Ob.Gyn. News

Breast cancer in women remains one of the most common types of cancer in the United States, affecting about one in eight women¹ over the course of their lifetime. Despite its pervasiveness, the 5-year survival rate for women with breast cancer remains high, estimated at around 90%² based on data from 2010-2016, in large part because of early detection and treatment through screening. However, many organizations disagree on when to start and how often to screen women at average risk.

Important to discussions about breast cancer screening is the trend that many women delay childbirth until their 30s and 40s. In 2018 the birth rate increased for women ages 35-44, and the mean age of first birth increased from the prior year across all racial and ethnic groups.³ Therefore, ob.gyns. may need to consider that their patients not only may have increased risk of developing breast cancer based on age alone – women aged 35-44 have four times greater risk of disease than women aged 20-34² – but that the pregnancy itself may further exacerbate risk in older women. A 2019 pooled analysis found that women who were older at first birth had a greater chance of developing breast cancer compared with women with no children.⁴

In addition, ob.gyns. should consider that their patients may have received a breast cancer diagnosis prior to initiation or completion of their family plans or that their patients are cancer survivors – in 2013-2017, breast cancer was the most common form of cancer in adolescents and young adults.⁵ Thus, practitioners should be prepared to discuss not only options for fertility preservation but the evidence regarding cancer recurrence after pregnancy.

We have invited Dr. Katherine Tkaczuk, professor of medicine at the University of Maryland School of Medicine* and director of the breast evaluation and treatment program at the Marlene and Stewart Greenebaum Comprehensive Cancer Center, to discuss the vital role of screening in the shared decision-making process of breast cancer prevention.
 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore,* as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

Correction, 1/8/21: *An earlier version of this article misstated the university affiliations for Dr. Tkaczuk and Dr. Reece.

References

1. U.S. Breast Cancer Statistics. breastcancer.org.

2. “Cancer Stat Facts: Female Breast Cancer,” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.

3. Martin JA et al. “Births: Final Data for 2018.” National Vital Statistics Reports. 2019 Nov 27;68(13):1-46.

4. Nichols HB et al. Ann Intern Med. 2019 Jan;170(1):22-30.

5. “Cancer Stat Facts: Cancer Among Adolescents and Young Adults (AYAs) (Ages 15-39),” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.
 

Breast cancer in women remains one of the most common types of cancer in the United States, affecting about one in eight women¹ over the course of their lifetime. Despite its pervasiveness, the 5-year survival rate for women with breast cancer remains high, estimated at around 90%² based on data from 2010-2016, in large part because of early detection and treatment through screening. However, many organizations disagree on when to start and how often to screen women at average risk.

Important to discussions about breast cancer screening is the trend that many women delay childbirth until their 30s and 40s. In 2018 the birth rate increased for women ages 35-44, and the mean age of first birth increased from the prior year across all racial and ethnic groups.³ Therefore, ob.gyns. may need to consider that their patients not only may have increased risk of developing breast cancer based on age alone – women aged 35-44 have four times greater risk of disease than women aged 20-34² – but that the pregnancy itself may further exacerbate risk in older women. A 2019 pooled analysis found that women who were older at first birth had a greater chance of developing breast cancer compared with women with no children.⁴

In addition, ob.gyns. should consider that their patients may have received a breast cancer diagnosis prior to initiation or completion of their family plans or that their patients are cancer survivors – in 2013-2017, breast cancer was the most common form of cancer in adolescents and young adults.⁵ Thus, practitioners should be prepared to discuss not only options for fertility preservation but the evidence regarding cancer recurrence after pregnancy.

We have invited Dr. Katherine Tkaczuk, professor of medicine at the University of Maryland School of Medicine* and director of the breast evaluation and treatment program at the Marlene and Stewart Greenebaum Comprehensive Cancer Center, to discuss the vital role of screening in the shared decision-making process of breast cancer prevention.
 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore,* as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

Correction, 1/8/21: *An earlier version of this article misstated the university affiliations for Dr. Tkaczuk and Dr. Reece.

References

1. U.S. Breast Cancer Statistics. breastcancer.org.

2. “Cancer Stat Facts: Female Breast Cancer,” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.

3. Martin JA et al. “Births: Final Data for 2018.” National Vital Statistics Reports. 2019 Nov 27;68(13):1-46.

4. Nichols HB et al. Ann Intern Med. 2019 Jan;170(1):22-30.

5. “Cancer Stat Facts: Cancer Among Adolescents and Young Adults (AYAs) (Ages 15-39),” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.
 

Breast cancer in women remains one of the most common types of cancer in the United States, affecting about one in eight women¹ over the course of their lifetime. Despite its pervasiveness, the 5-year survival rate for women with breast cancer remains high, estimated at around 90%² based on data from 2010-2016, in large part because of early detection and treatment through screening. However, many organizations disagree on when to start and how often to screen women at average risk.

Important to discussions about breast cancer screening is the trend that many women delay childbirth until their 30s and 40s. In 2018 the birth rate increased for women ages 35-44, and the mean age of first birth increased from the prior year across all racial and ethnic groups.³ Therefore, ob.gyns. may need to consider that their patients not only may have increased risk of developing breast cancer based on age alone – women aged 35-44 have four times greater risk of disease than women aged 20-34² – but that the pregnancy itself may further exacerbate risk in older women. A 2019 pooled analysis found that women who were older at first birth had a greater chance of developing breast cancer compared with women with no children.⁴

In addition, ob.gyns. should consider that their patients may have received a breast cancer diagnosis prior to initiation or completion of their family plans or that their patients are cancer survivors – in 2013-2017, breast cancer was the most common form of cancer in adolescents and young adults.⁵ Thus, practitioners should be prepared to discuss not only options for fertility preservation but the evidence regarding cancer recurrence after pregnancy.

We have invited Dr. Katherine Tkaczuk, professor of medicine at the University of Maryland School of Medicine* and director of the breast evaluation and treatment program at the Marlene and Stewart Greenebaum Comprehensive Cancer Center, to discuss the vital role of screening in the shared decision-making process of breast cancer prevention.
 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore,* as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

Correction, 1/8/21: *An earlier version of this article misstated the university affiliations for Dr. Tkaczuk and Dr. Reece.

References

1. U.S. Breast Cancer Statistics. breastcancer.org.

2. “Cancer Stat Facts: Female Breast Cancer,” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.

3. Martin JA et al. “Births: Final Data for 2018.” National Vital Statistics Reports. 2019 Nov 27;68(13):1-46.

4. Nichols HB et al. Ann Intern Med. 2019 Jan;170(1):22-30.

5. “Cancer Stat Facts: Cancer Among Adolescents and Young Adults (AYAs) (Ages 15-39),” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.
 

Screening mammography has contributed to the lowering of mortality from breast cancer by facilitating earlier diagnosis and a lower stage at diagnosis. With more effective treatment options for women who are diagnosed with lower-stage breast cancer, the current 5-year survival rate has risen to 90% – significantly higher than the 5-year survival rate of 75% in 1975.¹

Courtesy Dr. Katherine Tkaczuk

Women who are at much higher risk for developing breast cancer – mainly because of family history, certain genetic mutations, or a history of radiation therapy to the chest – will benefit the most from earlier and more frequent screening mammography as well as enhanced screening with non-x-ray methods of breast imaging. It is important that ob.gyns. help to identify these women.

However, the majority of women who are screened with mammography are at “average risk,” with a lifetime risk for developing breast cancer of 12.9%, based on 2015-2017 data from the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results Program (SEER).¹ The median age at diagnosis of breast cancer in the U.S. is 62 years,¹ and advancing age is the most important risk factor for these women.

A 20% relative risk reduction in breast cancer mortality with screening mammography has been demonstrated both in systematic reviews of randomized and observational studies² and in a meta-analysis of 11 randomized trials comparing screening and no screening.³ Even though the majority of randomized trials were done in the age of film mammography, experts believe that we still see at least a 20% reduction today.

Among average-risk women, those aged 50-74 with a life expectancy of at least 10 years will benefit the most from regular screening. According to the 2016 screening guideline of the United States Preventive Services Task Force (USPSTF), relative risk reductions in breast cancer mortality from mammography screening, by age group, are 0.88 (confidence interval, 0.73-1.003) for ages 39-49; 0.86 (CI, 0.68-0.97) for ages 50-59; 0.67 (CI, 0.55-0.91) for ages 60-69; and 0.80 (CI, 0.51 to 1.28) for ages 70-74.²

For women aged 40-49 years, most of the guidelines in the United States recommend individualized screening every 1 or 2 years – screening that is guided by shared decision-making that takes into account each woman’s values regarding relative harms and benefits. This is because their risk of developing breast cancer is relatively low while the risk of false-positive results can be higher.

A few exceptions include guidelines by the National Comprehensive Cancer Network (NCCN) and the American College of Radiology, which recommend annual screening mammography starting at age 40 years for all average-risk women. In our program, we adhere to these latter recommendations and advise annual digital 3-D mammograms starting at age 40 and continuing until age 74, or longer if the woman is otherwise healthy with a life expectancy greater than 10 years.
 

Screening and overdiagnosis

Overdiagnosis – the diagnosis of cancers that may not actually cause mortality or may not even have become apparent without screening – is a concern for all women undergoing routine screening for breast cancer. There is significant uncertainty about its frequency, however.

Research cited by the USPSTF suggests that as many as one in five women diagnosed with breast cancer over approximately 10 years will be overdiagnosed. Other modeling studies have estimated one in eight overdiagnoses, for women aged 50-75 years specifically. By the more conservative estimate, according to the USPSTF, one breast cancer death will be prevented for every 2-3 cases of unnecessary treatment.²

Ductal carcinoma in situ is confined to the mammary ductal-lobular system and lacks the classic characteristics of cancer. Technically, it should not metastasize. But we do not know with certainty which cases of DCIS will or will not progress to invasive cancer. Therefore these women often are offered surgical approaches mirroring invasive cancer treatments (lumpectomy with radiation or even mastectomy in some cases), while for some, such treatments may be unnecessary.
 

Screening younger women (40-49)

Shared decision-making is always important for breast cancer screening, but in our program we routinely recommend annual screening in average-risk women starting at age 40 for several reasons. For one, younger women may present with more aggressive types of breast cancer such as triple-negative breast cancer. These are much less common than hormone-receptor positive breast cancers – they represent 15%-20% of all breast cancers – but they are faster growing and may develop in the interim if women are screened less often (at 2-year intervals).

In addition, finding an invasive breast cancer early is almost always beneficial. Earlier diagnosis (lower stage at diagnosis) is associated with increased breast cancer-specific and overall survival, as well as less-aggressive treatment approaches.

As a medical oncologist who treats women with breast cancer, I see these benefits firsthand. With earlier diagnosis, we are more likely to offer less aggressive surgical approaches such as partial mastectomy (lumpectomy) and sentinel lymph node biopsy as opposed to total mastectomy with axillary lymph node dissection, the latter of which is more likely to be associated with lymphedema and which can lead to postmastectomy chest wall pain syndromes.

We also are able to use less aggressive radiation therapy approaches such as partial breast radiation, and less aggressive breast cancer–specific systemic treatments for women with a lower stage of breast cancer at diagnosis. In some cases, adjuvant or neoadjuvant chemotherapy may not be needed – and when it is necessary, shorter courses of chemotherapy or targeted chemotherapeutic regimens may be offered. This means lower systemic toxicities, both early and late, such as less cytopenias, risk of infections, mucositis, hair loss, cardiotoxicity, secondary malignancies/leukemia, and peripheral sensory neuropathy.

It is important to note that Black women in the United States have the highest death rate from breast cancer – 27.3 per 100,000 per year, versus 19.6 per 100,000 per year for White women¹ – and that younger Black women appear to have a higher risk of developing triple-negative breast cancer, a more aggressive type of breast cancer. The higher breast cancer mortality in Black women is likely multifactorial and may be attributed partly to disparities in health care and partly to tumor biology. The case for annual screening in this population thus seems especially strong.
 

Screening modalities

Digital 3-D mammography, or digital breast tomosynthesis (DBT), is widely considered to be a more sensitive screening tool than conventional digital mammography alone. The NCCN recommends DBT for women with an average risk of developing breast cancer starting at age 40,^4,5 and the USPSTF, while offering no recommendation on DBT as a primary screening method (“insufficient evidence”), says that DBT appears to increase cancer detection rates.² So, I do routinely recommend it.

DBT may be especially beneficial for women with dense breast tissue (determined mammographically), who are most often premenopausal women – particularly non-Hispanic White women. Dense breast tissue itself can contribute to an increased risk of breast cancer – an approximately 20% higher relative risk in an average-risk woman with heterogeneously dense breast tissue, and an approximately 100% higher relative risk in a woman with extremely dense breasts⁶ – but unfortunately it affects the sensitivity and specificity of screening mammography.

I do not recommend routine supplemental screening with other methods (breast ultrasonography or MRI) for women at average risk of breast cancer who have dense breasts. MRI with gadolinium contrast is recommended as an adjunct to mammography for women who have a lifetime risk of developing breast cancer of more than 20%-25% (e.g., women with known BRCA1/2 mutations or radiation to breast tissue), and can be done annually at the same time as the screening mammogram is done. Some clinicians and patients prefer to alternate these two tests – one every 6 months.

Screening breast MRI is more sensitive but less specific than mammography; combining the two screening modalities leads to overall increased sensitivity and specificity in high-risk populations.
 

Risk assessment

Identifying higher-risk women who need to be sent to a genetic counselor is critically important. The USPSTF recommends that women who have family members with breast, ovarian, tubal or peritoneal cancer, or who have an ancestry associated with BRCA1/2 gene mutations, be assessed with a brief familial risk assessment tool such as the Pedigree Assessment Tool. This and other validated tools have been evaluated by the USPSTF and can be used to guide referrals to genetic counseling for more definitive risk assessment.⁷

These tools are different from general breast cancer risk assessment models, such as the NCI’s Breast Cancer Risk Assessment Tool,⁸ which are designed to calculate the 5-year and lifetime risk of developing invasive breast cancer for an average-risk woman but not to identify BRCA-related cancer risk. (The NCI’s tool is based on the Gail model, which has been widely used over the years.)

The general risk assessment models use a women’s personal medical and reproductive history as well as the history of breast cancer among her first-degree relatives to estimate her risk.
 

Dr. Tkaczuk reported that she has no disclosures.

References

1. “Cancer Stat Facts: Female Breast Cancer.” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.

2. Siu AL et al. Ann Intern Med. 2016 Feb 16. doi: 10.7326/M15-2886.

3. Independent UK Panel on Breast Cancer Screening. Lancet. 2012 Nov 17;380(9855):1778-86.

4. NCCN guidelines for Detection, Prevention, & Risk Reduction: Breast Cancer Screening and Diagnosis. National Comprehensive Cancer Network.

5. NCCN guidelines for Detection, Prevention, & Risk Reduction: Breast Cancer Risk Reduction. National Comprehensive Cancer Network.

6. Ziv E et al. Cancer Epidemiol Biomarkers Prev. 2004;13(12):2090-5.

7. USPSTF. JAMA. 2019;322(7):652-65.

8. The Breast Cancer Risk Assessment Tool. National Cancer Institute.
 

Screening mammography has contributed to the lowering of mortality from breast cancer by facilitating earlier diagnosis and a lower stage at diagnosis. With more effective treatment options for women who are diagnosed with lower-stage breast cancer, the current 5-year survival rate has risen to 90% – significantly higher than the 5-year survival rate of 75% in 1975.¹

Courtesy Dr. Katherine Tkaczuk

Women who are at much higher risk for developing breast cancer – mainly because of family history, certain genetic mutations, or a history of radiation therapy to the chest – will benefit the most from earlier and more frequent screening mammography as well as enhanced screening with non-x-ray methods of breast imaging. It is important that ob.gyns. help to identify these women.

However, the majority of women who are screened with mammography are at “average risk,” with a lifetime risk for developing breast cancer of 12.9%, based on 2015-2017 data from the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results Program (SEER).¹ The median age at diagnosis of breast cancer in the U.S. is 62 years,¹ and advancing age is the most important risk factor for these women.

A 20% relative risk reduction in breast cancer mortality with screening mammography has been demonstrated both in systematic reviews of randomized and observational studies² and in a meta-analysis of 11 randomized trials comparing screening and no screening.³ Even though the majority of randomized trials were done in the age of film mammography, experts believe that we still see at least a 20% reduction today.

Among average-risk women, those aged 50-74 with a life expectancy of at least 10 years will benefit the most from regular screening. According to the 2016 screening guideline of the United States Preventive Services Task Force (USPSTF), relative risk reductions in breast cancer mortality from mammography screening, by age group, are 0.88 (confidence interval, 0.73-1.003) for ages 39-49; 0.86 (CI, 0.68-0.97) for ages 50-59; 0.67 (CI, 0.55-0.91) for ages 60-69; and 0.80 (CI, 0.51 to 1.28) for ages 70-74.²

For women aged 40-49 years, most of the guidelines in the United States recommend individualized screening every 1 or 2 years – screening that is guided by shared decision-making that takes into account each woman’s values regarding relative harms and benefits. This is because their risk of developing breast cancer is relatively low while the risk of false-positive results can be higher.

A few exceptions include guidelines by the National Comprehensive Cancer Network (NCCN) and the American College of Radiology, which recommend annual screening mammography starting at age 40 years for all average-risk women. In our program, we adhere to these latter recommendations and advise annual digital 3-D mammograms starting at age 40 and continuing until age 74, or longer if the woman is otherwise healthy with a life expectancy greater than 10 years.
 

Screening and overdiagnosis

Overdiagnosis – the diagnosis of cancers that may not actually cause mortality or may not even have become apparent without screening – is a concern for all women undergoing routine screening for breast cancer. There is significant uncertainty about its frequency, however.

Research cited by the USPSTF suggests that as many as one in five women diagnosed with breast cancer over approximately 10 years will be overdiagnosed. Other modeling studies have estimated one in eight overdiagnoses, for women aged 50-75 years specifically. By the more conservative estimate, according to the USPSTF, one breast cancer death will be prevented for every 2-3 cases of unnecessary treatment.²

Ductal carcinoma in situ is confined to the mammary ductal-lobular system and lacks the classic characteristics of cancer. Technically, it should not metastasize. But we do not know with certainty which cases of DCIS will or will not progress to invasive cancer. Therefore these women often are offered surgical approaches mirroring invasive cancer treatments (lumpectomy with radiation or even mastectomy in some cases), while for some, such treatments may be unnecessary.
 

Screening younger women (40-49)

Shared decision-making is always important for breast cancer screening, but in our program we routinely recommend annual screening in average-risk women starting at age 40 for several reasons. For one, younger women may present with more aggressive types of breast cancer such as triple-negative breast cancer. These are much less common than hormone-receptor positive breast cancers – they represent 15%-20% of all breast cancers – but they are faster growing and may develop in the interim if women are screened less often (at 2-year intervals).

In addition, finding an invasive breast cancer early is almost always beneficial. Earlier diagnosis (lower stage at diagnosis) is associated with increased breast cancer-specific and overall survival, as well as less-aggressive treatment approaches.

As a medical oncologist who treats women with breast cancer, I see these benefits firsthand. With earlier diagnosis, we are more likely to offer less aggressive surgical approaches such as partial mastectomy (lumpectomy) and sentinel lymph node biopsy as opposed to total mastectomy with axillary lymph node dissection, the latter of which is more likely to be associated with lymphedema and which can lead to postmastectomy chest wall pain syndromes.

We also are able to use less aggressive radiation therapy approaches such as partial breast radiation, and less aggressive breast cancer–specific systemic treatments for women with a lower stage of breast cancer at diagnosis. In some cases, adjuvant or neoadjuvant chemotherapy may not be needed – and when it is necessary, shorter courses of chemotherapy or targeted chemotherapeutic regimens may be offered. This means lower systemic toxicities, both early and late, such as less cytopenias, risk of infections, mucositis, hair loss, cardiotoxicity, secondary malignancies/leukemia, and peripheral sensory neuropathy.

It is important to note that Black women in the United States have the highest death rate from breast cancer – 27.3 per 100,000 per year, versus 19.6 per 100,000 per year for White women¹ – and that younger Black women appear to have a higher risk of developing triple-negative breast cancer, a more aggressive type of breast cancer. The higher breast cancer mortality in Black women is likely multifactorial and may be attributed partly to disparities in health care and partly to tumor biology. The case for annual screening in this population thus seems especially strong.
 

Screening modalities

Digital 3-D mammography, or digital breast tomosynthesis (DBT), is widely considered to be a more sensitive screening tool than conventional digital mammography alone. The NCCN recommends DBT for women with an average risk of developing breast cancer starting at age 40,^4,5 and the USPSTF, while offering no recommendation on DBT as a primary screening method (“insufficient evidence”), says that DBT appears to increase cancer detection rates.² So, I do routinely recommend it.

DBT may be especially beneficial for women with dense breast tissue (determined mammographically), who are most often premenopausal women – particularly non-Hispanic White women. Dense breast tissue itself can contribute to an increased risk of breast cancer – an approximately 20% higher relative risk in an average-risk woman with heterogeneously dense breast tissue, and an approximately 100% higher relative risk in a woman with extremely dense breasts⁶ – but unfortunately it affects the sensitivity and specificity of screening mammography.

I do not recommend routine supplemental screening with other methods (breast ultrasonography or MRI) for women at average risk of breast cancer who have dense breasts. MRI with gadolinium contrast is recommended as an adjunct to mammography for women who have a lifetime risk of developing breast cancer of more than 20%-25% (e.g., women with known BRCA1/2 mutations or radiation to breast tissue), and can be done annually at the same time as the screening mammogram is done. Some clinicians and patients prefer to alternate these two tests – one every 6 months.

Screening breast MRI is more sensitive but less specific than mammography; combining the two screening modalities leads to overall increased sensitivity and specificity in high-risk populations.
 

Risk assessment

Identifying higher-risk women who need to be sent to a genetic counselor is critically important. The USPSTF recommends that women who have family members with breast, ovarian, tubal or peritoneal cancer, or who have an ancestry associated with BRCA1/2 gene mutations, be assessed with a brief familial risk assessment tool such as the Pedigree Assessment Tool. This and other validated tools have been evaluated by the USPSTF and can be used to guide referrals to genetic counseling for more definitive risk assessment.⁷

These tools are different from general breast cancer risk assessment models, such as the NCI’s Breast Cancer Risk Assessment Tool,⁸ which are designed to calculate the 5-year and lifetime risk of developing invasive breast cancer for an average-risk woman but not to identify BRCA-related cancer risk. (The NCI’s tool is based on the Gail model, which has been widely used over the years.)

The general risk assessment models use a women’s personal medical and reproductive history as well as the history of breast cancer among her first-degree relatives to estimate her risk.
 

Dr. Tkaczuk reported that she has no disclosures.

References

1. “Cancer Stat Facts: Female Breast Cancer.” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.

2. Siu AL et al. Ann Intern Med. 2016 Feb 16. doi: 10.7326/M15-2886.

3. Independent UK Panel on Breast Cancer Screening. Lancet. 2012 Nov 17;380(9855):1778-86.

4. NCCN guidelines for Detection, Prevention, & Risk Reduction: Breast Cancer Screening and Diagnosis. National Comprehensive Cancer Network.

5. NCCN guidelines for Detection, Prevention, & Risk Reduction: Breast Cancer Risk Reduction. National Comprehensive Cancer Network.

6. Ziv E et al. Cancer Epidemiol Biomarkers Prev. 2004;13(12):2090-5.

7. USPSTF. JAMA. 2019;322(7):652-65.

8. The Breast Cancer Risk Assessment Tool. National Cancer Institute.
 

Screening mammography has contributed to the lowering of mortality from breast cancer by facilitating earlier diagnosis and a lower stage at diagnosis. With more effective treatment options for women who are diagnosed with lower-stage breast cancer, the current 5-year survival rate has risen to 90% – significantly higher than the 5-year survival rate of 75% in 1975.¹

Courtesy Dr. Katherine Tkaczuk

Women who are at much higher risk for developing breast cancer – mainly because of family history, certain genetic mutations, or a history of radiation therapy to the chest – will benefit the most from earlier and more frequent screening mammography as well as enhanced screening with non-x-ray methods of breast imaging. It is important that ob.gyns. help to identify these women.

However, the majority of women who are screened with mammography are at “average risk,” with a lifetime risk for developing breast cancer of 12.9%, based on 2015-2017 data from the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results Program (SEER).¹ The median age at diagnosis of breast cancer in the U.S. is 62 years,¹ and advancing age is the most important risk factor for these women.

A 20% relative risk reduction in breast cancer mortality with screening mammography has been demonstrated both in systematic reviews of randomized and observational studies² and in a meta-analysis of 11 randomized trials comparing screening and no screening.³ Even though the majority of randomized trials were done in the age of film mammography, experts believe that we still see at least a 20% reduction today.

Among average-risk women, those aged 50-74 with a life expectancy of at least 10 years will benefit the most from regular screening. According to the 2016 screening guideline of the United States Preventive Services Task Force (USPSTF), relative risk reductions in breast cancer mortality from mammography screening, by age group, are 0.88 (confidence interval, 0.73-1.003) for ages 39-49; 0.86 (CI, 0.68-0.97) for ages 50-59; 0.67 (CI, 0.55-0.91) for ages 60-69; and 0.80 (CI, 0.51 to 1.28) for ages 70-74.²

For women aged 40-49 years, most of the guidelines in the United States recommend individualized screening every 1 or 2 years – screening that is guided by shared decision-making that takes into account each woman’s values regarding relative harms and benefits. This is because their risk of developing breast cancer is relatively low while the risk of false-positive results can be higher.

A few exceptions include guidelines by the National Comprehensive Cancer Network (NCCN) and the American College of Radiology, which recommend annual screening mammography starting at age 40 years for all average-risk women. In our program, we adhere to these latter recommendations and advise annual digital 3-D mammograms starting at age 40 and continuing until age 74, or longer if the woman is otherwise healthy with a life expectancy greater than 10 years.
 

Screening and overdiagnosis

Overdiagnosis – the diagnosis of cancers that may not actually cause mortality or may not even have become apparent without screening – is a concern for all women undergoing routine screening for breast cancer. There is significant uncertainty about its frequency, however.

Research cited by the USPSTF suggests that as many as one in five women diagnosed with breast cancer over approximately 10 years will be overdiagnosed. Other modeling studies have estimated one in eight overdiagnoses, for women aged 50-75 years specifically. By the more conservative estimate, according to the USPSTF, one breast cancer death will be prevented for every 2-3 cases of unnecessary treatment.²

Ductal carcinoma in situ is confined to the mammary ductal-lobular system and lacks the classic characteristics of cancer. Technically, it should not metastasize. But we do not know with certainty which cases of DCIS will or will not progress to invasive cancer. Therefore these women often are offered surgical approaches mirroring invasive cancer treatments (lumpectomy with radiation or even mastectomy in some cases), while for some, such treatments may be unnecessary.
 

Screening younger women (40-49)

Shared decision-making is always important for breast cancer screening, but in our program we routinely recommend annual screening in average-risk women starting at age 40 for several reasons. For one, younger women may present with more aggressive types of breast cancer such as triple-negative breast cancer. These are much less common than hormone-receptor positive breast cancers – they represent 15%-20% of all breast cancers – but they are faster growing and may develop in the interim if women are screened less often (at 2-year intervals).

In addition, finding an invasive breast cancer early is almost always beneficial. Earlier diagnosis (lower stage at diagnosis) is associated with increased breast cancer-specific and overall survival, as well as less-aggressive treatment approaches.

As a medical oncologist who treats women with breast cancer, I see these benefits firsthand. With earlier diagnosis, we are more likely to offer less aggressive surgical approaches such as partial mastectomy (lumpectomy) and sentinel lymph node biopsy as opposed to total mastectomy with axillary lymph node dissection, the latter of which is more likely to be associated with lymphedema and which can lead to postmastectomy chest wall pain syndromes.

We also are able to use less aggressive radiation therapy approaches such as partial breast radiation, and less aggressive breast cancer–specific systemic treatments for women with a lower stage of breast cancer at diagnosis. In some cases, adjuvant or neoadjuvant chemotherapy may not be needed – and when it is necessary, shorter courses of chemotherapy or targeted chemotherapeutic regimens may be offered. This means lower systemic toxicities, both early and late, such as less cytopenias, risk of infections, mucositis, hair loss, cardiotoxicity, secondary malignancies/leukemia, and peripheral sensory neuropathy.

It is important to note that Black women in the United States have the highest death rate from breast cancer – 27.3 per 100,000 per year, versus 19.6 per 100,000 per year for White women¹ – and that younger Black women appear to have a higher risk of developing triple-negative breast cancer, a more aggressive type of breast cancer. The higher breast cancer mortality in Black women is likely multifactorial and may be attributed partly to disparities in health care and partly to tumor biology. The case for annual screening in this population thus seems especially strong.
 

Screening modalities

Digital 3-D mammography, or digital breast tomosynthesis (DBT), is widely considered to be a more sensitive screening tool than conventional digital mammography alone. The NCCN recommends DBT for women with an average risk of developing breast cancer starting at age 40,^4,5 and the USPSTF, while offering no recommendation on DBT as a primary screening method (“insufficient evidence”), says that DBT appears to increase cancer detection rates.² So, I do routinely recommend it.

DBT may be especially beneficial for women with dense breast tissue (determined mammographically), who are most often premenopausal women – particularly non-Hispanic White women. Dense breast tissue itself can contribute to an increased risk of breast cancer – an approximately 20% higher relative risk in an average-risk woman with heterogeneously dense breast tissue, and an approximately 100% higher relative risk in a woman with extremely dense breasts⁶ – but unfortunately it affects the sensitivity and specificity of screening mammography.

I do not recommend routine supplemental screening with other methods (breast ultrasonography or MRI) for women at average risk of breast cancer who have dense breasts. MRI with gadolinium contrast is recommended as an adjunct to mammography for women who have a lifetime risk of developing breast cancer of more than 20%-25% (e.g., women with known BRCA1/2 mutations or radiation to breast tissue), and can be done annually at the same time as the screening mammogram is done. Some clinicians and patients prefer to alternate these two tests – one every 6 months.

Screening breast MRI is more sensitive but less specific than mammography; combining the two screening modalities leads to overall increased sensitivity and specificity in high-risk populations.
 

Risk assessment

Identifying higher-risk women who need to be sent to a genetic counselor is critically important. The USPSTF recommends that women who have family members with breast, ovarian, tubal or peritoneal cancer, or who have an ancestry associated with BRCA1/2 gene mutations, be assessed with a brief familial risk assessment tool such as the Pedigree Assessment Tool. This and other validated tools have been evaluated by the USPSTF and can be used to guide referrals to genetic counseling for more definitive risk assessment.⁷

These tools are different from general breast cancer risk assessment models, such as the NCI’s Breast Cancer Risk Assessment Tool,⁸ which are designed to calculate the 5-year and lifetime risk of developing invasive breast cancer for an average-risk woman but not to identify BRCA-related cancer risk. (The NCI’s tool is based on the Gail model, which has been widely used over the years.)

The general risk assessment models use a women’s personal medical and reproductive history as well as the history of breast cancer among her first-degree relatives to estimate her risk.
 

Dr. Tkaczuk reported that she has no disclosures.

References

1. “Cancer Stat Facts: Female Breast Cancer.” Surveillance, Epidemiology, and End Results Program. National Cancer Institute.

2. Siu AL et al. Ann Intern Med. 2016 Feb 16. doi: 10.7326/M15-2886.

3. Independent UK Panel on Breast Cancer Screening. Lancet. 2012 Nov 17;380(9855):1778-86.

4. NCCN guidelines for Detection, Prevention, & Risk Reduction: Breast Cancer Screening and Diagnosis. National Comprehensive Cancer Network.

5. NCCN guidelines for Detection, Prevention, & Risk Reduction: Breast Cancer Risk Reduction. National Comprehensive Cancer Network.

6. Ziv E et al. Cancer Epidemiol Biomarkers Prev. 2004;13(12):2090-5.

7. USPSTF. JAMA. 2019;322(7):652-65.

8. The Breast Cancer Risk Assessment Tool. National Cancer Institute.
 

Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.

Christina Chambers

This is good news for the growth of more information about the safety of biologics and other drugs during pregnancy. Pregnancy outcomes data are increasingly emerging – particularly for tumor necrosis factor (TNF) inhibitors – but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.

And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.

Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”

OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).

Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).

Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.

Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.

An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.

OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.

It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”

The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.

The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.

“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.

Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.

Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”

The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”

(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)

Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.

Oklahoma Medical Research Foundation

Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”

“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”

She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”

Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”

Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.

The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.


To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
 

Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.

Christina Chambers

This is good news for the growth of more information about the safety of biologics and other drugs during pregnancy. Pregnancy outcomes data are increasingly emerging – particularly for tumor necrosis factor (TNF) inhibitors – but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.

And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.

Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”

OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).

Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).

Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.

Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.

An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.

OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.

It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”

The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.

The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.

“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.

Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.

Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”

The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”

(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)

Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.

Oklahoma Medical Research Foundation

Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”

“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”

She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”

Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”

Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.

The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.


To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
 

Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.

Christina Chambers

This is good news for the growth of more information about the safety of biologics and other drugs during pregnancy. Pregnancy outcomes data are increasingly emerging – particularly for tumor necrosis factor (TNF) inhibitors – but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.

And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.

Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”

OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).

Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).

Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.

Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.

An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.

OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.

It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”

The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.

The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.

“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.

Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.

Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”

The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”

(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)

Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.

Oklahoma Medical Research Foundation

Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”

“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”

She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”

Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”

Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.

The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.


To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
 

Among women with multiple sclerosis (MS), levels of serum neurofilament light (sNfL) are higher during pregnancy and the postpartum period. The increase in sNfL is independent of relapses, which suggests that patients have increased subclinical disease activity during this period, according to the researchers.

When the investigators controlled their data for exposure to disease-modifying therapy (DMT), the effect of pregnancy on sNfL was no longer evident. These data were presented said at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

The results suggest that “sNfL may qualify as a sensitive and minimally invasive measure of disease activity in pregnancy,” said Özgür Yaldizli, MD, consultant neurologist at University Hospital Basel (Switzerland). “Strategies allowing the continuation of DMT during pregnancy may be warranted.”

MS preferentially affects women in their reproductive years, said Dr. Yaldizli. Almost one-third of women with MS become pregnant after they receive their diagnosis. A decrease in disease activity is typical in the third trimester, as is an increase in relapse frequency post partum.

DMTs reduce the risk of relapse, but have potential side effects for the woman and the fetus. Some DMTs are immunosuppressants, and they increase the risk of infection during pregnancy. Other DMTs may harm the development of the fetus, particularly if administered early during pregnancy.

“There is an urgent need to identify patients with high disease activity during pregnancy,” said Dr. Yaldizli. Increased levels of NfL, a specific biomarker of neuroaxonal injury, are associated with relapses, MRI activity, and disability worsening among patients with MS. Response to DMT is associated with decreased NfL levels. But few data about sNfL during pregnancy or post partum are available.
 

Relapses were associated with increased sNfL

Dr. Yaldizli and colleagues examined data from the Swiss MS Cohort Study to describe DMT use before, during, and after pregnancy. They also sought to assess sNfL as a marker of disease activity during and after pregnancy and to evaluate whether interrupting DMT because of pregnancy leads to increased sNfL levels.

Eligible participants had prospectively documented pregnancies, and Dr. Yaldizli’s group excluded pregnancies with early termination from their analysis. Serum samples were collected every 6 or 12 months and analyzed using the Simoa NF-light assay. The investigators used univariable and multivariable mixed-effects models to investigate associations between clinical characteristics and longitudinal sNfL levels in women before pregnancy, during pregnancy, and post partum.

Dr. Yaldizli and colleagues included 72 pregnancies in 63 patients with relapsing MS in their analysis. Nine patients had two pregnancies during follow-up. The population’s median age was 31.4 years, and median disease duration was 7.1 years. Median Expanded Disability Status Scale (EDSS) score at last visit before birth was 1.5. Median follow-up time was 6 years.

Most patients were treated with DMT before or during pregnancy. For most patients (39), fingolimod or natalizumab was the last DMT given before birth. Four patients did not use DMT before, during, or after pregnancy. In 14 pregnancies, the patient continued DMT for more than 6 months.

The univariable analysis showed that sNfL levels were 22% higher during pregnancy, compared with outside the pregnancy and postpartum period. The investigators recorded 29 relapses during the pregnancy and postpartum period. Relapses were more likely to occur during the first trimester and the first 3 months post partum. In the multivariable analysis, relapses that occurred within 120 days before serum sampling were associated with 98% higher levels of sNfL. In addition, sNfL was 7% higher for each step increase in EDSS and 13% higher during the pregnancy and postpartum period, compared with outside of that period.

When the investigators included DMT exposure at sampling time in the model, however, the pregnancy and postpartum period no longer had an effect on sNfL. The sNfL levels were 12% lower among patients exposed to DMT, compared with patients without DMT exposure.

Some DMTs, such as interferon-beta, are relatively safe during pregnancy, but the greater the medication’s efficacy, the more problematic it can be, said Dr. Yaldizi. “There are medications that are given, for example, every 6 months, like ocrelizumab. There are other medications that have to be taken daily. Probably the safest medications are those that are not given so often during pregnancy.”

Future research should examine the escalation therapies (i.e., the newer and more effective DMTs) during pregnancy in patients with MS, he added. “Not only in pregnancy, but also in general, we have to look for ways to measure disease activity in patients who switch therapy, who deescalate therapy.”
 

Pregnancy may not forestall disease activity

“The results of this study demonstrate that DMT withdrawal in the context of pregnancy can lead to subclinical disease re-emergence, as evidenced by increased sNfL levels in the DMT-free period,” said Vilija G. Jokubaitis, PhD, senior research fellow in the department of neuroscience at Monash University, Melbourne. Dr. Jokubaitis was not involved in the study.

“Interestingly, the median EDSS score in this cohort was quite low, demonstrating that, even in women with mild disease, pregnancy may not be sufficient to protect against ongoing MS activity.” Nevertheless, 28 of the 63 women were exposed to monoclonal antibody therapy, so it is unclear whether these women have mild disease or well-managed disease on DMT, she added.

“This study provides further evidence that pregnancy planning requires advanced planning, and that therapy continuation into pregnancy should be considered, particularly in women with moderate disease activity, to protect against disease reactivation,” said Dr. Jokubaitis.

The strengths of the study include its prospective design, the investigators’ ability to describe the various DMT exposures before and during pregnancy, and the multivariable mixed-effects modeling, she added. On the other hand, the results are at the group level, individual trajectories in sNfL level are not described, and the small sample size prevented the investigators from differentiating between the effects of various DMTs on sNfL outcomes. In addition, Dr. Yaldizli and colleagues did not take time off DMT into account in the models; they considered DMT exposure as a dichotomous variable.

“More work is needed to determine the therapeutic strategies that will give women with MS the greatest protection against disease reactivation in pregnancy and post partum, whilst also protecting fetal and neonatal outcomes,” said Dr. Jokubaitis. Group studies will enable researchers to identify trends, but neurologists ultimately need to provide individualized advice to their patients. “There is a need to look at [the effect of] DMT identity, timing, and duration of DMT withdrawal on fluctuation of sNfL levels, and how these relate to baseline disease severity,” Dr. Jokubaitis added. Furthermore, researchers must compare sNfL changes in pregnancy between patients with MS and healthy women in large cohorts.

The analysis by Dr. Yaldizli and colleagues was conducted without outside funding. The Swiss MS Cohort receives funding from the Swiss MS society, Biogen, Celgene, Sanofi, Merck, Novartis, Roche, and research associations such as the International Progressive MS Alliance and the Swiss National Science Foundation. Dr. Yaldizli received grants from ECTRIMS/MAGNIMS, the University of Basel, Pro Patient Stiftung, University Hospital Basel, Free Academy Basel, and the Swiss MS Society. He has received advisory board fees from Sanofi Genzyme, Biogen, Almirall, and Novartis. Dr. Jokubaitis has received conference travel support from Merck and Roche and speakers honoraria from Biogen and Roche. These relationships are not related to the current study. Dr. Jokubaitis receives research support from the Australian National Health and Medical Research Grant and MS Research Australia.

[email protected]

Among women with multiple sclerosis (MS), levels of serum neurofilament light (sNfL) are higher during pregnancy and the postpartum period. The increase in sNfL is independent of relapses, which suggests that patients have increased subclinical disease activity during this period, according to the researchers.

When the investigators controlled their data for exposure to disease-modifying therapy (DMT), the effect of pregnancy on sNfL was no longer evident. These data were presented said at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

The results suggest that “sNfL may qualify as a sensitive and minimally invasive measure of disease activity in pregnancy,” said Özgür Yaldizli, MD, consultant neurologist at University Hospital Basel (Switzerland). “Strategies allowing the continuation of DMT during pregnancy may be warranted.”

MS preferentially affects women in their reproductive years, said Dr. Yaldizli. Almost one-third of women with MS become pregnant after they receive their diagnosis. A decrease in disease activity is typical in the third trimester, as is an increase in relapse frequency post partum.

DMTs reduce the risk of relapse, but have potential side effects for the woman and the fetus. Some DMTs are immunosuppressants, and they increase the risk of infection during pregnancy. Other DMTs may harm the development of the fetus, particularly if administered early during pregnancy.

“There is an urgent need to identify patients with high disease activity during pregnancy,” said Dr. Yaldizli. Increased levels of NfL, a specific biomarker of neuroaxonal injury, are associated with relapses, MRI activity, and disability worsening among patients with MS. Response to DMT is associated with decreased NfL levels. But few data about sNfL during pregnancy or post partum are available.
 

Relapses were associated with increased sNfL

Dr. Yaldizli and colleagues examined data from the Swiss MS Cohort Study to describe DMT use before, during, and after pregnancy. They also sought to assess sNfL as a marker of disease activity during and after pregnancy and to evaluate whether interrupting DMT because of pregnancy leads to increased sNfL levels.

Eligible participants had prospectively documented pregnancies, and Dr. Yaldizli’s group excluded pregnancies with early termination from their analysis. Serum samples were collected every 6 or 12 months and analyzed using the Simoa NF-light assay. The investigators used univariable and multivariable mixed-effects models to investigate associations between clinical characteristics and longitudinal sNfL levels in women before pregnancy, during pregnancy, and post partum.

Dr. Yaldizli and colleagues included 72 pregnancies in 63 patients with relapsing MS in their analysis. Nine patients had two pregnancies during follow-up. The population’s median age was 31.4 years, and median disease duration was 7.1 years. Median Expanded Disability Status Scale (EDSS) score at last visit before birth was 1.5. Median follow-up time was 6 years.

Most patients were treated with DMT before or during pregnancy. For most patients (39), fingolimod or natalizumab was the last DMT given before birth. Four patients did not use DMT before, during, or after pregnancy. In 14 pregnancies, the patient continued DMT for more than 6 months.

The univariable analysis showed that sNfL levels were 22% higher during pregnancy, compared with outside the pregnancy and postpartum period. The investigators recorded 29 relapses during the pregnancy and postpartum period. Relapses were more likely to occur during the first trimester and the first 3 months post partum. In the multivariable analysis, relapses that occurred within 120 days before serum sampling were associated with 98% higher levels of sNfL. In addition, sNfL was 7% higher for each step increase in EDSS and 13% higher during the pregnancy and postpartum period, compared with outside of that period.

When the investigators included DMT exposure at sampling time in the model, however, the pregnancy and postpartum period no longer had an effect on sNfL. The sNfL levels were 12% lower among patients exposed to DMT, compared with patients without DMT exposure.

Some DMTs, such as interferon-beta, are relatively safe during pregnancy, but the greater the medication’s efficacy, the more problematic it can be, said Dr. Yaldizi. “There are medications that are given, for example, every 6 months, like ocrelizumab. There are other medications that have to be taken daily. Probably the safest medications are those that are not given so often during pregnancy.”

Future research should examine the escalation therapies (i.e., the newer and more effective DMTs) during pregnancy in patients with MS, he added. “Not only in pregnancy, but also in general, we have to look for ways to measure disease activity in patients who switch therapy, who deescalate therapy.”
 

Pregnancy may not forestall disease activity

“The results of this study demonstrate that DMT withdrawal in the context of pregnancy can lead to subclinical disease re-emergence, as evidenced by increased sNfL levels in the DMT-free period,” said Vilija G. Jokubaitis, PhD, senior research fellow in the department of neuroscience at Monash University, Melbourne. Dr. Jokubaitis was not involved in the study.

“Interestingly, the median EDSS score in this cohort was quite low, demonstrating that, even in women with mild disease, pregnancy may not be sufficient to protect against ongoing MS activity.” Nevertheless, 28 of the 63 women were exposed to monoclonal antibody therapy, so it is unclear whether these women have mild disease or well-managed disease on DMT, she added.

“This study provides further evidence that pregnancy planning requires advanced planning, and that therapy continuation into pregnancy should be considered, particularly in women with moderate disease activity, to protect against disease reactivation,” said Dr. Jokubaitis.

The strengths of the study include its prospective design, the investigators’ ability to describe the various DMT exposures before and during pregnancy, and the multivariable mixed-effects modeling, she added. On the other hand, the results are at the group level, individual trajectories in sNfL level are not described, and the small sample size prevented the investigators from differentiating between the effects of various DMTs on sNfL outcomes. In addition, Dr. Yaldizli and colleagues did not take time off DMT into account in the models; they considered DMT exposure as a dichotomous variable.

“More work is needed to determine the therapeutic strategies that will give women with MS the greatest protection against disease reactivation in pregnancy and post partum, whilst also protecting fetal and neonatal outcomes,” said Dr. Jokubaitis. Group studies will enable researchers to identify trends, but neurologists ultimately need to provide individualized advice to their patients. “There is a need to look at [the effect of] DMT identity, timing, and duration of DMT withdrawal on fluctuation of sNfL levels, and how these relate to baseline disease severity,” Dr. Jokubaitis added. Furthermore, researchers must compare sNfL changes in pregnancy between patients with MS and healthy women in large cohorts.

The analysis by Dr. Yaldizli and colleagues was conducted without outside funding. The Swiss MS Cohort receives funding from the Swiss MS society, Biogen, Celgene, Sanofi, Merck, Novartis, Roche, and research associations such as the International Progressive MS Alliance and the Swiss National Science Foundation. Dr. Yaldizli received grants from ECTRIMS/MAGNIMS, the University of Basel, Pro Patient Stiftung, University Hospital Basel, Free Academy Basel, and the Swiss MS Society. He has received advisory board fees from Sanofi Genzyme, Biogen, Almirall, and Novartis. Dr. Jokubaitis has received conference travel support from Merck and Roche and speakers honoraria from Biogen and Roche. These relationships are not related to the current study. Dr. Jokubaitis receives research support from the Australian National Health and Medical Research Grant and MS Research Australia.

[email protected]

Among women with multiple sclerosis (MS), levels of serum neurofilament light (sNfL) are higher during pregnancy and the postpartum period. The increase in sNfL is independent of relapses, which suggests that patients have increased subclinical disease activity during this period, according to the researchers.

When the investigators controlled their data for exposure to disease-modifying therapy (DMT), the effect of pregnancy on sNfL was no longer evident. These data were presented said at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

The results suggest that “sNfL may qualify as a sensitive and minimally invasive measure of disease activity in pregnancy,” said Özgür Yaldizli, MD, consultant neurologist at University Hospital Basel (Switzerland). “Strategies allowing the continuation of DMT during pregnancy may be warranted.”

MS preferentially affects women in their reproductive years, said Dr. Yaldizli. Almost one-third of women with MS become pregnant after they receive their diagnosis. A decrease in disease activity is typical in the third trimester, as is an increase in relapse frequency post partum.

DMTs reduce the risk of relapse, but have potential side effects for the woman and the fetus. Some DMTs are immunosuppressants, and they increase the risk of infection during pregnancy. Other DMTs may harm the development of the fetus, particularly if administered early during pregnancy.

“There is an urgent need to identify patients with high disease activity during pregnancy,” said Dr. Yaldizli. Increased levels of NfL, a specific biomarker of neuroaxonal injury, are associated with relapses, MRI activity, and disability worsening among patients with MS. Response to DMT is associated with decreased NfL levels. But few data about sNfL during pregnancy or post partum are available.
 

Relapses were associated with increased sNfL

Dr. Yaldizli and colleagues examined data from the Swiss MS Cohort Study to describe DMT use before, during, and after pregnancy. They also sought to assess sNfL as a marker of disease activity during and after pregnancy and to evaluate whether interrupting DMT because of pregnancy leads to increased sNfL levels.

Eligible participants had prospectively documented pregnancies, and Dr. Yaldizli’s group excluded pregnancies with early termination from their analysis. Serum samples were collected every 6 or 12 months and analyzed using the Simoa NF-light assay. The investigators used univariable and multivariable mixed-effects models to investigate associations between clinical characteristics and longitudinal sNfL levels in women before pregnancy, during pregnancy, and post partum.

Dr. Yaldizli and colleagues included 72 pregnancies in 63 patients with relapsing MS in their analysis. Nine patients had two pregnancies during follow-up. The population’s median age was 31.4 years, and median disease duration was 7.1 years. Median Expanded Disability Status Scale (EDSS) score at last visit before birth was 1.5. Median follow-up time was 6 years.

Most patients were treated with DMT before or during pregnancy. For most patients (39), fingolimod or natalizumab was the last DMT given before birth. Four patients did not use DMT before, during, or after pregnancy. In 14 pregnancies, the patient continued DMT for more than 6 months.

The univariable analysis showed that sNfL levels were 22% higher during pregnancy, compared with outside the pregnancy and postpartum period. The investigators recorded 29 relapses during the pregnancy and postpartum period. Relapses were more likely to occur during the first trimester and the first 3 months post partum. In the multivariable analysis, relapses that occurred within 120 days before serum sampling were associated with 98% higher levels of sNfL. In addition, sNfL was 7% higher for each step increase in EDSS and 13% higher during the pregnancy and postpartum period, compared with outside of that period.

When the investigators included DMT exposure at sampling time in the model, however, the pregnancy and postpartum period no longer had an effect on sNfL. The sNfL levels were 12% lower among patients exposed to DMT, compared with patients without DMT exposure.

Some DMTs, such as interferon-beta, are relatively safe during pregnancy, but the greater the medication’s efficacy, the more problematic it can be, said Dr. Yaldizi. “There are medications that are given, for example, every 6 months, like ocrelizumab. There are other medications that have to be taken daily. Probably the safest medications are those that are not given so often during pregnancy.”

Future research should examine the escalation therapies (i.e., the newer and more effective DMTs) during pregnancy in patients with MS, he added. “Not only in pregnancy, but also in general, we have to look for ways to measure disease activity in patients who switch therapy, who deescalate therapy.”
 

Pregnancy may not forestall disease activity

“The results of this study demonstrate that DMT withdrawal in the context of pregnancy can lead to subclinical disease re-emergence, as evidenced by increased sNfL levels in the DMT-free period,” said Vilija G. Jokubaitis, PhD, senior research fellow in the department of neuroscience at Monash University, Melbourne. Dr. Jokubaitis was not involved in the study.

“Interestingly, the median EDSS score in this cohort was quite low, demonstrating that, even in women with mild disease, pregnancy may not be sufficient to protect against ongoing MS activity.” Nevertheless, 28 of the 63 women were exposed to monoclonal antibody therapy, so it is unclear whether these women have mild disease or well-managed disease on DMT, she added.

“This study provides further evidence that pregnancy planning requires advanced planning, and that therapy continuation into pregnancy should be considered, particularly in women with moderate disease activity, to protect against disease reactivation,” said Dr. Jokubaitis.

The strengths of the study include its prospective design, the investigators’ ability to describe the various DMT exposures before and during pregnancy, and the multivariable mixed-effects modeling, she added. On the other hand, the results are at the group level, individual trajectories in sNfL level are not described, and the small sample size prevented the investigators from differentiating between the effects of various DMTs on sNfL outcomes. In addition, Dr. Yaldizli and colleagues did not take time off DMT into account in the models; they considered DMT exposure as a dichotomous variable.

“More work is needed to determine the therapeutic strategies that will give women with MS the greatest protection against disease reactivation in pregnancy and post partum, whilst also protecting fetal and neonatal outcomes,” said Dr. Jokubaitis. Group studies will enable researchers to identify trends, but neurologists ultimately need to provide individualized advice to their patients. “There is a need to look at [the effect of] DMT identity, timing, and duration of DMT withdrawal on fluctuation of sNfL levels, and how these relate to baseline disease severity,” Dr. Jokubaitis added. Furthermore, researchers must compare sNfL changes in pregnancy between patients with MS and healthy women in large cohorts.

The analysis by Dr. Yaldizli and colleagues was conducted without outside funding. The Swiss MS Cohort receives funding from the Swiss MS society, Biogen, Celgene, Sanofi, Merck, Novartis, Roche, and research associations such as the International Progressive MS Alliance and the Swiss National Science Foundation. Dr. Yaldizli received grants from ECTRIMS/MAGNIMS, the University of Basel, Pro Patient Stiftung, University Hospital Basel, Free Academy Basel, and the Swiss MS Society. He has received advisory board fees from Sanofi Genzyme, Biogen, Almirall, and Novartis. Dr. Jokubaitis has received conference travel support from Merck and Roche and speakers honoraria from Biogen and Roche. These relationships are not related to the current study. Dr. Jokubaitis receives research support from the Australian National Health and Medical Research Grant and MS Research Australia.

[email protected]

Brachial plexus injury often is thought to co-occur with shoulder dystocia, but the two complications appear to be unrelated, according to research published in Obstetrics & Gynecology.

dimarik/iStock/Getty Images

Grace J. Johnson, MD, and colleagues at Baylor College of Medicine in Houston performed a medical review of 41,525 deliveries at Texas Children’s Hospital between March 2012 and July 2019, identifying cases of brachial plexus injury, with and without shoulder dystocia, occurring and persisting. The researchers also evaluated whether clinical experience (5 years or fewer, 6-15 years, or more than 15 years since training) and education impacted the risk of children developing shoulder dystocia or brachial plexus injury.

There were 547 cases of shoulder dystocia in 26,163 vaginal births (2.1%) and 9 cases in 15,362 cesarean births (0.06%), while 33 cases of brachial plexus injury occurred overall. Nearly all brachial plexus injuries were in vaginal deliveries (30 cases; 0.1%), while 3 cases occurred in cesarean deliveries (0.02%). Of these, 14 cases (42%) of brachial plexus injury did not co-occur with shoulder dystocia. Brachial plexus injury that persisted to discharge was similar for children with shoulder dystocia (17 of 19 cases; 89%) and without shoulder dystocia (10 of 14 cases; 71%). In the 27 children with persistent brachial plexus injury, 2 of 23 children who received follow-up care continued to experience persistent brachial plexus injury at 9 months (1 case with shoulder dystocia) and 12 months (1 case without shoulder dystocia).

“The frequent co-occurrence of shoulder dystocia and brachial plexus injury coupled with the equally frequent occurrence of isolated brachial plexus injury suggests that both brachial plexus injury and shoulder dystocia often reflect two causally unrelated complications of uterine forces driving a fetus through the birth canal in the presence of disproportion between the passage and the shoulder girdle of the passenger,” Dr. Johnson and colleagues wrote.
 

Results unchanged by clinician experience

Factors that impacted the risk of brachial plexus injury in children without shoulder dystocia were lack of maternal diabetes (0 women vs. 6 women; P = .03) and second-stage labor length (mean 103 minutes vs. 53 minutes; P = .08). Dr. Johnson and colleagues found no significant between-group differences regarding operative delivery, maternal age, or gestational age.

The researchers also examined the experience of the clinician who delivered children with brachial plexus injuries, and discovered there were no significant differences in children who had transient as opposed to persistent brachial plexus injury based on the number of years a clinician had been in practice (P = .97). There also were no significant changes in the “ratios of brachial plexus injury per total deliveries, brachial plexus injury per vaginal deliveries, and brachial plexus injury per shoulder dystocia” despite the presence of education and training for shoulder dystocia.
 

Questions require further study

Torri Metz, MD, MS, a maternal-fetal medicine subspecialist and associate professor of obstetrics and gynecology at University of Utah Health in Salt Lake City, said in an interview that the review by Johnson and colleagues was able to address limitations in previous studies by looking at the medical records of shoulder dystocia cases at a single tertiary care center.

“Brachial plexus injury occurs both with and without a diagnosis of shoulder dystocia. The finding that the non–shoulder dystocia brachial plexus injuries were associated with a longer second stage of labor suggests that these injuries can occur even prior to delivery of the fetal head and are often not related to maneuvers employed by an obstetrician during delivery,” Dr. Metz said.

The findings that brachial plexus injury severity was unrelated to clinician experience suggests “the occurrence, severity, and persistence of brachial plexus injury may be unrelated to maneuvers by the practitioner at the time of delivery,” she said.

Although Johnson et al. found education and training initiatives did not significantly impact the ratio of brachial plexus injury cases, “importantly, there are likely many other benefits to shoulder dystocia simulation including team communication and comfort of the practitioner in an obstetrical emergency. Thus, the conclusion should not be that simulation training should be abandoned,” Dr. Metz explained.

The results of the study should be confirmed in future research, she noted. “Despite looking at all cases of shoulder dystocia at a tertiary center over a 7-year period, the incidence of brachial plexus injury is low enough that only 33 cases were evaluated. As such, many questions about obstetrical management and the risk of brachial plexus injury still require further study,” said Dr. Metz, who was asked to comment on the study.

The authors reported no relevant financial disclosures. Dr. Metz is an editorial board member for Obstetrics and Gynecology. She was not involved in the review of this manuscript or the decision to publish it.

SOURCE: Johnson GJ et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004013.

Brachial plexus injury often is thought to co-occur with shoulder dystocia, but the two complications appear to be unrelated, according to research published in Obstetrics & Gynecology.

dimarik/iStock/Getty Images

Grace J. Johnson, MD, and colleagues at Baylor College of Medicine in Houston performed a medical review of 41,525 deliveries at Texas Children’s Hospital between March 2012 and July 2019, identifying cases of brachial plexus injury, with and without shoulder dystocia, occurring and persisting. The researchers also evaluated whether clinical experience (5 years or fewer, 6-15 years, or more than 15 years since training) and education impacted the risk of children developing shoulder dystocia or brachial plexus injury.

There were 547 cases of shoulder dystocia in 26,163 vaginal births (2.1%) and 9 cases in 15,362 cesarean births (0.06%), while 33 cases of brachial plexus injury occurred overall. Nearly all brachial plexus injuries were in vaginal deliveries (30 cases; 0.1%), while 3 cases occurred in cesarean deliveries (0.02%). Of these, 14 cases (42%) of brachial plexus injury did not co-occur with shoulder dystocia. Brachial plexus injury that persisted to discharge was similar for children with shoulder dystocia (17 of 19 cases; 89%) and without shoulder dystocia (10 of 14 cases; 71%). In the 27 children with persistent brachial plexus injury, 2 of 23 children who received follow-up care continued to experience persistent brachial plexus injury at 9 months (1 case with shoulder dystocia) and 12 months (1 case without shoulder dystocia).

“The frequent co-occurrence of shoulder dystocia and brachial plexus injury coupled with the equally frequent occurrence of isolated brachial plexus injury suggests that both brachial plexus injury and shoulder dystocia often reflect two causally unrelated complications of uterine forces driving a fetus through the birth canal in the presence of disproportion between the passage and the shoulder girdle of the passenger,” Dr. Johnson and colleagues wrote.
 

Results unchanged by clinician experience

Factors that impacted the risk of brachial plexus injury in children without shoulder dystocia were lack of maternal diabetes (0 women vs. 6 women; P = .03) and second-stage labor length (mean 103 minutes vs. 53 minutes; P = .08). Dr. Johnson and colleagues found no significant between-group differences regarding operative delivery, maternal age, or gestational age.

The researchers also examined the experience of the clinician who delivered children with brachial plexus injuries, and discovered there were no significant differences in children who had transient as opposed to persistent brachial plexus injury based on the number of years a clinician had been in practice (P = .97). There also were no significant changes in the “ratios of brachial plexus injury per total deliveries, brachial plexus injury per vaginal deliveries, and brachial plexus injury per shoulder dystocia” despite the presence of education and training for shoulder dystocia.
 

Questions require further study

Torri Metz, MD, MS, a maternal-fetal medicine subspecialist and associate professor of obstetrics and gynecology at University of Utah Health in Salt Lake City, said in an interview that the review by Johnson and colleagues was able to address limitations in previous studies by looking at the medical records of shoulder dystocia cases at a single tertiary care center.

“Brachial plexus injury occurs both with and without a diagnosis of shoulder dystocia. The finding that the non–shoulder dystocia brachial plexus injuries were associated with a longer second stage of labor suggests that these injuries can occur even prior to delivery of the fetal head and are often not related to maneuvers employed by an obstetrician during delivery,” Dr. Metz said.

The findings that brachial plexus injury severity was unrelated to clinician experience suggests “the occurrence, severity, and persistence of brachial plexus injury may be unrelated to maneuvers by the practitioner at the time of delivery,” she said.

Although Johnson et al. found education and training initiatives did not significantly impact the ratio of brachial plexus injury cases, “importantly, there are likely many other benefits to shoulder dystocia simulation including team communication and comfort of the practitioner in an obstetrical emergency. Thus, the conclusion should not be that simulation training should be abandoned,” Dr. Metz explained.

The results of the study should be confirmed in future research, she noted. “Despite looking at all cases of shoulder dystocia at a tertiary center over a 7-year period, the incidence of brachial plexus injury is low enough that only 33 cases were evaluated. As such, many questions about obstetrical management and the risk of brachial plexus injury still require further study,” said Dr. Metz, who was asked to comment on the study.

The authors reported no relevant financial disclosures. Dr. Metz is an editorial board member for Obstetrics and Gynecology. She was not involved in the review of this manuscript or the decision to publish it.

SOURCE: Johnson GJ et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004013.

Brachial plexus injury often is thought to co-occur with shoulder dystocia, but the two complications appear to be unrelated, according to research published in Obstetrics & Gynecology.

dimarik/iStock/Getty Images

Grace J. Johnson, MD, and colleagues at Baylor College of Medicine in Houston performed a medical review of 41,525 deliveries at Texas Children’s Hospital between March 2012 and July 2019, identifying cases of brachial plexus injury, with and without shoulder dystocia, occurring and persisting. The researchers also evaluated whether clinical experience (5 years or fewer, 6-15 years, or more than 15 years since training) and education impacted the risk of children developing shoulder dystocia or brachial plexus injury.

There were 547 cases of shoulder dystocia in 26,163 vaginal births (2.1%) and 9 cases in 15,362 cesarean births (0.06%), while 33 cases of brachial plexus injury occurred overall. Nearly all brachial plexus injuries were in vaginal deliveries (30 cases; 0.1%), while 3 cases occurred in cesarean deliveries (0.02%). Of these, 14 cases (42%) of brachial plexus injury did not co-occur with shoulder dystocia. Brachial plexus injury that persisted to discharge was similar for children with shoulder dystocia (17 of 19 cases; 89%) and without shoulder dystocia (10 of 14 cases; 71%). In the 27 children with persistent brachial plexus injury, 2 of 23 children who received follow-up care continued to experience persistent brachial plexus injury at 9 months (1 case with shoulder dystocia) and 12 months (1 case without shoulder dystocia).

“The frequent co-occurrence of shoulder dystocia and brachial plexus injury coupled with the equally frequent occurrence of isolated brachial plexus injury suggests that both brachial plexus injury and shoulder dystocia often reflect two causally unrelated complications of uterine forces driving a fetus through the birth canal in the presence of disproportion between the passage and the shoulder girdle of the passenger,” Dr. Johnson and colleagues wrote.
 

Results unchanged by clinician experience

Factors that impacted the risk of brachial plexus injury in children without shoulder dystocia were lack of maternal diabetes (0 women vs. 6 women; P = .03) and second-stage labor length (mean 103 minutes vs. 53 minutes; P = .08). Dr. Johnson and colleagues found no significant between-group differences regarding operative delivery, maternal age, or gestational age.

The researchers also examined the experience of the clinician who delivered children with brachial plexus injuries, and discovered there were no significant differences in children who had transient as opposed to persistent brachial plexus injury based on the number of years a clinician had been in practice (P = .97). There also were no significant changes in the “ratios of brachial plexus injury per total deliveries, brachial plexus injury per vaginal deliveries, and brachial plexus injury per shoulder dystocia” despite the presence of education and training for shoulder dystocia.
 

Questions require further study

Torri Metz, MD, MS, a maternal-fetal medicine subspecialist and associate professor of obstetrics and gynecology at University of Utah Health in Salt Lake City, said in an interview that the review by Johnson and colleagues was able to address limitations in previous studies by looking at the medical records of shoulder dystocia cases at a single tertiary care center.

“Brachial plexus injury occurs both with and without a diagnosis of shoulder dystocia. The finding that the non–shoulder dystocia brachial plexus injuries were associated with a longer second stage of labor suggests that these injuries can occur even prior to delivery of the fetal head and are often not related to maneuvers employed by an obstetrician during delivery,” Dr. Metz said.

The findings that brachial plexus injury severity was unrelated to clinician experience suggests “the occurrence, severity, and persistence of brachial plexus injury may be unrelated to maneuvers by the practitioner at the time of delivery,” she said.

Although Johnson et al. found education and training initiatives did not significantly impact the ratio of brachial plexus injury cases, “importantly, there are likely many other benefits to shoulder dystocia simulation including team communication and comfort of the practitioner in an obstetrical emergency. Thus, the conclusion should not be that simulation training should be abandoned,” Dr. Metz explained.

The results of the study should be confirmed in future research, she noted. “Despite looking at all cases of shoulder dystocia at a tertiary center over a 7-year period, the incidence of brachial plexus injury is low enough that only 33 cases were evaluated. As such, many questions about obstetrical management and the risk of brachial plexus injury still require further study,” said Dr. Metz, who was asked to comment on the study.

The authors reported no relevant financial disclosures. Dr. Metz is an editorial board member for Obstetrics and Gynecology. She was not involved in the review of this manuscript or the decision to publish it.

SOURCE: Johnson GJ et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004013.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

[email protected]

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

[email protected]

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

[email protected]

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

Requests for self-managed abortion via a telemedicine service increased by 27% from March 20, 2020, to April 11, 2020, in the United States in the wake of widespread lockdowns and shelter-in-place directives because of the COVID-19 pandemic, based on data from a provider of such services.

nortonrsx/Getty Images

Access to abortion care is challenging in many areas under ordinary circumstances, but the disruption of the COVID-19 pandemic led to many states suspending or limiting in-clinic services, wrote Abigail R.A. Aiken, MD, PhD, of the University of Texas at Austin and colleagues.

“As a result, people may increasingly be seeking self-managed abortion outside the formal health care system,” they said.

In a research letter published in Obstetrics & Gynecology, the investigators reviewed request data from Aid Access, a telemedicine service that provides medication for abortion at up to 10 weeks’ gestation for users who complete an online consultation form. They also collected data on the implementation and scope of COVID-19–related abortion restrictions by state.

The analysis included all 49,935 requests made between January 1, 2019, and April 11, 2020.

Overall, the rate of requests for self-managed medical abortions increased significantly, by 27%, during the period from March 20, 2020, to April 11, 2020, which reflected the average period after clinic restrictions or closures at the state level. A total of 11 states showed individually significant increases in requests for self-managed medical abortions, with the highest of 94% in Texas and the lowest of 22% in Ohio. In these 11 states, the median time spent at home was 5% higher than in states without significant increases in requests for self-managed medical abortions during the same period. These states also had “particularly high COVID-19 rates or more severe COVID-19–related restrictions on in-clinic abortion access,” the researchers noted.

Patients want alternatives to in-person care

“Our results may reflect two distinct phenomena,” Dr. Aiken and associates wrote. “First, more people may be seeking abortion through all channels, whether due to COVID-19 risks during pregnancy, reduced access to prenatal care, or the pandemic-related economic downturn. Second, there may be shift in demand from in-clinic to self-managed abortion during the pandemic, possibly owing to fear of infection during in-person care or inability to get to a clinic because of childcare and transit disruptions,” they explained.

The study findings were limited by the inability to measure all options for women to achieve self-managed abortions and a lack of power to detect changes in states with low request numbers or where restrictions were implemented at later dates, the researchers noted. However, the results suggest that telemedicine services for medication abortion should be a policy priority because patients may continue to seek alternatives while in-clinic services remain restricted, they said.

In fact, “the World Health Organization recommends telemedicine and self-management abortion-care models during the pandemic, and the United Kingdom has temporarily implemented fully remote provision of abortion medications,” the researchers wrote. However, similar strategies in the United States “would depend on sustained changes to the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy, which requires patients to collect mifepristone at a hospital or medical facility, as well as changes to state-specific laws that prohibit remote provider consultation,” Dr. Aiken and associates concluded.

Lift barriers to protect patients

“This important and timely article assesses the association between the disruptions of the coronavirus pandemic and online requests for telemedicine abortion,” Eve Espey, MD, of the University of New Mexico, Albuquerque, said in an interview.

“As background, state abortion restrictions have increased exponentially over the last decade, while research over the same time period has demonstrated the safety of telemedicine abortion – a form of self-managed abortion – with no in-person visit for appropriate candidates,” she said.

“Enter the coronavirus pandemic with safety concerns related to in-person medical visits and certain states leveraging the opportunity to enact even more stringent abortion restrictions. Unsurprisingly, the result, as documented in this excellent research report, is a significant increase in requests for telemedicine abortion in many states, particularly the most restrictive, from the single online service in the United States, Aid Access,” said Dr. Espey.

“Barriers to self-managed abortion include the [FDA] Risk Evaluation and Mitigation Strategy for mifepristone, a set of unnecessary restrictions requiring that providers meet certain qualifications and dispense the medication only in a clinic, office, or hospital,” she said. “The REMS precludes the use of telemedicine abortion; Aid Access and the FDA are in legal proceedings,” she noted.

“Most recently, the [American Civil Liberties Union] sued the FDA on behalf of a coalition of medical experts led by [American College of Obstetricians and Gynecologists] to suspend the REMS for mifepristone during the COVID public health emergency, to allow patients to receive the medications for early abortion without a visit to a health care provider,” Dr. Espey said. “Fortunately, a federal district court required the temporary suspension of the in-person dispensing restriction. Although this is a great step to improve abortion access during the pandemic, a permanent removal of the REMS would pave the way for ongoing safe, effective, and patient-centered early abortion care,” noted Dr. Espey, who was asked to comment on the research letter.

Dr. Aiken disclosed serving as a consultant for Agile Therapeutics, and a coauthor is the founder and director of Aid Access. Dr. Espey had no financial conflicts to disclose. She is a member of the Ob.Gyn. News Editorial Advisory Board.

SOURCE: Aiken ARA et al. Obstet Gynecol. 2020 Jul 21. doi: 10.1097/AOG.0000000000004081.

Requests for self-managed abortion via a telemedicine service increased by 27% from March 20, 2020, to April 11, 2020, in the United States in the wake of widespread lockdowns and shelter-in-place directives because of the COVID-19 pandemic, based on data from a provider of such services.

nortonrsx/Getty Images

Access to abortion care is challenging in many areas under ordinary circumstances, but the disruption of the COVID-19 pandemic led to many states suspending or limiting in-clinic services, wrote Abigail R.A. Aiken, MD, PhD, of the University of Texas at Austin and colleagues.

“As a result, people may increasingly be seeking self-managed abortion outside the formal health care system,” they said.

In a research letter published in Obstetrics & Gynecology, the investigators reviewed request data from Aid Access, a telemedicine service that provides medication for abortion at up to 10 weeks’ gestation for users who complete an online consultation form. They also collected data on the implementation and scope of COVID-19–related abortion restrictions by state.

The analysis included all 49,935 requests made between January 1, 2019, and April 11, 2020.

Overall, the rate of requests for self-managed medical abortions increased significantly, by 27%, during the period from March 20, 2020, to April 11, 2020, which reflected the average period after clinic restrictions or closures at the state level. A total of 11 states showed individually significant increases in requests for self-managed medical abortions, with the highest of 94% in Texas and the lowest of 22% in Ohio. In these 11 states, the median time spent at home was 5% higher than in states without significant increases in requests for self-managed medical abortions during the same period. These states also had “particularly high COVID-19 rates or more severe COVID-19–related restrictions on in-clinic abortion access,” the researchers noted.

Patients want alternatives to in-person care

“Our results may reflect two distinct phenomena,” Dr. Aiken and associates wrote. “First, more people may be seeking abortion through all channels, whether due to COVID-19 risks during pregnancy, reduced access to prenatal care, or the pandemic-related economic downturn. Second, there may be shift in demand from in-clinic to self-managed abortion during the pandemic, possibly owing to fear of infection during in-person care or inability to get to a clinic because of childcare and transit disruptions,” they explained.

The study findings were limited by the inability to measure all options for women to achieve self-managed abortions and a lack of power to detect changes in states with low request numbers or where restrictions were implemented at later dates, the researchers noted. However, the results suggest that telemedicine services for medication abortion should be a policy priority because patients may continue to seek alternatives while in-clinic services remain restricted, they said.

In fact, “the World Health Organization recommends telemedicine and self-management abortion-care models during the pandemic, and the United Kingdom has temporarily implemented fully remote provision of abortion medications,” the researchers wrote. However, similar strategies in the United States “would depend on sustained changes to the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy, which requires patients to collect mifepristone at a hospital or medical facility, as well as changes to state-specific laws that prohibit remote provider consultation,” Dr. Aiken and associates concluded.

Lift barriers to protect patients

“This important and timely article assesses the association between the disruptions of the coronavirus pandemic and online requests for telemedicine abortion,” Eve Espey, MD, of the University of New Mexico, Albuquerque, said in an interview.

“As background, state abortion restrictions have increased exponentially over the last decade, while research over the same time period has demonstrated the safety of telemedicine abortion – a form of self-managed abortion – with no in-person visit for appropriate candidates,” she said.

“Enter the coronavirus pandemic with safety concerns related to in-person medical visits and certain states leveraging the opportunity to enact even more stringent abortion restrictions. Unsurprisingly, the result, as documented in this excellent research report, is a significant increase in requests for telemedicine abortion in many states, particularly the most restrictive, from the single online service in the United States, Aid Access,” said Dr. Espey.

“Barriers to self-managed abortion include the [FDA] Risk Evaluation and Mitigation Strategy for mifepristone, a set of unnecessary restrictions requiring that providers meet certain qualifications and dispense the medication only in a clinic, office, or hospital,” she said. “The REMS precludes the use of telemedicine abortion; Aid Access and the FDA are in legal proceedings,” she noted.

“Most recently, the [American Civil Liberties Union] sued the FDA on behalf of a coalition of medical experts led by [American College of Obstetricians and Gynecologists] to suspend the REMS for mifepristone during the COVID public health emergency, to allow patients to receive the medications for early abortion without a visit to a health care provider,” Dr. Espey said. “Fortunately, a federal district court required the temporary suspension of the in-person dispensing restriction. Although this is a great step to improve abortion access during the pandemic, a permanent removal of the REMS would pave the way for ongoing safe, effective, and patient-centered early abortion care,” noted Dr. Espey, who was asked to comment on the research letter.

Dr. Aiken disclosed serving as a consultant for Agile Therapeutics, and a coauthor is the founder and director of Aid Access. Dr. Espey had no financial conflicts to disclose. She is a member of the Ob.Gyn. News Editorial Advisory Board.

SOURCE: Aiken ARA et al. Obstet Gynecol. 2020 Jul 21. doi: 10.1097/AOG.0000000000004081.

Requests for self-managed abortion via a telemedicine service increased by 27% from March 20, 2020, to April 11, 2020, in the United States in the wake of widespread lockdowns and shelter-in-place directives because of the COVID-19 pandemic, based on data from a provider of such services.

nortonrsx/Getty Images

Access to abortion care is challenging in many areas under ordinary circumstances, but the disruption of the COVID-19 pandemic led to many states suspending or limiting in-clinic services, wrote Abigail R.A. Aiken, MD, PhD, of the University of Texas at Austin and colleagues.

“As a result, people may increasingly be seeking self-managed abortion outside the formal health care system,” they said.

In a research letter published in Obstetrics & Gynecology, the investigators reviewed request data from Aid Access, a telemedicine service that provides medication for abortion at up to 10 weeks’ gestation for users who complete an online consultation form. They also collected data on the implementation and scope of COVID-19–related abortion restrictions by state.

The analysis included all 49,935 requests made between January 1, 2019, and April 11, 2020.

Overall, the rate of requests for self-managed medical abortions increased significantly, by 27%, during the period from March 20, 2020, to April 11, 2020, which reflected the average period after clinic restrictions or closures at the state level. A total of 11 states showed individually significant increases in requests for self-managed medical abortions, with the highest of 94% in Texas and the lowest of 22% in Ohio. In these 11 states, the median time spent at home was 5% higher than in states without significant increases in requests for self-managed medical abortions during the same period. These states also had “particularly high COVID-19 rates or more severe COVID-19–related restrictions on in-clinic abortion access,” the researchers noted.

Patients want alternatives to in-person care

“Our results may reflect two distinct phenomena,” Dr. Aiken and associates wrote. “First, more people may be seeking abortion through all channels, whether due to COVID-19 risks during pregnancy, reduced access to prenatal care, or the pandemic-related economic downturn. Second, there may be shift in demand from in-clinic to self-managed abortion during the pandemic, possibly owing to fear of infection during in-person care or inability to get to a clinic because of childcare and transit disruptions,” they explained.

The study findings were limited by the inability to measure all options for women to achieve self-managed abortions and a lack of power to detect changes in states with low request numbers or where restrictions were implemented at later dates, the researchers noted. However, the results suggest that telemedicine services for medication abortion should be a policy priority because patients may continue to seek alternatives while in-clinic services remain restricted, they said.

In fact, “the World Health Organization recommends telemedicine and self-management abortion-care models during the pandemic, and the United Kingdom has temporarily implemented fully remote provision of abortion medications,” the researchers wrote. However, similar strategies in the United States “would depend on sustained changes to the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy, which requires patients to collect mifepristone at a hospital or medical facility, as well as changes to state-specific laws that prohibit remote provider consultation,” Dr. Aiken and associates concluded.

Lift barriers to protect patients

“This important and timely article assesses the association between the disruptions of the coronavirus pandemic and online requests for telemedicine abortion,” Eve Espey, MD, of the University of New Mexico, Albuquerque, said in an interview.

“As background, state abortion restrictions have increased exponentially over the last decade, while research over the same time period has demonstrated the safety of telemedicine abortion – a form of self-managed abortion – with no in-person visit for appropriate candidates,” she said.

“Enter the coronavirus pandemic with safety concerns related to in-person medical visits and certain states leveraging the opportunity to enact even more stringent abortion restrictions. Unsurprisingly, the result, as documented in this excellent research report, is a significant increase in requests for telemedicine abortion in many states, particularly the most restrictive, from the single online service in the United States, Aid Access,” said Dr. Espey.

“Barriers to self-managed abortion include the [FDA] Risk Evaluation and Mitigation Strategy for mifepristone, a set of unnecessary restrictions requiring that providers meet certain qualifications and dispense the medication only in a clinic, office, or hospital,” she said. “The REMS precludes the use of telemedicine abortion; Aid Access and the FDA are in legal proceedings,” she noted.

“Most recently, the [American Civil Liberties Union] sued the FDA on behalf of a coalition of medical experts led by [American College of Obstetricians and Gynecologists] to suspend the REMS for mifepristone during the COVID public health emergency, to allow patients to receive the medications for early abortion without a visit to a health care provider,” Dr. Espey said. “Fortunately, a federal district court required the temporary suspension of the in-person dispensing restriction. Although this is a great step to improve abortion access during the pandemic, a permanent removal of the REMS would pave the way for ongoing safe, effective, and patient-centered early abortion care,” noted Dr. Espey, who was asked to comment on the research letter.

Dr. Aiken disclosed serving as a consultant for Agile Therapeutics, and a coauthor is the founder and director of Aid Access. Dr. Espey had no financial conflicts to disclose. She is a member of the Ob.Gyn. News Editorial Advisory Board.

SOURCE: Aiken ARA et al. Obstet Gynecol. 2020 Jul 21. doi: 10.1097/AOG.0000000000004081.

Rural primary care doctors are facing a new set of obstacles to practicing in the COVID-19 pandemic. These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.

Courtesy Dr. Jacqueline W. Fincher

Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.

In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.

But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.

Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.

“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”

Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.

“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
 

Starting up telemedicine

Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.

As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.

“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.

Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.

G&P Productions

In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.

But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.

“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”

“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.

G&P Productions

Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.

“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.

The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
 

Treating political adversaries

Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.

Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.

Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.

“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”

In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.

“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.

Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.

Courtesy Dr. Clara Shin

He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.

“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”

“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.

The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.

“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.

Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.

“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.

“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.

Rural primary care doctors are facing a new set of obstacles to practicing in the COVID-19 pandemic. These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.

Courtesy Dr. Jacqueline W. Fincher

Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.

In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.

But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.

Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.

“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”

Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.

“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
 

Starting up telemedicine

Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.

As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.

“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.

Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.

G&P Productions

In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.

But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.

“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”

“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.

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Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.

“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.

The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
 

Treating political adversaries

Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.

Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.

Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.

“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”

In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.

“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.

Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.

Courtesy Dr. Clara Shin

He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.

“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”

“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.

The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.

“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.

Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.

“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.

“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.

Rural primary care doctors are facing a new set of obstacles to practicing in the COVID-19 pandemic. These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.

Courtesy Dr. Jacqueline W. Fincher

Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.

In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.

But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.

Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.

“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”

Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.

“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
 

Starting up telemedicine

Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.

As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.

“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.

Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.

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In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.

But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.

“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”

“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.

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Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.

“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.

The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
 

Treating political adversaries

Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.

Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.

Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.

“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”

In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.

“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.

Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.

Courtesy Dr. Clara Shin

He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.

“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”

“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.

The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.

“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.

Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.

“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.

“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.