Gynecology

For much of the general public, in-home care from a physician is akin to the rotary telephone: a feature of a bygone age, long since replaced by vastly different systems. While approximately 40% of physician-patient interactions in 1930 were house calls, by the early 1980s this had dwindled to less than 1%,¹ with almost all physician-patient encounters taking place in a clinical setting, whether in a hospital or in a free-standing clinic. In the last 2 decades, a smattering of primary care and medical subspecialty clinicians started to incorporate some in-home care into their practices in the form of telemedicine, using video and telephone technology to facilitate care outside of the clinical setting, and by 2016, approximately 15% of physicians reported using some form of telemedicine in their interactions with patients.²

Despite these advances, prior to the COVID-19 pandemic, obstetricians lagged significantly behind in their use of at-home or remote care. Although there were some efforts to promote a hybrid care model that incorporated prenatal telemedicine,³ pre-pandemic ObGyn was one of the least likely fields to offer telemedicine to their patients, with only 9% of practices offering such services.² In this article, we discuss how the COVID-19 pandemic resulted in a shift from traditional, in-person care to a hybrid remote model and how this may benefit obstetrics patients as well as clinicians.

Pre-pandemic patient management

The traditional model of prenatal care presents a particularly intense time period for patients in terms of its demands. Women who are pregnant and start care in their first trimester typically have 12 to 14 visits during the subsequent 6 to 7 months, with additional visits for those with high-risk pregnancies. Although some of these visits coincide with the need for in-person laboratory work or imaging, many are chiefly oriented around assessment of vital signs or counseling. These frequent prenatal visits represent a significant commitment from patients in terms of transportation, time off work, and childcare resources—all of which may be exacerbated for patients who need to receive their care from overbooked, high-risk specialists.

After delivery, attending an in-person postpartum visit with a newborn can be even more daunting. Despite the increased recognition from professional groups of the importance of postpartum care to support breastfeeding, physical recovery, and mental health, as many as 40% of recently delivered patients do not attend their scheduled postpartum visit(s).⁴ Still, before 2020, few obstetricians had revised their workflows to “meet patients where they are,” with many continuing to only offer in-person care and assessments.

COVID-19: An impetus for change

As with so many things, the COVID-19 pandemic has challenged our ideas of what is normal. In a sense, the pandemic has catalyzed a revolution in the prenatal care model. The very real risks of exposure and contagion during the pandemic—for clinicians and patients alike—has forced ObGyns to reexamine the actual risks and benefits of in-person and in-clinic prenatal care. As a result, many ObGyns have rapidly adopted telemedicine into practices that were strictly in-person. For example, a national survey of 172 clinicians who offered contraception counseling during the pandemic found that 91% of them were now offering telemedicine services, with 78% of those clinicians new to telemedicine.⁵ Similarly, although a minority of surveyed obstetricians in New York City reported using telemedicine pre-pandemic, 89% planned to continue using such technology in the future.⁶

Continue to: Incorporating mobile technology...

Incorporating mobile technology

Obstetricians, forced to consolidate and maximize their in-person care to protect their patients’ safety, have started to realize that many of the conversations and counseling offered to patients can be managed equally effectively with telemedicine. Furthermore, basic home monitoring devices, such as blood pressure machines, can be safely and accurately used by patients without requiring them to come to the office.

More recent research into mobile medical devices suggests that patients can safely and appropriately manage more complex tools. One such example is a mobile, self-operated, ultrasound transducer that is controlled through a smartphone (Instinct, Pulsenmore Ltd). This device was evaluated in an observational, noninterventional trial of 100 women carrying a singleton fetus at 14/0 weeks’ to 39/6 weeks’ gestation. Patients performed 1,360 self-scans, which were reviewed by a clinician in real time online or subsequently off-line. Results showed successful detection rates of 95.3% for fetal heart activity, 88.3% for body movements, 69.4% for tone, 23.8% for breathing movements, and 92.2% for normal amniotic fluid volume.⁷ The authors concluded that this represents a feasible solution for remote sonographic fetal assessment.

Coordinating care with health care extenders

Remote monitoring options allow patients to be safely monitored during their pregnancies while remaining at home more often, especially when used in conjunction with trained health care extenders such as registered nurses, primary care associates, or “maternity navigators” who can facilitate off-site care. In fact, many aspects of prenatal care are particularly amenable to remote medicine or non–physician-based home care. Different variations of this model of “hybrid” prenatal care may be appropriate depending upon the needs of the patient population served by a given obstetrics practice. Ideally, a prenatal care model personalizes care based on the known risk factors that are identified at the beginning of prenatal care, the anticipated barriers to care, and the patient’s own preferences. As a result, alternatives to the traditional model may be to alternate in-person and telemedicine visits,^3,8 to incorporate in-person or remote group prenatal visits,^9,10 or to incorporate staff with basic health care skills to serve as health care extenders in the community and provide home visits for basic monitoring, laboratory work, and patient education.¹¹

Benefits of hybrid prenatal models

As we look ahead to the end of the pandemic, how should obstetricians view these hybrid prenatal care models? Are these models safe for patients? Were they only worthwhile to minimize infection risk, or do they have potential benefits for patients going forward?

In fact, data on the use of telemedicine in prenatal care indicate that these models may be equally as safe as the traditional model in terms of clinical outcomes and may have important additional benefits with regard to patient convenience and access to and satisfaction with care. Even audio-only prenatal televisits have been found to be equivalent to in-person visits in terms of serious perinatal outcomes.¹² Common pregnancy diagnoses are also well-served by telemedicine. For example, several recent investigations of patients with gestational diabetes have found that telemedicine was as effective as standard care for glucose control.^13,14 Management of hypertension during pregnancy, another antenatal condition that is commonly managed with frequent in-person check-ups, also was found to be adequately feasible with telemedicine using home monitors and symptom checklists, with high rates of patient satisfaction.¹⁵

With good evidence for safety, the added potential for patients to benefit in such hybrid models is multifactorial. For one, despite our collective hopes, the COVID-19 pandemic may have a long tail. Vaccine hesitancy and COVID-19 variants may mean that clinicians will have to consider the real threat of infection risk in the clinic setting for years to come. In-home prenatal care also provides a wide variety of social, economic, and psychological benefits for pregnant women across various patient populations. The pandemic has introduced many patients to the full potential of working and meeting remotely; pregnant patients are becoming more familiar with these technology platforms and appreciate its incorporation into their busy lives.⁵ Furthermore, hybrid models actually can provide otherwise “nonadherent” patients with better access to care. From the patient perspective, an in-person 15-minute health care provider visit actually represents a significant commitment of time and resources (ie, hours spent on public transportation, lost wages for those with inflexible work schedules, and childcare costs for patients discouraged from bringing their children to prenatal visits). Especially for patients with fewer socioeconomic resources, these barriers to in-person clinic visits may be daunting, if not insurmountable; the option of remote visits or house calls reduces these barriers and facilitates care.¹⁶

Such hybrid models benefit prenatal clinicians as well. In addition to a decreased risk of infection, clinicians may be able to attract a wider potential prenatal patient population with telemedicine by appealing to younger and potentially more technology-savvy patients.¹⁷ Importantly, telemedicine is increasingly recognized as on par with in-person visits in many billing algorithms. Changes during the pandemic led Medicare to cover telemedicine visits as well as in-person visits^18,19; among other groundbreaking changes, new patients can have an initial billable visit via telemedicine. Although the billing landscape will likely continue to evolve, such changes allow clinicians to focus on patient safety and convenience without financial risk to their practices.

The future of prenatal appointment scheduling

The future of prenatal care certainly doesn’t look like a dozen 15-minute visits in a private physician’s office. While these emerging hybrid models of prenatal care certainly can benefit patients with low-risk uncomplicated pregnancies, they are already being adopted by clinicians who care for patients with antenatal complications that require specialist consultation; for those with conditions that require frequent, low-complexity check-ins (gestational diabetes, chronic hypertension, history of pre-term birth, etc.); and for patients who struggle with financial or logistical barriers to in-person care. Although obstetrics may have lagged behind other subspecialties in revising its traditional health care models, the pandemic has opened up a new world of possibilities of remote and in-home care for this field. ●

For much of the general public, in-home care from a physician is akin to the rotary telephone: a feature of a bygone age, long since replaced by vastly different systems. While approximately 40% of physician-patient interactions in 1930 were house calls, by the early 1980s this had dwindled to less than 1%,¹ with almost all physician-patient encounters taking place in a clinical setting, whether in a hospital or in a free-standing clinic. In the last 2 decades, a smattering of primary care and medical subspecialty clinicians started to incorporate some in-home care into their practices in the form of telemedicine, using video and telephone technology to facilitate care outside of the clinical setting, and by 2016, approximately 15% of physicians reported using some form of telemedicine in their interactions with patients.²

Despite these advances, prior to the COVID-19 pandemic, obstetricians lagged significantly behind in their use of at-home or remote care. Although there were some efforts to promote a hybrid care model that incorporated prenatal telemedicine,³ pre-pandemic ObGyn was one of the least likely fields to offer telemedicine to their patients, with only 9% of practices offering such services.² In this article, we discuss how the COVID-19 pandemic resulted in a shift from traditional, in-person care to a hybrid remote model and how this may benefit obstetrics patients as well as clinicians.

Pre-pandemic patient management

The traditional model of prenatal care presents a particularly intense time period for patients in terms of its demands. Women who are pregnant and start care in their first trimester typically have 12 to 14 visits during the subsequent 6 to 7 months, with additional visits for those with high-risk pregnancies. Although some of these visits coincide with the need for in-person laboratory work or imaging, many are chiefly oriented around assessment of vital signs or counseling. These frequent prenatal visits represent a significant commitment from patients in terms of transportation, time off work, and childcare resources—all of which may be exacerbated for patients who need to receive their care from overbooked, high-risk specialists.

After delivery, attending an in-person postpartum visit with a newborn can be even more daunting. Despite the increased recognition from professional groups of the importance of postpartum care to support breastfeeding, physical recovery, and mental health, as many as 40% of recently delivered patients do not attend their scheduled postpartum visit(s).⁴ Still, before 2020, few obstetricians had revised their workflows to “meet patients where they are,” with many continuing to only offer in-person care and assessments.

COVID-19: An impetus for change

As with so many things, the COVID-19 pandemic has challenged our ideas of what is normal. In a sense, the pandemic has catalyzed a revolution in the prenatal care model. The very real risks of exposure and contagion during the pandemic—for clinicians and patients alike—has forced ObGyns to reexamine the actual risks and benefits of in-person and in-clinic prenatal care. As a result, many ObGyns have rapidly adopted telemedicine into practices that were strictly in-person. For example, a national survey of 172 clinicians who offered contraception counseling during the pandemic found that 91% of them were now offering telemedicine services, with 78% of those clinicians new to telemedicine.⁵ Similarly, although a minority of surveyed obstetricians in New York City reported using telemedicine pre-pandemic, 89% planned to continue using such technology in the future.⁶

Continue to: Incorporating mobile technology...

Incorporating mobile technology

Obstetricians, forced to consolidate and maximize their in-person care to protect their patients’ safety, have started to realize that many of the conversations and counseling offered to patients can be managed equally effectively with telemedicine. Furthermore, basic home monitoring devices, such as blood pressure machines, can be safely and accurately used by patients without requiring them to come to the office.

More recent research into mobile medical devices suggests that patients can safely and appropriately manage more complex tools. One such example is a mobile, self-operated, ultrasound transducer that is controlled through a smartphone (Instinct, Pulsenmore Ltd). This device was evaluated in an observational, noninterventional trial of 100 women carrying a singleton fetus at 14/0 weeks’ to 39/6 weeks’ gestation. Patients performed 1,360 self-scans, which were reviewed by a clinician in real time online or subsequently off-line. Results showed successful detection rates of 95.3% for fetal heart activity, 88.3% for body movements, 69.4% for tone, 23.8% for breathing movements, and 92.2% for normal amniotic fluid volume.⁷ The authors concluded that this represents a feasible solution for remote sonographic fetal assessment.

Coordinating care with health care extenders

Remote monitoring options allow patients to be safely monitored during their pregnancies while remaining at home more often, especially when used in conjunction with trained health care extenders such as registered nurses, primary care associates, or “maternity navigators” who can facilitate off-site care. In fact, many aspects of prenatal care are particularly amenable to remote medicine or non–physician-based home care. Different variations of this model of “hybrid” prenatal care may be appropriate depending upon the needs of the patient population served by a given obstetrics practice. Ideally, a prenatal care model personalizes care based on the known risk factors that are identified at the beginning of prenatal care, the anticipated barriers to care, and the patient’s own preferences. As a result, alternatives to the traditional model may be to alternate in-person and telemedicine visits,^3,8 to incorporate in-person or remote group prenatal visits,^9,10 or to incorporate staff with basic health care skills to serve as health care extenders in the community and provide home visits for basic monitoring, laboratory work, and patient education.¹¹

Benefits of hybrid prenatal models

As we look ahead to the end of the pandemic, how should obstetricians view these hybrid prenatal care models? Are these models safe for patients? Were they only worthwhile to minimize infection risk, or do they have potential benefits for patients going forward?

In fact, data on the use of telemedicine in prenatal care indicate that these models may be equally as safe as the traditional model in terms of clinical outcomes and may have important additional benefits with regard to patient convenience and access to and satisfaction with care. Even audio-only prenatal televisits have been found to be equivalent to in-person visits in terms of serious perinatal outcomes.¹² Common pregnancy diagnoses are also well-served by telemedicine. For example, several recent investigations of patients with gestational diabetes have found that telemedicine was as effective as standard care for glucose control.^13,14 Management of hypertension during pregnancy, another antenatal condition that is commonly managed with frequent in-person check-ups, also was found to be adequately feasible with telemedicine using home monitors and symptom checklists, with high rates of patient satisfaction.¹⁵

With good evidence for safety, the added potential for patients to benefit in such hybrid models is multifactorial. For one, despite our collective hopes, the COVID-19 pandemic may have a long tail. Vaccine hesitancy and COVID-19 variants may mean that clinicians will have to consider the real threat of infection risk in the clinic setting for years to come. In-home prenatal care also provides a wide variety of social, economic, and psychological benefits for pregnant women across various patient populations. The pandemic has introduced many patients to the full potential of working and meeting remotely; pregnant patients are becoming more familiar with these technology platforms and appreciate its incorporation into their busy lives.⁵ Furthermore, hybrid models actually can provide otherwise “nonadherent” patients with better access to care. From the patient perspective, an in-person 15-minute health care provider visit actually represents a significant commitment of time and resources (ie, hours spent on public transportation, lost wages for those with inflexible work schedules, and childcare costs for patients discouraged from bringing their children to prenatal visits). Especially for patients with fewer socioeconomic resources, these barriers to in-person clinic visits may be daunting, if not insurmountable; the option of remote visits or house calls reduces these barriers and facilitates care.¹⁶

Such hybrid models benefit prenatal clinicians as well. In addition to a decreased risk of infection, clinicians may be able to attract a wider potential prenatal patient population with telemedicine by appealing to younger and potentially more technology-savvy patients.¹⁷ Importantly, telemedicine is increasingly recognized as on par with in-person visits in many billing algorithms. Changes during the pandemic led Medicare to cover telemedicine visits as well as in-person visits^18,19; among other groundbreaking changes, new patients can have an initial billable visit via telemedicine. Although the billing landscape will likely continue to evolve, such changes allow clinicians to focus on patient safety and convenience without financial risk to their practices.

The future of prenatal appointment scheduling

The future of prenatal care certainly doesn’t look like a dozen 15-minute visits in a private physician’s office. While these emerging hybrid models of prenatal care certainly can benefit patients with low-risk uncomplicated pregnancies, they are already being adopted by clinicians who care for patients with antenatal complications that require specialist consultation; for those with conditions that require frequent, low-complexity check-ins (gestational diabetes, chronic hypertension, history of pre-term birth, etc.); and for patients who struggle with financial or logistical barriers to in-person care. Although obstetrics may have lagged behind other subspecialties in revising its traditional health care models, the pandemic has opened up a new world of possibilities of remote and in-home care for this field. ●

For much of the general public, in-home care from a physician is akin to the rotary telephone: a feature of a bygone age, long since replaced by vastly different systems. While approximately 40% of physician-patient interactions in 1930 were house calls, by the early 1980s this had dwindled to less than 1%,¹ with almost all physician-patient encounters taking place in a clinical setting, whether in a hospital or in a free-standing clinic. In the last 2 decades, a smattering of primary care and medical subspecialty clinicians started to incorporate some in-home care into their practices in the form of telemedicine, using video and telephone technology to facilitate care outside of the clinical setting, and by 2016, approximately 15% of physicians reported using some form of telemedicine in their interactions with patients.²

Despite these advances, prior to the COVID-19 pandemic, obstetricians lagged significantly behind in their use of at-home or remote care. Although there were some efforts to promote a hybrid care model that incorporated prenatal telemedicine,³ pre-pandemic ObGyn was one of the least likely fields to offer telemedicine to their patients, with only 9% of practices offering such services.² In this article, we discuss how the COVID-19 pandemic resulted in a shift from traditional, in-person care to a hybrid remote model and how this may benefit obstetrics patients as well as clinicians.

Pre-pandemic patient management

The traditional model of prenatal care presents a particularly intense time period for patients in terms of its demands. Women who are pregnant and start care in their first trimester typically have 12 to 14 visits during the subsequent 6 to 7 months, with additional visits for those with high-risk pregnancies. Although some of these visits coincide with the need for in-person laboratory work or imaging, many are chiefly oriented around assessment of vital signs or counseling. These frequent prenatal visits represent a significant commitment from patients in terms of transportation, time off work, and childcare resources—all of which may be exacerbated for patients who need to receive their care from overbooked, high-risk specialists.

After delivery, attending an in-person postpartum visit with a newborn can be even more daunting. Despite the increased recognition from professional groups of the importance of postpartum care to support breastfeeding, physical recovery, and mental health, as many as 40% of recently delivered patients do not attend their scheduled postpartum visit(s).⁴ Still, before 2020, few obstetricians had revised their workflows to “meet patients where they are,” with many continuing to only offer in-person care and assessments.

COVID-19: An impetus for change

As with so many things, the COVID-19 pandemic has challenged our ideas of what is normal. In a sense, the pandemic has catalyzed a revolution in the prenatal care model. The very real risks of exposure and contagion during the pandemic—for clinicians and patients alike—has forced ObGyns to reexamine the actual risks and benefits of in-person and in-clinic prenatal care. As a result, many ObGyns have rapidly adopted telemedicine into practices that were strictly in-person. For example, a national survey of 172 clinicians who offered contraception counseling during the pandemic found that 91% of them were now offering telemedicine services, with 78% of those clinicians new to telemedicine.⁵ Similarly, although a minority of surveyed obstetricians in New York City reported using telemedicine pre-pandemic, 89% planned to continue using such technology in the future.⁶

Continue to: Incorporating mobile technology...

Incorporating mobile technology

Obstetricians, forced to consolidate and maximize their in-person care to protect their patients’ safety, have started to realize that many of the conversations and counseling offered to patients can be managed equally effectively with telemedicine. Furthermore, basic home monitoring devices, such as blood pressure machines, can be safely and accurately used by patients without requiring them to come to the office.

More recent research into mobile medical devices suggests that patients can safely and appropriately manage more complex tools. One such example is a mobile, self-operated, ultrasound transducer that is controlled through a smartphone (Instinct, Pulsenmore Ltd). This device was evaluated in an observational, noninterventional trial of 100 women carrying a singleton fetus at 14/0 weeks’ to 39/6 weeks’ gestation. Patients performed 1,360 self-scans, which were reviewed by a clinician in real time online or subsequently off-line. Results showed successful detection rates of 95.3% for fetal heart activity, 88.3% for body movements, 69.4% for tone, 23.8% for breathing movements, and 92.2% for normal amniotic fluid volume.⁷ The authors concluded that this represents a feasible solution for remote sonographic fetal assessment.

Coordinating care with health care extenders

Remote monitoring options allow patients to be safely monitored during their pregnancies while remaining at home more often, especially when used in conjunction with trained health care extenders such as registered nurses, primary care associates, or “maternity navigators” who can facilitate off-site care. In fact, many aspects of prenatal care are particularly amenable to remote medicine or non–physician-based home care. Different variations of this model of “hybrid” prenatal care may be appropriate depending upon the needs of the patient population served by a given obstetrics practice. Ideally, a prenatal care model personalizes care based on the known risk factors that are identified at the beginning of prenatal care, the anticipated barriers to care, and the patient’s own preferences. As a result, alternatives to the traditional model may be to alternate in-person and telemedicine visits,^3,8 to incorporate in-person or remote group prenatal visits,^9,10 or to incorporate staff with basic health care skills to serve as health care extenders in the community and provide home visits for basic monitoring, laboratory work, and patient education.¹¹

Benefits of hybrid prenatal models

As we look ahead to the end of the pandemic, how should obstetricians view these hybrid prenatal care models? Are these models safe for patients? Were they only worthwhile to minimize infection risk, or do they have potential benefits for patients going forward?

In fact, data on the use of telemedicine in prenatal care indicate that these models may be equally as safe as the traditional model in terms of clinical outcomes and may have important additional benefits with regard to patient convenience and access to and satisfaction with care. Even audio-only prenatal televisits have been found to be equivalent to in-person visits in terms of serious perinatal outcomes.¹² Common pregnancy diagnoses are also well-served by telemedicine. For example, several recent investigations of patients with gestational diabetes have found that telemedicine was as effective as standard care for glucose control.^13,14 Management of hypertension during pregnancy, another antenatal condition that is commonly managed with frequent in-person check-ups, also was found to be adequately feasible with telemedicine using home monitors and symptom checklists, with high rates of patient satisfaction.¹⁵

With good evidence for safety, the added potential for patients to benefit in such hybrid models is multifactorial. For one, despite our collective hopes, the COVID-19 pandemic may have a long tail. Vaccine hesitancy and COVID-19 variants may mean that clinicians will have to consider the real threat of infection risk in the clinic setting for years to come. In-home prenatal care also provides a wide variety of social, economic, and psychological benefits for pregnant women across various patient populations. The pandemic has introduced many patients to the full potential of working and meeting remotely; pregnant patients are becoming more familiar with these technology platforms and appreciate its incorporation into their busy lives.⁵ Furthermore, hybrid models actually can provide otherwise “nonadherent” patients with better access to care. From the patient perspective, an in-person 15-minute health care provider visit actually represents a significant commitment of time and resources (ie, hours spent on public transportation, lost wages for those with inflexible work schedules, and childcare costs for patients discouraged from bringing their children to prenatal visits). Especially for patients with fewer socioeconomic resources, these barriers to in-person clinic visits may be daunting, if not insurmountable; the option of remote visits or house calls reduces these barriers and facilitates care.¹⁶

Such hybrid models benefit prenatal clinicians as well. In addition to a decreased risk of infection, clinicians may be able to attract a wider potential prenatal patient population with telemedicine by appealing to younger and potentially more technology-savvy patients.¹⁷ Importantly, telemedicine is increasingly recognized as on par with in-person visits in many billing algorithms. Changes during the pandemic led Medicare to cover telemedicine visits as well as in-person visits^18,19; among other groundbreaking changes, new patients can have an initial billable visit via telemedicine. Although the billing landscape will likely continue to evolve, such changes allow clinicians to focus on patient safety and convenience without financial risk to their practices.

The future of prenatal appointment scheduling

The future of prenatal care certainly doesn’t look like a dozen 15-minute visits in a private physician’s office. While these emerging hybrid models of prenatal care certainly can benefit patients with low-risk uncomplicated pregnancies, they are already being adopted by clinicians who care for patients with antenatal complications that require specialist consultation; for those with conditions that require frequent, low-complexity check-ins (gestational diabetes, chronic hypertension, history of pre-term birth, etc.); and for patients who struggle with financial or logistical barriers to in-person care. Although obstetrics may have lagged behind other subspecialties in revising its traditional health care models, the pandemic has opened up a new world of possibilities of remote and in-home care for this field. ●

The social reckoning of 2020 has led to many discussions and conversations around equity and disparities. With the COVID-19 pandemic, there has been a particular spotlight on health care disparities and race-based medicine. Racism in medicine is pervasive; little has been done over the years to dismantle and unlearn practices that continue to contribute to existing gaps and disparities. Race and ethnicity are both social constructs that have long been used within medical practice and in dictating the type of care an individual receives. Without a universal definition, race, ethnicity, and ancestry have long been used interchangeably within medicine and society. Appreciating that race and ethnicity-based constructs can have other social implications in health care, with their impact on structural racism beyond health care settings, these constructs may still be part of assessments and key modifiers to understanding health differences. It is imperative that medical providers examine the use of race and ethnicity within the care that they provide.

While racial determinants of health cannot be removed from historical access, utilization, and barriers related to reproductive care, guidelines structured around historical ethnicity and race further restrict universal access to carrier screening and informed reproductive testing decisions.

Carrier screening

The goal of preconception and prenatal carrier screening is to provide individuals and reproductive partners with information to optimize pregnancy outcomes based on personal values and preferences.¹ The practice of carrier screening began almost half a century ago with screening for individual conditions seen more frequently in certain populations, such as Tay-Sachs disease in those of Ashkenazi Jewish descent and sickle cell disease in those of African descent. Cystic fibrosis carrier screening was first recommended for individuals of Northern European descent in 2001 before being recommended for pan ethnic screening a decade later. Other individual conditions are also recommended for screening based on race/ethnicity (eg, Canavan disease in the Ashkenazi Jewish population, Tay-Sachs disease in individuals of Cajun or French-Canadian descent).^2-4 Practice guidelines from professional societies recommend offering carrier screening for individual conditions based on condition severity, race or ethnicity, prevalence, carrier frequency, detection rates, and residual risk.¹ However, this process can be problematic, as the data frequently used in updating guidelines and recommendations come primarily from studies and databases where much of the cohort is White.^5,6 Failing to identify genetic associations in diverse populations limits the ability to illuminate new discoveries that inform risk management and treatment, especially for populations that are disproportionately underserved in medicine.⁷

Need for expanded carrier screening

The evolution of genomics and technology within the realm of carrier screening has enabled the simultaneous screening for many serious Mendelian diseases, known as expanded carrier screening (ECS). A 2016 study illustrated that, in most racial/ethnic categories, the cumulative risk of severe and profound conditions found on ECS panels outside the guideline recommendations are greater than the risk identified by guideline-based panels.⁸ Additionally, a 2020 study showed that self-reported ethnicity was an imperfect indicator of genetic ancestry, with 9% of those in the cohort having a >50% genetic ancestry from a lineage inconsistent with their self-reported ethnicity.⁹ Data over the past decade have established the clinical utility,¹⁰ clinical validity,¹¹ analytical validity,¹² and cost-effectiveness¹³ of pan-ethnic ECS. In 2021, American College of Medical Genetics and Genomics (ACMG) recommended a panel of pan-ethnic conditions that should be offered to all patients due to smaller ethnicity-based panels failing to provide equitable evaluation of all racial and ethnic groups.¹⁴ The guidelines from the American College of Obstetricians and Gynecologists (ACOG) fall short of recommending that ECS be offered to all individuals in lieu of screening based on self-reported ethnicity.^3,4

Phasing out ethnicity-based carrier screening

This begs the question: Do race, ethnicity, or ancestry have a role in carrier screening? While each may have had a role at the inception of offering carrier screening due to high costs of technology, recent studies have shown the limitations of using self-reported ethnicity in screening. Guideline-based carrier screenings miss a significant percentage of pregnancies (13% to 94%) affected by serious conditions on expanded carrier screening panels.⁸ Additionally, 40% of Americans cannot identify the ethnicity of all 4 grandparents.¹⁵

Founder mutations due to ancestry patterns are still present; however, stratification of care should only be pursued when the presence or absence of these markers would alter clinical management. While the reproductive risk an individual may receive varies based on their self-reported ethnicity, the clinically indicated follow-up testing is the same: offering carrier screening for the reproductive partner or gamete donor. With increased detection rates via sequencing for most autosomal recessive conditions, if the reproductive partner or gamete donor is not identified as a carrier, no further testing is generally indicated regardless of ancestry. Genotyping platforms should not be used for partner carrier screening as they primarily target common pathogenic variants based on dominant ancestry groups and do not provide the same risk reduction.

Continue to: Variant reporting...

We have long known that databases and registries in the United States have an increased representation of individuals from European ancestries.^5,6 However, there have been limited conversations about how the lack of representation within our databases and registries leads to inequities in guidelines and the care that we provide to patients. As a result, studies have shown higher rates of variants of uncertain significance (VUS) identified during genetic testing in non-White individuals than in Whites.¹⁶ When it comes to reporting of variants, carrier screening laboratories follow guidelines set forth by the ACMG, and most laboratories only report likely pathogenic or pathogenic variants.¹⁷ It is unknown how the higher rate of VUSs in the non-White population, and lack of data and representation in databases and software used to calculate predicted phenotype, impacts identification of at-risk carrier couples in these underrepresented populations. It is imperative that we increase knowledge and representation of variants across ethnicities to improve sensitivity and specificity across the population and not just for those of European descent.

Moving forward

Being aware of social- and race-based biases in carrier screening is important, but modifying structural systems to increase representation, access, and utility of carrier screening is a critical next step. Organizations like ACOG and ACMG have committed not only to understanding but also to addressing factors that have led to disparities and inequities in health care delivery and access.^18,19 Actionable steps include offering a universal carrier screening program to all preconception and prenatal patients that addresses conditions with increased carrier frequency, in any population, defined as severe and moderate phenotype with established natural history.^3,4 Educational materials should be provided to detail risks, benefits, and limitations of carrier screening, as well as shared decision making between patient and provider to align the patient’s wishes for the information provided by carrier screening.

A broader number of conditions offered through carrier screening will increase the likelihood of positive carrier results. The increase in carriers identified should be viewed as more accurate reproductive risk assessment in the context of equitable care, rather than justification for panels to be limited to specific ancestries. Simultaneous or tandem reproductive partner or donor testing can be considered to reduce clinical workload and time for results return.

In addition, increased representation of individuals who are from diverse ancestries in promotional and educational resources can reinforce that risk for Mendelian conditions is not specific to single ancestries or for targeted conditions. Future research should be conducted to examine the role of racial disparities related to carrier screening and greater inclusion and recruitment of diverse populations in data sets and research studies.

Learned biases toward race, religion, gender identity, sexual orientation, and economic status in the context of carrier screening should be examined and challenged to increase access for all patients who may benefit from this testing. For example, the use of gendered language within carrier screening guidelines and policies and how such screening is offered to patients should be examined. Guidelines do not specify what to do when someone is adopted, for instance, or does not know their ethnicity. It is important that, as genomic testing becomes more available, individuals and groups are not left behind and existing gaps are not further widened. Assessing for genetic variation that modifies for disease or treatment will be more powerful than stratifying based on race. Carrier screening panels should be comprehensive regardless of ancestry to ensure coverage for global genetic variation and to increase access for all patients to risk assessments that promote informed reproductive decision making.

Health equity requires unlearning certain behaviors

As clinicians we all have a commitment to educate and empower one another to offer care that helps promote health equity. Equitable care requires us to look at the current gaps and figure out what programs and initiatives need to be designed to address those gaps. Carrier screening is one such area in which we can work together to improve the overall care that our patients receive, but it is imperative that we examine our practices and unlearn behaviors that contribute to existing disparities. ●

The social reckoning of 2020 has led to many discussions and conversations around equity and disparities. With the COVID-19 pandemic, there has been a particular spotlight on health care disparities and race-based medicine. Racism in medicine is pervasive; little has been done over the years to dismantle and unlearn practices that continue to contribute to existing gaps and disparities. Race and ethnicity are both social constructs that have long been used within medical practice and in dictating the type of care an individual receives. Without a universal definition, race, ethnicity, and ancestry have long been used interchangeably within medicine and society. Appreciating that race and ethnicity-based constructs can have other social implications in health care, with their impact on structural racism beyond health care settings, these constructs may still be part of assessments and key modifiers to understanding health differences. It is imperative that medical providers examine the use of race and ethnicity within the care that they provide.

While racial determinants of health cannot be removed from historical access, utilization, and barriers related to reproductive care, guidelines structured around historical ethnicity and race further restrict universal access to carrier screening and informed reproductive testing decisions.

Carrier screening

The goal of preconception and prenatal carrier screening is to provide individuals and reproductive partners with information to optimize pregnancy outcomes based on personal values and preferences.¹ The practice of carrier screening began almost half a century ago with screening for individual conditions seen more frequently in certain populations, such as Tay-Sachs disease in those of Ashkenazi Jewish descent and sickle cell disease in those of African descent. Cystic fibrosis carrier screening was first recommended for individuals of Northern European descent in 2001 before being recommended for pan ethnic screening a decade later. Other individual conditions are also recommended for screening based on race/ethnicity (eg, Canavan disease in the Ashkenazi Jewish population, Tay-Sachs disease in individuals of Cajun or French-Canadian descent).^2-4 Practice guidelines from professional societies recommend offering carrier screening for individual conditions based on condition severity, race or ethnicity, prevalence, carrier frequency, detection rates, and residual risk.¹ However, this process can be problematic, as the data frequently used in updating guidelines and recommendations come primarily from studies and databases where much of the cohort is White.^5,6 Failing to identify genetic associations in diverse populations limits the ability to illuminate new discoveries that inform risk management and treatment, especially for populations that are disproportionately underserved in medicine.⁷

Need for expanded carrier screening

The evolution of genomics and technology within the realm of carrier screening has enabled the simultaneous screening for many serious Mendelian diseases, known as expanded carrier screening (ECS). A 2016 study illustrated that, in most racial/ethnic categories, the cumulative risk of severe and profound conditions found on ECS panels outside the guideline recommendations are greater than the risk identified by guideline-based panels.⁸ Additionally, a 2020 study showed that self-reported ethnicity was an imperfect indicator of genetic ancestry, with 9% of those in the cohort having a >50% genetic ancestry from a lineage inconsistent with their self-reported ethnicity.⁹ Data over the past decade have established the clinical utility,¹⁰ clinical validity,¹¹ analytical validity,¹² and cost-effectiveness¹³ of pan-ethnic ECS. In 2021, American College of Medical Genetics and Genomics (ACMG) recommended a panel of pan-ethnic conditions that should be offered to all patients due to smaller ethnicity-based panels failing to provide equitable evaluation of all racial and ethnic groups.¹⁴ The guidelines from the American College of Obstetricians and Gynecologists (ACOG) fall short of recommending that ECS be offered to all individuals in lieu of screening based on self-reported ethnicity.^3,4

Phasing out ethnicity-based carrier screening

This begs the question: Do race, ethnicity, or ancestry have a role in carrier screening? While each may have had a role at the inception of offering carrier screening due to high costs of technology, recent studies have shown the limitations of using self-reported ethnicity in screening. Guideline-based carrier screenings miss a significant percentage of pregnancies (13% to 94%) affected by serious conditions on expanded carrier screening panels.⁸ Additionally, 40% of Americans cannot identify the ethnicity of all 4 grandparents.¹⁵

Founder mutations due to ancestry patterns are still present; however, stratification of care should only be pursued when the presence or absence of these markers would alter clinical management. While the reproductive risk an individual may receive varies based on their self-reported ethnicity, the clinically indicated follow-up testing is the same: offering carrier screening for the reproductive partner or gamete donor. With increased detection rates via sequencing for most autosomal recessive conditions, if the reproductive partner or gamete donor is not identified as a carrier, no further testing is generally indicated regardless of ancestry. Genotyping platforms should not be used for partner carrier screening as they primarily target common pathogenic variants based on dominant ancestry groups and do not provide the same risk reduction.

Continue to: Variant reporting...

We have long known that databases and registries in the United States have an increased representation of individuals from European ancestries.^5,6 However, there have been limited conversations about how the lack of representation within our databases and registries leads to inequities in guidelines and the care that we provide to patients. As a result, studies have shown higher rates of variants of uncertain significance (VUS) identified during genetic testing in non-White individuals than in Whites.¹⁶ When it comes to reporting of variants, carrier screening laboratories follow guidelines set forth by the ACMG, and most laboratories only report likely pathogenic or pathogenic variants.¹⁷ It is unknown how the higher rate of VUSs in the non-White population, and lack of data and representation in databases and software used to calculate predicted phenotype, impacts identification of at-risk carrier couples in these underrepresented populations. It is imperative that we increase knowledge and representation of variants across ethnicities to improve sensitivity and specificity across the population and not just for those of European descent.

Moving forward

Being aware of social- and race-based biases in carrier screening is important, but modifying structural systems to increase representation, access, and utility of carrier screening is a critical next step. Organizations like ACOG and ACMG have committed not only to understanding but also to addressing factors that have led to disparities and inequities in health care delivery and access.^18,19 Actionable steps include offering a universal carrier screening program to all preconception and prenatal patients that addresses conditions with increased carrier frequency, in any population, defined as severe and moderate phenotype with established natural history.^3,4 Educational materials should be provided to detail risks, benefits, and limitations of carrier screening, as well as shared decision making between patient and provider to align the patient’s wishes for the information provided by carrier screening.

A broader number of conditions offered through carrier screening will increase the likelihood of positive carrier results. The increase in carriers identified should be viewed as more accurate reproductive risk assessment in the context of equitable care, rather than justification for panels to be limited to specific ancestries. Simultaneous or tandem reproductive partner or donor testing can be considered to reduce clinical workload and time for results return.

In addition, increased representation of individuals who are from diverse ancestries in promotional and educational resources can reinforce that risk for Mendelian conditions is not specific to single ancestries or for targeted conditions. Future research should be conducted to examine the role of racial disparities related to carrier screening and greater inclusion and recruitment of diverse populations in data sets and research studies.

Learned biases toward race, religion, gender identity, sexual orientation, and economic status in the context of carrier screening should be examined and challenged to increase access for all patients who may benefit from this testing. For example, the use of gendered language within carrier screening guidelines and policies and how such screening is offered to patients should be examined. Guidelines do not specify what to do when someone is adopted, for instance, or does not know their ethnicity. It is important that, as genomic testing becomes more available, individuals and groups are not left behind and existing gaps are not further widened. Assessing for genetic variation that modifies for disease or treatment will be more powerful than stratifying based on race. Carrier screening panels should be comprehensive regardless of ancestry to ensure coverage for global genetic variation and to increase access for all patients to risk assessments that promote informed reproductive decision making.

Health equity requires unlearning certain behaviors

As clinicians we all have a commitment to educate and empower one another to offer care that helps promote health equity. Equitable care requires us to look at the current gaps and figure out what programs and initiatives need to be designed to address those gaps. Carrier screening is one such area in which we can work together to improve the overall care that our patients receive, but it is imperative that we examine our practices and unlearn behaviors that contribute to existing disparities. ●

The social reckoning of 2020 has led to many discussions and conversations around equity and disparities. With the COVID-19 pandemic, there has been a particular spotlight on health care disparities and race-based medicine. Racism in medicine is pervasive; little has been done over the years to dismantle and unlearn practices that continue to contribute to existing gaps and disparities. Race and ethnicity are both social constructs that have long been used within medical practice and in dictating the type of care an individual receives. Without a universal definition, race, ethnicity, and ancestry have long been used interchangeably within medicine and society. Appreciating that race and ethnicity-based constructs can have other social implications in health care, with their impact on structural racism beyond health care settings, these constructs may still be part of assessments and key modifiers to understanding health differences. It is imperative that medical providers examine the use of race and ethnicity within the care that they provide.

While racial determinants of health cannot be removed from historical access, utilization, and barriers related to reproductive care, guidelines structured around historical ethnicity and race further restrict universal access to carrier screening and informed reproductive testing decisions.

Carrier screening

The goal of preconception and prenatal carrier screening is to provide individuals and reproductive partners with information to optimize pregnancy outcomes based on personal values and preferences.¹ The practice of carrier screening began almost half a century ago with screening for individual conditions seen more frequently in certain populations, such as Tay-Sachs disease in those of Ashkenazi Jewish descent and sickle cell disease in those of African descent. Cystic fibrosis carrier screening was first recommended for individuals of Northern European descent in 2001 before being recommended for pan ethnic screening a decade later. Other individual conditions are also recommended for screening based on race/ethnicity (eg, Canavan disease in the Ashkenazi Jewish population, Tay-Sachs disease in individuals of Cajun or French-Canadian descent).^2-4 Practice guidelines from professional societies recommend offering carrier screening for individual conditions based on condition severity, race or ethnicity, prevalence, carrier frequency, detection rates, and residual risk.¹ However, this process can be problematic, as the data frequently used in updating guidelines and recommendations come primarily from studies and databases where much of the cohort is White.^5,6 Failing to identify genetic associations in diverse populations limits the ability to illuminate new discoveries that inform risk management and treatment, especially for populations that are disproportionately underserved in medicine.⁷

Need for expanded carrier screening

The evolution of genomics and technology within the realm of carrier screening has enabled the simultaneous screening for many serious Mendelian diseases, known as expanded carrier screening (ECS). A 2016 study illustrated that, in most racial/ethnic categories, the cumulative risk of severe and profound conditions found on ECS panels outside the guideline recommendations are greater than the risk identified by guideline-based panels.⁸ Additionally, a 2020 study showed that self-reported ethnicity was an imperfect indicator of genetic ancestry, with 9% of those in the cohort having a >50% genetic ancestry from a lineage inconsistent with their self-reported ethnicity.⁹ Data over the past decade have established the clinical utility,¹⁰ clinical validity,¹¹ analytical validity,¹² and cost-effectiveness¹³ of pan-ethnic ECS. In 2021, American College of Medical Genetics and Genomics (ACMG) recommended a panel of pan-ethnic conditions that should be offered to all patients due to smaller ethnicity-based panels failing to provide equitable evaluation of all racial and ethnic groups.¹⁴ The guidelines from the American College of Obstetricians and Gynecologists (ACOG) fall short of recommending that ECS be offered to all individuals in lieu of screening based on self-reported ethnicity.^3,4

Phasing out ethnicity-based carrier screening

This begs the question: Do race, ethnicity, or ancestry have a role in carrier screening? While each may have had a role at the inception of offering carrier screening due to high costs of technology, recent studies have shown the limitations of using self-reported ethnicity in screening. Guideline-based carrier screenings miss a significant percentage of pregnancies (13% to 94%) affected by serious conditions on expanded carrier screening panels.⁸ Additionally, 40% of Americans cannot identify the ethnicity of all 4 grandparents.¹⁵

Founder mutations due to ancestry patterns are still present; however, stratification of care should only be pursued when the presence or absence of these markers would alter clinical management. While the reproductive risk an individual may receive varies based on their self-reported ethnicity, the clinically indicated follow-up testing is the same: offering carrier screening for the reproductive partner or gamete donor. With increased detection rates via sequencing for most autosomal recessive conditions, if the reproductive partner or gamete donor is not identified as a carrier, no further testing is generally indicated regardless of ancestry. Genotyping platforms should not be used for partner carrier screening as they primarily target common pathogenic variants based on dominant ancestry groups and do not provide the same risk reduction.

Continue to: Variant reporting...

We have long known that databases and registries in the United States have an increased representation of individuals from European ancestries.^5,6 However, there have been limited conversations about how the lack of representation within our databases and registries leads to inequities in guidelines and the care that we provide to patients. As a result, studies have shown higher rates of variants of uncertain significance (VUS) identified during genetic testing in non-White individuals than in Whites.¹⁶ When it comes to reporting of variants, carrier screening laboratories follow guidelines set forth by the ACMG, and most laboratories only report likely pathogenic or pathogenic variants.¹⁷ It is unknown how the higher rate of VUSs in the non-White population, and lack of data and representation in databases and software used to calculate predicted phenotype, impacts identification of at-risk carrier couples in these underrepresented populations. It is imperative that we increase knowledge and representation of variants across ethnicities to improve sensitivity and specificity across the population and not just for those of European descent.

Moving forward

Being aware of social- and race-based biases in carrier screening is important, but modifying structural systems to increase representation, access, and utility of carrier screening is a critical next step. Organizations like ACOG and ACMG have committed not only to understanding but also to addressing factors that have led to disparities and inequities in health care delivery and access.^18,19 Actionable steps include offering a universal carrier screening program to all preconception and prenatal patients that addresses conditions with increased carrier frequency, in any population, defined as severe and moderate phenotype with established natural history.^3,4 Educational materials should be provided to detail risks, benefits, and limitations of carrier screening, as well as shared decision making between patient and provider to align the patient’s wishes for the information provided by carrier screening.

A broader number of conditions offered through carrier screening will increase the likelihood of positive carrier results. The increase in carriers identified should be viewed as more accurate reproductive risk assessment in the context of equitable care, rather than justification for panels to be limited to specific ancestries. Simultaneous or tandem reproductive partner or donor testing can be considered to reduce clinical workload and time for results return.

In addition, increased representation of individuals who are from diverse ancestries in promotional and educational resources can reinforce that risk for Mendelian conditions is not specific to single ancestries or for targeted conditions. Future research should be conducted to examine the role of racial disparities related to carrier screening and greater inclusion and recruitment of diverse populations in data sets and research studies.

Learned biases toward race, religion, gender identity, sexual orientation, and economic status in the context of carrier screening should be examined and challenged to increase access for all patients who may benefit from this testing. For example, the use of gendered language within carrier screening guidelines and policies and how such screening is offered to patients should be examined. Guidelines do not specify what to do when someone is adopted, for instance, or does not know their ethnicity. It is important that, as genomic testing becomes more available, individuals and groups are not left behind and existing gaps are not further widened. Assessing for genetic variation that modifies for disease or treatment will be more powerful than stratifying based on race. Carrier screening panels should be comprehensive regardless of ancestry to ensure coverage for global genetic variation and to increase access for all patients to risk assessments that promote informed reproductive decision making.

Health equity requires unlearning certain behaviors

As clinicians we all have a commitment to educate and empower one another to offer care that helps promote health equity. Equitable care requires us to look at the current gaps and figure out what programs and initiatives need to be designed to address those gaps. Carrier screening is one such area in which we can work together to improve the overall care that our patients receive, but it is imperative that we examine our practices and unlearn behaviors that contribute to existing disparities. ●

_{Text copyright DenseBreast-info.org.}

Answer

C. Overall, tomosynthesis depicts an additional 1 to 2 cancers per thousand women screened in the first round of screening when added to standard digital mammography;^1-3 however, this improvement in cancer detection is only observed in women with fatty breasts (category A), scattered fibroglandular tissue (category B), and heterogeneously dense breasts (category C). Importantly, tomosynthesis does not significantly improve breast cancer detection in women with extremely dense breasts (category D).^2,4

Digital breast tomosynthesis, also referred to as “3-dimensional mammography” (3D mammography) or tomosynthesis, uses a dedicated electronic detector system to obtain multiple projection images that are reconstructed by the computer to create thin slices or slabs of multiple slices of the breast. These slices can be individually “scrolled through” by the radiologist to reduce tissue overlap that may obscure breast cancers on a standard mammogram. While tomosynthesis improves breast cancer detection in women with fatty, scattered fibroglandular density, and heterogeneously dense breasts, there is very little soft tissue contrast in extremely dense breasts due to insufficient fat, and some cancers will remain hidden by dense tissue even on sliced images through the breast.

FIGURE 2 shows an example of cancer that was missed on tomosynthesis in a 51-year-old woman with extremely dense breasts and right breast pain. The cancer was masked by extremely dense tissue on standard digital mammography and tomosynthesis; no abnormalities were detected. Ultrasonography showed a 1.6-cm, irregular, hypoechoic mass at the site of pain, and biopsy revealed a grade 3 triple-receptor negative invasive ductal carcinoma.

_{Text copyright DenseBreast-info.org.}

Answer

C. Overall, tomosynthesis depicts an additional 1 to 2 cancers per thousand women screened in the first round of screening when added to standard digital mammography;^1-3 however, this improvement in cancer detection is only observed in women with fatty breasts (category A), scattered fibroglandular tissue (category B), and heterogeneously dense breasts (category C). Importantly, tomosynthesis does not significantly improve breast cancer detection in women with extremely dense breasts (category D).^2,4

Digital breast tomosynthesis, also referred to as “3-dimensional mammography” (3D mammography) or tomosynthesis, uses a dedicated electronic detector system to obtain multiple projection images that are reconstructed by the computer to create thin slices or slabs of multiple slices of the breast. These slices can be individually “scrolled through” by the radiologist to reduce tissue overlap that may obscure breast cancers on a standard mammogram. While tomosynthesis improves breast cancer detection in women with fatty, scattered fibroglandular density, and heterogeneously dense breasts, there is very little soft tissue contrast in extremely dense breasts due to insufficient fat, and some cancers will remain hidden by dense tissue even on sliced images through the breast.

FIGURE 2 shows an example of cancer that was missed on tomosynthesis in a 51-year-old woman with extremely dense breasts and right breast pain. The cancer was masked by extremely dense tissue on standard digital mammography and tomosynthesis; no abnormalities were detected. Ultrasonography showed a 1.6-cm, irregular, hypoechoic mass at the site of pain, and biopsy revealed a grade 3 triple-receptor negative invasive ductal carcinoma.

_{Text copyright DenseBreast-info.org.}

Answer

C. Overall, tomosynthesis depicts an additional 1 to 2 cancers per thousand women screened in the first round of screening when added to standard digital mammography;^1-3 however, this improvement in cancer detection is only observed in women with fatty breasts (category A), scattered fibroglandular tissue (category B), and heterogeneously dense breasts (category C). Importantly, tomosynthesis does not significantly improve breast cancer detection in women with extremely dense breasts (category D).^2,4

Digital breast tomosynthesis, also referred to as “3-dimensional mammography” (3D mammography) or tomosynthesis, uses a dedicated electronic detector system to obtain multiple projection images that are reconstructed by the computer to create thin slices or slabs of multiple slices of the breast. These slices can be individually “scrolled through” by the radiologist to reduce tissue overlap that may obscure breast cancers on a standard mammogram. While tomosynthesis improves breast cancer detection in women with fatty, scattered fibroglandular density, and heterogeneously dense breasts, there is very little soft tissue contrast in extremely dense breasts due to insufficient fat, and some cancers will remain hidden by dense tissue even on sliced images through the breast.

FIGURE 2 shows an example of cancer that was missed on tomosynthesis in a 51-year-old woman with extremely dense breasts and right breast pain. The cancer was masked by extremely dense tissue on standard digital mammography and tomosynthesis; no abnormalities were detected. Ultrasonography showed a 1.6-cm, irregular, hypoechoic mass at the site of pain, and biopsy revealed a grade 3 triple-receptor negative invasive ductal carcinoma.

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

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

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

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

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

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

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Which of the following statements about breast density is TRUE?

_{Text copyright DenseBreast-info.org.}

Answer

D. The risks associated with dense breast tissue are 2-fold: Dense tissue can mask cancer on a mammogram, and having dense breasts also increases the risk of developing breast cancer. As breast density increases, the sensitivity of mammography decreases, and the risk of developing breast cancer increases.

A woman’s breast density is usually determined by a radiologist’s visual evaluation of the mammogram. Breast density also can be measured quantitatively by computer software or estimated on computed tomography scan or magnetic resonance imaging. Breast density cannot be determined by the way a breast looks or feels.

Breast density and mammographic sensitivity

Cancers can be hidden or “masked” by dense tissue. On a mammogram, cancer is white. Normal dense tissue also appears white. If a cancer develops in an area of normal dense tissue, it can be harder or sometimes impossible to see it on the mammogram, like trying to see a snowman in a blizzard. As breast density increases, the ability to see cancer on mammography decreases (FIGURE 1).

Standard 2D mammography has been shown to miss about 40% of cancers present in women with extremely dense breasts and 25% of cancers present in women with heterogeneously dense breasts.^1-6 A cancer still can be masked on tomosynthesis (3D mammography) if it occurs in an area of dense tissue (where breast cancers more commonly occur), and tomosynthesis does not improve cancer detection appreciably in women with extremely dense breasts. To find cancer in a woman with dense breasts, additional screening beyond mammography should be considered.

Breast density and breast cancer risk

Dense breast tissue not only reduces mammography effectiveness, it also is a risk factor for the development of breast cancer: the denser the breast, the higher the risk.⁷ A meta-analysis across many studies concluded that magnitude of risk increases with each increase in density category, and women with extremely dense breasts (category D) have a 4-fold greater risk of developing breast cancer than do women with fatty breasts (category A), with upper limit of nearly 6-fold greater risk (FIGURE 2).⁸

Most women do not have fatty breasts, however. More women have breasts with scattered fibroglandular density.⁹ Women with heterogeneously dense breasts (category C) have about a 1.5-fold greater risk of developing breast cancer than those with scattered fibroglandular density (category B), while women with extremely dense breasts (category D) have about a 2-fold greater risk.

There are probably several reasons that dense tissue increases breast cancer risk. One is that cancers arise microscopically in the glandular tissue. The more glandular tissue, the more susceptible tissue where cancer can develop. Glandular cells divide with hormonal stimulation throughout a woman’s lifetime, and each time a cell divides, “mistakes” can be made. An accumulation of mistakes can result in cancer. The more glandular the tissue, the greater the breast cancer risk. Women who have had breast reduction experience a reduced risk for breast cancer: thus, even a reduced absolute amount of glandular tissue reduces the risk for breast cancer. The second is that the local environment around the glands may produce certain growth hormones that stimulate cells to divide, and this is observed with fibrous breast tissue more than fatty breast tissue. ●

Which of the following statements about breast density is TRUE?

_{Text copyright DenseBreast-info.org.}

Answer

D. The risks associated with dense breast tissue are 2-fold: Dense tissue can mask cancer on a mammogram, and having dense breasts also increases the risk of developing breast cancer. As breast density increases, the sensitivity of mammography decreases, and the risk of developing breast cancer increases.

A woman’s breast density is usually determined by a radiologist’s visual evaluation of the mammogram. Breast density also can be measured quantitatively by computer software or estimated on computed tomography scan or magnetic resonance imaging. Breast density cannot be determined by the way a breast looks or feels.

Breast density and mammographic sensitivity

Cancers can be hidden or “masked” by dense tissue. On a mammogram, cancer is white. Normal dense tissue also appears white. If a cancer develops in an area of normal dense tissue, it can be harder or sometimes impossible to see it on the mammogram, like trying to see a snowman in a blizzard. As breast density increases, the ability to see cancer on mammography decreases (FIGURE 1).

Standard 2D mammography has been shown to miss about 40% of cancers present in women with extremely dense breasts and 25% of cancers present in women with heterogeneously dense breasts.^1-6 A cancer still can be masked on tomosynthesis (3D mammography) if it occurs in an area of dense tissue (where breast cancers more commonly occur), and tomosynthesis does not improve cancer detection appreciably in women with extremely dense breasts. To find cancer in a woman with dense breasts, additional screening beyond mammography should be considered.

Breast density and breast cancer risk

Dense breast tissue not only reduces mammography effectiveness, it also is a risk factor for the development of breast cancer: the denser the breast, the higher the risk.⁷ A meta-analysis across many studies concluded that magnitude of risk increases with each increase in density category, and women with extremely dense breasts (category D) have a 4-fold greater risk of developing breast cancer than do women with fatty breasts (category A), with upper limit of nearly 6-fold greater risk (FIGURE 2).⁸

Most women do not have fatty breasts, however. More women have breasts with scattered fibroglandular density.⁹ Women with heterogeneously dense breasts (category C) have about a 1.5-fold greater risk of developing breast cancer than those with scattered fibroglandular density (category B), while women with extremely dense breasts (category D) have about a 2-fold greater risk.

There are probably several reasons that dense tissue increases breast cancer risk. One is that cancers arise microscopically in the glandular tissue. The more glandular tissue, the more susceptible tissue where cancer can develop. Glandular cells divide with hormonal stimulation throughout a woman’s lifetime, and each time a cell divides, “mistakes” can be made. An accumulation of mistakes can result in cancer. The more glandular the tissue, the greater the breast cancer risk. Women who have had breast reduction experience a reduced risk for breast cancer: thus, even a reduced absolute amount of glandular tissue reduces the risk for breast cancer. The second is that the local environment around the glands may produce certain growth hormones that stimulate cells to divide, and this is observed with fibrous breast tissue more than fatty breast tissue. ●

Which of the following statements about breast density is TRUE?

_{Text copyright DenseBreast-info.org.}

Answer

D. The risks associated with dense breast tissue are 2-fold: Dense tissue can mask cancer on a mammogram, and having dense breasts also increases the risk of developing breast cancer. As breast density increases, the sensitivity of mammography decreases, and the risk of developing breast cancer increases.

A woman’s breast density is usually determined by a radiologist’s visual evaluation of the mammogram. Breast density also can be measured quantitatively by computer software or estimated on computed tomography scan or magnetic resonance imaging. Breast density cannot be determined by the way a breast looks or feels.

Breast density and mammographic sensitivity

Cancers can be hidden or “masked” by dense tissue. On a mammogram, cancer is white. Normal dense tissue also appears white. If a cancer develops in an area of normal dense tissue, it can be harder or sometimes impossible to see it on the mammogram, like trying to see a snowman in a blizzard. As breast density increases, the ability to see cancer on mammography decreases (FIGURE 1).

Standard 2D mammography has been shown to miss about 40% of cancers present in women with extremely dense breasts and 25% of cancers present in women with heterogeneously dense breasts.^1-6 A cancer still can be masked on tomosynthesis (3D mammography) if it occurs in an area of dense tissue (where breast cancers more commonly occur), and tomosynthesis does not improve cancer detection appreciably in women with extremely dense breasts. To find cancer in a woman with dense breasts, additional screening beyond mammography should be considered.

Breast density and breast cancer risk

Dense breast tissue not only reduces mammography effectiveness, it also is a risk factor for the development of breast cancer: the denser the breast, the higher the risk.⁷ A meta-analysis across many studies concluded that magnitude of risk increases with each increase in density category, and women with extremely dense breasts (category D) have a 4-fold greater risk of developing breast cancer than do women with fatty breasts (category A), with upper limit of nearly 6-fold greater risk (FIGURE 2).⁸

Most women do not have fatty breasts, however. More women have breasts with scattered fibroglandular density.⁹ Women with heterogeneously dense breasts (category C) have about a 1.5-fold greater risk of developing breast cancer than those with scattered fibroglandular density (category B), while women with extremely dense breasts (category D) have about a 2-fold greater risk.

There are probably several reasons that dense tissue increases breast cancer risk. One is that cancers arise microscopically in the glandular tissue. The more glandular tissue, the more susceptible tissue where cancer can develop. Glandular cells divide with hormonal stimulation throughout a woman’s lifetime, and each time a cell divides, “mistakes” can be made. An accumulation of mistakes can result in cancer. The more glandular the tissue, the greater the breast cancer risk. Women who have had breast reduction experience a reduced risk for breast cancer: thus, even a reduced absolute amount of glandular tissue reduces the risk for breast cancer. The second is that the local environment around the glands may produce certain growth hormones that stimulate cells to divide, and this is observed with fibrous breast tissue more than fatty breast tissue. ●

Study results of an experimental agent that improves symptoms of major depression and boosts quality of life in as little as 3 days suggest it may be an effective short-term treatment option.

Jupiterimages/ThinkStock

Phase 3 results of a randomized, placebo-controlled trial compared zuranolone, an neuroactive steroid that binds to both synaptic and extra-synaptic GABA-A receptors, to placebo in patients with major depressive disorder (MDD). Overall, 30% of participants were already taking antidepressants.

Investigators found the drug was associated with a significant improvement in depression scores versus placebo, with benefit observed as early as day 3. This was accompanied by improved function and well-being.

The drug was also “generally well tolerated” and had a safety profile that was “consistent” with what has been seen previously with the drug, said study presenter Colville Brown, MD, Sage Therapeutics, Cambridge, Mass.

“These data continue to support the development of zuranolone as a potential 14-day short course treatment for major depressive disorder episodes.”

The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
 

High placebo response

However, despite being significant, the drug’s benefit was only slightly higher than that of placebo, raising questions about the study design and the true performance of the drug.

Dr. Brown explained that patients with MDD were randomized to oral zuranolone 50 mg or placebo once daily for 14 days, with dose reductions to 40 mg or matching placebo permitted in case of perceived intolerance.

Patients were assessed at baseline and day 15 via the 17-item Hamilton Rating Scale for Depression (HAMD-17) before entering a 28-day follow-up period off the study drug.

Among the 268 participants who received zuranolone, 90.3% completed the study, compared with 87.4% of 269 patients in the placebo group.

The mean age of participants was 40 years. Women made up 69.4% of those who received zuranolone and 61.7% assigned to placebo.

The mean HAMD-17 score at baseline was 26.8 and 26.9 in the zuranolone and placebo groups, respectively. Dr. Brown noted that 29.5% of patients in the zuranolone group and 30.1% of those assigned to placebo were taking antidepressants at baseline.

The study’s primary endpoint was met, with patients taking the study drug experiencing a significantly greater reduction in HAMD-17 scores from baseline to day 15 versus those given placebo, at 14.1 versus 12.3 points (P = .0141).

Dr. Brown highlighted that the difference in reduction in HAMD-17 scores between the zuranolone and placebo groups was already significant at day 3 (P < .0001), and again at day 8 (P < .0001) and day 12 (P < .001).

At day 3, response rates on the HAMD-17 were significantly higher among zuranolone-treated patients than among those given placebo, at 29.3% versus 16.3% (P < .001). However, the differences on day 15 and on day 42 were no longer significant.

A similar effect was seen for HAMD-17 remissions, which were seen in 7.6% of zuranolone-treated patients and 2.3% of those given placebo at day 3 (P < .01), rising to 29.8% versus 27.1% at day 15, and 30.8% versus 29.6% at day 42, and neither difference was significant.

Dr. Brown also showed that, at all time points during the treatment and follow-up periods, improvements in response rates in Global Improvement on the Clinical Global Impression scale favored zuranolone.

On the SF-36v2 quality of life questionnaire, improvements again favored zuranolone on all domains, although the difference between active treatment and placebo was significant only for vitality on day 15, at 12.8 versus 9.7 points (P < .05).

Treatment-emergent adverse events were more common with zuranolone, with 60.1% of patients experiencing at least one event of any grade versus 44.6% with placebo. However, severe events were seen in only 3.0% versus 1.1% of patients, and serious adverse events were recorded in only two patients (0.7%) in both groups.

The most common adverse events were somnolence, dizziness, headache, sedation, and diarrhea, with no increase in suicidal ideation or withdrawal. Dr. Brown noted that there was “no change in the safety signal” between patients with or without prior antidepressant therapy.

From the audience, Marie-Josée Filteau, MD, department of psychiatry, Laval University, Quebec, drew attention to the similarity in the improvement in HAMD-17 scores between the zuranolone and placebo groups, asking: “How is that compelling?”

Dr. Brown replied that “what they are excited about is that change from baseline with zuranolone,” adding: “You do see it in the placebo group as well, and ... this isn’t new to psychiatry.

“This is a heterogeneous disease, and remember this [study] was conducted during COVID, so patients were being seen with clinic visits during COVID.

“What impact did that have? The placebo is not really placebo” in this case.

More effective than results suggest?

Approached for comment by this news organization, Maurizio Fava, MD, executive vice chair, department of psychiatry, and executive director, Clinical Trials Network and Institute, Massachusetts General Hospital, Boston, noted there are several issues with the trial.

Because of those, the drug “is likely to be much more efficacious than it looks because it achieved statistical significance despite an extremely high placebo response,” he said

“Whenever your change on placebo is greater than 10 points on the HAMD, you have an excessive response ... and a very, very low chance of detecting a signal,” he said.

Dr. Fava said that another issue was including patients who were either on or off antidepressants, which meant the population was not sufficiently homogenous.

Another “flaw” was to assume that the placebo effect would be “transient” and deteriorate over time, whereas the results showed the opposite.

Nevertheless, “it’s a positive study because of the sample size ... that provides further evidence for the antidepressant activity of zuranolone” and the drug was “well tolerated.”

Dr. Fava expects zuranolone “will make it to the market,” as an indication from the Food and Drug Administration is likely, “but if you’re asking me: Is the drug as effective as shown in their studies? It’s probably much more effective.”

The study was funded by Sage Therapeutics and Biogen. Dr. Brown is an employee of Sage Therapeutics. Lead investigator Anita Clayton, MD, University of Virginia, Charlottesville, has reported relationships with Dario Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Sage Therapeutics, Fabre-Kramer, MindCure, Ovoca Bio, PureTech Health, S1 Biopharma, Vella Bioscience, WCG MedAvante-ProPhase, Ballantine Books/Random House, Guilford Publications, Euthymics, and Mediflix.

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

Study results of an experimental agent that improves symptoms of major depression and boosts quality of life in as little as 3 days suggest it may be an effective short-term treatment option.

Jupiterimages/ThinkStock

Phase 3 results of a randomized, placebo-controlled trial compared zuranolone, an neuroactive steroid that binds to both synaptic and extra-synaptic GABA-A receptors, to placebo in patients with major depressive disorder (MDD). Overall, 30% of participants were already taking antidepressants.

Investigators found the drug was associated with a significant improvement in depression scores versus placebo, with benefit observed as early as day 3. This was accompanied by improved function and well-being.

The drug was also “generally well tolerated” and had a safety profile that was “consistent” with what has been seen previously with the drug, said study presenter Colville Brown, MD, Sage Therapeutics, Cambridge, Mass.

“These data continue to support the development of zuranolone as a potential 14-day short course treatment for major depressive disorder episodes.”

The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
 

High placebo response

However, despite being significant, the drug’s benefit was only slightly higher than that of placebo, raising questions about the study design and the true performance of the drug.

Dr. Brown explained that patients with MDD were randomized to oral zuranolone 50 mg or placebo once daily for 14 days, with dose reductions to 40 mg or matching placebo permitted in case of perceived intolerance.

Patients were assessed at baseline and day 15 via the 17-item Hamilton Rating Scale for Depression (HAMD-17) before entering a 28-day follow-up period off the study drug.

Among the 268 participants who received zuranolone, 90.3% completed the study, compared with 87.4% of 269 patients in the placebo group.

The mean age of participants was 40 years. Women made up 69.4% of those who received zuranolone and 61.7% assigned to placebo.

The mean HAMD-17 score at baseline was 26.8 and 26.9 in the zuranolone and placebo groups, respectively. Dr. Brown noted that 29.5% of patients in the zuranolone group and 30.1% of those assigned to placebo were taking antidepressants at baseline.

The study’s primary endpoint was met, with patients taking the study drug experiencing a significantly greater reduction in HAMD-17 scores from baseline to day 15 versus those given placebo, at 14.1 versus 12.3 points (P = .0141).

Dr. Brown highlighted that the difference in reduction in HAMD-17 scores between the zuranolone and placebo groups was already significant at day 3 (P < .0001), and again at day 8 (P < .0001) and day 12 (P < .001).

At day 3, response rates on the HAMD-17 were significantly higher among zuranolone-treated patients than among those given placebo, at 29.3% versus 16.3% (P < .001). However, the differences on day 15 and on day 42 were no longer significant.

A similar effect was seen for HAMD-17 remissions, which were seen in 7.6% of zuranolone-treated patients and 2.3% of those given placebo at day 3 (P < .01), rising to 29.8% versus 27.1% at day 15, and 30.8% versus 29.6% at day 42, and neither difference was significant.

Dr. Brown also showed that, at all time points during the treatment and follow-up periods, improvements in response rates in Global Improvement on the Clinical Global Impression scale favored zuranolone.

On the SF-36v2 quality of life questionnaire, improvements again favored zuranolone on all domains, although the difference between active treatment and placebo was significant only for vitality on day 15, at 12.8 versus 9.7 points (P < .05).

Treatment-emergent adverse events were more common with zuranolone, with 60.1% of patients experiencing at least one event of any grade versus 44.6% with placebo. However, severe events were seen in only 3.0% versus 1.1% of patients, and serious adverse events were recorded in only two patients (0.7%) in both groups.

The most common adverse events were somnolence, dizziness, headache, sedation, and diarrhea, with no increase in suicidal ideation or withdrawal. Dr. Brown noted that there was “no change in the safety signal” between patients with or without prior antidepressant therapy.

From the audience, Marie-Josée Filteau, MD, department of psychiatry, Laval University, Quebec, drew attention to the similarity in the improvement in HAMD-17 scores between the zuranolone and placebo groups, asking: “How is that compelling?”

Dr. Brown replied that “what they are excited about is that change from baseline with zuranolone,” adding: “You do see it in the placebo group as well, and ... this isn’t new to psychiatry.

“This is a heterogeneous disease, and remember this [study] was conducted during COVID, so patients were being seen with clinic visits during COVID.

“What impact did that have? The placebo is not really placebo” in this case.

More effective than results suggest?

Approached for comment by this news organization, Maurizio Fava, MD, executive vice chair, department of psychiatry, and executive director, Clinical Trials Network and Institute, Massachusetts General Hospital, Boston, noted there are several issues with the trial.

Because of those, the drug “is likely to be much more efficacious than it looks because it achieved statistical significance despite an extremely high placebo response,” he said

“Whenever your change on placebo is greater than 10 points on the HAMD, you have an excessive response ... and a very, very low chance of detecting a signal,” he said.

Dr. Fava said that another issue was including patients who were either on or off antidepressants, which meant the population was not sufficiently homogenous.

Another “flaw” was to assume that the placebo effect would be “transient” and deteriorate over time, whereas the results showed the opposite.

Nevertheless, “it’s a positive study because of the sample size ... that provides further evidence for the antidepressant activity of zuranolone” and the drug was “well tolerated.”

Dr. Fava expects zuranolone “will make it to the market,” as an indication from the Food and Drug Administration is likely, “but if you’re asking me: Is the drug as effective as shown in their studies? It’s probably much more effective.”

The study was funded by Sage Therapeutics and Biogen. Dr. Brown is an employee of Sage Therapeutics. Lead investigator Anita Clayton, MD, University of Virginia, Charlottesville, has reported relationships with Dario Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Sage Therapeutics, Fabre-Kramer, MindCure, Ovoca Bio, PureTech Health, S1 Biopharma, Vella Bioscience, WCG MedAvante-ProPhase, Ballantine Books/Random House, Guilford Publications, Euthymics, and Mediflix.

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

Study results of an experimental agent that improves symptoms of major depression and boosts quality of life in as little as 3 days suggest it may be an effective short-term treatment option.

Jupiterimages/ThinkStock

Phase 3 results of a randomized, placebo-controlled trial compared zuranolone, an neuroactive steroid that binds to both synaptic and extra-synaptic GABA-A receptors, to placebo in patients with major depressive disorder (MDD). Overall, 30% of participants were already taking antidepressants.

Investigators found the drug was associated with a significant improvement in depression scores versus placebo, with benefit observed as early as day 3. This was accompanied by improved function and well-being.

The drug was also “generally well tolerated” and had a safety profile that was “consistent” with what has been seen previously with the drug, said study presenter Colville Brown, MD, Sage Therapeutics, Cambridge, Mass.

“These data continue to support the development of zuranolone as a potential 14-day short course treatment for major depressive disorder episodes.”

The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
 

High placebo response

However, despite being significant, the drug’s benefit was only slightly higher than that of placebo, raising questions about the study design and the true performance of the drug.

Dr. Brown explained that patients with MDD were randomized to oral zuranolone 50 mg or placebo once daily for 14 days, with dose reductions to 40 mg or matching placebo permitted in case of perceived intolerance.

Patients were assessed at baseline and day 15 via the 17-item Hamilton Rating Scale for Depression (HAMD-17) before entering a 28-day follow-up period off the study drug.

Among the 268 participants who received zuranolone, 90.3% completed the study, compared with 87.4% of 269 patients in the placebo group.

The mean age of participants was 40 years. Women made up 69.4% of those who received zuranolone and 61.7% assigned to placebo.

The mean HAMD-17 score at baseline was 26.8 and 26.9 in the zuranolone and placebo groups, respectively. Dr. Brown noted that 29.5% of patients in the zuranolone group and 30.1% of those assigned to placebo were taking antidepressants at baseline.

The study’s primary endpoint was met, with patients taking the study drug experiencing a significantly greater reduction in HAMD-17 scores from baseline to day 15 versus those given placebo, at 14.1 versus 12.3 points (P = .0141).

Dr. Brown highlighted that the difference in reduction in HAMD-17 scores between the zuranolone and placebo groups was already significant at day 3 (P < .0001), and again at day 8 (P < .0001) and day 12 (P < .001).

At day 3, response rates on the HAMD-17 were significantly higher among zuranolone-treated patients than among those given placebo, at 29.3% versus 16.3% (P < .001). However, the differences on day 15 and on day 42 were no longer significant.

A similar effect was seen for HAMD-17 remissions, which were seen in 7.6% of zuranolone-treated patients and 2.3% of those given placebo at day 3 (P < .01), rising to 29.8% versus 27.1% at day 15, and 30.8% versus 29.6% at day 42, and neither difference was significant.

Dr. Brown also showed that, at all time points during the treatment and follow-up periods, improvements in response rates in Global Improvement on the Clinical Global Impression scale favored zuranolone.

On the SF-36v2 quality of life questionnaire, improvements again favored zuranolone on all domains, although the difference between active treatment and placebo was significant only for vitality on day 15, at 12.8 versus 9.7 points (P < .05).

Treatment-emergent adverse events were more common with zuranolone, with 60.1% of patients experiencing at least one event of any grade versus 44.6% with placebo. However, severe events were seen in only 3.0% versus 1.1% of patients, and serious adverse events were recorded in only two patients (0.7%) in both groups.

The most common adverse events were somnolence, dizziness, headache, sedation, and diarrhea, with no increase in suicidal ideation or withdrawal. Dr. Brown noted that there was “no change in the safety signal” between patients with or without prior antidepressant therapy.

From the audience, Marie-Josée Filteau, MD, department of psychiatry, Laval University, Quebec, drew attention to the similarity in the improvement in HAMD-17 scores between the zuranolone and placebo groups, asking: “How is that compelling?”

Dr. Brown replied that “what they are excited about is that change from baseline with zuranolone,” adding: “You do see it in the placebo group as well, and ... this isn’t new to psychiatry.

“This is a heterogeneous disease, and remember this [study] was conducted during COVID, so patients were being seen with clinic visits during COVID.

“What impact did that have? The placebo is not really placebo” in this case.

More effective than results suggest?

Approached for comment by this news organization, Maurizio Fava, MD, executive vice chair, department of psychiatry, and executive director, Clinical Trials Network and Institute, Massachusetts General Hospital, Boston, noted there are several issues with the trial.

Because of those, the drug “is likely to be much more efficacious than it looks because it achieved statistical significance despite an extremely high placebo response,” he said

“Whenever your change on placebo is greater than 10 points on the HAMD, you have an excessive response ... and a very, very low chance of detecting a signal,” he said.

Dr. Fava said that another issue was including patients who were either on or off antidepressants, which meant the population was not sufficiently homogenous.

Another “flaw” was to assume that the placebo effect would be “transient” and deteriorate over time, whereas the results showed the opposite.

Nevertheless, “it’s a positive study because of the sample size ... that provides further evidence for the antidepressant activity of zuranolone” and the drug was “well tolerated.”

Dr. Fava expects zuranolone “will make it to the market,” as an indication from the Food and Drug Administration is likely, “but if you’re asking me: Is the drug as effective as shown in their studies? It’s probably much more effective.”

The study was funded by Sage Therapeutics and Biogen. Dr. Brown is an employee of Sage Therapeutics. Lead investigator Anita Clayton, MD, University of Virginia, Charlottesville, has reported relationships with Dario Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Sage Therapeutics, Fabre-Kramer, MindCure, Ovoca Bio, PureTech Health, S1 Biopharma, Vella Bioscience, WCG MedAvante-ProPhase, Ballantine Books/Random House, Guilford Publications, Euthymics, and Mediflix.

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

Barnhart K, Hansen KR, Stephenson MD, et al; Reproductive Medicine Network. Effect of an active vs expectant management strategy on successful resolution of pregnancy among patients with a persisting pregnancy of unknown location: the ACT or NOT randomized clinical trial. JAMA. 2021;326:390-400.

EXPERT COMMENTARY

Among patients with persistent PUL, it can be difficult to distinguish between ectopic pregnancy and an early nonviable intrauterine pregnancy.¹ If untreated, ectopic pregnancy can lead to serious morbidity and mortality.² Management options for persistent PUL include expectant management, empirical methotrexate, or diagnostic uterine evacuation with methotrexate as needed. Data on the potential for these options to achieve pregnancy resolution is valuable for patients and clinicians choosing a treatment plan.

Details of the study

Barnhart and colleagues conducted a multicenter, randomized controlled trial that enrolled 225 women with persistent PUL (defined by transvaginal ultrasound imaging without a definitive intrauterine or extrauterine gestation and at least 2 consecutive human chorionic gonadotropin [hCG] values with less than a 15% rise per day). Participants were randomly assigned to 1 of 3 treatment groups: expectant management, empirical methotrexate, or uterine evacuation followed by methotrexate if needed.

The primary outcome was pregnancy resolution without a change in management strategy. A secondary outcome was noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed in achieving pregnancy resolution.

Results. The active management groups were significantly more likely to achieve pregnancy resolution without changing strategies than the expectant management group (51.5% vs 36.0%; difference, 15.4%). However, 39% of enrolled participants declined their randomized allocation and crossed over into a different management strategy.

Empirical methotrexate was found to be noninferior to uterine evacuation followed by methotrexate as needed in achieving pregnancy resolution (54.9% vs 48.3%; difference, 6.6%).

Study strengths and limitations

Prior studies of hemodynamically stable patients with persistent PUL or stable tubal ectopic pregnancy and low initial hCG values (<2,000 IU/L) failed to demonstrate that active management with methotrexate or uterine evacuation leads to more successful or faster pregnancy resolution.^3-5 Barnhart and colleagues’ study results, however, found that active management with 2-dose empirical methotrexate or uterine evacuation was more likely to lead to pregnancy resolution without requiring a change in management plan than was expectant management. The authors performed both an intention-to-treat and an as-treated analysis to confirm results.

The 39% crossover rate between the treatment groups likely reflected both patient preference and clinical presentation, potentially biasing the results. The low overall rate of adverse events confirms the safety and acceptability of a patient-centered approach to persistent PUL management. ●

Barnhart K, Hansen KR, Stephenson MD, et al; Reproductive Medicine Network. Effect of an active vs expectant management strategy on successful resolution of pregnancy among patients with a persisting pregnancy of unknown location: the ACT or NOT randomized clinical trial. JAMA. 2021;326:390-400.

EXPERT COMMENTARY

Among patients with persistent PUL, it can be difficult to distinguish between ectopic pregnancy and an early nonviable intrauterine pregnancy.¹ If untreated, ectopic pregnancy can lead to serious morbidity and mortality.² Management options for persistent PUL include expectant management, empirical methotrexate, or diagnostic uterine evacuation with methotrexate as needed. Data on the potential for these options to achieve pregnancy resolution is valuable for patients and clinicians choosing a treatment plan.

Details of the study

Barnhart and colleagues conducted a multicenter, randomized controlled trial that enrolled 225 women with persistent PUL (defined by transvaginal ultrasound imaging without a definitive intrauterine or extrauterine gestation and at least 2 consecutive human chorionic gonadotropin [hCG] values with less than a 15% rise per day). Participants were randomly assigned to 1 of 3 treatment groups: expectant management, empirical methotrexate, or uterine evacuation followed by methotrexate if needed.

The primary outcome was pregnancy resolution without a change in management strategy. A secondary outcome was noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed in achieving pregnancy resolution.

Results. The active management groups were significantly more likely to achieve pregnancy resolution without changing strategies than the expectant management group (51.5% vs 36.0%; difference, 15.4%). However, 39% of enrolled participants declined their randomized allocation and crossed over into a different management strategy.

Empirical methotrexate was found to be noninferior to uterine evacuation followed by methotrexate as needed in achieving pregnancy resolution (54.9% vs 48.3%; difference, 6.6%).

Study strengths and limitations

Prior studies of hemodynamically stable patients with persistent PUL or stable tubal ectopic pregnancy and low initial hCG values (<2,000 IU/L) failed to demonstrate that active management with methotrexate or uterine evacuation leads to more successful or faster pregnancy resolution.^3-5 Barnhart and colleagues’ study results, however, found that active management with 2-dose empirical methotrexate or uterine evacuation was more likely to lead to pregnancy resolution without requiring a change in management plan than was expectant management. The authors performed both an intention-to-treat and an as-treated analysis to confirm results.

The 39% crossover rate between the treatment groups likely reflected both patient preference and clinical presentation, potentially biasing the results. The low overall rate of adverse events confirms the safety and acceptability of a patient-centered approach to persistent PUL management. ●

Barnhart K, Hansen KR, Stephenson MD, et al; Reproductive Medicine Network. Effect of an active vs expectant management strategy on successful resolution of pregnancy among patients with a persisting pregnancy of unknown location: the ACT or NOT randomized clinical trial. JAMA. 2021;326:390-400.

EXPERT COMMENTARY

Among patients with persistent PUL, it can be difficult to distinguish between ectopic pregnancy and an early nonviable intrauterine pregnancy.¹ If untreated, ectopic pregnancy can lead to serious morbidity and mortality.² Management options for persistent PUL include expectant management, empirical methotrexate, or diagnostic uterine evacuation with methotrexate as needed. Data on the potential for these options to achieve pregnancy resolution is valuable for patients and clinicians choosing a treatment plan.

Details of the study

Barnhart and colleagues conducted a multicenter, randomized controlled trial that enrolled 225 women with persistent PUL (defined by transvaginal ultrasound imaging without a definitive intrauterine or extrauterine gestation and at least 2 consecutive human chorionic gonadotropin [hCG] values with less than a 15% rise per day). Participants were randomly assigned to 1 of 3 treatment groups: expectant management, empirical methotrexate, or uterine evacuation followed by methotrexate if needed.

The primary outcome was pregnancy resolution without a change in management strategy. A secondary outcome was noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed in achieving pregnancy resolution.

Results. The active management groups were significantly more likely to achieve pregnancy resolution without changing strategies than the expectant management group (51.5% vs 36.0%; difference, 15.4%). However, 39% of enrolled participants declined their randomized allocation and crossed over into a different management strategy.

Empirical methotrexate was found to be noninferior to uterine evacuation followed by methotrexate as needed in achieving pregnancy resolution (54.9% vs 48.3%; difference, 6.6%).

Study strengths and limitations

Prior studies of hemodynamically stable patients with persistent PUL or stable tubal ectopic pregnancy and low initial hCG values (<2,000 IU/L) failed to demonstrate that active management with methotrexate or uterine evacuation leads to more successful or faster pregnancy resolution.^3-5 Barnhart and colleagues’ study results, however, found that active management with 2-dose empirical methotrexate or uterine evacuation was more likely to lead to pregnancy resolution without requiring a change in management plan than was expectant management. The authors performed both an intention-to-treat and an as-treated analysis to confirm results.

The 39% crossover rate between the treatment groups likely reflected both patient preference and clinical presentation, potentially biasing the results. The low overall rate of adverse events confirms the safety and acceptability of a patient-centered approach to persistent PUL management. ●

Prior to 1980, medical record notes were generally hand-written, short, and to the point. Senior physicians often wrote their 3-line notes using a fountain pen in an elegant cursive. With the transition to electronic medical records, notes have become bloated with irrelevant information and frequently lack a focus on the critical clinical insights that optimize patient care. The use of smart phrases to pull vast amounts of raw data into the note is a major contributor to note bloat. The unrestrained use of the copy and paste functionality generates a sequence of cloned notes that grow in length as new information is added and little information from prior notes removed. With each subsequent clone the note often becomes less accurate, lengthier, and more difficult for a reader to understand. In one survey of 253 physicians who wrote electronic notes, 90% reported that they used the copy and paste function, with 71% reporting that use of this function caused inconsistencies within and among notes and increased the repetitive presentation of outdated information in the note.¹ Although the surveyed clinicians recognized that the copy and paste function caused problems, 80% reported that they planned to continue to use the copy and paste function.¹

The SOAP note

The problem-oriented SOAP note is written in the classic structure of subjective and objective information, followed by an assessment and plan.² The structure of the SOAP note emphasizes the logical and sequential collection of data followed by data analysis, resulting in a focused assessment and plan. When notes were hand-written and short, the entire SOAP note could be viewed on one page. Like a dashboard, the eye could quickly scan each key component of the note, facilitating the simultaneous integration of all 4 components of the note, facilitating understanding of the patient’s clinical situation. When the SOAP note structure is used to create a multipage electronic note, the result is a note that often confuses rather than enlightens the reader. A 5- to 10-page SOAP note is often useless for patient care but demonstrates the ability of computer-savvy clinicians to quickly generate a note thousands of words in length.

The APSO note, a response to note bloat

When a medical record note becomes a multipage document, clinicians should consider switching from the SOAP note structure to the APSO note, where the assessment and plan are at the top of the note, and the subjective and objective information is below the assessment and plan. The APSO format permits the reader to more quickly grasp the critical thinking of the author and facilitates a focus on key points relevant to the patient’s condition. The note can be written in the SOAP format, but then the assessment and plan are brought to the top of the note. In my clinical experience fewer than 10% of clinicians are using an APSO note structure. I believe that, with a multipage note, the APSO structure improves the experience of the reader and should be more widely utilized, especially by clinicians who are prone to crafting a bloated note. In a survey of more than 3,000 clinicians, approximately two-thirds of the respondents reported that, compared with SOAP notes, APSO notes were easier and faster to read, and APSO notes made it easier to follow the clinical reasoning of the author.³

Continue to: New evaluation and management billing guidelines—An opportunity to reduce note bloat...

New evaluation and management billing guidelines—An opportunity to reduce note bloat

Previous evaluation and management federal billing guidelines emphasized documentation of a myriad of clinically irrelevant details contributing to note bloat. The new federal evaluation and management billing guidelines pivot the focus of the note to the quality and complexity of medical decision making as demonstrated in the assessment and plan.⁴ Prioritizing the assessment and plan as the key feature of the medical record note should help reduce the length of notes. The American College of Physicians recently recommended deleting the complete review of systems and prior histories from most notes unless relevant to medical decision making and the assessment and plan.⁵

The open note

The open note mandate was contained in federal regulations developed to implement the 21st Century Cures Act, which required patients to have access to the information in their medical record. In order to comply with the regulation, health systems are sending most notes and test results to the patient through the health system’s patient gateway. The open note process entered my practice through a stealthy progression, from an initial step of permitting a clinician to easily share their note with a patient to a top-down edict that all notes, except some notes that have a high risk of causing patient harm, must be sent immediately to the patient. Obviously, an open note supports “transparency,” but I am unaware of high quality evidence that open notes improve the health of a population or reduce morbidity or mortality from health problems.

The federal mandate that clinicians share their notes or risk fiscal penalties is coercive and undermines the independence of health professionals. Open notes may have many benefits, including:

• improving a patient’s comprehension and sense of control over their health issues
• increasing patient trust in their health system
• increasing the number of questions patients ask their clinician.⁶

Open notes may also cause unintended adverse emotional trauma to patients, especially when the note communicates “bad news.” In one study of 100 oncology patients, approximately 25% of respondents reported that reading clinical notes was emotionally difficult, and they sometimes regretted having read the note.⁶ One patient reported, “I think MyChart is great but in this whole cancer thing MyChart has not been a good thing.” Another patient reported, “Reading serious stuff like that is just too taxing for me to be honest with you.”⁶ An additional finding of the study was that patients reported their notes were written with too much medical jargon and repetition of information.

Open laboratory, pathology, and imaging data—Helpful or harmful?

A component of the open note mandate is that laboratory, pathology, and imaging data must be shared timely with patients. Some health systems incorporate a 3-day pause prior to sharing such data, in order to provide the clinical team with time to communicate with the patient before the test results are shared. Some health systems, including my health system, have engineered the open note data-sharing system to immediately share the results of most completed laboratory, pathology, and imaging studies with the patient. Immediate sharing of data may result in the patient first learning that they have a serious, life-threatening health problem, such as cancer, from their patient portal rather than from a clinician. As an example, a patient may first learn that they have metastatic cancer from a CT scan that was ordered for a benign indication.

Another example is that a patient may first learn that they have an HIV infection from their patient portal. This can be a shocking and emotionally damaging experience for the patient. For many test results, it would be best if a clinician were able to communicate the result to the patient, providing support and context to the meaning of the result, rather than sending sensitive, life-altering information directly from the laboratory or imaging department to the patient. Leaders in medical education have spent decades teaching clinicians how to communicate “bad news” in a sensitive, supportive, and effective manner. The open sharing of laboratory, pathology, and imaging data short-circuits the superior process of relying on a highly capable clinician to communicate bad news.

Continue to: Crafting the open medical record note...

Building on the advice that “when life gives you lemons, make lemonade,” I have begun to pivot the purpose of my medical notes from a product useful to myself and other clinicians to a product whose primary purpose is to be helpful for the patient. The open note can facilitate building a trusting relationship with the patient. My notes are becoming a series of written conversations with the patient, emphasizing compassion and empathy. I am increasing significantly the amount of educational information in the note to help the patient understand their situation. In addition, I am replacing traditional medical terms with verbiage more appropriate in the context of a conversation with the patient, reducing the use of medical jargon. For example, I have stopped using “chief complaint” and replaced it with “health issues.” I am diligently avoiding the use of medical terms that have negative connotations, including “obese,” “psychosomatic,” “alcoholic,” and “drug addiction.” I include encouragement and positive comments in many of my notes. For example, “Ms. X is successfully managing her health issues and experiencing improved health. It is a pleasure collaborating with her on achieving optimal health.”

Can we bring sanity back to medical note writing?

The primary role of a clinician is to spend as much time as possible listening to patients, understanding their needs, and helping them achieve optimal health. There are many benefits to an electronic medical record, including legibility, accessibility, interoperability, and efficiency. However, in current practice “note bloat” undermines the potential of the electronic medical record and makes many notes ineffective to the process of advancing the patient’s health. We are competent and highly trained clinicians. We can craft notes that are simple, specific, story-driven, compassionate, and empathetic. If we return to the ABCs of note writing, focusing on accuracy, brevity, and clarity, we will make note writing and reading more rewarding and improve patient care. ●

Prior to 1980, medical record notes were generally hand-written, short, and to the point. Senior physicians often wrote their 3-line notes using a fountain pen in an elegant cursive. With the transition to electronic medical records, notes have become bloated with irrelevant information and frequently lack a focus on the critical clinical insights that optimize patient care. The use of smart phrases to pull vast amounts of raw data into the note is a major contributor to note bloat. The unrestrained use of the copy and paste functionality generates a sequence of cloned notes that grow in length as new information is added and little information from prior notes removed. With each subsequent clone the note often becomes less accurate, lengthier, and more difficult for a reader to understand. In one survey of 253 physicians who wrote electronic notes, 90% reported that they used the copy and paste function, with 71% reporting that use of this function caused inconsistencies within and among notes and increased the repetitive presentation of outdated information in the note.¹ Although the surveyed clinicians recognized that the copy and paste function caused problems, 80% reported that they planned to continue to use the copy and paste function.¹

The SOAP note

The problem-oriented SOAP note is written in the classic structure of subjective and objective information, followed by an assessment and plan.² The structure of the SOAP note emphasizes the logical and sequential collection of data followed by data analysis, resulting in a focused assessment and plan. When notes were hand-written and short, the entire SOAP note could be viewed on one page. Like a dashboard, the eye could quickly scan each key component of the note, facilitating the simultaneous integration of all 4 components of the note, facilitating understanding of the patient’s clinical situation. When the SOAP note structure is used to create a multipage electronic note, the result is a note that often confuses rather than enlightens the reader. A 5- to 10-page SOAP note is often useless for patient care but demonstrates the ability of computer-savvy clinicians to quickly generate a note thousands of words in length.

The APSO note, a response to note bloat

When a medical record note becomes a multipage document, clinicians should consider switching from the SOAP note structure to the APSO note, where the assessment and plan are at the top of the note, and the subjective and objective information is below the assessment and plan. The APSO format permits the reader to more quickly grasp the critical thinking of the author and facilitates a focus on key points relevant to the patient’s condition. The note can be written in the SOAP format, but then the assessment and plan are brought to the top of the note. In my clinical experience fewer than 10% of clinicians are using an APSO note structure. I believe that, with a multipage note, the APSO structure improves the experience of the reader and should be more widely utilized, especially by clinicians who are prone to crafting a bloated note. In a survey of more than 3,000 clinicians, approximately two-thirds of the respondents reported that, compared with SOAP notes, APSO notes were easier and faster to read, and APSO notes made it easier to follow the clinical reasoning of the author.³

Continue to: New evaluation and management billing guidelines—An opportunity to reduce note bloat...

New evaluation and management billing guidelines—An opportunity to reduce note bloat

Previous evaluation and management federal billing guidelines emphasized documentation of a myriad of clinically irrelevant details contributing to note bloat. The new federal evaluation and management billing guidelines pivot the focus of the note to the quality and complexity of medical decision making as demonstrated in the assessment and plan.⁴ Prioritizing the assessment and plan as the key feature of the medical record note should help reduce the length of notes. The American College of Physicians recently recommended deleting the complete review of systems and prior histories from most notes unless relevant to medical decision making and the assessment and plan.⁵

The open note

The open note mandate was contained in federal regulations developed to implement the 21st Century Cures Act, which required patients to have access to the information in their medical record. In order to comply with the regulation, health systems are sending most notes and test results to the patient through the health system’s patient gateway. The open note process entered my practice through a stealthy progression, from an initial step of permitting a clinician to easily share their note with a patient to a top-down edict that all notes, except some notes that have a high risk of causing patient harm, must be sent immediately to the patient. Obviously, an open note supports “transparency,” but I am unaware of high quality evidence that open notes improve the health of a population or reduce morbidity or mortality from health problems.

The federal mandate that clinicians share their notes or risk fiscal penalties is coercive and undermines the independence of health professionals. Open notes may have many benefits, including:

• improving a patient’s comprehension and sense of control over their health issues
• increasing patient trust in their health system
• increasing the number of questions patients ask their clinician.⁶

Open notes may also cause unintended adverse emotional trauma to patients, especially when the note communicates “bad news.” In one study of 100 oncology patients, approximately 25% of respondents reported that reading clinical notes was emotionally difficult, and they sometimes regretted having read the note.⁶ One patient reported, “I think MyChart is great but in this whole cancer thing MyChart has not been a good thing.” Another patient reported, “Reading serious stuff like that is just too taxing for me to be honest with you.”⁶ An additional finding of the study was that patients reported their notes were written with too much medical jargon and repetition of information.

Open laboratory, pathology, and imaging data—Helpful or harmful?

A component of the open note mandate is that laboratory, pathology, and imaging data must be shared timely with patients. Some health systems incorporate a 3-day pause prior to sharing such data, in order to provide the clinical team with time to communicate with the patient before the test results are shared. Some health systems, including my health system, have engineered the open note data-sharing system to immediately share the results of most completed laboratory, pathology, and imaging studies with the patient. Immediate sharing of data may result in the patient first learning that they have a serious, life-threatening health problem, such as cancer, from their patient portal rather than from a clinician. As an example, a patient may first learn that they have metastatic cancer from a CT scan that was ordered for a benign indication.

Another example is that a patient may first learn that they have an HIV infection from their patient portal. This can be a shocking and emotionally damaging experience for the patient. For many test results, it would be best if a clinician were able to communicate the result to the patient, providing support and context to the meaning of the result, rather than sending sensitive, life-altering information directly from the laboratory or imaging department to the patient. Leaders in medical education have spent decades teaching clinicians how to communicate “bad news” in a sensitive, supportive, and effective manner. The open sharing of laboratory, pathology, and imaging data short-circuits the superior process of relying on a highly capable clinician to communicate bad news.

Continue to: Crafting the open medical record note...

Building on the advice that “when life gives you lemons, make lemonade,” I have begun to pivot the purpose of my medical notes from a product useful to myself and other clinicians to a product whose primary purpose is to be helpful for the patient. The open note can facilitate building a trusting relationship with the patient. My notes are becoming a series of written conversations with the patient, emphasizing compassion and empathy. I am increasing significantly the amount of educational information in the note to help the patient understand their situation. In addition, I am replacing traditional medical terms with verbiage more appropriate in the context of a conversation with the patient, reducing the use of medical jargon. For example, I have stopped using “chief complaint” and replaced it with “health issues.” I am diligently avoiding the use of medical terms that have negative connotations, including “obese,” “psychosomatic,” “alcoholic,” and “drug addiction.” I include encouragement and positive comments in many of my notes. For example, “Ms. X is successfully managing her health issues and experiencing improved health. It is a pleasure collaborating with her on achieving optimal health.”

Can we bring sanity back to medical note writing?

The primary role of a clinician is to spend as much time as possible listening to patients, understanding their needs, and helping them achieve optimal health. There are many benefits to an electronic medical record, including legibility, accessibility, interoperability, and efficiency. However, in current practice “note bloat” undermines the potential of the electronic medical record and makes many notes ineffective to the process of advancing the patient’s health. We are competent and highly trained clinicians. We can craft notes that are simple, specific, story-driven, compassionate, and empathetic. If we return to the ABCs of note writing, focusing on accuracy, brevity, and clarity, we will make note writing and reading more rewarding and improve patient care. ●

Prior to 1980, medical record notes were generally hand-written, short, and to the point. Senior physicians often wrote their 3-line notes using a fountain pen in an elegant cursive. With the transition to electronic medical records, notes have become bloated with irrelevant information and frequently lack a focus on the critical clinical insights that optimize patient care. The use of smart phrases to pull vast amounts of raw data into the note is a major contributor to note bloat. The unrestrained use of the copy and paste functionality generates a sequence of cloned notes that grow in length as new information is added and little information from prior notes removed. With each subsequent clone the note often becomes less accurate, lengthier, and more difficult for a reader to understand. In one survey of 253 physicians who wrote electronic notes, 90% reported that they used the copy and paste function, with 71% reporting that use of this function caused inconsistencies within and among notes and increased the repetitive presentation of outdated information in the note.¹ Although the surveyed clinicians recognized that the copy and paste function caused problems, 80% reported that they planned to continue to use the copy and paste function.¹

The SOAP note

The problem-oriented SOAP note is written in the classic structure of subjective and objective information, followed by an assessment and plan.² The structure of the SOAP note emphasizes the logical and sequential collection of data followed by data analysis, resulting in a focused assessment and plan. When notes were hand-written and short, the entire SOAP note could be viewed on one page. Like a dashboard, the eye could quickly scan each key component of the note, facilitating the simultaneous integration of all 4 components of the note, facilitating understanding of the patient’s clinical situation. When the SOAP note structure is used to create a multipage electronic note, the result is a note that often confuses rather than enlightens the reader. A 5- to 10-page SOAP note is often useless for patient care but demonstrates the ability of computer-savvy clinicians to quickly generate a note thousands of words in length.

The APSO note, a response to note bloat

When a medical record note becomes a multipage document, clinicians should consider switching from the SOAP note structure to the APSO note, where the assessment and plan are at the top of the note, and the subjective and objective information is below the assessment and plan. The APSO format permits the reader to more quickly grasp the critical thinking of the author and facilitates a focus on key points relevant to the patient’s condition. The note can be written in the SOAP format, but then the assessment and plan are brought to the top of the note. In my clinical experience fewer than 10% of clinicians are using an APSO note structure. I believe that, with a multipage note, the APSO structure improves the experience of the reader and should be more widely utilized, especially by clinicians who are prone to crafting a bloated note. In a survey of more than 3,000 clinicians, approximately two-thirds of the respondents reported that, compared with SOAP notes, APSO notes were easier and faster to read, and APSO notes made it easier to follow the clinical reasoning of the author.³

Continue to: New evaluation and management billing guidelines—An opportunity to reduce note bloat...

New evaluation and management billing guidelines—An opportunity to reduce note bloat

Previous evaluation and management federal billing guidelines emphasized documentation of a myriad of clinically irrelevant details contributing to note bloat. The new federal evaluation and management billing guidelines pivot the focus of the note to the quality and complexity of medical decision making as demonstrated in the assessment and plan.⁴ Prioritizing the assessment and plan as the key feature of the medical record note should help reduce the length of notes. The American College of Physicians recently recommended deleting the complete review of systems and prior histories from most notes unless relevant to medical decision making and the assessment and plan.⁵

The open note

The open note mandate was contained in federal regulations developed to implement the 21st Century Cures Act, which required patients to have access to the information in their medical record. In order to comply with the regulation, health systems are sending most notes and test results to the patient through the health system’s patient gateway. The open note process entered my practice through a stealthy progression, from an initial step of permitting a clinician to easily share their note with a patient to a top-down edict that all notes, except some notes that have a high risk of causing patient harm, must be sent immediately to the patient. Obviously, an open note supports “transparency,” but I am unaware of high quality evidence that open notes improve the health of a population or reduce morbidity or mortality from health problems.

The federal mandate that clinicians share their notes or risk fiscal penalties is coercive and undermines the independence of health professionals. Open notes may have many benefits, including:

• improving a patient’s comprehension and sense of control over their health issues
• increasing patient trust in their health system
• increasing the number of questions patients ask their clinician.⁶

Open notes may also cause unintended adverse emotional trauma to patients, especially when the note communicates “bad news.” In one study of 100 oncology patients, approximately 25% of respondents reported that reading clinical notes was emotionally difficult, and they sometimes regretted having read the note.⁶ One patient reported, “I think MyChart is great but in this whole cancer thing MyChart has not been a good thing.” Another patient reported, “Reading serious stuff like that is just too taxing for me to be honest with you.”⁶ An additional finding of the study was that patients reported their notes were written with too much medical jargon and repetition of information.

Open laboratory, pathology, and imaging data—Helpful or harmful?

A component of the open note mandate is that laboratory, pathology, and imaging data must be shared timely with patients. Some health systems incorporate a 3-day pause prior to sharing such data, in order to provide the clinical team with time to communicate with the patient before the test results are shared. Some health systems, including my health system, have engineered the open note data-sharing system to immediately share the results of most completed laboratory, pathology, and imaging studies with the patient. Immediate sharing of data may result in the patient first learning that they have a serious, life-threatening health problem, such as cancer, from their patient portal rather than from a clinician. As an example, a patient may first learn that they have metastatic cancer from a CT scan that was ordered for a benign indication.

Another example is that a patient may first learn that they have an HIV infection from their patient portal. This can be a shocking and emotionally damaging experience for the patient. For many test results, it would be best if a clinician were able to communicate the result to the patient, providing support and context to the meaning of the result, rather than sending sensitive, life-altering information directly from the laboratory or imaging department to the patient. Leaders in medical education have spent decades teaching clinicians how to communicate “bad news” in a sensitive, supportive, and effective manner. The open sharing of laboratory, pathology, and imaging data short-circuits the superior process of relying on a highly capable clinician to communicate bad news.

Continue to: Crafting the open medical record note...

Building on the advice that “when life gives you lemons, make lemonade,” I have begun to pivot the purpose of my medical notes from a product useful to myself and other clinicians to a product whose primary purpose is to be helpful for the patient. The open note can facilitate building a trusting relationship with the patient. My notes are becoming a series of written conversations with the patient, emphasizing compassion and empathy. I am increasing significantly the amount of educational information in the note to help the patient understand their situation. In addition, I am replacing traditional medical terms with verbiage more appropriate in the context of a conversation with the patient, reducing the use of medical jargon. For example, I have stopped using “chief complaint” and replaced it with “health issues.” I am diligently avoiding the use of medical terms that have negative connotations, including “obese,” “psychosomatic,” “alcoholic,” and “drug addiction.” I include encouragement and positive comments in many of my notes. For example, “Ms. X is successfully managing her health issues and experiencing improved health. It is a pleasure collaborating with her on achieving optimal health.”

Can we bring sanity back to medical note writing?

The primary role of a clinician is to spend as much time as possible listening to patients, understanding their needs, and helping them achieve optimal health. There are many benefits to an electronic medical record, including legibility, accessibility, interoperability, and efficiency. However, in current practice “note bloat” undermines the potential of the electronic medical record and makes many notes ineffective to the process of advancing the patient’s health. We are competent and highly trained clinicians. We can craft notes that are simple, specific, story-driven, compassionate, and empathetic. If we return to the ABCs of note writing, focusing on accuracy, brevity, and clarity, we will make note writing and reading more rewarding and improve patient care. ●

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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