Individuals with nonsevere hemophilia A (NSHA) in the United States showed increased mortality based upon increasing age, male sex, and infections, according to the results of a large database analysis.

However, even though inhibitors, which can develop from factor VIII (FVIII) hemophilia therapy, were detected at an earlier age than previously reported, their presence was not associated with an increased risk of mortality according to the report published in Blood Advances (2020;4[19]:4739-47).

The researchers assessed 6,624 individuals born between 1920 and 2018 (5,694 [86.0%] men and 930 women) with NSHA from the ATHNdataset, according to Ming Y. Lim, MBBCH, MS, of the division of hematology and hematologic malignancies, University of Utah, Salt Lake City, and colleagues.

Demographically, the proportion of Black participants in the ATHNdataset was lower at 8.2%, than the 11.6% found in U.S. hemophilia population as a whole. A total of 77.3% (n = 5,122) had documented exposure to FVIII concentrates, 8.4% (n = 555) had no documented exposure, and information was unknown for the remaining 14.3%.
 

Causes of mortality

The researchers found that inhibitors occurred at an early age of 13 years with a prevalence of 2.6%, compared with the commonly reported median age of about 30 years for inhibitor development, but their presence was not associated with an increased risk of mortality, according to the authors. Instead, they found that mortality rates in the NSHA cohort were influenced by age, male sex, and hepatitis C and HIV infections.

The researchers speculated that the earlier age of inhibitor development may be due to the fact of the increased availability of FVIII concentrates over time, and that they may have been used more often from 2010 to 2018, compared with previously reported INSIGHT study (1980-2011).

In a multivariable analysis, men with NSHA were found to have 2.6 times the risk of death. Mortality risk increased twofold with each additional decade of age. Persons with hepatitis C had twice the risk of death and persons with HIV had almost four times the risk, compared with persons without these conditions.

The most common primary cause of death was malignancy (20.0%). The observed number of deaths from liver disease in the NSHA cohort was almost five times the expected death rate at 14%. Hemophilia-related deaths were 5.9%.

“Continued monitoring of persons with NSHA by comprehensive care visits at HTC should occur annually to address hemophilia-related issues and other age-related comorbidities, in collaboration with the primary care physician and other subspecialists. Importantly, we found that in the NSHA cohort, the development of inhibitors occurred at an earlier age than previously reported. This highlights the importance of routine monitoring for inhibitors in the NSHA population, regardless of age, especially if they have recently received intense factor replacement therapy,” the researchers concluded.

Ms. Lim reported no conflicts. Other authors reported research and consulting funding from a variety of pharmaceutical and biotechnology companies.

[email protected]

SOURCE: Lim MY et al. Blood Adv. 2020;4(19):4739-47.

Individuals with nonsevere hemophilia A (NSHA) in the United States showed increased mortality based upon increasing age, male sex, and infections, according to the results of a large database analysis.

However, even though inhibitors, which can develop from factor VIII (FVIII) hemophilia therapy, were detected at an earlier age than previously reported, their presence was not associated with an increased risk of mortality according to the report published in Blood Advances (2020;4[19]:4739-47).

The researchers assessed 6,624 individuals born between 1920 and 2018 (5,694 [86.0%] men and 930 women) with NSHA from the ATHNdataset, according to Ming Y. Lim, MBBCH, MS, of the division of hematology and hematologic malignancies, University of Utah, Salt Lake City, and colleagues.

Demographically, the proportion of Black participants in the ATHNdataset was lower at 8.2%, than the 11.6% found in U.S. hemophilia population as a whole. A total of 77.3% (n = 5,122) had documented exposure to FVIII concentrates, 8.4% (n = 555) had no documented exposure, and information was unknown for the remaining 14.3%.
 

Causes of mortality

The researchers found that inhibitors occurred at an early age of 13 years with a prevalence of 2.6%, compared with the commonly reported median age of about 30 years for inhibitor development, but their presence was not associated with an increased risk of mortality, according to the authors. Instead, they found that mortality rates in the NSHA cohort were influenced by age, male sex, and hepatitis C and HIV infections.

The researchers speculated that the earlier age of inhibitor development may be due to the fact of the increased availability of FVIII concentrates over time, and that they may have been used more often from 2010 to 2018, compared with previously reported INSIGHT study (1980-2011).

In a multivariable analysis, men with NSHA were found to have 2.6 times the risk of death. Mortality risk increased twofold with each additional decade of age. Persons with hepatitis C had twice the risk of death and persons with HIV had almost four times the risk, compared with persons without these conditions.

The most common primary cause of death was malignancy (20.0%). The observed number of deaths from liver disease in the NSHA cohort was almost five times the expected death rate at 14%. Hemophilia-related deaths were 5.9%.

“Continued monitoring of persons with NSHA by comprehensive care visits at HTC should occur annually to address hemophilia-related issues and other age-related comorbidities, in collaboration with the primary care physician and other subspecialists. Importantly, we found that in the NSHA cohort, the development of inhibitors occurred at an earlier age than previously reported. This highlights the importance of routine monitoring for inhibitors in the NSHA population, regardless of age, especially if they have recently received intense factor replacement therapy,” the researchers concluded.

Ms. Lim reported no conflicts. Other authors reported research and consulting funding from a variety of pharmaceutical and biotechnology companies.

[email protected]

SOURCE: Lim MY et al. Blood Adv. 2020;4(19):4739-47.

Individuals with nonsevere hemophilia A (NSHA) in the United States showed increased mortality based upon increasing age, male sex, and infections, according to the results of a large database analysis.

However, even though inhibitors, which can develop from factor VIII (FVIII) hemophilia therapy, were detected at an earlier age than previously reported, their presence was not associated with an increased risk of mortality according to the report published in Blood Advances (2020;4[19]:4739-47).

The researchers assessed 6,624 individuals born between 1920 and 2018 (5,694 [86.0%] men and 930 women) with NSHA from the ATHNdataset, according to Ming Y. Lim, MBBCH, MS, of the division of hematology and hematologic malignancies, University of Utah, Salt Lake City, and colleagues.

Demographically, the proportion of Black participants in the ATHNdataset was lower at 8.2%, than the 11.6% found in U.S. hemophilia population as a whole. A total of 77.3% (n = 5,122) had documented exposure to FVIII concentrates, 8.4% (n = 555) had no documented exposure, and information was unknown for the remaining 14.3%.
 

Causes of mortality

The researchers found that inhibitors occurred at an early age of 13 years with a prevalence of 2.6%, compared with the commonly reported median age of about 30 years for inhibitor development, but their presence was not associated with an increased risk of mortality, according to the authors. Instead, they found that mortality rates in the NSHA cohort were influenced by age, male sex, and hepatitis C and HIV infections.

The researchers speculated that the earlier age of inhibitor development may be due to the fact of the increased availability of FVIII concentrates over time, and that they may have been used more often from 2010 to 2018, compared with previously reported INSIGHT study (1980-2011).

In a multivariable analysis, men with NSHA were found to have 2.6 times the risk of death. Mortality risk increased twofold with each additional decade of age. Persons with hepatitis C had twice the risk of death and persons with HIV had almost four times the risk, compared with persons without these conditions.

The most common primary cause of death was malignancy (20.0%). The observed number of deaths from liver disease in the NSHA cohort was almost five times the expected death rate at 14%. Hemophilia-related deaths were 5.9%.

“Continued monitoring of persons with NSHA by comprehensive care visits at HTC should occur annually to address hemophilia-related issues and other age-related comorbidities, in collaboration with the primary care physician and other subspecialists. Importantly, we found that in the NSHA cohort, the development of inhibitors occurred at an earlier age than previously reported. This highlights the importance of routine monitoring for inhibitors in the NSHA population, regardless of age, especially if they have recently received intense factor replacement therapy,” the researchers concluded.

Ms. Lim reported no conflicts. Other authors reported research and consulting funding from a variety of pharmaceutical and biotechnology companies.

[email protected]

SOURCE: Lim MY et al. Blood Adv. 2020;4(19):4739-47.

To the Editor:

Female pattern hair loss is common, and the literature suggests that up to 56% of women experience hair thinning in their lifetime, with increased prevalence in older women.¹ Pathophysiology is incompletely understood and involves the nonscarring progressive miniaturization of hair follicles, causing decreased production of terminal hairs relative to more delicate vellus hairs. Because vellus hairs have a shorter anagen growth phase than terminal hairs, hair loss is expedited. Androgen excess, when present, hastens the process by inducing early transition of hair follicles from the anagen phase to the senescent telogen phase. Serum testosterone levels are within reference range in most female patients with hair loss, suggesting the presence of additional contributing factors.²

Given the high prevalence of female pattern hair loss and the harm of overlooking androgen excess and an androgen-secreting neoplasm, dermatologists must recognize indications for further evaluation. Additional signs of hyperandrogenism, such as menstrual irregularities, acne, hirsutism, anabolic appearance, voice deepening, and clitoromegaly, are reasons for concern.³ Elevated serum androgen levels also should raise suspicion of malignancy. Historically, a total testosterone level above 200 ng/dL or a dehydroepiandrosterone sulfate (DHEA-S) level greater than 700 µg/dL prompted evaluation for a tumor.⁴ More recent studies show that tumor-induced increases in serum androgen levels are highly variable, challenging the utility of these cutoffs.⁵

A 70-year-old woman presented with hair loss over the last 12 years with accentuated thinning on the frontal and vertex scalp. The patient’s primary care physician previously made a diagnosis of androgenetic alopecia and recommended topical minoxidil. Although the patient had a history of excess facial and body hair since young adulthood, she noted a progressive increase in the density of chest and back hair, prominent coarsening of the texture of the facial and body hair, and new facial acne in the last 3 years. Prior to these changes, the density and texture of the scalp and body hair had been stable for many years.

Although other postmenopausal females in the patient’s family displayed patterned hair loss, they did not possess coarse and dense hair on the face and trunk. Her family history was notable for ovarian cancer in her mother (in her 70s) and breast cancer in her maternal grandmother (in her 80s).

A review of systems was notable only for decreased energy. Physical examination revealed a well-appearing older woman with coarse terminal hair growth on the cheeks, submental chin, neck, chest, back, and forearms. Scalp examination indicated diffusely decreased hair density, most marked over the vertex, crown, and frontal scalp, without scale, erythema, or loss of follicular ostia (Figure 1).

Pelvic ultrasonography was suspicious for an ovarian pathology. Follow-up pelvic magnetic resonance imaging (MRI) demonstrated a 2.5-cm mass abutting the left ovary (Figure 2). The patient was given a diagnosis of stage IIIA high-grade ovarian serous carcinoma with lymph node involvement. Other notable findings from the workup included a BRCA2 mutation and concurrent renal cell carcinoma. After bilateral salpingo-oophorectomy, partial nephrectomy, and chemotherapy with carboplatin and paclitaxel, the testosterone level returned to within reference range and remained stable for the next 2 years of follow-up.

Imaging is indicated for a patient presenting with both clinical and biochemical hyperandrogenism. Patients with an isolated testosterone level elevation can be evaluated with transvaginal ultrasonography; however, detection and characterization of malignancies is highly dependent on the skill of the examiner.^8,9 The higher sensitivity and specificity of pelvic MRI reduces the likelihood of missing a malignancy and unnecessary surgery. Tumors too small to be visualized by MRI rarely are malignant.¹⁰

Sex cord-stromal cell tumors, despite representing fewer than 10% of ovarian tumors, are responsible for the majority of androgen-secreting malignancies. Our patient presented with clinical hyperandrogenism with an elevated testosterone level in the setting of a serous ovarian carcinoma, which is an epithelial neoplasm. Epithelial tumors are the most common type of ovarian tumor and typically are nonfunctional, though they have been reported to cause hyperandrogenism through indirect mechanisms. It is thought that both benign and malignant epithelial tumors can induce stromal hyperplasia or luteinization, leading to an increase in androgen levels.⁶

Due to the high prevalence of androgenetic alopecia and hirsutism in aging women, identification of androgen-secreting neoplasms by clinical presentation is challenging. A wide range of serum testosterone levels is possible at presentation, which complicates diagnosis. This case highlights the importance of correlating clinical and biochemical hyperandrogenism in raising suspicion of malignancy in older women presenting with hair loss.

To the Editor:

Female pattern hair loss is common, and the literature suggests that up to 56% of women experience hair thinning in their lifetime, with increased prevalence in older women.¹ Pathophysiology is incompletely understood and involves the nonscarring progressive miniaturization of hair follicles, causing decreased production of terminal hairs relative to more delicate vellus hairs. Because vellus hairs have a shorter anagen growth phase than terminal hairs, hair loss is expedited. Androgen excess, when present, hastens the process by inducing early transition of hair follicles from the anagen phase to the senescent telogen phase. Serum testosterone levels are within reference range in most female patients with hair loss, suggesting the presence of additional contributing factors.²

Given the high prevalence of female pattern hair loss and the harm of overlooking androgen excess and an androgen-secreting neoplasm, dermatologists must recognize indications for further evaluation. Additional signs of hyperandrogenism, such as menstrual irregularities, acne, hirsutism, anabolic appearance, voice deepening, and clitoromegaly, are reasons for concern.³ Elevated serum androgen levels also should raise suspicion of malignancy. Historically, a total testosterone level above 200 ng/dL or a dehydroepiandrosterone sulfate (DHEA-S) level greater than 700 µg/dL prompted evaluation for a tumor.⁴ More recent studies show that tumor-induced increases in serum androgen levels are highly variable, challenging the utility of these cutoffs.⁵

A 70-year-old woman presented with hair loss over the last 12 years with accentuated thinning on the frontal and vertex scalp. The patient’s primary care physician previously made a diagnosis of androgenetic alopecia and recommended topical minoxidil. Although the patient had a history of excess facial and body hair since young adulthood, she noted a progressive increase in the density of chest and back hair, prominent coarsening of the texture of the facial and body hair, and new facial acne in the last 3 years. Prior to these changes, the density and texture of the scalp and body hair had been stable for many years.

Although other postmenopausal females in the patient’s family displayed patterned hair loss, they did not possess coarse and dense hair on the face and trunk. Her family history was notable for ovarian cancer in her mother (in her 70s) and breast cancer in her maternal grandmother (in her 80s).

A review of systems was notable only for decreased energy. Physical examination revealed a well-appearing older woman with coarse terminal hair growth on the cheeks, submental chin, neck, chest, back, and forearms. Scalp examination indicated diffusely decreased hair density, most marked over the vertex, crown, and frontal scalp, without scale, erythema, or loss of follicular ostia (Figure 1).

Pelvic ultrasonography was suspicious for an ovarian pathology. Follow-up pelvic magnetic resonance imaging (MRI) demonstrated a 2.5-cm mass abutting the left ovary (Figure 2). The patient was given a diagnosis of stage IIIA high-grade ovarian serous carcinoma with lymph node involvement. Other notable findings from the workup included a BRCA2 mutation and concurrent renal cell carcinoma. After bilateral salpingo-oophorectomy, partial nephrectomy, and chemotherapy with carboplatin and paclitaxel, the testosterone level returned to within reference range and remained stable for the next 2 years of follow-up.

Imaging is indicated for a patient presenting with both clinical and biochemical hyperandrogenism. Patients with an isolated testosterone level elevation can be evaluated with transvaginal ultrasonography; however, detection and characterization of malignancies is highly dependent on the skill of the examiner.^8,9 The higher sensitivity and specificity of pelvic MRI reduces the likelihood of missing a malignancy and unnecessary surgery. Tumors too small to be visualized by MRI rarely are malignant.¹⁰

Sex cord-stromal cell tumors, despite representing fewer than 10% of ovarian tumors, are responsible for the majority of androgen-secreting malignancies. Our patient presented with clinical hyperandrogenism with an elevated testosterone level in the setting of a serous ovarian carcinoma, which is an epithelial neoplasm. Epithelial tumors are the most common type of ovarian tumor and typically are nonfunctional, though they have been reported to cause hyperandrogenism through indirect mechanisms. It is thought that both benign and malignant epithelial tumors can induce stromal hyperplasia or luteinization, leading to an increase in androgen levels.⁶

Due to the high prevalence of androgenetic alopecia and hirsutism in aging women, identification of androgen-secreting neoplasms by clinical presentation is challenging. A wide range of serum testosterone levels is possible at presentation, which complicates diagnosis. This case highlights the importance of correlating clinical and biochemical hyperandrogenism in raising suspicion of malignancy in older women presenting with hair loss.

To the Editor:

Female pattern hair loss is common, and the literature suggests that up to 56% of women experience hair thinning in their lifetime, with increased prevalence in older women.¹ Pathophysiology is incompletely understood and involves the nonscarring progressive miniaturization of hair follicles, causing decreased production of terminal hairs relative to more delicate vellus hairs. Because vellus hairs have a shorter anagen growth phase than terminal hairs, hair loss is expedited. Androgen excess, when present, hastens the process by inducing early transition of hair follicles from the anagen phase to the senescent telogen phase. Serum testosterone levels are within reference range in most female patients with hair loss, suggesting the presence of additional contributing factors.²

Given the high prevalence of female pattern hair loss and the harm of overlooking androgen excess and an androgen-secreting neoplasm, dermatologists must recognize indications for further evaluation. Additional signs of hyperandrogenism, such as menstrual irregularities, acne, hirsutism, anabolic appearance, voice deepening, and clitoromegaly, are reasons for concern.³ Elevated serum androgen levels also should raise suspicion of malignancy. Historically, a total testosterone level above 200 ng/dL or a dehydroepiandrosterone sulfate (DHEA-S) level greater than 700 µg/dL prompted evaluation for a tumor.⁴ More recent studies show that tumor-induced increases in serum androgen levels are highly variable, challenging the utility of these cutoffs.⁵

A 70-year-old woman presented with hair loss over the last 12 years with accentuated thinning on the frontal and vertex scalp. The patient’s primary care physician previously made a diagnosis of androgenetic alopecia and recommended topical minoxidil. Although the patient had a history of excess facial and body hair since young adulthood, she noted a progressive increase in the density of chest and back hair, prominent coarsening of the texture of the facial and body hair, and new facial acne in the last 3 years. Prior to these changes, the density and texture of the scalp and body hair had been stable for many years.

Although other postmenopausal females in the patient’s family displayed patterned hair loss, they did not possess coarse and dense hair on the face and trunk. Her family history was notable for ovarian cancer in her mother (in her 70s) and breast cancer in her maternal grandmother (in her 80s).

A review of systems was notable only for decreased energy. Physical examination revealed a well-appearing older woman with coarse terminal hair growth on the cheeks, submental chin, neck, chest, back, and forearms. Scalp examination indicated diffusely decreased hair density, most marked over the vertex, crown, and frontal scalp, without scale, erythema, or loss of follicular ostia (Figure 1).

Pelvic ultrasonography was suspicious for an ovarian pathology. Follow-up pelvic magnetic resonance imaging (MRI) demonstrated a 2.5-cm mass abutting the left ovary (Figure 2). The patient was given a diagnosis of stage IIIA high-grade ovarian serous carcinoma with lymph node involvement. Other notable findings from the workup included a BRCA2 mutation and concurrent renal cell carcinoma. After bilateral salpingo-oophorectomy, partial nephrectomy, and chemotherapy with carboplatin and paclitaxel, the testosterone level returned to within reference range and remained stable for the next 2 years of follow-up.

Imaging is indicated for a patient presenting with both clinical and biochemical hyperandrogenism. Patients with an isolated testosterone level elevation can be evaluated with transvaginal ultrasonography; however, detection and characterization of malignancies is highly dependent on the skill of the examiner.^8,9 The higher sensitivity and specificity of pelvic MRI reduces the likelihood of missing a malignancy and unnecessary surgery. Tumors too small to be visualized by MRI rarely are malignant.¹⁰

Sex cord-stromal cell tumors, despite representing fewer than 10% of ovarian tumors, are responsible for the majority of androgen-secreting malignancies. Our patient presented with clinical hyperandrogenism with an elevated testosterone level in the setting of a serous ovarian carcinoma, which is an epithelial neoplasm. Epithelial tumors are the most common type of ovarian tumor and typically are nonfunctional, though they have been reported to cause hyperandrogenism through indirect mechanisms. It is thought that both benign and malignant epithelial tumors can induce stromal hyperplasia or luteinization, leading to an increase in androgen levels.⁶

Due to the high prevalence of androgenetic alopecia and hirsutism in aging women, identification of androgen-secreting neoplasms by clinical presentation is challenging. A wide range of serum testosterone levels is possible at presentation, which complicates diagnosis. This case highlights the importance of correlating clinical and biochemical hyperandrogenism in raising suspicion of malignancy in older women presenting with hair loss.

The Food and Drug Administration has issued a safety communication about the potential for false results from a rapid COVID-19 test from Curative, which is being used in Los Angeles and other large metropolitan areas in the United States.

The real-time reverse transcription polymerase chain reaction (PCR) test was developed by Menlo Park, Calif.–based health care start-up Curative. Results are analyzed by the company’s clinical lab, KorvaLabs. The test, which is authorized for prescription use only, received emergency-use authorization from the FDA on April 16, 2020. By Nov. 9, the company had processed 6 million test results, according to the company.

The FDA alert cautions that false negative results from any COVID-19 test can lead to delays in or the lack of supportive treatment and increase the risk for viral spread.

To mitigate the risk for false negatives, the agency advises clinicians to perform the Curative test as described in the product’s Fact Sheet for Healthcare Providers. This includes limiting its use to people who have had COVID-19 symptoms for 14 days or less. “Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test,” the FDA alert stated. “If testing was performed more than 2 weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.”

The alert also notes that a negative result from the Curative PCR test “does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.”

According to a press release issued by Curative on Oct. 7, its PCR test is being used by the Department of Defense, as well as the states of Alaska, California, Colorado, Delaware, Florida, Georgia (Atlanta and Savannah), Illinois (Chicago), Louisiana, Texas, and Wyoming. The company also operates Clinical Laboratory Improvement Amendments–certified laboratories in San Dimas, Calif.; Washington, D.C.; and Pflugerville, Tex.

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

The Food and Drug Administration has issued a safety communication about the potential for false results from a rapid COVID-19 test from Curative, which is being used in Los Angeles and other large metropolitan areas in the United States.

The real-time reverse transcription polymerase chain reaction (PCR) test was developed by Menlo Park, Calif.–based health care start-up Curative. Results are analyzed by the company’s clinical lab, KorvaLabs. The test, which is authorized for prescription use only, received emergency-use authorization from the FDA on April 16, 2020. By Nov. 9, the company had processed 6 million test results, according to the company.

The FDA alert cautions that false negative results from any COVID-19 test can lead to delays in or the lack of supportive treatment and increase the risk for viral spread.

To mitigate the risk for false negatives, the agency advises clinicians to perform the Curative test as described in the product’s Fact Sheet for Healthcare Providers. This includes limiting its use to people who have had COVID-19 symptoms for 14 days or less. “Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test,” the FDA alert stated. “If testing was performed more than 2 weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.”

The alert also notes that a negative result from the Curative PCR test “does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.”

According to a press release issued by Curative on Oct. 7, its PCR test is being used by the Department of Defense, as well as the states of Alaska, California, Colorado, Delaware, Florida, Georgia (Atlanta and Savannah), Illinois (Chicago), Louisiana, Texas, and Wyoming. The company also operates Clinical Laboratory Improvement Amendments–certified laboratories in San Dimas, Calif.; Washington, D.C.; and Pflugerville, Tex.

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

The Food and Drug Administration has issued a safety communication about the potential for false results from a rapid COVID-19 test from Curative, which is being used in Los Angeles and other large metropolitan areas in the United States.

The real-time reverse transcription polymerase chain reaction (PCR) test was developed by Menlo Park, Calif.–based health care start-up Curative. Results are analyzed by the company’s clinical lab, KorvaLabs. The test, which is authorized for prescription use only, received emergency-use authorization from the FDA on April 16, 2020. By Nov. 9, the company had processed 6 million test results, according to the company.

The FDA alert cautions that false negative results from any COVID-19 test can lead to delays in or the lack of supportive treatment and increase the risk for viral spread.

To mitigate the risk for false negatives, the agency advises clinicians to perform the Curative test as described in the product’s Fact Sheet for Healthcare Providers. This includes limiting its use to people who have had COVID-19 symptoms for 14 days or less. “Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test,” the FDA alert stated. “If testing was performed more than 2 weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.”

The alert also notes that a negative result from the Curative PCR test “does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.”

According to a press release issued by Curative on Oct. 7, its PCR test is being used by the Department of Defense, as well as the states of Alaska, California, Colorado, Delaware, Florida, Georgia (Atlanta and Savannah), Illinois (Chicago), Louisiana, Texas, and Wyoming. The company also operates Clinical Laboratory Improvement Amendments–certified laboratories in San Dimas, Calif.; Washington, D.C.; and Pflugerville, Tex.

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

During a busy morning of rounds, our patient, Mrs. M., appeared distraught. She was diagnosed with COVID-19 2 weeks prior and remained inpatient because of medicosocial reasons. Since admission she remained on the same ward, in the same room, cared for by the same group of providers donned in masks, gowns, gloves, and face shields. The personal protective equipment helped to shield us from the virus, but it also shielded Mrs. M. from us.

During initial interaction, Mrs. M. appeared anxious, tearful, and detached. It seemed that she recognized a new voice; however, she did not express much interest in engaging during the visit. When she realized that she was not being discharged, Mrs. M. appeared to lose further interest. She wanted to go home. Her outpatient dialysis arrangements were not complete, and that precluded hospital discharge. Prescribed anxiolytics were doing little to relieve her symptoms.

The next day, Mrs. M. continued to ask if she could go home. She stated that there was nothing for her to do while in the hospital. She was tired of watching TV, she was unable to call her friends, and was not able to see her family. Because of COVID-19 status, Mrs. M was not permitted to leave her hospital room, and she was transported to the dialysis unit via stretcher, being unable to walk. The more we talked, the more engaged Mrs. M. had become. When it was time to complete the encounter, Mrs. M. started pleading with us to “stay a little longer, please don’t leave.”

Throughout her hospitalization, Mrs. M. had an extremely limited number of human encounters. Those encounters were fragmented and brief, centered on the infection mitigation. The chaplain was not permitted to enter her room, and she was unwilling to use the phone. The subspecialty consultants utilized telemedicine visits. As a result, Mrs. M. felt isolated and lonely. Social distancing in the hospital makes human interactions particularly challenging and contributes to the development of isolation, loneliness, and fear.
 

Loneliness is real

Loneliness is the “subjective experience of involuntary social isolation.”¹ As the COVID-19 pandemic began to entrap the world in early 2020, many people have faced new challenges – loneliness and its impact on physical and mental health. The prevalence of loneliness nearly tripled in the early months of the pandemic, leading to psychological distress and reopening conversations on ethical issues.²

Ethical implications of loneliness

Social distancing challenges all four main ethical principles: autonomy, beneficence, nonmaleficence, and justice. How do we reconcile these principles from the standpoint of each affected individual, their caregivers, health care providers, and public health at large? How can we continue to mitigate the spread of COVID-19, but also remain attentive to our patients who are still in need of human interactions to recover and thrive?

Social distancing is important, but so is social interaction. What strategies do we have in place to combat loneliness? How do we help our hospitalized patients who feel connected to the “outside world?” Is battling loneliness worth the risks of additional exposure to COVID-19? These dilemmas cannot be easily resolved. However, it is important for us to recognize the negative impacts of loneliness and identify measures to help our patients.

In our mission to fulfill the beneficence and nonmaleficence principles of caring for patients affected by COVID-19, patients like Mrs. M. lose much of their autonomy during hospital admission. Despite our best efforts, our isolated patients during the pandemic, remain alone, which further heightens their feeling of loneliness.
 

Clinical implications of loneliness

With the advancements in technology, our capabilities to substitute personal human interactions have grown exponentially. The use of telemedicine, video- and audio-conferencing communications have changed the landscape of our capacities to exchange information. This could be a blessing and a curse. While the use of digital platforms for virtual communication is tempting, we should preserve human interactions as much as possible, particularly when caring for patients affected by COVID-19. Interpersonal “connectedness” plays a crucial role in providing psychological and psychotherapeutic support, particularly when the number of human encounters is already limited.

Social distancing requirements have magnified loneliness. Several studies demonstrate that the perception of loneliness leads to poor health outcomes, including lower immunity, increased peripheral vascular resistance,³ and higher overall mortality.⁴ Loneliness can lead to functional impairment, such as poor social skills, and even increased inflammation.⁵ The negative emotional impact of SARS-CoV-2 echoes the experiences of patients affected by the severe acute respiratory syndrome (SARS) outbreak in 2003. However, with COVID-19, we are witnessing the amplified effects of loneliness on a global scale. The majority of affected patients during the 2003 SARS outbreak in Canada reported loneliness, fear, aggression, and boredom: They had concerns about the impacts of the infection on loved ones, and psychological support was required for many patients with mild to moderate SARS disease.⁶
 

Nonpharmacological management strategies for battling loneliness

Utilization of early supportive services has been well described in literature and includes extending additional resources such as books, newspapers and, most importantly, additional in-person time to our patients.⁶ Maintaining rapport with patients’ families is also helpful in reducing anxiety and fear. The following measures have been suggested to prevent the negative impacts of loneliness and should be considered when caring for hospitalized patients diagnosed with COVID-19.⁷

• Screen patients for depression and delirium and utilize delirium prevention measures throughout the hospitalization.
• Educate patients about the signs and symptoms of loneliness, fear, and anxiety.
• Extend additional resources to patients, including books, magazines, and newspapers.
• Keep the patient’s cell or hospital phone within their reach.
• Adequately manage pain and prevent insomnia.
• Communicate frequently, utilizing audio- and visual-teleconferencing platforms that simultaneously include the patient and their loved ones.
• For patients who continue to exhibit feelings of loneliness despite the above interventions, consider consultations with psychiatry to offer additional coping strategies.
• Ensure a multidisciplinary approach when applicable – proactive consultation with the members of a palliative care team, ethics, spiritual health, social and ancillary services.

It is important to recognize how vulnerable our patients are. Diagnosed with COVID-19, and caught in the midst of the current pandemic, not only do they suffer from the physical effects of this novel disease, but they also have to endure prolonged confinement, social isolation, and uncertainty – all wrapped in a cloak of loneliness and fear.

With our main focus being on the management of a largely unknown viral illness, patients’ personal experiences can be easily overlooked. It is vital for us as health care providers on the front lines to recognize, reflect, and reform to ease our patients’ journey through COVID-19.

Dr. Burklin is an assistant professor of medicine, division of hospital medicine, at the department of medicine, Emory University, Atlanta. Dr. Wiley is an assistant professor of medicine, division of infectious disease, at the department of Medicine, Emory University, Atlanta.

References

1. Schlomann A et al. Use of information and communication technology (ICT) devices among the oldest-old: Loneliness, anomie, and autonomy. Innov Aging. 2020 Jan 1;4(2):igz050.

2. McGinty E et al. Psychological distress and loneliness reported by U.S. adults in 2018 and April 2020. JAMA. 2020 Jun 3. doi: 10.1001/jama.2020.9740. 3. Wang J et al. Associations between loneliness and perceived social support and outcomes of mental health problems: A systematic review. BMC Psychiatry. 2018 May 29;18(1):156.

4. Luo Y et al. Loneliness, health, and mortality in old age: A national longitudinal study. Soc Sci Med. 2012 Mar;74(6):907-14.

5. Smith KJ et al. The association between loneliness, social isolation, and inflammation: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2020 Feb 21; 112:519-41.

6. Maunder R et al. The immediate psychological and occupational impact of the 2003 SARS outbreak in a teaching hospital. CMAJ. 2003 May 13;168(10):1245-51.

7. Masi CM et al. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66.

During a busy morning of rounds, our patient, Mrs. M., appeared distraught. She was diagnosed with COVID-19 2 weeks prior and remained inpatient because of medicosocial reasons. Since admission she remained on the same ward, in the same room, cared for by the same group of providers donned in masks, gowns, gloves, and face shields. The personal protective equipment helped to shield us from the virus, but it also shielded Mrs. M. from us.

During initial interaction, Mrs. M. appeared anxious, tearful, and detached. It seemed that she recognized a new voice; however, she did not express much interest in engaging during the visit. When she realized that she was not being discharged, Mrs. M. appeared to lose further interest. She wanted to go home. Her outpatient dialysis arrangements were not complete, and that precluded hospital discharge. Prescribed anxiolytics were doing little to relieve her symptoms.

The next day, Mrs. M. continued to ask if she could go home. She stated that there was nothing for her to do while in the hospital. She was tired of watching TV, she was unable to call her friends, and was not able to see her family. Because of COVID-19 status, Mrs. M was not permitted to leave her hospital room, and she was transported to the dialysis unit via stretcher, being unable to walk. The more we talked, the more engaged Mrs. M. had become. When it was time to complete the encounter, Mrs. M. started pleading with us to “stay a little longer, please don’t leave.”

Throughout her hospitalization, Mrs. M. had an extremely limited number of human encounters. Those encounters were fragmented and brief, centered on the infection mitigation. The chaplain was not permitted to enter her room, and she was unwilling to use the phone. The subspecialty consultants utilized telemedicine visits. As a result, Mrs. M. felt isolated and lonely. Social distancing in the hospital makes human interactions particularly challenging and contributes to the development of isolation, loneliness, and fear.
 

Loneliness is real

Loneliness is the “subjective experience of involuntary social isolation.”¹ As the COVID-19 pandemic began to entrap the world in early 2020, many people have faced new challenges – loneliness and its impact on physical and mental health. The prevalence of loneliness nearly tripled in the early months of the pandemic, leading to psychological distress and reopening conversations on ethical issues.²

Ethical implications of loneliness

Social distancing challenges all four main ethical principles: autonomy, beneficence, nonmaleficence, and justice. How do we reconcile these principles from the standpoint of each affected individual, their caregivers, health care providers, and public health at large? How can we continue to mitigate the spread of COVID-19, but also remain attentive to our patients who are still in need of human interactions to recover and thrive?

Social distancing is important, but so is social interaction. What strategies do we have in place to combat loneliness? How do we help our hospitalized patients who feel connected to the “outside world?” Is battling loneliness worth the risks of additional exposure to COVID-19? These dilemmas cannot be easily resolved. However, it is important for us to recognize the negative impacts of loneliness and identify measures to help our patients.

In our mission to fulfill the beneficence and nonmaleficence principles of caring for patients affected by COVID-19, patients like Mrs. M. lose much of their autonomy during hospital admission. Despite our best efforts, our isolated patients during the pandemic, remain alone, which further heightens their feeling of loneliness.
 

Clinical implications of loneliness

With the advancements in technology, our capabilities to substitute personal human interactions have grown exponentially. The use of telemedicine, video- and audio-conferencing communications have changed the landscape of our capacities to exchange information. This could be a blessing and a curse. While the use of digital platforms for virtual communication is tempting, we should preserve human interactions as much as possible, particularly when caring for patients affected by COVID-19. Interpersonal “connectedness” plays a crucial role in providing psychological and psychotherapeutic support, particularly when the number of human encounters is already limited.

Social distancing requirements have magnified loneliness. Several studies demonstrate that the perception of loneliness leads to poor health outcomes, including lower immunity, increased peripheral vascular resistance,³ and higher overall mortality.⁴ Loneliness can lead to functional impairment, such as poor social skills, and even increased inflammation.⁵ The negative emotional impact of SARS-CoV-2 echoes the experiences of patients affected by the severe acute respiratory syndrome (SARS) outbreak in 2003. However, with COVID-19, we are witnessing the amplified effects of loneliness on a global scale. The majority of affected patients during the 2003 SARS outbreak in Canada reported loneliness, fear, aggression, and boredom: They had concerns about the impacts of the infection on loved ones, and psychological support was required for many patients with mild to moderate SARS disease.⁶
 

Nonpharmacological management strategies for battling loneliness

Utilization of early supportive services has been well described in literature and includes extending additional resources such as books, newspapers and, most importantly, additional in-person time to our patients.⁶ Maintaining rapport with patients’ families is also helpful in reducing anxiety and fear. The following measures have been suggested to prevent the negative impacts of loneliness and should be considered when caring for hospitalized patients diagnosed with COVID-19.⁷

• Screen patients for depression and delirium and utilize delirium prevention measures throughout the hospitalization.
• Educate patients about the signs and symptoms of loneliness, fear, and anxiety.
• Extend additional resources to patients, including books, magazines, and newspapers.
• Keep the patient’s cell or hospital phone within their reach.
• Adequately manage pain and prevent insomnia.
• Communicate frequently, utilizing audio- and visual-teleconferencing platforms that simultaneously include the patient and their loved ones.
• For patients who continue to exhibit feelings of loneliness despite the above interventions, consider consultations with psychiatry to offer additional coping strategies.
• Ensure a multidisciplinary approach when applicable – proactive consultation with the members of a palliative care team, ethics, spiritual health, social and ancillary services.

It is important to recognize how vulnerable our patients are. Diagnosed with COVID-19, and caught in the midst of the current pandemic, not only do they suffer from the physical effects of this novel disease, but they also have to endure prolonged confinement, social isolation, and uncertainty – all wrapped in a cloak of loneliness and fear.

With our main focus being on the management of a largely unknown viral illness, patients’ personal experiences can be easily overlooked. It is vital for us as health care providers on the front lines to recognize, reflect, and reform to ease our patients’ journey through COVID-19.

Dr. Burklin is an assistant professor of medicine, division of hospital medicine, at the department of medicine, Emory University, Atlanta. Dr. Wiley is an assistant professor of medicine, division of infectious disease, at the department of Medicine, Emory University, Atlanta.

References

1. Schlomann A et al. Use of information and communication technology (ICT) devices among the oldest-old: Loneliness, anomie, and autonomy. Innov Aging. 2020 Jan 1;4(2):igz050.

2. McGinty E et al. Psychological distress and loneliness reported by U.S. adults in 2018 and April 2020. JAMA. 2020 Jun 3. doi: 10.1001/jama.2020.9740. 3. Wang J et al. Associations between loneliness and perceived social support and outcomes of mental health problems: A systematic review. BMC Psychiatry. 2018 May 29;18(1):156.

4. Luo Y et al. Loneliness, health, and mortality in old age: A national longitudinal study. Soc Sci Med. 2012 Mar;74(6):907-14.

5. Smith KJ et al. The association between loneliness, social isolation, and inflammation: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2020 Feb 21; 112:519-41.

6. Maunder R et al. The immediate psychological and occupational impact of the 2003 SARS outbreak in a teaching hospital. CMAJ. 2003 May 13;168(10):1245-51.

7. Masi CM et al. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66.

During a busy morning of rounds, our patient, Mrs. M., appeared distraught. She was diagnosed with COVID-19 2 weeks prior and remained inpatient because of medicosocial reasons. Since admission she remained on the same ward, in the same room, cared for by the same group of providers donned in masks, gowns, gloves, and face shields. The personal protective equipment helped to shield us from the virus, but it also shielded Mrs. M. from us.

During initial interaction, Mrs. M. appeared anxious, tearful, and detached. It seemed that she recognized a new voice; however, she did not express much interest in engaging during the visit. When she realized that she was not being discharged, Mrs. M. appeared to lose further interest. She wanted to go home. Her outpatient dialysis arrangements were not complete, and that precluded hospital discharge. Prescribed anxiolytics were doing little to relieve her symptoms.

The next day, Mrs. M. continued to ask if she could go home. She stated that there was nothing for her to do while in the hospital. She was tired of watching TV, she was unable to call her friends, and was not able to see her family. Because of COVID-19 status, Mrs. M was not permitted to leave her hospital room, and she was transported to the dialysis unit via stretcher, being unable to walk. The more we talked, the more engaged Mrs. M. had become. When it was time to complete the encounter, Mrs. M. started pleading with us to “stay a little longer, please don’t leave.”

Throughout her hospitalization, Mrs. M. had an extremely limited number of human encounters. Those encounters were fragmented and brief, centered on the infection mitigation. The chaplain was not permitted to enter her room, and she was unwilling to use the phone. The subspecialty consultants utilized telemedicine visits. As a result, Mrs. M. felt isolated and lonely. Social distancing in the hospital makes human interactions particularly challenging and contributes to the development of isolation, loneliness, and fear.
 

Loneliness is real

Loneliness is the “subjective experience of involuntary social isolation.”¹ As the COVID-19 pandemic began to entrap the world in early 2020, many people have faced new challenges – loneliness and its impact on physical and mental health. The prevalence of loneliness nearly tripled in the early months of the pandemic, leading to psychological distress and reopening conversations on ethical issues.²

Ethical implications of loneliness

Social distancing challenges all four main ethical principles: autonomy, beneficence, nonmaleficence, and justice. How do we reconcile these principles from the standpoint of each affected individual, their caregivers, health care providers, and public health at large? How can we continue to mitigate the spread of COVID-19, but also remain attentive to our patients who are still in need of human interactions to recover and thrive?

Social distancing is important, but so is social interaction. What strategies do we have in place to combat loneliness? How do we help our hospitalized patients who feel connected to the “outside world?” Is battling loneliness worth the risks of additional exposure to COVID-19? These dilemmas cannot be easily resolved. However, it is important for us to recognize the negative impacts of loneliness and identify measures to help our patients.

In our mission to fulfill the beneficence and nonmaleficence principles of caring for patients affected by COVID-19, patients like Mrs. M. lose much of their autonomy during hospital admission. Despite our best efforts, our isolated patients during the pandemic, remain alone, which further heightens their feeling of loneliness.
 

Clinical implications of loneliness

With the advancements in technology, our capabilities to substitute personal human interactions have grown exponentially. The use of telemedicine, video- and audio-conferencing communications have changed the landscape of our capacities to exchange information. This could be a blessing and a curse. While the use of digital platforms for virtual communication is tempting, we should preserve human interactions as much as possible, particularly when caring for patients affected by COVID-19. Interpersonal “connectedness” plays a crucial role in providing psychological and psychotherapeutic support, particularly when the number of human encounters is already limited.

Social distancing requirements have magnified loneliness. Several studies demonstrate that the perception of loneliness leads to poor health outcomes, including lower immunity, increased peripheral vascular resistance,³ and higher overall mortality.⁴ Loneliness can lead to functional impairment, such as poor social skills, and even increased inflammation.⁵ The negative emotional impact of SARS-CoV-2 echoes the experiences of patients affected by the severe acute respiratory syndrome (SARS) outbreak in 2003. However, with COVID-19, we are witnessing the amplified effects of loneliness on a global scale. The majority of affected patients during the 2003 SARS outbreak in Canada reported loneliness, fear, aggression, and boredom: They had concerns about the impacts of the infection on loved ones, and psychological support was required for many patients with mild to moderate SARS disease.⁶
 

Nonpharmacological management strategies for battling loneliness

Utilization of early supportive services has been well described in literature and includes extending additional resources such as books, newspapers and, most importantly, additional in-person time to our patients.⁶ Maintaining rapport with patients’ families is also helpful in reducing anxiety and fear. The following measures have been suggested to prevent the negative impacts of loneliness and should be considered when caring for hospitalized patients diagnosed with COVID-19.⁷

• Screen patients for depression and delirium and utilize delirium prevention measures throughout the hospitalization.
• Educate patients about the signs and symptoms of loneliness, fear, and anxiety.
• Extend additional resources to patients, including books, magazines, and newspapers.
• Keep the patient’s cell or hospital phone within their reach.
• Adequately manage pain and prevent insomnia.
• Communicate frequently, utilizing audio- and visual-teleconferencing platforms that simultaneously include the patient and their loved ones.
• For patients who continue to exhibit feelings of loneliness despite the above interventions, consider consultations with psychiatry to offer additional coping strategies.
• Ensure a multidisciplinary approach when applicable – proactive consultation with the members of a palliative care team, ethics, spiritual health, social and ancillary services.

It is important to recognize how vulnerable our patients are. Diagnosed with COVID-19, and caught in the midst of the current pandemic, not only do they suffer from the physical effects of this novel disease, but they also have to endure prolonged confinement, social isolation, and uncertainty – all wrapped in a cloak of loneliness and fear.

With our main focus being on the management of a largely unknown viral illness, patients’ personal experiences can be easily overlooked. It is vital for us as health care providers on the front lines to recognize, reflect, and reform to ease our patients’ journey through COVID-19.

Dr. Burklin is an assistant professor of medicine, division of hospital medicine, at the department of medicine, Emory University, Atlanta. Dr. Wiley is an assistant professor of medicine, division of infectious disease, at the department of Medicine, Emory University, Atlanta.

References

1. Schlomann A et al. Use of information and communication technology (ICT) devices among the oldest-old: Loneliness, anomie, and autonomy. Innov Aging. 2020 Jan 1;4(2):igz050.

2. McGinty E et al. Psychological distress and loneliness reported by U.S. adults in 2018 and April 2020. JAMA. 2020 Jun 3. doi: 10.1001/jama.2020.9740. 3. Wang J et al. Associations between loneliness and perceived social support and outcomes of mental health problems: A systematic review. BMC Psychiatry. 2018 May 29;18(1):156.

4. Luo Y et al. Loneliness, health, and mortality in old age: A national longitudinal study. Soc Sci Med. 2012 Mar;74(6):907-14.

5. Smith KJ et al. The association between loneliness, social isolation, and inflammation: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2020 Feb 21; 112:519-41.

6. Maunder R et al. The immediate psychological and occupational impact of the 2003 SARS outbreak in a teaching hospital. CMAJ. 2003 May 13;168(10):1245-51.

7. Masi CM et al. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66.

The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome novel coronavirus 2 (SARS-CoV-2), has presented a unique challenge to providing essential care to patients. Increased demand for health care workers and medical supplies, in addition to the risk for COVID-19 infection and asymptomatic transmission of SARS-CoV-2 among health care workers and patients, prompted the delay of nonessential services during the surge of cases this summer.¹ Key considerations for continuing operation included current and projected COVID-19 cases in the region, ability to implement telehealth, staffing availability, personal protective equipment availability, and office capacity.² Providing care that is deemed essential often was determined by the urgency of the treatment or service.

The Centers for Medicare & Medicaid Services outlined a strategy to stratify patients, based on level of acuity, during the COVID-19 surge³:

• Low-acuity treatments or services: includes routine primary, specialty, or preventive care visits. They should be postponed; telehealth follow-ups should be considered.
• Intermediate-acuity treatments or services: includes pediatric and neonatal care, follow-up visits for existing conditions, and evaluation of new symptoms (including those consistent with COVID-19). These services should initially be evaluated using telehealth, then triaged to the appropriate site and level of care.
• High-acuity treatments or services: address symptoms consistent with COVID-19 or other severe disease, of which the lack of in-person evaluation would result in harm to the patient.

Employees in hospitals and health care clinics were classified as essential, but dermatologists were not given explicit direction regarding clinic operation. Many practices have restricted services, especially those in an area of higher COVID-19 prevalence. However, the challenge of determining day-to-day operation may have been left to the provider in most cases.⁴ As many states in the United States continue to relax restrictions, total cases and the rate of positivity of COVID-19 have been sharply rising again, after months of decline,⁵ which suggests increased transmission of SARS-CoV-2 and potential resurgence of the high case burden on our health care system. Furthermore, a lack of a widely distributed vaccine or herd immunity suggests we will need to take many of the same precautions as in the first surge.⁶

In general, patients with cancer have been found to be at greater risk for adverse outcomes and mortality after COVID-19.⁷ Therefore, resource rationing is particularly concerning for patients with skin cancer, including melanoma, Merkel cell carcinoma, mycosis fungoides, and keratinocyte carcinoma. Triaging patients based on level of acuity, type of skin cancer, disease burden, host immunosuppression, and risk for progression must be carefully considered in this population.² Treatment and follow-up present additional challenges.

Guidelines provided by the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) elaborated on key considerations for the treatment of melanoma, keratinocyte carcinoma, and Merkel cell carcinoma during the COVID-19 pandemic.^8-10 Guidelines from the NCCN concentrated on clear divisions between disease stages to determine provider response. Guidelines for melanoma patients proposed by the ESMO assign tiers by value-based priority in various treatment settings, which offered flexibility to providers as the COVID-19 landscape continued to change. Recommendations from the NCCN and ESMO are summarized in Tables 1 to 5.

Tips for Performing Dermatologic Surgery

Careful consideration should be made to protect both the patient and staff during office-based excisional surgery during the COVID-19 pandemic. To minimize the risk of transmission of SARS-CoV-2, patients and staff should (1) be screened for symptoms of COVID-19 at least 48 hours prior to entering the office via telephone screening questions, and (2) follow proper hygiene and contact procedures once entering the office. Consider obtaining a nasal polymerase chain reaction swab or saliva test 48 hours prior to the procedure if the patient is undergoing a head and neck procedure or there is risk for transmission.

Guidelines from the ESMO recommended that all patients undergoing surgery or therapy should be swabbed for SARS-CoV-2 before each treatment.¹¹ Patients should wear a mask, remain 6-feet apart in the waiting room, and avoid touching objects until they enter the procedure room. Objects that the patient must touch, such as pens, should be cleaned immediately after such contact with either alcohol or soap and water for 20 seconds.

Office capacity should be reduced by allowing no more than 1 person to accompany the patient and ensuring the presence of only the minimum staff needed for the procedure. Staff who are deemed necessary should wear a mask continuously and gloves during patient contact.

Once in the procedure room, providers might be at elevated risk of contracting COVID-19 or transmitting SARS-CoV-2. A properly fitted N95 respirator and a face shield are recommended, especially for facial cases. N95 respirators can be reused by following the latest Centers for Disease Control and Prevention recommendations for reuse and decontamination techniques,¹³ which may include protecting the N95 respirator with a surgical mask and storing it in a paper bag when not in use. Consider testing asymptomatic patients in facial cases when they cannot wear a mask.

Steps should be taken to reduce in-person visits. Dissolving sutures can help avoid return visits. Follow-up visits and postprocedural questions should be managed by telehealth. However, patients with a high-risk underlying conditions (eg, posttransplantation, immunosuppressed) should continue to obtain regular skin checks because they are at higher risk for more aggressive malignancies, such as Merkel cell carcinoma.

Conclusion

The future trajectory of the COVID-19 pandemic is uncertain. Dermatologists should continue providing care for patients with skin cancer while mitigating the risk for COVID-19 infection and transmission of SARS-CoV-2. Guidelines provided by the NCCN and ESMO should help providers triage patients. Decisions should be made case by case, keeping in mind the availability of resources and practicing in compliance with local guidance.

The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome novel coronavirus 2 (SARS-CoV-2), has presented a unique challenge to providing essential care to patients. Increased demand for health care workers and medical supplies, in addition to the risk for COVID-19 infection and asymptomatic transmission of SARS-CoV-2 among health care workers and patients, prompted the delay of nonessential services during the surge of cases this summer.¹ Key considerations for continuing operation included current and projected COVID-19 cases in the region, ability to implement telehealth, staffing availability, personal protective equipment availability, and office capacity.² Providing care that is deemed essential often was determined by the urgency of the treatment or service.

The Centers for Medicare & Medicaid Services outlined a strategy to stratify patients, based on level of acuity, during the COVID-19 surge³:

• Low-acuity treatments or services: includes routine primary, specialty, or preventive care visits. They should be postponed; telehealth follow-ups should be considered.
• Intermediate-acuity treatments or services: includes pediatric and neonatal care, follow-up visits for existing conditions, and evaluation of new symptoms (including those consistent with COVID-19). These services should initially be evaluated using telehealth, then triaged to the appropriate site and level of care.
• High-acuity treatments or services: address symptoms consistent with COVID-19 or other severe disease, of which the lack of in-person evaluation would result in harm to the patient.

Employees in hospitals and health care clinics were classified as essential, but dermatologists were not given explicit direction regarding clinic operation. Many practices have restricted services, especially those in an area of higher COVID-19 prevalence. However, the challenge of determining day-to-day operation may have been left to the provider in most cases.⁴ As many states in the United States continue to relax restrictions, total cases and the rate of positivity of COVID-19 have been sharply rising again, after months of decline,⁵ which suggests increased transmission of SARS-CoV-2 and potential resurgence of the high case burden on our health care system. Furthermore, a lack of a widely distributed vaccine or herd immunity suggests we will need to take many of the same precautions as in the first surge.⁶

In general, patients with cancer have been found to be at greater risk for adverse outcomes and mortality after COVID-19.⁷ Therefore, resource rationing is particularly concerning for patients with skin cancer, including melanoma, Merkel cell carcinoma, mycosis fungoides, and keratinocyte carcinoma. Triaging patients based on level of acuity, type of skin cancer, disease burden, host immunosuppression, and risk for progression must be carefully considered in this population.² Treatment and follow-up present additional challenges.

Guidelines provided by the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) elaborated on key considerations for the treatment of melanoma, keratinocyte carcinoma, and Merkel cell carcinoma during the COVID-19 pandemic.^8-10 Guidelines from the NCCN concentrated on clear divisions between disease stages to determine provider response. Guidelines for melanoma patients proposed by the ESMO assign tiers by value-based priority in various treatment settings, which offered flexibility to providers as the COVID-19 landscape continued to change. Recommendations from the NCCN and ESMO are summarized in Tables 1 to 5.

Tips for Performing Dermatologic Surgery

Careful consideration should be made to protect both the patient and staff during office-based excisional surgery during the COVID-19 pandemic. To minimize the risk of transmission of SARS-CoV-2, patients and staff should (1) be screened for symptoms of COVID-19 at least 48 hours prior to entering the office via telephone screening questions, and (2) follow proper hygiene and contact procedures once entering the office. Consider obtaining a nasal polymerase chain reaction swab or saliva test 48 hours prior to the procedure if the patient is undergoing a head and neck procedure or there is risk for transmission.

Guidelines from the ESMO recommended that all patients undergoing surgery or therapy should be swabbed for SARS-CoV-2 before each treatment.¹¹ Patients should wear a mask, remain 6-feet apart in the waiting room, and avoid touching objects until they enter the procedure room. Objects that the patient must touch, such as pens, should be cleaned immediately after such contact with either alcohol or soap and water for 20 seconds.

Office capacity should be reduced by allowing no more than 1 person to accompany the patient and ensuring the presence of only the minimum staff needed for the procedure. Staff who are deemed necessary should wear a mask continuously and gloves during patient contact.

Once in the procedure room, providers might be at elevated risk of contracting COVID-19 or transmitting SARS-CoV-2. A properly fitted N95 respirator and a face shield are recommended, especially for facial cases. N95 respirators can be reused by following the latest Centers for Disease Control and Prevention recommendations for reuse and decontamination techniques,¹³ which may include protecting the N95 respirator with a surgical mask and storing it in a paper bag when not in use. Consider testing asymptomatic patients in facial cases when they cannot wear a mask.

Steps should be taken to reduce in-person visits. Dissolving sutures can help avoid return visits. Follow-up visits and postprocedural questions should be managed by telehealth. However, patients with a high-risk underlying conditions (eg, posttransplantation, immunosuppressed) should continue to obtain regular skin checks because they are at higher risk for more aggressive malignancies, such as Merkel cell carcinoma.

Conclusion

The future trajectory of the COVID-19 pandemic is uncertain. Dermatologists should continue providing care for patients with skin cancer while mitigating the risk for COVID-19 infection and transmission of SARS-CoV-2. Guidelines provided by the NCCN and ESMO should help providers triage patients. Decisions should be made case by case, keeping in mind the availability of resources and practicing in compliance with local guidance.

The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome novel coronavirus 2 (SARS-CoV-2), has presented a unique challenge to providing essential care to patients. Increased demand for health care workers and medical supplies, in addition to the risk for COVID-19 infection and asymptomatic transmission of SARS-CoV-2 among health care workers and patients, prompted the delay of nonessential services during the surge of cases this summer.¹ Key considerations for continuing operation included current and projected COVID-19 cases in the region, ability to implement telehealth, staffing availability, personal protective equipment availability, and office capacity.² Providing care that is deemed essential often was determined by the urgency of the treatment or service.

The Centers for Medicare & Medicaid Services outlined a strategy to stratify patients, based on level of acuity, during the COVID-19 surge³:

• Low-acuity treatments or services: includes routine primary, specialty, or preventive care visits. They should be postponed; telehealth follow-ups should be considered.
• Intermediate-acuity treatments or services: includes pediatric and neonatal care, follow-up visits for existing conditions, and evaluation of new symptoms (including those consistent with COVID-19). These services should initially be evaluated using telehealth, then triaged to the appropriate site and level of care.
• High-acuity treatments or services: address symptoms consistent with COVID-19 or other severe disease, of which the lack of in-person evaluation would result in harm to the patient.

Employees in hospitals and health care clinics were classified as essential, but dermatologists were not given explicit direction regarding clinic operation. Many practices have restricted services, especially those in an area of higher COVID-19 prevalence. However, the challenge of determining day-to-day operation may have been left to the provider in most cases.⁴ As many states in the United States continue to relax restrictions, total cases and the rate of positivity of COVID-19 have been sharply rising again, after months of decline,⁵ which suggests increased transmission of SARS-CoV-2 and potential resurgence of the high case burden on our health care system. Furthermore, a lack of a widely distributed vaccine or herd immunity suggests we will need to take many of the same precautions as in the first surge.⁶

In general, patients with cancer have been found to be at greater risk for adverse outcomes and mortality after COVID-19.⁷ Therefore, resource rationing is particularly concerning for patients with skin cancer, including melanoma, Merkel cell carcinoma, mycosis fungoides, and keratinocyte carcinoma. Triaging patients based on level of acuity, type of skin cancer, disease burden, host immunosuppression, and risk for progression must be carefully considered in this population.² Treatment and follow-up present additional challenges.

Guidelines provided by the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) elaborated on key considerations for the treatment of melanoma, keratinocyte carcinoma, and Merkel cell carcinoma during the COVID-19 pandemic.^8-10 Guidelines from the NCCN concentrated on clear divisions between disease stages to determine provider response. Guidelines for melanoma patients proposed by the ESMO assign tiers by value-based priority in various treatment settings, which offered flexibility to providers as the COVID-19 landscape continued to change. Recommendations from the NCCN and ESMO are summarized in Tables 1 to 5.

Tips for Performing Dermatologic Surgery

Careful consideration should be made to protect both the patient and staff during office-based excisional surgery during the COVID-19 pandemic. To minimize the risk of transmission of SARS-CoV-2, patients and staff should (1) be screened for symptoms of COVID-19 at least 48 hours prior to entering the office via telephone screening questions, and (2) follow proper hygiene and contact procedures once entering the office. Consider obtaining a nasal polymerase chain reaction swab or saliva test 48 hours prior to the procedure if the patient is undergoing a head and neck procedure or there is risk for transmission.

Guidelines from the ESMO recommended that all patients undergoing surgery or therapy should be swabbed for SARS-CoV-2 before each treatment.¹¹ Patients should wear a mask, remain 6-feet apart in the waiting room, and avoid touching objects until they enter the procedure room. Objects that the patient must touch, such as pens, should be cleaned immediately after such contact with either alcohol or soap and water for 20 seconds.

Office capacity should be reduced by allowing no more than 1 person to accompany the patient and ensuring the presence of only the minimum staff needed for the procedure. Staff who are deemed necessary should wear a mask continuously and gloves during patient contact.

Once in the procedure room, providers might be at elevated risk of contracting COVID-19 or transmitting SARS-CoV-2. A properly fitted N95 respirator and a face shield are recommended, especially for facial cases. N95 respirators can be reused by following the latest Centers for Disease Control and Prevention recommendations for reuse and decontamination techniques,¹³ which may include protecting the N95 respirator with a surgical mask and storing it in a paper bag when not in use. Consider testing asymptomatic patients in facial cases when they cannot wear a mask.

Steps should be taken to reduce in-person visits. Dissolving sutures can help avoid return visits. Follow-up visits and postprocedural questions should be managed by telehealth. However, patients with a high-risk underlying conditions (eg, posttransplantation, immunosuppressed) should continue to obtain regular skin checks because they are at higher risk for more aggressive malignancies, such as Merkel cell carcinoma.

Conclusion

The future trajectory of the COVID-19 pandemic is uncertain. Dermatologists should continue providing care for patients with skin cancer while mitigating the risk for COVID-19 infection and transmission of SARS-CoV-2. Guidelines provided by the NCCN and ESMO should help providers triage patients. Decisions should be made case by case, keeping in mind the availability of resources and practicing in compliance with local guidance.

There is a significant association between routine attendance at annual well-child care visits and a reduction in both total asthma exacerbations and severe exacerbations, Jason E. Lang, MD, MPH, of Duke University, Durham, N.C. reported in a study published in Pediatrics.

Louis-Paul St-Onge/iStockphoto

In a retrospective cohort study of 5,656 pediatric asthma patients under care at the Duke University Health System, Dr. Lang and colleagues sought to determine the effect yearly well-child care (WCC) visits have on the hazard rate of asthma exacerbations occurring during the following year. Patients included in the study were aged 5-17 years and had been receiving care between Jan. 1, 2014, and Dec. 31, 2019.
 

WCC visits demonstrate reduced exacerbations and hospitalizations

Nearly one-third of patients were found to have full WCC visit attendance, half were partially compliant, and 14% did not attend at all. A total of 2,974 asthma exacerbations were reported during the study period. Of those with a WCC visit during the previous year, exacerbations were reduced by 10% and asthma hospitalizations were lowered by 47%. Children with recent WCC visits were also more likely to be prescribed daily preventive medication and to experience an exacerbation in ambulatory care, which could play a crucial role in preventing further progression of the disease.

Of the WCC visits reported, 9.9% represented prescribing of new or changed asthma medication, 28.2% represented delivery of seasonal influenza vaccine, and 11% addressed assessment or management of asthma-related comorbidities. There was no observed difference in attendance between younger and older children.

Given that pediatric WCC visit attendance is “far from optimal,” with attendance improving from 46% in 1996-1998 to almost 60% in 2007-2008, “improving access to and attendance of WCC visits (especially from previously low-adhering families) may be an important public health intervention to reduce the problems of severe exacerbations and outcome disparities,” observed Dr. Lang and colleagues. The Abdus study also found that low WCC attendance appeared to be more common in those with lower income, lower parental education, and African American race.
 

Continuity of care providers across WCC visits plays a crucial role

Primary care pediatricians play a key role in successful management of chronic asthma, as evidenced in several studies showing the importance of continuity of care with the same provider for WCC. Such continuity encourages ongoing dialogue about asthma, and as the researchers speculated, may even reduce asthma hospitalization through better parental understanding of disease management, prevention, and management of comorbid conditions.

Although the study did not include measures of health literacy, the authors did conclude that pediatric asthma patients seen annually are more likely to be more knowledgeable about asthma and in a better position to recognize symptom exacerbation so they can seek timely care. In the past, lower health literacy has demonstrated both lower WCC visit attendance and increased emergency care visits and hospitalizations.

Because the study was conducted in a single university-based health system, the researchers were not able to capture fragmented care data. They also acknowledged the possible omission of confounding factors, especially those related to parental influence behaviors affecting daily disease management. One strength of the study was the ability researchers had to abstract granular data from their EHR system to document the time-varying effects that insurance status, obesity status, and WCC visits may have played. Given that they were able to assess effects according to sociodemographic factors, such as race and insurance status, the results should prove very helpful to other cities and health systems aiming to improve pediatric asthma control, observed Dr. Lang and colleagues.

Future studies should seek to further evaluate the role of WCC visits in promoting asthma control. Making WCC visits a renewed public health priority offers the possibility to limit severe asthma exacerbations, the researchers advised.

In a separate interview, Sydney Leibel, MD, MPH, a pediatric allergist/immunologist at Rady Children’s Hospital, San Diego, noted: “The outcomes of this study shine a light on the importance of regular primary care pediatrician follow-up in decreasing asthma-related health care utilization. Childhood asthma is a dynamic condition and follow-up with the pediatrician allows for modification of the treatment plan and reinforcement of good inhaler technique. It also allows for patients to express their concerns and gives the opportunity for subspecialty referral, if symptoms remain uncontrolled.

“This article also highlights the health disparities that exist in pediatric asthma in the United States. In our experience, treating children from lower-socioeconomic communities with difficult-to-control and severe asthma, case management has been very important in making sure our patient population understands our instructions, pick up their medications, and make their scheduled follow-up appointments,” Dr. Leibel continued.

“Regardless of the patient’s background, efforts to improve attendance of WCC visits, where good asthma control can be promoted, would be in our patient’s best interest and could go a long way in preventing unnecessary asthma exacerbations that require an ED visit or hospitalization,” the specialist concluded.

The study was funded by a grant from the National Heart, Lung, and Blood Institute, Duke Children’s Health & Discovery Initiative, and the National Institutes of Health. Dr. Lang and colleagues had no conflicts of interest and no relevant financial disclosures. Dr. Leibel said he had no relevant financial disclosures.

SOURCE: Lang JE et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1023.

There is a significant association between routine attendance at annual well-child care visits and a reduction in both total asthma exacerbations and severe exacerbations, Jason E. Lang, MD, MPH, of Duke University, Durham, N.C. reported in a study published in Pediatrics.

Louis-Paul St-Onge/iStockphoto

In a retrospective cohort study of 5,656 pediatric asthma patients under care at the Duke University Health System, Dr. Lang and colleagues sought to determine the effect yearly well-child care (WCC) visits have on the hazard rate of asthma exacerbations occurring during the following year. Patients included in the study were aged 5-17 years and had been receiving care between Jan. 1, 2014, and Dec. 31, 2019.
 

WCC visits demonstrate reduced exacerbations and hospitalizations

Nearly one-third of patients were found to have full WCC visit attendance, half were partially compliant, and 14% did not attend at all. A total of 2,974 asthma exacerbations were reported during the study period. Of those with a WCC visit during the previous year, exacerbations were reduced by 10% and asthma hospitalizations were lowered by 47%. Children with recent WCC visits were also more likely to be prescribed daily preventive medication and to experience an exacerbation in ambulatory care, which could play a crucial role in preventing further progression of the disease.

Of the WCC visits reported, 9.9% represented prescribing of new or changed asthma medication, 28.2% represented delivery of seasonal influenza vaccine, and 11% addressed assessment or management of asthma-related comorbidities. There was no observed difference in attendance between younger and older children.

Given that pediatric WCC visit attendance is “far from optimal,” with attendance improving from 46% in 1996-1998 to almost 60% in 2007-2008, “improving access to and attendance of WCC visits (especially from previously low-adhering families) may be an important public health intervention to reduce the problems of severe exacerbations and outcome disparities,” observed Dr. Lang and colleagues. The Abdus study also found that low WCC attendance appeared to be more common in those with lower income, lower parental education, and African American race.
 

Continuity of care providers across WCC visits plays a crucial role

Primary care pediatricians play a key role in successful management of chronic asthma, as evidenced in several studies showing the importance of continuity of care with the same provider for WCC. Such continuity encourages ongoing dialogue about asthma, and as the researchers speculated, may even reduce asthma hospitalization through better parental understanding of disease management, prevention, and management of comorbid conditions.

Although the study did not include measures of health literacy, the authors did conclude that pediatric asthma patients seen annually are more likely to be more knowledgeable about asthma and in a better position to recognize symptom exacerbation so they can seek timely care. In the past, lower health literacy has demonstrated both lower WCC visit attendance and increased emergency care visits and hospitalizations.

Because the study was conducted in a single university-based health system, the researchers were not able to capture fragmented care data. They also acknowledged the possible omission of confounding factors, especially those related to parental influence behaviors affecting daily disease management. One strength of the study was the ability researchers had to abstract granular data from their EHR system to document the time-varying effects that insurance status, obesity status, and WCC visits may have played. Given that they were able to assess effects according to sociodemographic factors, such as race and insurance status, the results should prove very helpful to other cities and health systems aiming to improve pediatric asthma control, observed Dr. Lang and colleagues.

Future studies should seek to further evaluate the role of WCC visits in promoting asthma control. Making WCC visits a renewed public health priority offers the possibility to limit severe asthma exacerbations, the researchers advised.

In a separate interview, Sydney Leibel, MD, MPH, a pediatric allergist/immunologist at Rady Children’s Hospital, San Diego, noted: “The outcomes of this study shine a light on the importance of regular primary care pediatrician follow-up in decreasing asthma-related health care utilization. Childhood asthma is a dynamic condition and follow-up with the pediatrician allows for modification of the treatment plan and reinforcement of good inhaler technique. It also allows for patients to express their concerns and gives the opportunity for subspecialty referral, if symptoms remain uncontrolled.

“This article also highlights the health disparities that exist in pediatric asthma in the United States. In our experience, treating children from lower-socioeconomic communities with difficult-to-control and severe asthma, case management has been very important in making sure our patient population understands our instructions, pick up their medications, and make their scheduled follow-up appointments,” Dr. Leibel continued.

“Regardless of the patient’s background, efforts to improve attendance of WCC visits, where good asthma control can be promoted, would be in our patient’s best interest and could go a long way in preventing unnecessary asthma exacerbations that require an ED visit or hospitalization,” the specialist concluded.

The study was funded by a grant from the National Heart, Lung, and Blood Institute, Duke Children’s Health & Discovery Initiative, and the National Institutes of Health. Dr. Lang and colleagues had no conflicts of interest and no relevant financial disclosures. Dr. Leibel said he had no relevant financial disclosures.

SOURCE: Lang JE et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1023.

There is a significant association between routine attendance at annual well-child care visits and a reduction in both total asthma exacerbations and severe exacerbations, Jason E. Lang, MD, MPH, of Duke University, Durham, N.C. reported in a study published in Pediatrics.

Louis-Paul St-Onge/iStockphoto

In a retrospective cohort study of 5,656 pediatric asthma patients under care at the Duke University Health System, Dr. Lang and colleagues sought to determine the effect yearly well-child care (WCC) visits have on the hazard rate of asthma exacerbations occurring during the following year. Patients included in the study were aged 5-17 years and had been receiving care between Jan. 1, 2014, and Dec. 31, 2019.
 

WCC visits demonstrate reduced exacerbations and hospitalizations

Nearly one-third of patients were found to have full WCC visit attendance, half were partially compliant, and 14% did not attend at all. A total of 2,974 asthma exacerbations were reported during the study period. Of those with a WCC visit during the previous year, exacerbations were reduced by 10% and asthma hospitalizations were lowered by 47%. Children with recent WCC visits were also more likely to be prescribed daily preventive medication and to experience an exacerbation in ambulatory care, which could play a crucial role in preventing further progression of the disease.

Of the WCC visits reported, 9.9% represented prescribing of new or changed asthma medication, 28.2% represented delivery of seasonal influenza vaccine, and 11% addressed assessment or management of asthma-related comorbidities. There was no observed difference in attendance between younger and older children.

Given that pediatric WCC visit attendance is “far from optimal,” with attendance improving from 46% in 1996-1998 to almost 60% in 2007-2008, “improving access to and attendance of WCC visits (especially from previously low-adhering families) may be an important public health intervention to reduce the problems of severe exacerbations and outcome disparities,” observed Dr. Lang and colleagues. The Abdus study also found that low WCC attendance appeared to be more common in those with lower income, lower parental education, and African American race.
 

Continuity of care providers across WCC visits plays a crucial role

Primary care pediatricians play a key role in successful management of chronic asthma, as evidenced in several studies showing the importance of continuity of care with the same provider for WCC. Such continuity encourages ongoing dialogue about asthma, and as the researchers speculated, may even reduce asthma hospitalization through better parental understanding of disease management, prevention, and management of comorbid conditions.

Although the study did not include measures of health literacy, the authors did conclude that pediatric asthma patients seen annually are more likely to be more knowledgeable about asthma and in a better position to recognize symptom exacerbation so they can seek timely care. In the past, lower health literacy has demonstrated both lower WCC visit attendance and increased emergency care visits and hospitalizations.

Because the study was conducted in a single university-based health system, the researchers were not able to capture fragmented care data. They also acknowledged the possible omission of confounding factors, especially those related to parental influence behaviors affecting daily disease management. One strength of the study was the ability researchers had to abstract granular data from their EHR system to document the time-varying effects that insurance status, obesity status, and WCC visits may have played. Given that they were able to assess effects according to sociodemographic factors, such as race and insurance status, the results should prove very helpful to other cities and health systems aiming to improve pediatric asthma control, observed Dr. Lang and colleagues.

Future studies should seek to further evaluate the role of WCC visits in promoting asthma control. Making WCC visits a renewed public health priority offers the possibility to limit severe asthma exacerbations, the researchers advised.

In a separate interview, Sydney Leibel, MD, MPH, a pediatric allergist/immunologist at Rady Children’s Hospital, San Diego, noted: “The outcomes of this study shine a light on the importance of regular primary care pediatrician follow-up in decreasing asthma-related health care utilization. Childhood asthma is a dynamic condition and follow-up with the pediatrician allows for modification of the treatment plan and reinforcement of good inhaler technique. It also allows for patients to express their concerns and gives the opportunity for subspecialty referral, if symptoms remain uncontrolled.

“This article also highlights the health disparities that exist in pediatric asthma in the United States. In our experience, treating children from lower-socioeconomic communities with difficult-to-control and severe asthma, case management has been very important in making sure our patient population understands our instructions, pick up their medications, and make their scheduled follow-up appointments,” Dr. Leibel continued.

“Regardless of the patient’s background, efforts to improve attendance of WCC visits, where good asthma control can be promoted, would be in our patient’s best interest and could go a long way in preventing unnecessary asthma exacerbations that require an ED visit or hospitalization,” the specialist concluded.

The study was funded by a grant from the National Heart, Lung, and Blood Institute, Duke Children’s Health & Discovery Initiative, and the National Institutes of Health. Dr. Lang and colleagues had no conflicts of interest and no relevant financial disclosures. Dr. Leibel said he had no relevant financial disclosures.

SOURCE: Lang JE et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1023.

The majority of women in the United States remain unaware of the benefits breastfeeding offers in reducing the risk of breast cancer, reported Adrienne Hoyt-Austin, DO, and colleagues at University of California, Davis.

oksun70/ThinkStock

Using nationally representative data collected from the 2015-2017 National Survey of Family Growth, Dr. Hoyt-Austin and colleagues analyzed responses to the question: “Do you think that breastfeeding decreases a woman’s chances of getting breast cancer a lot, a little, or not at all, no opinion, or don’t know?” A total of 5,554 female respondents aged 15-49 years participated. The response rate was 66.7%.
 

Multiparous status and education play a role in decreased awareness

Those who had given birth more than once, who had no more than a high school education, or who were U.S.-born Hispanic had the lowest level of awareness, believing that breastfeeding offers only “a little” protection. Of those who were aware of the link, 44% reported that breastfeeding provides “a lot” of protection, and foreign-born participants as well as those who breastfed for more than a year were more likely to conclude that breastfeeding offers “a lot” of protection. The researchers found that neither mammogram or personal family history of breast cancer had any bearing on awareness.

Although multiple studies have found breastfeeding to confer a lower rate of cancer risk, morbidity and mortality, with a 26% lower lifetime risk for those mothers who breastfeed for 12 months or longer, only 36% of women in the United States actually breastfeed.
 

Limited data indicate whether respondents were breastfed themselves

“Public health initiatives must consider the complex roots of disparities in breastfeeding,” noted Dr. Hoyt-Austin and colleagues. They acknowledged the subjectivity of perceptions of “a lot” versus “a little” and noted that the study was limited by a lack of data on whether participants were breastfed themselves.

Clinicians have an opportunity to play a key role in better educating families concerning the benefits of breastfeeding, both for mother and child, they advised. According to one recent study, just 5 minutes of counseling on the benefits of breastfeeding “significantly strengthened women’s intentions to breastfeed.

In a separate interview, Amy E. Cyr, MD, FACS, section of surgical oncology at Washington University, St. Louis, noted that “many breast cancer risk factors – age, sex, family history, and age of menopause – are nonmodifiable.” And while other risk factors, including alcohol use, diet, and exercise are controllable, “pregnancies and breastfeeding don’t always go as planned,” Dr. Cyr added.

“Although Dr. Hoyt-Austin et al. observed that many women aren’t aware that breastfeeding decreases breast cancer risk – or to what extent (they cite a 26% cancer risk reduction after 12 or more months of breastfeeding) – most studies haven’t shown that large a drop in breast cancer risk,“ she pointed out, adding that “I think it’s an overstatement to suggest that breastfeeding reduces cancer risk by ‘a lot,’ as one of the survey choices offered in the study suggests.”

Whether or not a woman breastfeeds depends not only on desire but on social and economic support and biology; for some, breastfeeding simply isn’t an option. “I agree that we should educate women about the benefits of breastfeeding so they can make an informed decision for themselves and their infants, but we also need to acknowledge the complexity of this issue,” she cautioned.

One coauthor reported a travel stipend by the Human Milk Banking Association of North America; Dr. Hoyt-Austin and the other authors had no conflicts of interest to report. Dr. Cyr had no conflicts of interest to report.

SOURCE: Hoyt-Austin A et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004162.

The majority of women in the United States remain unaware of the benefits breastfeeding offers in reducing the risk of breast cancer, reported Adrienne Hoyt-Austin, DO, and colleagues at University of California, Davis.

oksun70/ThinkStock

Using nationally representative data collected from the 2015-2017 National Survey of Family Growth, Dr. Hoyt-Austin and colleagues analyzed responses to the question: “Do you think that breastfeeding decreases a woman’s chances of getting breast cancer a lot, a little, or not at all, no opinion, or don’t know?” A total of 5,554 female respondents aged 15-49 years participated. The response rate was 66.7%.
 

Multiparous status and education play a role in decreased awareness

Those who had given birth more than once, who had no more than a high school education, or who were U.S.-born Hispanic had the lowest level of awareness, believing that breastfeeding offers only “a little” protection. Of those who were aware of the link, 44% reported that breastfeeding provides “a lot” of protection, and foreign-born participants as well as those who breastfed for more than a year were more likely to conclude that breastfeeding offers “a lot” of protection. The researchers found that neither mammogram or personal family history of breast cancer had any bearing on awareness.

Although multiple studies have found breastfeeding to confer a lower rate of cancer risk, morbidity and mortality, with a 26% lower lifetime risk for those mothers who breastfeed for 12 months or longer, only 36% of women in the United States actually breastfeed.
 

Limited data indicate whether respondents were breastfed themselves

“Public health initiatives must consider the complex roots of disparities in breastfeeding,” noted Dr. Hoyt-Austin and colleagues. They acknowledged the subjectivity of perceptions of “a lot” versus “a little” and noted that the study was limited by a lack of data on whether participants were breastfed themselves.

Clinicians have an opportunity to play a key role in better educating families concerning the benefits of breastfeeding, both for mother and child, they advised. According to one recent study, just 5 minutes of counseling on the benefits of breastfeeding “significantly strengthened women’s intentions to breastfeed.

In a separate interview, Amy E. Cyr, MD, FACS, section of surgical oncology at Washington University, St. Louis, noted that “many breast cancer risk factors – age, sex, family history, and age of menopause – are nonmodifiable.” And while other risk factors, including alcohol use, diet, and exercise are controllable, “pregnancies and breastfeeding don’t always go as planned,” Dr. Cyr added.

“Although Dr. Hoyt-Austin et al. observed that many women aren’t aware that breastfeeding decreases breast cancer risk – or to what extent (they cite a 26% cancer risk reduction after 12 or more months of breastfeeding) – most studies haven’t shown that large a drop in breast cancer risk,“ she pointed out, adding that “I think it’s an overstatement to suggest that breastfeeding reduces cancer risk by ‘a lot,’ as one of the survey choices offered in the study suggests.”

Whether or not a woman breastfeeds depends not only on desire but on social and economic support and biology; for some, breastfeeding simply isn’t an option. “I agree that we should educate women about the benefits of breastfeeding so they can make an informed decision for themselves and their infants, but we also need to acknowledge the complexity of this issue,” she cautioned.

One coauthor reported a travel stipend by the Human Milk Banking Association of North America; Dr. Hoyt-Austin and the other authors had no conflicts of interest to report. Dr. Cyr had no conflicts of interest to report.

SOURCE: Hoyt-Austin A et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004162.

The majority of women in the United States remain unaware of the benefits breastfeeding offers in reducing the risk of breast cancer, reported Adrienne Hoyt-Austin, DO, and colleagues at University of California, Davis.

oksun70/ThinkStock

Using nationally representative data collected from the 2015-2017 National Survey of Family Growth, Dr. Hoyt-Austin and colleagues analyzed responses to the question: “Do you think that breastfeeding decreases a woman’s chances of getting breast cancer a lot, a little, or not at all, no opinion, or don’t know?” A total of 5,554 female respondents aged 15-49 years participated. The response rate was 66.7%.
 

Multiparous status and education play a role in decreased awareness

Those who had given birth more than once, who had no more than a high school education, or who were U.S.-born Hispanic had the lowest level of awareness, believing that breastfeeding offers only “a little” protection. Of those who were aware of the link, 44% reported that breastfeeding provides “a lot” of protection, and foreign-born participants as well as those who breastfed for more than a year were more likely to conclude that breastfeeding offers “a lot” of protection. The researchers found that neither mammogram or personal family history of breast cancer had any bearing on awareness.

Although multiple studies have found breastfeeding to confer a lower rate of cancer risk, morbidity and mortality, with a 26% lower lifetime risk for those mothers who breastfeed for 12 months or longer, only 36% of women in the United States actually breastfeed.
 

Limited data indicate whether respondents were breastfed themselves

“Public health initiatives must consider the complex roots of disparities in breastfeeding,” noted Dr. Hoyt-Austin and colleagues. They acknowledged the subjectivity of perceptions of “a lot” versus “a little” and noted that the study was limited by a lack of data on whether participants were breastfed themselves.

Clinicians have an opportunity to play a key role in better educating families concerning the benefits of breastfeeding, both for mother and child, they advised. According to one recent study, just 5 minutes of counseling on the benefits of breastfeeding “significantly strengthened women’s intentions to breastfeed.

In a separate interview, Amy E. Cyr, MD, FACS, section of surgical oncology at Washington University, St. Louis, noted that “many breast cancer risk factors – age, sex, family history, and age of menopause – are nonmodifiable.” And while other risk factors, including alcohol use, diet, and exercise are controllable, “pregnancies and breastfeeding don’t always go as planned,” Dr. Cyr added.

“Although Dr. Hoyt-Austin et al. observed that many women aren’t aware that breastfeeding decreases breast cancer risk – or to what extent (they cite a 26% cancer risk reduction after 12 or more months of breastfeeding) – most studies haven’t shown that large a drop in breast cancer risk,“ she pointed out, adding that “I think it’s an overstatement to suggest that breastfeeding reduces cancer risk by ‘a lot,’ as one of the survey choices offered in the study suggests.”

Whether or not a woman breastfeeds depends not only on desire but on social and economic support and biology; for some, breastfeeding simply isn’t an option. “I agree that we should educate women about the benefits of breastfeeding so they can make an informed decision for themselves and their infants, but we also need to acknowledge the complexity of this issue,” she cautioned.

One coauthor reported a travel stipend by the Human Milk Banking Association of North America; Dr. Hoyt-Austin and the other authors had no conflicts of interest to report. Dr. Cyr had no conflicts of interest to report.

SOURCE: Hoyt-Austin A et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004162.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Incorporating gender-nonconforming patients into practice can seem like a daunting task at first. However, obstetricians/gynecologists, midwives, and other advanced women’s health care practitioners can provide quality care for both transgender men and women. Basic preventative services such as routine health and cancer screening and testing for sexually transmitted infections does not require specialized training in transgender health. In fact, administration of hormonal therapy and some surgical interventions are well within the scope of practice of the general obstetrician/gynecologist, as long as the provider has undergone appropriate training to achieve expertise. For example, organizations such as the World Professional Association for Transgender Health (WPATH) not only provides standards of care regarding the treatment of transgender individuals, but they also have training and educational opportunities targeted at providers who wish to become certified in more advanced care of the transgender patient. If an obstetrician/gynecologist is interested in prescribing hormone therapy, seeking further training within the field is a must.

It is important to remember that the process by which transgender individuals express their gender is a spectrum. Not all patients who identify as transgender will seek hormone therapy or surgical procedures. However, even if a provider has not undergone more specific training to administer hormone therapy, it is still very important to have a basic understanding of the hormones, routes of administration, and side effects.

While cross-sex hormone therapy does differ in practice, compared with hormone replacement therapy in cisgender counterparts, the principles are relatively similar. Testosterone therapy is the mainstay treatment for transgender men who desire medical transition.^1,2 The overall goal of therapy is to achieve testosterone levels within the cisgender male physiologic range (300-1000 ng/dL). While the most common route of administration is subcutaneous or intramuscular injections in weekly, biweekly, or quarterly intervals, other routes may include daily transdermal patches and gels or oral formulations.1 Within the first few months of use, patients will notice signs of masculinization such as increased facial and body hair, increased muscle mass, increased libido, and amenorrhea. Other changes include male-pattern hair loss, clitoromegaly, redistribution of fat, voice deepening, and mood changes.¹

Hormone therapy for transgender women is a bit more complicated as estrogen alone will often not achieve feminizing characteristics that are satisfying for patients.³ Estrogen therapy can include oral formulations of 17-beta estradiol or conjugated estrogens, although the latter is typically avoided because of the marked increase in thromboembolic events. Estrogens can also be administered in sublingual, intramuscular, or transdermal forms. Antiandrogens are often required to help decrease endogenous testosterone levels to cisgender female levels (30-100 ng/dL).³ Spironolactone is most commonly prescribed as an adjunct to estrogen therapy. Finasteride and GnRH agonists like leuprolide acetate can also be added if spironolactone is not effective or not tolerated by the patient. Feminizing effects of estrogen can take several months and most commonly include decreased spontaneous erections, decreased libido, breast growth, redistribution of fat to the waist and hips, decreased skin oiliness, and softening of the skin.³

Overall, hormone therapy for both transgender men and women is considered effective, safe, and well tolerated.⁴ Monitoring is typically performed every 3 months within the first year after initiating hormone therapy, and then continued every 6-12 months thereafter. Routine screening for all organs and tissues present (e.g. prostate, breast) should be undertaken.³ While this simply highlights the therapy and surveillance for patients, it is important to remember that many transgender men and women will see an obstetrician/gynecologist at some interval during their transition. Ultimately, it is paramount that we as obstetricians/gynecologists have a basic understanding of the treatments available so we can provide our patients with competent and compassionate care.
 

Dr. Brandt is an obstetrician/gynecologist and a plastic surgeon at Reading Hospital/Tower Health System in West Reading, Pa., where she has developed a gender-affirming medical and surgical clinic for ob.gyn. residents and plastic surgeon fellows.

References

1. World Professional Association for Transgender Health. Standards of care for the health of transsexual, transgender, and gender nonconforming people. 7th version. Accessed 10/15/20.

2. Joint meeting of the International Society of Endocrinology and the Endocrine Society 2014; ICE/ENDO 2014, Paper 14354. Accessed 01/08/16.

3. Qian R, Safer JD. Hormone treatment for the adult transgender patient, in “Comprehensive Care of the Transgender Patient,” 1st ed. Philadelphia: Elsevier, 2020, pp. 34-6.

4. Weinand JD and Safer JD. Hormone therapy in transgender adults is safe with provider supervision: A review of hormone therapy sequelae for transgender individuals. J Clin Transl Endocrinol. 2015;2(2):55-60.
 

Incorporating gender-nonconforming patients into practice can seem like a daunting task at first. However, obstetricians/gynecologists, midwives, and other advanced women’s health care practitioners can provide quality care for both transgender men and women. Basic preventative services such as routine health and cancer screening and testing for sexually transmitted infections does not require specialized training in transgender health. In fact, administration of hormonal therapy and some surgical interventions are well within the scope of practice of the general obstetrician/gynecologist, as long as the provider has undergone appropriate training to achieve expertise. For example, organizations such as the World Professional Association for Transgender Health (WPATH) not only provides standards of care regarding the treatment of transgender individuals, but they also have training and educational opportunities targeted at providers who wish to become certified in more advanced care of the transgender patient. If an obstetrician/gynecologist is interested in prescribing hormone therapy, seeking further training within the field is a must.

It is important to remember that the process by which transgender individuals express their gender is a spectrum. Not all patients who identify as transgender will seek hormone therapy or surgical procedures. However, even if a provider has not undergone more specific training to administer hormone therapy, it is still very important to have a basic understanding of the hormones, routes of administration, and side effects.

While cross-sex hormone therapy does differ in practice, compared with hormone replacement therapy in cisgender counterparts, the principles are relatively similar. Testosterone therapy is the mainstay treatment for transgender men who desire medical transition.^1,2 The overall goal of therapy is to achieve testosterone levels within the cisgender male physiologic range (300-1000 ng/dL). While the most common route of administration is subcutaneous or intramuscular injections in weekly, biweekly, or quarterly intervals, other routes may include daily transdermal patches and gels or oral formulations.1 Within the first few months of use, patients will notice signs of masculinization such as increased facial and body hair, increased muscle mass, increased libido, and amenorrhea. Other changes include male-pattern hair loss, clitoromegaly, redistribution of fat, voice deepening, and mood changes.¹

Hormone therapy for transgender women is a bit more complicated as estrogen alone will often not achieve feminizing characteristics that are satisfying for patients.³ Estrogen therapy can include oral formulations of 17-beta estradiol or conjugated estrogens, although the latter is typically avoided because of the marked increase in thromboembolic events. Estrogens can also be administered in sublingual, intramuscular, or transdermal forms. Antiandrogens are often required to help decrease endogenous testosterone levels to cisgender female levels (30-100 ng/dL).³ Spironolactone is most commonly prescribed as an adjunct to estrogen therapy. Finasteride and GnRH agonists like leuprolide acetate can also be added if spironolactone is not effective or not tolerated by the patient. Feminizing effects of estrogen can take several months and most commonly include decreased spontaneous erections, decreased libido, breast growth, redistribution of fat to the waist and hips, decreased skin oiliness, and softening of the skin.³

Overall, hormone therapy for both transgender men and women is considered effective, safe, and well tolerated.⁴ Monitoring is typically performed every 3 months within the first year after initiating hormone therapy, and then continued every 6-12 months thereafter. Routine screening for all organs and tissues present (e.g. prostate, breast) should be undertaken.³ While this simply highlights the therapy and surveillance for patients, it is important to remember that many transgender men and women will see an obstetrician/gynecologist at some interval during their transition. Ultimately, it is paramount that we as obstetricians/gynecologists have a basic understanding of the treatments available so we can provide our patients with competent and compassionate care.
 

Dr. Brandt is an obstetrician/gynecologist and a plastic surgeon at Reading Hospital/Tower Health System in West Reading, Pa., where she has developed a gender-affirming medical and surgical clinic for ob.gyn. residents and plastic surgeon fellows.

References

1. World Professional Association for Transgender Health. Standards of care for the health of transsexual, transgender, and gender nonconforming people. 7th version. Accessed 10/15/20.

2. Joint meeting of the International Society of Endocrinology and the Endocrine Society 2014; ICE/ENDO 2014, Paper 14354. Accessed 01/08/16.

3. Qian R, Safer JD. Hormone treatment for the adult transgender patient, in “Comprehensive Care of the Transgender Patient,” 1st ed. Philadelphia: Elsevier, 2020, pp. 34-6.

4. Weinand JD and Safer JD. Hormone therapy in transgender adults is safe with provider supervision: A review of hormone therapy sequelae for transgender individuals. J Clin Transl Endocrinol. 2015;2(2):55-60.
 

Incorporating gender-nonconforming patients into practice can seem like a daunting task at first. However, obstetricians/gynecologists, midwives, and other advanced women’s health care practitioners can provide quality care for both transgender men and women. Basic preventative services such as routine health and cancer screening and testing for sexually transmitted infections does not require specialized training in transgender health. In fact, administration of hormonal therapy and some surgical interventions are well within the scope of practice of the general obstetrician/gynecologist, as long as the provider has undergone appropriate training to achieve expertise. For example, organizations such as the World Professional Association for Transgender Health (WPATH) not only provides standards of care regarding the treatment of transgender individuals, but they also have training and educational opportunities targeted at providers who wish to become certified in more advanced care of the transgender patient. If an obstetrician/gynecologist is interested in prescribing hormone therapy, seeking further training within the field is a must.

It is important to remember that the process by which transgender individuals express their gender is a spectrum. Not all patients who identify as transgender will seek hormone therapy or surgical procedures. However, even if a provider has not undergone more specific training to administer hormone therapy, it is still very important to have a basic understanding of the hormones, routes of administration, and side effects.

While cross-sex hormone therapy does differ in practice, compared with hormone replacement therapy in cisgender counterparts, the principles are relatively similar. Testosterone therapy is the mainstay treatment for transgender men who desire medical transition.^1,2 The overall goal of therapy is to achieve testosterone levels within the cisgender male physiologic range (300-1000 ng/dL). While the most common route of administration is subcutaneous or intramuscular injections in weekly, biweekly, or quarterly intervals, other routes may include daily transdermal patches and gels or oral formulations.1 Within the first few months of use, patients will notice signs of masculinization such as increased facial and body hair, increased muscle mass, increased libido, and amenorrhea. Other changes include male-pattern hair loss, clitoromegaly, redistribution of fat, voice deepening, and mood changes.¹

Hormone therapy for transgender women is a bit more complicated as estrogen alone will often not achieve feminizing characteristics that are satisfying for patients.³ Estrogen therapy can include oral formulations of 17-beta estradiol or conjugated estrogens, although the latter is typically avoided because of the marked increase in thromboembolic events. Estrogens can also be administered in sublingual, intramuscular, or transdermal forms. Antiandrogens are often required to help decrease endogenous testosterone levels to cisgender female levels (30-100 ng/dL).³ Spironolactone is most commonly prescribed as an adjunct to estrogen therapy. Finasteride and GnRH agonists like leuprolide acetate can also be added if spironolactone is not effective or not tolerated by the patient. Feminizing effects of estrogen can take several months and most commonly include decreased spontaneous erections, decreased libido, breast growth, redistribution of fat to the waist and hips, decreased skin oiliness, and softening of the skin.³

Overall, hormone therapy for both transgender men and women is considered effective, safe, and well tolerated.⁴ Monitoring is typically performed every 3 months within the first year after initiating hormone therapy, and then continued every 6-12 months thereafter. Routine screening for all organs and tissues present (e.g. prostate, breast) should be undertaken.³ While this simply highlights the therapy and surveillance for patients, it is important to remember that many transgender men and women will see an obstetrician/gynecologist at some interval during their transition. Ultimately, it is paramount that we as obstetricians/gynecologists have a basic understanding of the treatments available so we can provide our patients with competent and compassionate care.
 

Dr. Brandt is an obstetrician/gynecologist and a plastic surgeon at Reading Hospital/Tower Health System in West Reading, Pa., where she has developed a gender-affirming medical and surgical clinic for ob.gyn. residents and plastic surgeon fellows.

References

1. World Professional Association for Transgender Health. Standards of care for the health of transsexual, transgender, and gender nonconforming people. 7th version. Accessed 10/15/20.

2. Joint meeting of the International Society of Endocrinology and the Endocrine Society 2014; ICE/ENDO 2014, Paper 14354. Accessed 01/08/16.

3. Qian R, Safer JD. Hormone treatment for the adult transgender patient, in “Comprehensive Care of the Transgender Patient,” 1st ed. Philadelphia: Elsevier, 2020, pp. 34-6.

4. Weinand JD and Safer JD. Hormone therapy in transgender adults is safe with provider supervision: A review of hormone therapy sequelae for transgender individuals. J Clin Transl Endocrinol. 2015;2(2):55-60.
 

In reproductive medicine, there are few, if any, more pressing concerns from our patients than the biological clock, i.e., ovarian aging. While addressing this issue with women can be challenging, particularly for those who are anxious regarding their advanced maternal age, gynecologists must possess a thorough understanding of available diagnostic testing. This article will review the various methods to assess ovarian age and appropriate clinical management.

Ovarian reserve tests

Ovarian reserve represents the quality and quantity of oocytes. The former is defined by the woman’s chronologic age, which is the greatest predictor of fertility. From a peak monthly fecundity rate at age 30 of approximately 20%, the slow and steady decline of fertility ensues. Quantity represents the number of oocytes remaining from the original cohort.

Ovarian reserve is most provocatively gauged by the follicle response to gonadotropin stimulation, typically during an in vitro fertilization (IVF) cycle.

Several biomarkers have been used to assess ovarian age. These include FSH, estradiol, and inhibin B. In general, these tests are more specific than sensitive, i.e., “normal” results do not necessarily exclude decreased ovarian reserve. But as a screening tool for decreased ovarian reserve, the most important factor is the positive predictive value (PPV). Statistically, in a population of women at low risk for decreased ovarian reserve, the PPV will be low despite sensitivity and specificity.

While inhibin B is a more direct and earlier reflection of ovarian function produced by granulose cells, assays lacked consistent results and a standardized cut-off value. FSH is the last biomarker to be affected by decreased ovarian reserve so elevations reflect more “end-stage” ovarian aging.

Additional tests for decreased ovarian reserve include antral follicle count (AFC) and the clomiphene citrate challenge test (CCCT). AFC is determined by using transvaginal ultrasound to count the number of follicular cysts in the 2- to 9-mm range. While AFC can be performed on any day of the cycle, the ovary is most optimally measured on menses because of less cystic activity. A combined AFC of 3-6 is considered severe decreased ovarian reserve. The CCCT involves prescribing clomiphene citrate 100 mg daily from cycle day 5-9 to measure FSH on cycle days 3 and 10. An FSH level greater than 10 IU/L or any elevation in FSH following CCCT is considered decreased ovarian reserve.

FSH had been the standard but levels may dramatically change monthly, making testing only valuable if it is elevated. Consequently, antimüllerian hormone (AMH) and AFC are considered the most useful tools to determine decreased ovarian reserve because of less variability. The other distinct advantage is the ability to obtain AMH any day in the menstrual cycle. Recently, in women undergoing IVF, AMH was superior to FSH in predicting live birth, particularly when their values were discordant (J Ovarian Res. 2018;11:60). While there is no established consensus, the ideal interval for repeating AMH appears to be approximately 3 months (Obstet Gynecol 2016;127:65S-6S).
 

AMH

AMH is expressed in the embryo at 8 weeks by the Sertoli cells of the testis causing the female reproductive internal system (müllerian) to regress. Without AMH expression, the müllerian system remains and the male (woffian duct system) regresses. The discovery of AMH production by the granulosa cells of the ovary launched a new era in the evaluation and management of infertile women. First reported in Fertility & Sterility in 2002 as a much earlier potential marker of ovarian aging, low levels of AMH predict a lower number of eggs in IVF.

AMH levels are produced in the embryo at 36 weeks’ gestation and increase up to the age of 24.5 years, decreasing thereafter. AMH reflects primordial (early) follicles that are FSH independent. The median AMH level decreases per year according to age groups are: 0.25 ng/mL in ages 26-30; 0.2 ng/mL in ages 31-36 years; and 0.1 ng/mL above age 36. (PLOS ONE 2015 doi: 10.1371/journal.pone.0125216).

AMH has also been studied as a potential biomarker to diagnose PCOS. While many women with PCOS have elevated AMH levels (typically greater than 3 ng/mL), there is no consensus on an AMH value that would be a criterion.

Many women, particularly those electing to defer fertility, express interest in obtaining their AMH level to consider planned oocyte cryopreservation, AKA, social egg freezing. While it is possible the results of AMH screening may compel women to electively freeze their eggs, extensive counseling on the implications and pitfalls of AMH levels is essential. Further, AMH cannot be used to accurately predict menopause.
 

Predicting outcomes

No biomarker is necessarily predictive of pregnancy but more a gauge of gonadotropin dosage to induce multifollicular development. AMH is a great predictor of oocyte yield with IVF (J Assist Reprod Genet. 2009;26[7]:383-9). However, in women older than 35 undergoing IVF, low AMH levels have been shown to reduce pregnancy rates (J Hum Reprod Sci. 2017;10:24–30). During IVF cycle attempts, an ultra-low AMH (≤0.4) resulted in high cancellation rates, reduced the number of oocytes retrieved and embryos developed, and lowered pregnancy rates in women of advanced reproductive age.

Alternatively, a study of 750 women who were not infertile and were actively trying to conceive demonstrated no difference in natural pregnancy rates in women aged 30-44 irrespective of AMH levels (JAMA. 2017;318[14]:1367-76).

A special consideration is for cancer patients who are status postgonadotoxic chemotherapy. Their oocyte attrition can be accelerated and AMH levels can become profoundly low. In those patients, current data suggest there is a modest recovery of postchemotherapy AMH levels up to 1 year. Further, oocyte yield following stimulation may be higher than expected despite a poor AMH level.
 

Conclusion

Ovarian aging is currently best measured by combining chronologic age, AFC, and AMH. There is no current evidence that AMH levels should be used to exclude patients from undergoing IVF or to recommend egg donation. Random screening of AMH levels in a low-risk population for decreased ovarian reserve may result in unnecessary alarm.

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

In reproductive medicine, there are few, if any, more pressing concerns from our patients than the biological clock, i.e., ovarian aging. While addressing this issue with women can be challenging, particularly for those who are anxious regarding their advanced maternal age, gynecologists must possess a thorough understanding of available diagnostic testing. This article will review the various methods to assess ovarian age and appropriate clinical management.

Ovarian reserve tests

Ovarian reserve represents the quality and quantity of oocytes. The former is defined by the woman’s chronologic age, which is the greatest predictor of fertility. From a peak monthly fecundity rate at age 30 of approximately 20%, the slow and steady decline of fertility ensues. Quantity represents the number of oocytes remaining from the original cohort.

Ovarian reserve is most provocatively gauged by the follicle response to gonadotropin stimulation, typically during an in vitro fertilization (IVF) cycle.

Several biomarkers have been used to assess ovarian age. These include FSH, estradiol, and inhibin B. In general, these tests are more specific than sensitive, i.e., “normal” results do not necessarily exclude decreased ovarian reserve. But as a screening tool for decreased ovarian reserve, the most important factor is the positive predictive value (PPV). Statistically, in a population of women at low risk for decreased ovarian reserve, the PPV will be low despite sensitivity and specificity.

While inhibin B is a more direct and earlier reflection of ovarian function produced by granulose cells, assays lacked consistent results and a standardized cut-off value. FSH is the last biomarker to be affected by decreased ovarian reserve so elevations reflect more “end-stage” ovarian aging.

Additional tests for decreased ovarian reserve include antral follicle count (AFC) and the clomiphene citrate challenge test (CCCT). AFC is determined by using transvaginal ultrasound to count the number of follicular cysts in the 2- to 9-mm range. While AFC can be performed on any day of the cycle, the ovary is most optimally measured on menses because of less cystic activity. A combined AFC of 3-6 is considered severe decreased ovarian reserve. The CCCT involves prescribing clomiphene citrate 100 mg daily from cycle day 5-9 to measure FSH on cycle days 3 and 10. An FSH level greater than 10 IU/L or any elevation in FSH following CCCT is considered decreased ovarian reserve.

FSH had been the standard but levels may dramatically change monthly, making testing only valuable if it is elevated. Consequently, antimüllerian hormone (AMH) and AFC are considered the most useful tools to determine decreased ovarian reserve because of less variability. The other distinct advantage is the ability to obtain AMH any day in the menstrual cycle. Recently, in women undergoing IVF, AMH was superior to FSH in predicting live birth, particularly when their values were discordant (J Ovarian Res. 2018;11:60). While there is no established consensus, the ideal interval for repeating AMH appears to be approximately 3 months (Obstet Gynecol 2016;127:65S-6S).
 

AMH

AMH is expressed in the embryo at 8 weeks by the Sertoli cells of the testis causing the female reproductive internal system (müllerian) to regress. Without AMH expression, the müllerian system remains and the male (woffian duct system) regresses. The discovery of AMH production by the granulosa cells of the ovary launched a new era in the evaluation and management of infertile women. First reported in Fertility & Sterility in 2002 as a much earlier potential marker of ovarian aging, low levels of AMH predict a lower number of eggs in IVF.

AMH levels are produced in the embryo at 36 weeks’ gestation and increase up to the age of 24.5 years, decreasing thereafter. AMH reflects primordial (early) follicles that are FSH independent. The median AMH level decreases per year according to age groups are: 0.25 ng/mL in ages 26-30; 0.2 ng/mL in ages 31-36 years; and 0.1 ng/mL above age 36. (PLOS ONE 2015 doi: 10.1371/journal.pone.0125216).

AMH has also been studied as a potential biomarker to diagnose PCOS. While many women with PCOS have elevated AMH levels (typically greater than 3 ng/mL), there is no consensus on an AMH value that would be a criterion.

Many women, particularly those electing to defer fertility, express interest in obtaining their AMH level to consider planned oocyte cryopreservation, AKA, social egg freezing. While it is possible the results of AMH screening may compel women to electively freeze their eggs, extensive counseling on the implications and pitfalls of AMH levels is essential. Further, AMH cannot be used to accurately predict menopause.
 

Predicting outcomes

No biomarker is necessarily predictive of pregnancy but more a gauge of gonadotropin dosage to induce multifollicular development. AMH is a great predictor of oocyte yield with IVF (J Assist Reprod Genet. 2009;26[7]:383-9). However, in women older than 35 undergoing IVF, low AMH levels have been shown to reduce pregnancy rates (J Hum Reprod Sci. 2017;10:24–30). During IVF cycle attempts, an ultra-low AMH (≤0.4) resulted in high cancellation rates, reduced the number of oocytes retrieved and embryos developed, and lowered pregnancy rates in women of advanced reproductive age.

Alternatively, a study of 750 women who were not infertile and were actively trying to conceive demonstrated no difference in natural pregnancy rates in women aged 30-44 irrespective of AMH levels (JAMA. 2017;318[14]:1367-76).

A special consideration is for cancer patients who are status postgonadotoxic chemotherapy. Their oocyte attrition can be accelerated and AMH levels can become profoundly low. In those patients, current data suggest there is a modest recovery of postchemotherapy AMH levels up to 1 year. Further, oocyte yield following stimulation may be higher than expected despite a poor AMH level.
 

Conclusion

Ovarian aging is currently best measured by combining chronologic age, AFC, and AMH. There is no current evidence that AMH levels should be used to exclude patients from undergoing IVF or to recommend egg donation. Random screening of AMH levels in a low-risk population for decreased ovarian reserve may result in unnecessary alarm.

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

In reproductive medicine, there are few, if any, more pressing concerns from our patients than the biological clock, i.e., ovarian aging. While addressing this issue with women can be challenging, particularly for those who are anxious regarding their advanced maternal age, gynecologists must possess a thorough understanding of available diagnostic testing. This article will review the various methods to assess ovarian age and appropriate clinical management.

Ovarian reserve tests

Ovarian reserve represents the quality and quantity of oocytes. The former is defined by the woman’s chronologic age, which is the greatest predictor of fertility. From a peak monthly fecundity rate at age 30 of approximately 20%, the slow and steady decline of fertility ensues. Quantity represents the number of oocytes remaining from the original cohort.

Ovarian reserve is most provocatively gauged by the follicle response to gonadotropin stimulation, typically during an in vitro fertilization (IVF) cycle.

Several biomarkers have been used to assess ovarian age. These include FSH, estradiol, and inhibin B. In general, these tests are more specific than sensitive, i.e., “normal” results do not necessarily exclude decreased ovarian reserve. But as a screening tool for decreased ovarian reserve, the most important factor is the positive predictive value (PPV). Statistically, in a population of women at low risk for decreased ovarian reserve, the PPV will be low despite sensitivity and specificity.

While inhibin B is a more direct and earlier reflection of ovarian function produced by granulose cells, assays lacked consistent results and a standardized cut-off value. FSH is the last biomarker to be affected by decreased ovarian reserve so elevations reflect more “end-stage” ovarian aging.

Additional tests for decreased ovarian reserve include antral follicle count (AFC) and the clomiphene citrate challenge test (CCCT). AFC is determined by using transvaginal ultrasound to count the number of follicular cysts in the 2- to 9-mm range. While AFC can be performed on any day of the cycle, the ovary is most optimally measured on menses because of less cystic activity. A combined AFC of 3-6 is considered severe decreased ovarian reserve. The CCCT involves prescribing clomiphene citrate 100 mg daily from cycle day 5-9 to measure FSH on cycle days 3 and 10. An FSH level greater than 10 IU/L or any elevation in FSH following CCCT is considered decreased ovarian reserve.

FSH had been the standard but levels may dramatically change monthly, making testing only valuable if it is elevated. Consequently, antimüllerian hormone (AMH) and AFC are considered the most useful tools to determine decreased ovarian reserve because of less variability. The other distinct advantage is the ability to obtain AMH any day in the menstrual cycle. Recently, in women undergoing IVF, AMH was superior to FSH in predicting live birth, particularly when their values were discordant (J Ovarian Res. 2018;11:60). While there is no established consensus, the ideal interval for repeating AMH appears to be approximately 3 months (Obstet Gynecol 2016;127:65S-6S).
 

AMH

AMH is expressed in the embryo at 8 weeks by the Sertoli cells of the testis causing the female reproductive internal system (müllerian) to regress. Without AMH expression, the müllerian system remains and the male (woffian duct system) regresses. The discovery of AMH production by the granulosa cells of the ovary launched a new era in the evaluation and management of infertile women. First reported in Fertility & Sterility in 2002 as a much earlier potential marker of ovarian aging, low levels of AMH predict a lower number of eggs in IVF.

AMH levels are produced in the embryo at 36 weeks’ gestation and increase up to the age of 24.5 years, decreasing thereafter. AMH reflects primordial (early) follicles that are FSH independent. The median AMH level decreases per year according to age groups are: 0.25 ng/mL in ages 26-30; 0.2 ng/mL in ages 31-36 years; and 0.1 ng/mL above age 36. (PLOS ONE 2015 doi: 10.1371/journal.pone.0125216).

AMH has also been studied as a potential biomarker to diagnose PCOS. While many women with PCOS have elevated AMH levels (typically greater than 3 ng/mL), there is no consensus on an AMH value that would be a criterion.

Many women, particularly those electing to defer fertility, express interest in obtaining their AMH level to consider planned oocyte cryopreservation, AKA, social egg freezing. While it is possible the results of AMH screening may compel women to electively freeze their eggs, extensive counseling on the implications and pitfalls of AMH levels is essential. Further, AMH cannot be used to accurately predict menopause.
 

Predicting outcomes

No biomarker is necessarily predictive of pregnancy but more a gauge of gonadotropin dosage to induce multifollicular development. AMH is a great predictor of oocyte yield with IVF (J Assist Reprod Genet. 2009;26[7]:383-9). However, in women older than 35 undergoing IVF, low AMH levels have been shown to reduce pregnancy rates (J Hum Reprod Sci. 2017;10:24–30). During IVF cycle attempts, an ultra-low AMH (≤0.4) resulted in high cancellation rates, reduced the number of oocytes retrieved and embryos developed, and lowered pregnancy rates in women of advanced reproductive age.

Alternatively, a study of 750 women who were not infertile and were actively trying to conceive demonstrated no difference in natural pregnancy rates in women aged 30-44 irrespective of AMH levels (JAMA. 2017;318[14]:1367-76).

A special consideration is for cancer patients who are status postgonadotoxic chemotherapy. Their oocyte attrition can be accelerated and AMH levels can become profoundly low. In those patients, current data suggest there is a modest recovery of postchemotherapy AMH levels up to 1 year. Further, oocyte yield following stimulation may be higher than expected despite a poor AMH level.
 

Conclusion

Ovarian aging is currently best measured by combining chronologic age, AFC, and AMH. There is no current evidence that AMH levels should be used to exclude patients from undergoing IVF or to recommend egg donation. Random screening of AMH levels in a low-risk population for decreased ovarian reserve may result in unnecessary alarm.

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