrument that corresponds best with the data they have available,” but “lack of a widely recognized gold standard or easily utilized diagnostic tool makes frailty rather difficult to formally assess in a clinical setting,” she said.

The investigators found a “surprisingly high rate” of frail patients (82%) who underwent total abdominal hysterectomies compared to less invasive options, with 16.5% undergoing extended procedures. The reason is unknown because stage, tumor grade, and histology – factors that likely influenced decision making – were not captured in the analysis.

However, almost half of the frail subjects were 70 years or older, and increasing age is associated with more aggressive tumor characteristics and worse prognosis.

The team said future research should integrate screening instruments into routine clinic workflow, but there have been a number of roadblocks. Current screening instruments are “cumbersome to use and difficult to implement ... as they typically require measurement of a frailty phenotype such as a timed up-and-go test or grip strength and require numerous patient surveys,” they added.

Proposed screening tools include the Frailty Index, Memorial Sloan Kettering–Frailty Index, Hopkins’ frailty indicator, and the Vulnerable Elders Survey, but no preferred method has emerged, and each scale captures different subpopulations of frailty and differs in its prognostic ability.

There was no external funding, and Dr. Sia didn’t have any disclosures.

aotto@mdedge.com

Endometrial cancer patients should be screened for frailty before hysterectomies, and frail patients should be counseled thoroughly about their increased risk for poor outcomes, according to a review of 144,809 cases in the Nationwide Readmissions Database.

©Wavebreakmedia Ltd/thinkstockphotos.com

Overall, 1.8% of the women were frail according to the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator, which characterizes patients as frail or not based on diagnostic codes in a range of areas, including abnormal weight loss, dementia, urinary or fecal incontinence, difficulty walking, inadequate social support, and other matters.

Frailty was associated with an almost fourfold increased risk of intensive care after surgery; a more than twofold risk of inpatient mortality, and a 59% increased risk of something other than routine discharge to home. Frail patients were 33% more likely to be readmitted within 30 days and 21% more likely to be readmitted within 90 days, and they had a higher risk of dying on readmission. Hospital costs and lengths of stay were higher for frail women, according to the report, which was published online in Gynecologic Oncology.

The findings were adjusted for patient, hospital, and clinical factors, and the readmission outcomes were unchanged when limited to patients who had minimally invasive surgery.

Frailty is a well-known risk factor for poor surgical outcomes, so it “comes as little surprise” that it was associated with worse outcomes in hysterectomies for endometrial cancer. Even so, “frailty is oftentimes not screened for in oncology clinics” leading to “a large number of potentially unrecognized frail patients who are recommended to undergo surgery,” said investigators led by Tiffany Sia, MD, an obstetrics and gynecology resident at Columbia University, New York.

“We believe that each potential patient’s frailty status should be assessed during the preoperative period ... frail patients should be counseled regarding these risks in the perioperative setting,” Dr. Sia said in an interview.

“Researchers and clinicians have adopted the scoring instrument that corresponds best with the data they have available,” but “lack of a widely recognized gold standard or easily utilized diagnostic tool makes frailty rather difficult to formally assess in a clinical setting,” she said.

The investigators found a “surprisingly high rate” of frail patients (82%) who underwent total abdominal hysterectomies compared to less invasive options, with 16.5% undergoing extended procedures. The reason is unknown because stage, tumor grade, and histology – factors that likely influenced decision making – were not captured in the analysis.

However, almost half of the frail subjects were 70 years or older, and increasing age is associated with more aggressive tumor characteristics and worse prognosis.

The team said future research should integrate screening instruments into routine clinic workflow, but there have been a number of roadblocks. Current screening instruments are “cumbersome to use and difficult to implement ... as they typically require measurement of a frailty phenotype such as a timed up-and-go test or grip strength and require numerous patient surveys,” they added.

Proposed screening tools include the Frailty Index, Memorial Sloan Kettering–Frailty Index, Hopkins’ frailty indicator, and the Vulnerable Elders Survey, but no preferred method has emerged, and each scale captures different subpopulations of frailty and differs in its prognostic ability.

There was no external funding, and Dr. Sia didn’t have any disclosures.

aotto@mdedge.com

A novel risk-based approach could be an effective way to triage women for mammography during times of limited capacity, such as the situation during the COVID-19 pandemic, according to new findings.

Researchers evaluated almost 2 million mammograms that had been performed at more than 90 radiology centers and found that 12% of mammograms with “high” and “very high” cancer risk rates accounted for 55% of detected cancers.

In contrast, 44% of mammograms with very low cancer risk rates accounted for 13% of detected cancers. The study was published online March 25, 2021, in JAMA Network Open.

Cancer screening programs dramatically slowed or even came to a screeching halt during 2020, when restrictions and lockdowns were in place. The American Cancer Society even recommended that “no one should go to a health care facility for routine cancer screening,” as part of COVID-19 precautions.

However, concern was voiced that the pause in screening would allow patients with asymptomatic cancers or precursor lesions to develop into a more serious disease state.

The authors pointed out that several professional associations had posted guidance for scheduling individuals for breast imaging services during the COVID-19 pandemic, but these recommendations were based on expert opinion. The investigators’ goal was to help imaging facilities optimize the number of breast cancers that could be detected during periods of reduced capacity using clinical indication and individual characteristics.

The result was a risk-based strategy for triaging mammograms during periods of decreased capacity, which lead author Diana L. Miglioretti, PhD, explained was feasible to implement. Dr. Miglioretti is division chief of biostatistics in the department of public health sciences at University of California, Davis.

“Our risk model used information that is commonly collected by radiology facilities,” she said in an interview. “Vendors of electronic medical records could create tools that pull the information from the medical record, or could create fields in the scheduling system to efficiently collect this information when the mammogram is scheduled.”

Dr. Miglioretti emphasized that, once the information is collected in a standardized manner, “it would be straightforward to use a computer program to apply our algorithm to rank women based on their likelihood of having a breast cancer detected.”

“I think it is worth the investment to create these electronic tools now, given the potential for future shutdowns or periods of reduced capacity due to a variety of reasons, such as natural disasters and cyberattacks – or another pandemic,” she said.

Some facilities are still working through backlogs of mammograms that need to be rescheduled, which would be another way that this algorithm could be used. “They could use this approach to determine who should be scheduled first by using data available in the electronic medical record,” she added.
 

Five risk groups

Dr. Miglioretti and colleagues conducted a cohort study using data that was prospectively collected from mammography examinations performed from 2014 to 2019 at 92 radiology facilities in the Breast Cancer Surveillance Consortium. The cohort included 898,415 individuals who contributed to 1.8 million mammograms.

Information that included clinical indication for screening, breast symptoms, personal history of breast cancer, age, time since last mammogram/screening interval, family history of breast cancer, breast density, and history of high-risk breast lesion was collected from self-administered questionnaires at the time of mammography or extracted from electronic health records.

Following analysis, the data was categorized into five risk groups: very high (>50), high (22-50), moderate (10-22), low (5-10), and very low (<5) cancer detection rate per 1,000 mammograms. These thresholds were chosen based on the observed cancer detection rates and clinical expertise.

Of the group, about 1.7 million mammograms were from women without a personal history of breast cancer and 156,104 mammograms were from women with a breast cancer history. Most of the cohort were aged 50-69 years at the time of imaging, and 67.9% were White (11.2% Black, 11.3% Asian or Pacific Islander, 7% Hispanic, and 2.2% were another race/ethnicity or mixed race/ethnicity).

Their results showed that 12% of mammograms with very high (89.6-122.3 cancers detected per 1,000 mammograms) or high (36.1-47.5 cancers detected per 1,000 mammograms) cancer detection rates accounted for 55% of all detected cancers. These included mammograms that were done to evaluate an abnormal test or breast lump in individuals of all ages regardless of breast cancer history.

On the opposite end, 44.2% of mammograms with very low cancer detection rates accounted for 13.1% of detected cancers and that included annual screening tests in women aged 50-69 years (3.8 cancers detected per 1,000 mammograms) and all screening mammograms in individuals younger than 50 years regardless of screening interval (2.8 cancers detected per 1000 mammograms).
 

Treat with caution

In an accompanying editorial, Sarah M. Friedewald, MD, and Dipti Gupta, MD, both from Northwestern University, Chicago, pointed out that, while the authors examined a large dataset to identify a subgroup of patients who would most likely benefit from breast imaging in a setting where capacity is limited, “these data should be used with caution as the only barometer for whether a patient merits cancer screening during a period of rationing.”

They noted that, in the context of an acute crisis, when patient volume needs to be reduced very quickly, it is often impractical for clinicians to sift through patient records in order to capture the information necessary for triage. In addition, asking nonclinical schedulers to accurately pull data at this level, at the time when the patient calls to make an appointment, is unrealistic.

In the context of the pandemic, the editorialists wrote that, while this model uses risk for breast cancer to prioritize those to be seen in the clinic, the risk for complications from COVID-19 may also be an important factor to consider. For example, an older patient may be at a higher risk for breast cancer but may also face a higher risk for COVID-related complications. Conversely, a younger woman at a lower risk for serious COVID-related disease but who has breast cancer detected early will gain more life-years than an older patient.

There are also no algorithms to account for each patient’s perceived risk for breast cancer or COVID-19, and “the downstream effect of delaying cancer diagnosis may similarly lead to unintended consequences but may take longer to become apparent,” they wrote. “Focusing efforts on the operations of accommodating as many patients as possible, such as extending clinic hours, would be preferable.”

Finally, Dr. Friedewald and Dr. Gupta concluded that “the practicality of this process during the COVID-19 pandemic and extrapolation to other emergent settings are less obvious.”

The study was supported through a Patient-centered Outcomes Research Institute program award. Dr. Miglioretti reported receiving royalties from Elsevier outside the submitted work. Several coauthors report relationships with industry. Dr. Friedewald reported receiving grants from Hologic Research during the conduct of the study. Dr. Gupta disclosed no relevant financial relationships.

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

A novel risk-based approach could be an effective way to triage women for mammography during times of limited capacity, such as the situation during the COVID-19 pandemic, according to new findings.

Researchers evaluated almost 2 million mammograms that had been performed at more than 90 radiology centers and found that 12% of mammograms with “high” and “very high” cancer risk rates accounted for 55% of detected cancers.

In contrast, 44% of mammograms with very low cancer risk rates accounted for 13% of detected cancers. The study was published online March 25, 2021, in JAMA Network Open.

Cancer screening programs dramatically slowed or even came to a screeching halt during 2020, when restrictions and lockdowns were in place. The American Cancer Society even recommended that “no one should go to a health care facility for routine cancer screening,” as part of COVID-19 precautions.

However, concern was voiced that the pause in screening would allow patients with asymptomatic cancers or precursor lesions to develop into a more serious disease state.

The authors pointed out that several professional associations had posted guidance for scheduling individuals for breast imaging services during the COVID-19 pandemic, but these recommendations were based on expert opinion. The investigators’ goal was to help imaging facilities optimize the number of breast cancers that could be detected during periods of reduced capacity using clinical indication and individual characteristics.

The result was a risk-based strategy for triaging mammograms during periods of decreased capacity, which lead author Diana L. Miglioretti, PhD, explained was feasible to implement. Dr. Miglioretti is division chief of biostatistics in the department of public health sciences at University of California, Davis.

“Our risk model used information that is commonly collected by radiology facilities,” she said in an interview. “Vendors of electronic medical records could create tools that pull the information from the medical record, or could create fields in the scheduling system to efficiently collect this information when the mammogram is scheduled.”

Dr. Miglioretti emphasized that, once the information is collected in a standardized manner, “it would be straightforward to use a computer program to apply our algorithm to rank women based on their likelihood of having a breast cancer detected.”

“I think it is worth the investment to create these electronic tools now, given the potential for future shutdowns or periods of reduced capacity due to a variety of reasons, such as natural disasters and cyberattacks – or another pandemic,” she said.

Some facilities are still working through backlogs of mammograms that need to be rescheduled, which would be another way that this algorithm could be used. “They could use this approach to determine who should be scheduled first by using data available in the electronic medical record,” she added.
 

Five risk groups

Dr. Miglioretti and colleagues conducted a cohort study using data that was prospectively collected from mammography examinations performed from 2014 to 2019 at 92 radiology facilities in the Breast Cancer Surveillance Consortium. The cohort included 898,415 individuals who contributed to 1.8 million mammograms.

Information that included clinical indication for screening, breast symptoms, personal history of breast cancer, age, time since last mammogram/screening interval, family history of breast cancer, breast density, and history of high-risk breast lesion was collected from self-administered questionnaires at the time of mammography or extracted from electronic health records.

Following analysis, the data was categorized into five risk groups: very high (>50), high (22-50), moderate (10-22), low (5-10), and very low (<5) cancer detection rate per 1,000 mammograms. These thresholds were chosen based on the observed cancer detection rates and clinical expertise.

Of the group, about 1.7 million mammograms were from women without a personal history of breast cancer and 156,104 mammograms were from women with a breast cancer history. Most of the cohort were aged 50-69 years at the time of imaging, and 67.9% were White (11.2% Black, 11.3% Asian or Pacific Islander, 7% Hispanic, and 2.2% were another race/ethnicity or mixed race/ethnicity).

Their results showed that 12% of mammograms with very high (89.6-122.3 cancers detected per 1,000 mammograms) or high (36.1-47.5 cancers detected per 1,000 mammograms) cancer detection rates accounted for 55% of all detected cancers. These included mammograms that were done to evaluate an abnormal test or breast lump in individuals of all ages regardless of breast cancer history.

On the opposite end, 44.2% of mammograms with very low cancer detection rates accounted for 13.1% of detected cancers and that included annual screening tests in women aged 50-69 years (3.8 cancers detected per 1,000 mammograms) and all screening mammograms in individuals younger than 50 years regardless of screening interval (2.8 cancers detected per 1000 mammograms).
 

Treat with caution

In an accompanying editorial, Sarah M. Friedewald, MD, and Dipti Gupta, MD, both from Northwestern University, Chicago, pointed out that, while the authors examined a large dataset to identify a subgroup of patients who would most likely benefit from breast imaging in a setting where capacity is limited, “these data should be used with caution as the only barometer for whether a patient merits cancer screening during a period of rationing.”

They noted that, in the context of an acute crisis, when patient volume needs to be reduced very quickly, it is often impractical for clinicians to sift through patient records in order to capture the information necessary for triage. In addition, asking nonclinical schedulers to accurately pull data at this level, at the time when the patient calls to make an appointment, is unrealistic.

In the context of the pandemic, the editorialists wrote that, while this model uses risk for breast cancer to prioritize those to be seen in the clinic, the risk for complications from COVID-19 may also be an important factor to consider. For example, an older patient may be at a higher risk for breast cancer but may also face a higher risk for COVID-related complications. Conversely, a younger woman at a lower risk for serious COVID-related disease but who has breast cancer detected early will gain more life-years than an older patient.

There are also no algorithms to account for each patient’s perceived risk for breast cancer or COVID-19, and “the downstream effect of delaying cancer diagnosis may similarly lead to unintended consequences but may take longer to become apparent,” they wrote. “Focusing efforts on the operations of accommodating as many patients as possible, such as extending clinic hours, would be preferable.”

Finally, Dr. Friedewald and Dr. Gupta concluded that “the practicality of this process during the COVID-19 pandemic and extrapolation to other emergent settings are less obvious.”

The study was supported through a Patient-centered Outcomes Research Institute program award. Dr. Miglioretti reported receiving royalties from Elsevier outside the submitted work. Several coauthors report relationships with industry. Dr. Friedewald reported receiving grants from Hologic Research during the conduct of the study. Dr. Gupta disclosed no relevant financial relationships.

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

A novel risk-based approach could be an effective way to triage women for mammography during times of limited capacity, such as the situation during the COVID-19 pandemic, according to new findings.

Researchers evaluated almost 2 million mammograms that had been performed at more than 90 radiology centers and found that 12% of mammograms with “high” and “very high” cancer risk rates accounted for 55% of detected cancers.

In contrast, 44% of mammograms with very low cancer risk rates accounted for 13% of detected cancers. The study was published online March 25, 2021, in JAMA Network Open.

Cancer screening programs dramatically slowed or even came to a screeching halt during 2020, when restrictions and lockdowns were in place. The American Cancer Society even recommended that “no one should go to a health care facility for routine cancer screening,” as part of COVID-19 precautions.

However, concern was voiced that the pause in screening would allow patients with asymptomatic cancers or precursor lesions to develop into a more serious disease state.

The authors pointed out that several professional associations had posted guidance for scheduling individuals for breast imaging services during the COVID-19 pandemic, but these recommendations were based on expert opinion. The investigators’ goal was to help imaging facilities optimize the number of breast cancers that could be detected during periods of reduced capacity using clinical indication and individual characteristics.

The result was a risk-based strategy for triaging mammograms during periods of decreased capacity, which lead author Diana L. Miglioretti, PhD, explained was feasible to implement. Dr. Miglioretti is division chief of biostatistics in the department of public health sciences at University of California, Davis.

“Our risk model used information that is commonly collected by radiology facilities,” she said in an interview. “Vendors of electronic medical records could create tools that pull the information from the medical record, or could create fields in the scheduling system to efficiently collect this information when the mammogram is scheduled.”

Dr. Miglioretti emphasized that, once the information is collected in a standardized manner, “it would be straightforward to use a computer program to apply our algorithm to rank women based on their likelihood of having a breast cancer detected.”

“I think it is worth the investment to create these electronic tools now, given the potential for future shutdowns or periods of reduced capacity due to a variety of reasons, such as natural disasters and cyberattacks – or another pandemic,” she said.

Some facilities are still working through backlogs of mammograms that need to be rescheduled, which would be another way that this algorithm could be used. “They could use this approach to determine who should be scheduled first by using data available in the electronic medical record,” she added.
 

Five risk groups

Dr. Miglioretti and colleagues conducted a cohort study using data that was prospectively collected from mammography examinations performed from 2014 to 2019 at 92 radiology facilities in the Breast Cancer Surveillance Consortium. The cohort included 898,415 individuals who contributed to 1.8 million mammograms.

Information that included clinical indication for screening, breast symptoms, personal history of breast cancer, age, time since last mammogram/screening interval, family history of breast cancer, breast density, and history of high-risk breast lesion was collected from self-administered questionnaires at the time of mammography or extracted from electronic health records.

Following analysis, the data was categorized into five risk groups: very high (>50), high (22-50), moderate (10-22), low (5-10), and very low (<5) cancer detection rate per 1,000 mammograms. These thresholds were chosen based on the observed cancer detection rates and clinical expertise.

Of the group, about 1.7 million mammograms were from women without a personal history of breast cancer and 156,104 mammograms were from women with a breast cancer history. Most of the cohort were aged 50-69 years at the time of imaging, and 67.9% were White (11.2% Black, 11.3% Asian or Pacific Islander, 7% Hispanic, and 2.2% were another race/ethnicity or mixed race/ethnicity).

Their results showed that 12% of mammograms with very high (89.6-122.3 cancers detected per 1,000 mammograms) or high (36.1-47.5 cancers detected per 1,000 mammograms) cancer detection rates accounted for 55% of all detected cancers. These included mammograms that were done to evaluate an abnormal test or breast lump in individuals of all ages regardless of breast cancer history.

On the opposite end, 44.2% of mammograms with very low cancer detection rates accounted for 13.1% of detected cancers and that included annual screening tests in women aged 50-69 years (3.8 cancers detected per 1,000 mammograms) and all screening mammograms in individuals younger than 50 years regardless of screening interval (2.8 cancers detected per 1000 mammograms).
 

Treat with caution

In an accompanying editorial, Sarah M. Friedewald, MD, and Dipti Gupta, MD, both from Northwestern University, Chicago, pointed out that, while the authors examined a large dataset to identify a subgroup of patients who would most likely benefit from breast imaging in a setting where capacity is limited, “these data should be used with caution as the only barometer for whether a patient merits cancer screening during a period of rationing.”

They noted that, in the context of an acute crisis, when patient volume needs to be reduced very quickly, it is often impractical for clinicians to sift through patient records in order to capture the information necessary for triage. In addition, asking nonclinical schedulers to accurately pull data at this level, at the time when the patient calls to make an appointment, is unrealistic.

In the context of the pandemic, the editorialists wrote that, while this model uses risk for breast cancer to prioritize those to be seen in the clinic, the risk for complications from COVID-19 may also be an important factor to consider. For example, an older patient may be at a higher risk for breast cancer but may also face a higher risk for COVID-related complications. Conversely, a younger woman at a lower risk for serious COVID-related disease but who has breast cancer detected early will gain more life-years than an older patient.

There are also no algorithms to account for each patient’s perceived risk for breast cancer or COVID-19, and “the downstream effect of delaying cancer diagnosis may similarly lead to unintended consequences but may take longer to become apparent,” they wrote. “Focusing efforts on the operations of accommodating as many patients as possible, such as extending clinic hours, would be preferable.”

Finally, Dr. Friedewald and Dr. Gupta concluded that “the practicality of this process during the COVID-19 pandemic and extrapolation to other emergent settings are less obvious.”

The study was supported through a Patient-centered Outcomes Research Institute program award. Dr. Miglioretti reported receiving royalties from Elsevier outside the submitted work. Several coauthors report relationships with industry. Dr. Friedewald reported receiving grants from Hologic Research during the conduct of the study. Dr. Gupta disclosed no relevant financial relationships.

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

Treatment was attempted for both a suspected spider bite (2 weeks of topical triamcinolone 0.1%) and presumed cellulitis (oral doxycycline 100 mg bid/5 d), but neither improved her condition. Concerned for the possibility of cutaneous breast cancer, a punch biopsy was ordered and revealed diffuse dermal angiomatosis (DDA).

DDA is an uncommon proliferation of cutaneous blood vessels causing a reticular blood vessel pattern, as seen in this image. Typically, DDA is associated with tissue hypoxia due to arterial insufficiency from peripheral artery disease. In recent years, there have been numerous case reports of painful ulcerated lesions and reticular blood vessels occurring in women with large, pendulous breasts, increased body mass index, and a history of smoking. One theory suggests that the weight of the breasts causes tissue to stretch, compressing the blood vessels. This, combined with smoking, leads to localized hypoxia and DDA.

Treatments have included oral isotretinoin, calcium channel blockers, aspirin, or pentoxifylline to help circulation. Smoking cessation is recommended, as well as reduction mammoplasty to decrease the stretch on the tissues and relieve the local hypoxia. Although invasive, breast reduction surgery has moved to the forefront of therapy, with reports having shown resolution of the ulcers and pain.¹

Two important aspects of clinical medicine are highlighted by this case. First, nonhealing lesions that are not responding to prescribed therapies may require biopsy to rule out malignancy. Second, when there is difficulty making a diagnosis, especially with uncommon diseases, biopsy and input from a pathologist can be extremely helpful.

In this case, the patient was referred to Plastic Surgery and scheduled for reduction mammoplasty. The patient was advised to stop smoking for at least 4 weeks prior to the surgery to possibly improve her condition and reduce the likelihood of postoperative complications.

‌

Photo courtesy of Michael Louie, MD, and text courtesy of Michael Louie, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Treatment was attempted for both a suspected spider bite (2 weeks of topical triamcinolone 0.1%) and presumed cellulitis (oral doxycycline 100 mg bid/5 d), but neither improved her condition. Concerned for the possibility of cutaneous breast cancer, a punch biopsy was ordered and revealed diffuse dermal angiomatosis (DDA).

DDA is an uncommon proliferation of cutaneous blood vessels causing a reticular blood vessel pattern, as seen in this image. Typically, DDA is associated with tissue hypoxia due to arterial insufficiency from peripheral artery disease. In recent years, there have been numerous case reports of painful ulcerated lesions and reticular blood vessels occurring in women with large, pendulous breasts, increased body mass index, and a history of smoking. One theory suggests that the weight of the breasts causes tissue to stretch, compressing the blood vessels. This, combined with smoking, leads to localized hypoxia and DDA.

Treatments have included oral isotretinoin, calcium channel blockers, aspirin, or pentoxifylline to help circulation. Smoking cessation is recommended, as well as reduction mammoplasty to decrease the stretch on the tissues and relieve the local hypoxia. Although invasive, breast reduction surgery has moved to the forefront of therapy, with reports having shown resolution of the ulcers and pain.¹

Two important aspects of clinical medicine are highlighted by this case. First, nonhealing lesions that are not responding to prescribed therapies may require biopsy to rule out malignancy. Second, when there is difficulty making a diagnosis, especially with uncommon diseases, biopsy and input from a pathologist can be extremely helpful.

In this case, the patient was referred to Plastic Surgery and scheduled for reduction mammoplasty. The patient was advised to stop smoking for at least 4 weeks prior to the surgery to possibly improve her condition and reduce the likelihood of postoperative complications.

‌

Photo courtesy of Michael Louie, MD, and text courtesy of Michael Louie, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Treatment was attempted for both a suspected spider bite (2 weeks of topical triamcinolone 0.1%) and presumed cellulitis (oral doxycycline 100 mg bid/5 d), but neither improved her condition. Concerned for the possibility of cutaneous breast cancer, a punch biopsy was ordered and revealed diffuse dermal angiomatosis (DDA).

DDA is an uncommon proliferation of cutaneous blood vessels causing a reticular blood vessel pattern, as seen in this image. Typically, DDA is associated with tissue hypoxia due to arterial insufficiency from peripheral artery disease. In recent years, there have been numerous case reports of painful ulcerated lesions and reticular blood vessels occurring in women with large, pendulous breasts, increased body mass index, and a history of smoking. One theory suggests that the weight of the breasts causes tissue to stretch, compressing the blood vessels. This, combined with smoking, leads to localized hypoxia and DDA.

Treatments have included oral isotretinoin, calcium channel blockers, aspirin, or pentoxifylline to help circulation. Smoking cessation is recommended, as well as reduction mammoplasty to decrease the stretch on the tissues and relieve the local hypoxia. Although invasive, breast reduction surgery has moved to the forefront of therapy, with reports having shown resolution of the ulcers and pain.¹

Two important aspects of clinical medicine are highlighted by this case. First, nonhealing lesions that are not responding to prescribed therapies may require biopsy to rule out malignancy. Second, when there is difficulty making a diagnosis, especially with uncommon diseases, biopsy and input from a pathologist can be extremely helpful.

In this case, the patient was referred to Plastic Surgery and scheduled for reduction mammoplasty. The patient was advised to stop smoking for at least 4 weeks prior to the surgery to possibly improve her condition and reduce the likelihood of postoperative complications.

‌

Photo courtesy of Michael Louie, MD, and text courtesy of Michael Louie, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

A controversial, big-budget breast cancer screening trial that has been chronically unable to attract enough female participants since its debut in 2017 got a vote of confidence from a special working group of the National Cancer Institute (NCI) on March 17.

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) should continue, but with modification, the expert group concluded in its report.

The randomized trial, with an estimated cost of $100 million, compares two kinds of mammography screenings for breast cancer in healthy women. One group of patients is screened with digital breast tomosynthesis, also known as 3-D mammography; the other is screened with the older, less expensive 2-D digital technology.

Tomosynthesis is already considered superior in detecting small cancers and reducing callbacks and is increasingly being used in the real world, leading some experts in the field to say that TMIST is critically hampered by women’s and radiologists’ preference for 3-D mammography.

At a meeting of an NCI advisory board in September 2020, there was a suggestion that the federal agency may kill the trial.

But at the latest meeting, the working group proposed that the trial should live on.

One of the main problems with the trial has been recruitment; the recommended changes discussed at the meeting include reducing the number of women needed in the study (from 165,000 to 102,000), which would allow patient “accrual to be completed more quickly,” the working group noted. In addition, the target date for completing patient accrual would be moved to 2023, 3 years after the original completion date of 2020.

The group’s recommendations now go to NCI staff for scientific review. The NCI will then decide about implementing the proposed changes.

The trial, which is the NCI’s largest and most expensive screening study, has never come close to targeted monthly enrollment. It was enrolling fewer than 1,500 patients per month over a 2-year period, instead of the projected 5,500 per month, Philip Castle, PhD, MPH, director of the NCI’s Division of Cancer Prevention, said last year. He called for a review of TMIST’s “feasibility and relevance” in view of the increasing use of tomosynthesis in the United States, as well as other factors.

The new technology has been “rapidly adopted” by facilities in North America, the working group noted. As of December 2020, approximately 74% of breast cancer screening clinics in the United States had at least one tomosynthesis or 3-D system; 42% of the mammography machines were 3-D.

This trend of increasing use of 3-D machines might be too much for TMIST to surmount, said Nancy Davidson, MD, of the Fred Hutchinson Cancer Research Center, in Seattle, who chaired the working group.

“We are worried the challenges [to patient accrual] may persist due to the increasing adoption of three-dimensional breast tomosynthesis in the United States over time,” she said during the working group’s virtual presentation of the report to the NCI’s Clinical Trials and Translational Research Advisory Committee.

Committee member Smita Bhatia, MD, PhD, of the University of Alabama at Birmingham, wondered, “What are the ongoing barriers that [TMIST investigators] are going to face beside recruitment?”

Dr. Davidson answered by speaking, again, about market penetration of tomosynthesis machines and suggested that the recruitment problems and the availability of 3-D mammography are intertwined.

“Is this a technology that has or will arrive, at which point it may not be very easy to put the genie back in the bottle?” she asked.

That question has already been answered – widespread use of tomosynthesis is here to stay, argued Daniel Kopans, MD, of Harvard Medical School, Boston, who invented digital breast tomosynthesis but no longer benefits financially from his invention because the patent has expired.

“The horse is out of the barn,” Dr. Kopans said in an interview. By the time the study results are available, digital mammography will be a tool of the past, he said.

TMIST is a trial “that should never have been started in the first place, and it’s failing,” he said. “I was hoping they [the NCI] would say, ‘Let’s stop this because there’s not enough accrual.’ But it looks like they’re not.”

“TMIST is a waste of money,” said Dr. Kopans, repeating a criticism he has made in the past.
 

A drop in study power

The new recommendations for TMIST come about 1 year after Medscape Medical News reported that the study was lagging in enrollment of both patients and participating sites/physicians.

Last year, two TMIST study investigators said it had been difficult enlisting sites, in part because many radiologists and facilities – informed by their experience and previous research results – already believe that the 3-D technology is superior.

Currently, most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). Thus, 3-D is widely described as allowing clinicians to flip through the images like “pages in a book” and as offering a superior read of the breast.

The NCI working group concedes that “there is evidence that screening utilizing tomosynthesis may reduce recall rates and improve cancer detection,” but it says the trial is needed to address “questions that still remain regarding the overall benefit to patients.”

Furthermore, tomosynthesis “may carry higher out-of-pocket costs for women and is more labor intensive and costly for health care systems in that it requires about twice as much reader time for interpretation,” the working group said.

The “main hypothesis of TMIST” is that “tomosynthesis will decrease the cumulative incidence of advanced breast cancers, a surrogate for mortality, compared to standard digital mammography,” posits the group.

Advanced breast cancer is defined in TMIST as invasive breast cancers that meet any of the following criteria:

• Distant metastases
• At least one lymph node macrometastasis
• Tumor size >1 cm and triple-negative or positive for human epidermal growth factor receptor
• Tumor size ≥ 20 mm unless of pure mucinous or other favorable histologies.

In the original study design, the sample size was estimated to be sufficient to provide 90% power to detect a 20% relative reduction in the proportion of advanced cancers in the intervention arm (tomosynthesis, or 3-D) compared to the control arm (digital mammography, or 2-D) 4.5 years from randomization.

Now, with fewer patients and a revised analytic approach, the study’s statistical power will be decreased to 80% from the original 90%.

Also, an advanced cancer is counted “if it occurs at any time while the participant is on study.”

Dr. Kopans says that is a problem.

“That is a huge mistake, since digital breast tomosynthesis cannot impact prevalent cancers. They are already there. This means that their ‘power calculation’ is wrong, and they won’t have the power that they are claiming,” he said.

Dr. Kopans explained that the first screen in TMIST will have “no effect on the number of advanced cancers.” That’s because the cancers will have already grown enough to become advanced, he said.

On the other hand, an initial screening might detect and thus lead to the removal of nonadvanced, smaller cancers, which, had they not been detected and removed, would have grown to become advanced cancers by the next year. Thus, the screenings done after the first year are the ones that potentially prove the effect of the intervention.

However, the working group report says that changes to the study will not affect anything other than a 10% reduction in the study’s power.

The working group is concerned about TMIST going on for years and years. For that reason, they recommended that the NCI establish “strict criteria for termination of the study” if accrual goals are not met. However, those parameters have not been developed, and it was not part of the study group’s mission to establish them.

The working group was sponsored by the NCI. Dr. Kopans reports consulting with DART Imaging in China.

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

A controversial, big-budget breast cancer screening trial that has been chronically unable to attract enough female participants since its debut in 2017 got a vote of confidence from a special working group of the National Cancer Institute (NCI) on March 17.

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) should continue, but with modification, the expert group concluded in its report.

The randomized trial, with an estimated cost of $100 million, compares two kinds of mammography screenings for breast cancer in healthy women. One group of patients is screened with digital breast tomosynthesis, also known as 3-D mammography; the other is screened with the older, less expensive 2-D digital technology.

Tomosynthesis is already considered superior in detecting small cancers and reducing callbacks and is increasingly being used in the real world, leading some experts in the field to say that TMIST is critically hampered by women’s and radiologists’ preference for 3-D mammography.

At a meeting of an NCI advisory board in September 2020, there was a suggestion that the federal agency may kill the trial.

But at the latest meeting, the working group proposed that the trial should live on.

One of the main problems with the trial has been recruitment; the recommended changes discussed at the meeting include reducing the number of women needed in the study (from 165,000 to 102,000), which would allow patient “accrual to be completed more quickly,” the working group noted. In addition, the target date for completing patient accrual would be moved to 2023, 3 years after the original completion date of 2020.

The group’s recommendations now go to NCI staff for scientific review. The NCI will then decide about implementing the proposed changes.

The trial, which is the NCI’s largest and most expensive screening study, has never come close to targeted monthly enrollment. It was enrolling fewer than 1,500 patients per month over a 2-year period, instead of the projected 5,500 per month, Philip Castle, PhD, MPH, director of the NCI’s Division of Cancer Prevention, said last year. He called for a review of TMIST’s “feasibility and relevance” in view of the increasing use of tomosynthesis in the United States, as well as other factors.

The new technology has been “rapidly adopted” by facilities in North America, the working group noted. As of December 2020, approximately 74% of breast cancer screening clinics in the United States had at least one tomosynthesis or 3-D system; 42% of the mammography machines were 3-D.

This trend of increasing use of 3-D machines might be too much for TMIST to surmount, said Nancy Davidson, MD, of the Fred Hutchinson Cancer Research Center, in Seattle, who chaired the working group.

“We are worried the challenges [to patient accrual] may persist due to the increasing adoption of three-dimensional breast tomosynthesis in the United States over time,” she said during the working group’s virtual presentation of the report to the NCI’s Clinical Trials and Translational Research Advisory Committee.

Committee member Smita Bhatia, MD, PhD, of the University of Alabama at Birmingham, wondered, “What are the ongoing barriers that [TMIST investigators] are going to face beside recruitment?”

Dr. Davidson answered by speaking, again, about market penetration of tomosynthesis machines and suggested that the recruitment problems and the availability of 3-D mammography are intertwined.

“Is this a technology that has or will arrive, at which point it may not be very easy to put the genie back in the bottle?” she asked.

That question has already been answered – widespread use of tomosynthesis is here to stay, argued Daniel Kopans, MD, of Harvard Medical School, Boston, who invented digital breast tomosynthesis but no longer benefits financially from his invention because the patent has expired.

“The horse is out of the barn,” Dr. Kopans said in an interview. By the time the study results are available, digital mammography will be a tool of the past, he said.

TMIST is a trial “that should never have been started in the first place, and it’s failing,” he said. “I was hoping they [the NCI] would say, ‘Let’s stop this because there’s not enough accrual.’ But it looks like they’re not.”

“TMIST is a waste of money,” said Dr. Kopans, repeating a criticism he has made in the past.
 

A drop in study power

The new recommendations for TMIST come about 1 year after Medscape Medical News reported that the study was lagging in enrollment of both patients and participating sites/physicians.

Last year, two TMIST study investigators said it had been difficult enlisting sites, in part because many radiologists and facilities – informed by their experience and previous research results – already believe that the 3-D technology is superior.

Currently, most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). Thus, 3-D is widely described as allowing clinicians to flip through the images like “pages in a book” and as offering a superior read of the breast.

The NCI working group concedes that “there is evidence that screening utilizing tomosynthesis may reduce recall rates and improve cancer detection,” but it says the trial is needed to address “questions that still remain regarding the overall benefit to patients.”

Furthermore, tomosynthesis “may carry higher out-of-pocket costs for women and is more labor intensive and costly for health care systems in that it requires about twice as much reader time for interpretation,” the working group said.

The “main hypothesis of TMIST” is that “tomosynthesis will decrease the cumulative incidence of advanced breast cancers, a surrogate for mortality, compared to standard digital mammography,” posits the group.

Advanced breast cancer is defined in TMIST as invasive breast cancers that meet any of the following criteria:

• Distant metastases
• At least one lymph node macrometastasis
• Tumor size >1 cm and triple-negative or positive for human epidermal growth factor receptor
• Tumor size ≥ 20 mm unless of pure mucinous or other favorable histologies.

In the original study design, the sample size was estimated to be sufficient to provide 90% power to detect a 20% relative reduction in the proportion of advanced cancers in the intervention arm (tomosynthesis, or 3-D) compared to the control arm (digital mammography, or 2-D) 4.5 years from randomization.

Now, with fewer patients and a revised analytic approach, the study’s statistical power will be decreased to 80% from the original 90%.

Also, an advanced cancer is counted “if it occurs at any time while the participant is on study.”

Dr. Kopans says that is a problem.

“That is a huge mistake, since digital breast tomosynthesis cannot impact prevalent cancers. They are already there. This means that their ‘power calculation’ is wrong, and they won’t have the power that they are claiming,” he said.

Dr. Kopans explained that the first screen in TMIST will have “no effect on the number of advanced cancers.” That’s because the cancers will have already grown enough to become advanced, he said.

On the other hand, an initial screening might detect and thus lead to the removal of nonadvanced, smaller cancers, which, had they not been detected and removed, would have grown to become advanced cancers by the next year. Thus, the screenings done after the first year are the ones that potentially prove the effect of the intervention.

However, the working group report says that changes to the study will not affect anything other than a 10% reduction in the study’s power.

The working group is concerned about TMIST going on for years and years. For that reason, they recommended that the NCI establish “strict criteria for termination of the study” if accrual goals are not met. However, those parameters have not been developed, and it was not part of the study group’s mission to establish them.

The working group was sponsored by the NCI. Dr. Kopans reports consulting with DART Imaging in China.

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

A controversial, big-budget breast cancer screening trial that has been chronically unable to attract enough female participants since its debut in 2017 got a vote of confidence from a special working group of the National Cancer Institute (NCI) on March 17.

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) should continue, but with modification, the expert group concluded in its report.

The randomized trial, with an estimated cost of $100 million, compares two kinds of mammography screenings for breast cancer in healthy women. One group of patients is screened with digital breast tomosynthesis, also known as 3-D mammography; the other is screened with the older, less expensive 2-D digital technology.

Tomosynthesis is already considered superior in detecting small cancers and reducing callbacks and is increasingly being used in the real world, leading some experts in the field to say that TMIST is critically hampered by women’s and radiologists’ preference for 3-D mammography.

At a meeting of an NCI advisory board in September 2020, there was a suggestion that the federal agency may kill the trial.

But at the latest meeting, the working group proposed that the trial should live on.

One of the main problems with the trial has been recruitment; the recommended changes discussed at the meeting include reducing the number of women needed in the study (from 165,000 to 102,000), which would allow patient “accrual to be completed more quickly,” the working group noted. In addition, the target date for completing patient accrual would be moved to 2023, 3 years after the original completion date of 2020.

The group’s recommendations now go to NCI staff for scientific review. The NCI will then decide about implementing the proposed changes.

The trial, which is the NCI’s largest and most expensive screening study, has never come close to targeted monthly enrollment. It was enrolling fewer than 1,500 patients per month over a 2-year period, instead of the projected 5,500 per month, Philip Castle, PhD, MPH, director of the NCI’s Division of Cancer Prevention, said last year. He called for a review of TMIST’s “feasibility and relevance” in view of the increasing use of tomosynthesis in the United States, as well as other factors.

The new technology has been “rapidly adopted” by facilities in North America, the working group noted. As of December 2020, approximately 74% of breast cancer screening clinics in the United States had at least one tomosynthesis or 3-D system; 42% of the mammography machines were 3-D.

This trend of increasing use of 3-D machines might be too much for TMIST to surmount, said Nancy Davidson, MD, of the Fred Hutchinson Cancer Research Center, in Seattle, who chaired the working group.

“We are worried the challenges [to patient accrual] may persist due to the increasing adoption of three-dimensional breast tomosynthesis in the United States over time,” she said during the working group’s virtual presentation of the report to the NCI’s Clinical Trials and Translational Research Advisory Committee.

Committee member Smita Bhatia, MD, PhD, of the University of Alabama at Birmingham, wondered, “What are the ongoing barriers that [TMIST investigators] are going to face beside recruitment?”

Dr. Davidson answered by speaking, again, about market penetration of tomosynthesis machines and suggested that the recruitment problems and the availability of 3-D mammography are intertwined.

“Is this a technology that has or will arrive, at which point it may not be very easy to put the genie back in the bottle?” she asked.

That question has already been answered – widespread use of tomosynthesis is here to stay, argued Daniel Kopans, MD, of Harvard Medical School, Boston, who invented digital breast tomosynthesis but no longer benefits financially from his invention because the patent has expired.

“The horse is out of the barn,” Dr. Kopans said in an interview. By the time the study results are available, digital mammography will be a tool of the past, he said.

TMIST is a trial “that should never have been started in the first place, and it’s failing,” he said. “I was hoping they [the NCI] would say, ‘Let’s stop this because there’s not enough accrual.’ But it looks like they’re not.”

“TMIST is a waste of money,” said Dr. Kopans, repeating a criticism he has made in the past.
 

A drop in study power

The new recommendations for TMIST come about 1 year after Medscape Medical News reported that the study was lagging in enrollment of both patients and participating sites/physicians.

Last year, two TMIST study investigators said it had been difficult enlisting sites, in part because many radiologists and facilities – informed by their experience and previous research results – already believe that the 3-D technology is superior.

Currently, most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). Thus, 3-D is widely described as allowing clinicians to flip through the images like “pages in a book” and as offering a superior read of the breast.

The NCI working group concedes that “there is evidence that screening utilizing tomosynthesis may reduce recall rates and improve cancer detection,” but it says the trial is needed to address “questions that still remain regarding the overall benefit to patients.”

Furthermore, tomosynthesis “may carry higher out-of-pocket costs for women and is more labor intensive and costly for health care systems in that it requires about twice as much reader time for interpretation,” the working group said.

The “main hypothesis of TMIST” is that “tomosynthesis will decrease the cumulative incidence of advanced breast cancers, a surrogate for mortality, compared to standard digital mammography,” posits the group.

Advanced breast cancer is defined in TMIST as invasive breast cancers that meet any of the following criteria:

• Distant metastases
• At least one lymph node macrometastasis
• Tumor size >1 cm and triple-negative or positive for human epidermal growth factor receptor
• Tumor size ≥ 20 mm unless of pure mucinous or other favorable histologies.

In the original study design, the sample size was estimated to be sufficient to provide 90% power to detect a 20% relative reduction in the proportion of advanced cancers in the intervention arm (tomosynthesis, or 3-D) compared to the control arm (digital mammography, or 2-D) 4.5 years from randomization.

Now, with fewer patients and a revised analytic approach, the study’s statistical power will be decreased to 80% from the original 90%.

Also, an advanced cancer is counted “if it occurs at any time while the participant is on study.”

Dr. Kopans says that is a problem.

“That is a huge mistake, since digital breast tomosynthesis cannot impact prevalent cancers. They are already there. This means that their ‘power calculation’ is wrong, and they won’t have the power that they are claiming,” he said.

Dr. Kopans explained that the first screen in TMIST will have “no effect on the number of advanced cancers.” That’s because the cancers will have already grown enough to become advanced, he said.

On the other hand, an initial screening might detect and thus lead to the removal of nonadvanced, smaller cancers, which, had they not been detected and removed, would have grown to become advanced cancers by the next year. Thus, the screenings done after the first year are the ones that potentially prove the effect of the intervention.

However, the working group report says that changes to the study will not affect anything other than a 10% reduction in the study’s power.

The working group is concerned about TMIST going on for years and years. For that reason, they recommended that the NCI establish “strict criteria for termination of the study” if accrual goals are not met. However, those parameters have not been developed, and it was not part of the study group’s mission to establish them.

The working group was sponsored by the NCI. Dr. Kopans reports consulting with DART Imaging in China.

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