Ob.Gyn. News

In April, federal rules implementing the bipartisan federal 21st Century Cures Act went into effect that allow patients to see their clinical notes. While some clinicians consider it an unwelcome intrusion, advocates say it will improve communication and compliance.

Patient access to notes is not new. In many states, patients already have the ability to request copies of their charts, or to access truncated information via clinic websites. The difference is that most patients will now be able to click on a patient portal – such as MyChart, or other similar apps – and gain instantaneous, unfettered access to everything in their records.

Clinicians have traditionally thought of medical notes as private journal entries; but in the last few decades they have become an important component of the documentation necessary for billing, as well as evidence in the event of litigation. Now, with the implementation of the Cures Act, medical notes have evolved into a tool to communicate with the patient, rather than just among health care providers, lawyers, and billing departments.

Supporters contend that this change will make a big difference, because patients will be able to see exactly what their doctors have written, rather than just a list of confusing test results and diagnosis lists in “medicalese.”

OpenNotes, a think tank that has promoted the sharing of clinical notes with patients for years, calls the Cures Act legislation a “new world” where shared notes are valuable tools to improve communication between patients and physicians while strengthening their relationship. They cite evidence indicating that “when health professionals offer patients and families ready access to clinical notes, the quality and safety of care improves.”

Not all doctors are as enthusiastic. Many are concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.

Others worry about patients having immediate access to their records, perhaps even before their physicians. The American Academy of Dermatology is working with the American Medical Association and other groups to gather real-world instances where the release of lab results, reports, or notes directly to patients before their physician could review the information with them caused emotional harm or other adverse consequences.

Undoubtedly, there are scenarios where unrestricted display of clinical notes could be problematic. One example is the issue of adolescents and reproductive health. Since parents now have access to their children’s records, some teenagers might hesitate to confide in their physicians and deny themselves important medical care.

The new rules permit blocking access to records if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or third parties. Psychotherapy counseling notes, for example, are completely exempt from the new requirements.

There are also state-level laws that can supersede the new federal law and block access to notes. For example, California law forbids providers from posting cancer test results without discussing them with the patient first.

Research indicates that shared notes have benefits that should outweigh the concerns of most physicians. One study showed that about 70% of patients said reviewing their notes helped them understand why medications were prescribed, which improved their compliance. This was particularly true for patients whose primary language is not English. A British study found that patients felt empowered by shared notes, and thought they improved their relationship with their physicians.

Other advantages of sharing notes include the ability of family members to review what happened at visits, which can be particularly important when dementia or other disabilities are involved. Patients will also be able to share their medical records with physicians outside of their health network, thus avoiding unnecessary or repetitious workups.

OpenNotes contends that when patients review their doctors’ notes, they gain “a newfound, deeper respect for what physicians have to understand to do their jobs.” Other predicted advantages include improved medical record accuracy and less miscommunication. In a study published in 2019 that evaluated experiences of patients who read ambulatory visit notes, only 5% were more worried after reading the notes and 3% were confused.

Alleviating worry among clinicians may be a bigger problem; but as a general principle, you should avoid judgmental language, and never write anything in a chart that you wouldn’t want your patients or their family members – or lawyers – to see.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In April, federal rules implementing the bipartisan federal 21st Century Cures Act went into effect that allow patients to see their clinical notes. While some clinicians consider it an unwelcome intrusion, advocates say it will improve communication and compliance.

Patient access to notes is not new. In many states, patients already have the ability to request copies of their charts, or to access truncated information via clinic websites. The difference is that most patients will now be able to click on a patient portal – such as MyChart, or other similar apps – and gain instantaneous, unfettered access to everything in their records.

Clinicians have traditionally thought of medical notes as private journal entries; but in the last few decades they have become an important component of the documentation necessary for billing, as well as evidence in the event of litigation. Now, with the implementation of the Cures Act, medical notes have evolved into a tool to communicate with the patient, rather than just among health care providers, lawyers, and billing departments.

Supporters contend that this change will make a big difference, because patients will be able to see exactly what their doctors have written, rather than just a list of confusing test results and diagnosis lists in “medicalese.”

OpenNotes, a think tank that has promoted the sharing of clinical notes with patients for years, calls the Cures Act legislation a “new world” where shared notes are valuable tools to improve communication between patients and physicians while strengthening their relationship. They cite evidence indicating that “when health professionals offer patients and families ready access to clinical notes, the quality and safety of care improves.”

Not all doctors are as enthusiastic. Many are concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.

Others worry about patients having immediate access to their records, perhaps even before their physicians. The American Academy of Dermatology is working with the American Medical Association and other groups to gather real-world instances where the release of lab results, reports, or notes directly to patients before their physician could review the information with them caused emotional harm or other adverse consequences.

Undoubtedly, there are scenarios where unrestricted display of clinical notes could be problematic. One example is the issue of adolescents and reproductive health. Since parents now have access to their children’s records, some teenagers might hesitate to confide in their physicians and deny themselves important medical care.

The new rules permit blocking access to records if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or third parties. Psychotherapy counseling notes, for example, are completely exempt from the new requirements.

There are also state-level laws that can supersede the new federal law and block access to notes. For example, California law forbids providers from posting cancer test results without discussing them with the patient first.

Research indicates that shared notes have benefits that should outweigh the concerns of most physicians. One study showed that about 70% of patients said reviewing their notes helped them understand why medications were prescribed, which improved their compliance. This was particularly true for patients whose primary language is not English. A British study found that patients felt empowered by shared notes, and thought they improved their relationship with their physicians.

Other advantages of sharing notes include the ability of family members to review what happened at visits, which can be particularly important when dementia or other disabilities are involved. Patients will also be able to share their medical records with physicians outside of their health network, thus avoiding unnecessary or repetitious workups.

OpenNotes contends that when patients review their doctors’ notes, they gain “a newfound, deeper respect for what physicians have to understand to do their jobs.” Other predicted advantages include improved medical record accuracy and less miscommunication. In a study published in 2019 that evaluated experiences of patients who read ambulatory visit notes, only 5% were more worried after reading the notes and 3% were confused.

Alleviating worry among clinicians may be a bigger problem; but as a general principle, you should avoid judgmental language, and never write anything in a chart that you wouldn’t want your patients or their family members – or lawyers – to see.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In April, federal rules implementing the bipartisan federal 21st Century Cures Act went into effect that allow patients to see their clinical notes. While some clinicians consider it an unwelcome intrusion, advocates say it will improve communication and compliance.

Patient access to notes is not new. In many states, patients already have the ability to request copies of their charts, or to access truncated information via clinic websites. The difference is that most patients will now be able to click on a patient portal – such as MyChart, or other similar apps – and gain instantaneous, unfettered access to everything in their records.

Clinicians have traditionally thought of medical notes as private journal entries; but in the last few decades they have become an important component of the documentation necessary for billing, as well as evidence in the event of litigation. Now, with the implementation of the Cures Act, medical notes have evolved into a tool to communicate with the patient, rather than just among health care providers, lawyers, and billing departments.

Supporters contend that this change will make a big difference, because patients will be able to see exactly what their doctors have written, rather than just a list of confusing test results and diagnosis lists in “medicalese.”

OpenNotes, a think tank that has promoted the sharing of clinical notes with patients for years, calls the Cures Act legislation a “new world” where shared notes are valuable tools to improve communication between patients and physicians while strengthening their relationship. They cite evidence indicating that “when health professionals offer patients and families ready access to clinical notes, the quality and safety of care improves.”

Not all doctors are as enthusiastic. Many are concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.

Others worry about patients having immediate access to their records, perhaps even before their physicians. The American Academy of Dermatology is working with the American Medical Association and other groups to gather real-world instances where the release of lab results, reports, or notes directly to patients before their physician could review the information with them caused emotional harm or other adverse consequences.

Undoubtedly, there are scenarios where unrestricted display of clinical notes could be problematic. One example is the issue of adolescents and reproductive health. Since parents now have access to their children’s records, some teenagers might hesitate to confide in their physicians and deny themselves important medical care.

The new rules permit blocking access to records if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or third parties. Psychotherapy counseling notes, for example, are completely exempt from the new requirements.

There are also state-level laws that can supersede the new federal law and block access to notes. For example, California law forbids providers from posting cancer test results without discussing them with the patient first.

Research indicates that shared notes have benefits that should outweigh the concerns of most physicians. One study showed that about 70% of patients said reviewing their notes helped them understand why medications were prescribed, which improved their compliance. This was particularly true for patients whose primary language is not English. A British study found that patients felt empowered by shared notes, and thought they improved their relationship with their physicians.

Other advantages of sharing notes include the ability of family members to review what happened at visits, which can be particularly important when dementia or other disabilities are involved. Patients will also be able to share their medical records with physicians outside of their health network, thus avoiding unnecessary or repetitious workups.

OpenNotes contends that when patients review their doctors’ notes, they gain “a newfound, deeper respect for what physicians have to understand to do their jobs.” Other predicted advantages include improved medical record accuracy and less miscommunication. In a study published in 2019 that evaluated experiences of patients who read ambulatory visit notes, only 5% were more worried after reading the notes and 3% were confused.

Alleviating worry among clinicians may be a bigger problem; but as a general principle, you should avoid judgmental language, and never write anything in a chart that you wouldn’t want your patients or their family members – or lawyers – to see.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.

Johnson & Johnson

This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.

Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.

If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).

As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:

• A body mass index of at least 30 kg/m2
• Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
• Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
• Known familial or other thrombophilic conditions or chronic
• Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE

cookie_cutter/Thinkstock

Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.

Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.

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

A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.

Johnson & Johnson

This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.

Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.

If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).

As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:

• A body mass index of at least 30 kg/m2
• Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
• Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
• Known familial or other thrombophilic conditions or chronic
• Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE

cookie_cutter/Thinkstock

Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.

Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.

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

A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.

Johnson & Johnson

This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.

Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.

If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).

As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:

• A body mass index of at least 30 kg/m2
• Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
• Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
• Known familial or other thrombophilic conditions or chronic
• Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE

cookie_cutter/Thinkstock

Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.

Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.

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

Postpartum women with commercial health insurance use substantially more inpatient and outpatient care than nonpostpartum women, particularly in the first 2 months after giving birth, according to a retrospective cohort study published in the May 2021 issue of Obstetrics & Gynecology.

“These findings are consistent with previous studies that have documented elevated postpartum ED and hospitalization rates, and we contribute new evidence that indicates postpartum health care utilization rates are significantly higher than rates of health care utilization in the general population of reproductive aged women when they are not pregnant or postpartum,” Maria W. Steenland, ScD, of Brown University, Providence, R.I., and colleagues wrote. “Most notably, postpartum women were more than three times more likely to have an ED visit and eight times more likely to be hospitalized than nonpostpartum women in the early postpartum period.”

Approximately one-third of maternal deaths occur between 1 week and 1 year post partum, the authors noted in their background information. The overall U.S. maternal mortality rate was 17.4 per 100,000 live births in 2018, according to the Centers for Disease Control and Prevention.

“This study underscores the importance of access to health care for women, in particular in the postpartum period,” Iris Krishna, MD, MPH, an assistant professor of maternal-fetal medicine at Emory University, Atlanta, said in an interview. “Maternal mortality is a public health crisis. The majority of maternal deaths are preventable and occur up to 1 year postpartum. Studies such as these are needed as the postpartum period is a critical time in the care of reproductive age women that is often overlooked.”

Using data from a large national commercial claims database, the researchers analyzed data from 149,563 women aged 18-44 years who gave birth in 2016 and from 2,048,831 women who were neither pregnant nor post partum during the same study period. In postpartum women, the researchers specifically looked at hospitalization, preventive visits, problem visits, and ED visits during three periods for postpartum women: early postpartum, defined as within 21 days of giving birth; postpartum, defined as 21-60 days after birth; and extended postpartum, defined as 61 days to 1 year after birth. These data were then compared with equivalent periods in nonpostpartum women.

“For the comparison group, we created a random start date of follow-up by generating a random variable between 0 and 365 and adding this integer to Jan. 1, 2016,” the authors explained. “These start dates correspond to the range of possible follow-up start dates among postpartum women who gave birth in 2016.”

The groups differed in age composition: 62% of the postpartum women were between 25 and 34 years old while the nonpostpartum women were more evenly distributed across the age range. A higher proportion of nonpostpartum women had a chronic disease, but median income and geographic region were similar between the groups. Just over a third of the postpartum women (36%) had a cesarean delivery, higher than the 2016 national average of 32%.

Nearly a quarter (23.7%) of postpartum women had a problem visit in the early postpartum period, compared with one in five (19.7%) nonpostpartum women in the equivalent period. This 4-point difference increased to an 4.8-point difference after adjustment for age group, chronic disease, geographic region, income, and month when follow-up began.

Postpartum women were also three times more likely to have an ED visit (3.2%) in the early postpartum period than nonpostpartum women (1%). Postpartum women’s problem visits and ED visits were most prevalent in the first 2 weeks after childbirth: 12.4% in the first week and 10.4% in the second. Complaints for these visits primarily included urinary tract infections and other genitourinary issues, hypertension, breast or breastfeeding issues, and respiratory issues, such as shortness of breath or chest pain. Hospitalization rates were also higher in the early postpartum period for postpartum women (0.8%) than nonpostpartum women (0.1%).

Problem visits showed a similar pattern during the postpartum period from 21 to 60 days after birth: 39.4% of postpartum women, compared with 30.2% of nonpostpartum women. Rate differences were narrower for ED visits (2% post partum vs. 1.9% non–post partum) and hospitalization (0.3% post partum vs. 0.2% non–post partum), but the differences remained significant, and ED visits were still 0.3 points higher after adjustment.

The biggest differences between the groups in the first 2 months occurred with preventive care. In the early postpartum period, 15% of postpartum women had a preventive visit, compared with 3.3% of nonpostpartum women. Similarly, the rates were 28.2% in postpartum women and 6.5% in nonpostpartum women in the postpartum period.

Differences between the groups evened out in the extended postpartum period, when postpartum women had slightly fewer preventive visits (42.5%) than nonpostpartum women (42.7%). ED rates (11.2% postpartum vs 11.1%) and hospitalization rates (1.4% postpartum vs. 1.6%) were similar, but postpartum women were significantly more likely to have problem visits (79.2%) in the year after childbirth than nonpostpartum women (72.8%).

“Compared with postpartum women overall, postpartum women with chronic disease, pregnancy complications, and cesarean births were more likely to receive health care of all types in the early postpartum period,” the researchers reported. “Of the three subgroups, health care use was highest among postpartum women with chronic disease, among whom 35% had at least one outpatient problem visit, 5% had an ED visit, and 1.3% were hospitalized within the first 20 days of childbirth.”

These findings as a whole point to an increased need for health care not only in the first 3 weeks after women give birth but “beyond the traditional 6-week postpartum period, which adds to the argument that the way we care for women in the postpartum period should be revised,” Dr. Krishna said.

The American College of Obstetricians and Gynecologists updated their postpartum recommendations in 2018 to advise that all postpartum women have a follow-up visit in the first 3 weeks after birth.

Dr. Krishna reiterated that postpartum patients should ideally have an initial follow-up within 3 weeks of giving birth, which the rapid expansion of telehealth has made more viable for both clinicians and mothers.

The authors similarly noted that telehealth and home visits “are promising options to promote early and consistent health care contact and reduce known barriers to postpartum care seeking such as fatigue, lack of transportation, and child care.” Predischarge guidance may also help meet postpartum patients’ health care needs.

“Health care professionals also may be able to reduce the escalation of common early postpartum problems identified in this study (e.g., respiratory problems, pain, urinary tract infections) with anticipatory postpartum counseling and care before hospital discharge such as ensuring that women have inhalers at home, developing a pain management plan, and screening for signs of urinary tract infection,” the authors wrote.

Dr. Krishna also pointed out the need to address racial inequalities in health care and material mortality.

“Black women have a maternal mortality rate two times the rate of non-Hispanic White women,” Dr. Krishna said. “One way to address health disparities between commercially insured and uninsured women is improving access to health care through Medicaid expansion for at least 1 year post partum. States that participated in the Affordable Care Acts Medicaid expansion have noted improvement in maternal mortality and a decrease in racial/ethnic inequities.”

The research was funded by the Robert Wood Johnson Foundation and the National Institutes of Health. Data was provided by Aetna, Humana, Kaiser Permanente and UnitedHealthcare. The authors and Dr. Krishna reported no disclosures.

Postpartum women with commercial health insurance use substantially more inpatient and outpatient care than nonpostpartum women, particularly in the first 2 months after giving birth, according to a retrospective cohort study published in the May 2021 issue of Obstetrics & Gynecology.

“These findings are consistent with previous studies that have documented elevated postpartum ED and hospitalization rates, and we contribute new evidence that indicates postpartum health care utilization rates are significantly higher than rates of health care utilization in the general population of reproductive aged women when they are not pregnant or postpartum,” Maria W. Steenland, ScD, of Brown University, Providence, R.I., and colleagues wrote. “Most notably, postpartum women were more than three times more likely to have an ED visit and eight times more likely to be hospitalized than nonpostpartum women in the early postpartum period.”

Approximately one-third of maternal deaths occur between 1 week and 1 year post partum, the authors noted in their background information. The overall U.S. maternal mortality rate was 17.4 per 100,000 live births in 2018, according to the Centers for Disease Control and Prevention.

“This study underscores the importance of access to health care for women, in particular in the postpartum period,” Iris Krishna, MD, MPH, an assistant professor of maternal-fetal medicine at Emory University, Atlanta, said in an interview. “Maternal mortality is a public health crisis. The majority of maternal deaths are preventable and occur up to 1 year postpartum. Studies such as these are needed as the postpartum period is a critical time in the care of reproductive age women that is often overlooked.”

Using data from a large national commercial claims database, the researchers analyzed data from 149,563 women aged 18-44 years who gave birth in 2016 and from 2,048,831 women who were neither pregnant nor post partum during the same study period. In postpartum women, the researchers specifically looked at hospitalization, preventive visits, problem visits, and ED visits during three periods for postpartum women: early postpartum, defined as within 21 days of giving birth; postpartum, defined as 21-60 days after birth; and extended postpartum, defined as 61 days to 1 year after birth. These data were then compared with equivalent periods in nonpostpartum women.

“For the comparison group, we created a random start date of follow-up by generating a random variable between 0 and 365 and adding this integer to Jan. 1, 2016,” the authors explained. “These start dates correspond to the range of possible follow-up start dates among postpartum women who gave birth in 2016.”

The groups differed in age composition: 62% of the postpartum women were between 25 and 34 years old while the nonpostpartum women were more evenly distributed across the age range. A higher proportion of nonpostpartum women had a chronic disease, but median income and geographic region were similar between the groups. Just over a third of the postpartum women (36%) had a cesarean delivery, higher than the 2016 national average of 32%.

Nearly a quarter (23.7%) of postpartum women had a problem visit in the early postpartum period, compared with one in five (19.7%) nonpostpartum women in the equivalent period. This 4-point difference increased to an 4.8-point difference after adjustment for age group, chronic disease, geographic region, income, and month when follow-up began.

Postpartum women were also three times more likely to have an ED visit (3.2%) in the early postpartum period than nonpostpartum women (1%). Postpartum women’s problem visits and ED visits were most prevalent in the first 2 weeks after childbirth: 12.4% in the first week and 10.4% in the second. Complaints for these visits primarily included urinary tract infections and other genitourinary issues, hypertension, breast or breastfeeding issues, and respiratory issues, such as shortness of breath or chest pain. Hospitalization rates were also higher in the early postpartum period for postpartum women (0.8%) than nonpostpartum women (0.1%).

Problem visits showed a similar pattern during the postpartum period from 21 to 60 days after birth: 39.4% of postpartum women, compared with 30.2% of nonpostpartum women. Rate differences were narrower for ED visits (2% post partum vs. 1.9% non–post partum) and hospitalization (0.3% post partum vs. 0.2% non–post partum), but the differences remained significant, and ED visits were still 0.3 points higher after adjustment.

The biggest differences between the groups in the first 2 months occurred with preventive care. In the early postpartum period, 15% of postpartum women had a preventive visit, compared with 3.3% of nonpostpartum women. Similarly, the rates were 28.2% in postpartum women and 6.5% in nonpostpartum women in the postpartum period.

Differences between the groups evened out in the extended postpartum period, when postpartum women had slightly fewer preventive visits (42.5%) than nonpostpartum women (42.7%). ED rates (11.2% postpartum vs 11.1%) and hospitalization rates (1.4% postpartum vs. 1.6%) were similar, but postpartum women were significantly more likely to have problem visits (79.2%) in the year after childbirth than nonpostpartum women (72.8%).

“Compared with postpartum women overall, postpartum women with chronic disease, pregnancy complications, and cesarean births were more likely to receive health care of all types in the early postpartum period,” the researchers reported. “Of the three subgroups, health care use was highest among postpartum women with chronic disease, among whom 35% had at least one outpatient problem visit, 5% had an ED visit, and 1.3% were hospitalized within the first 20 days of childbirth.”

These findings as a whole point to an increased need for health care not only in the first 3 weeks after women give birth but “beyond the traditional 6-week postpartum period, which adds to the argument that the way we care for women in the postpartum period should be revised,” Dr. Krishna said.

The American College of Obstetricians and Gynecologists updated their postpartum recommendations in 2018 to advise that all postpartum women have a follow-up visit in the first 3 weeks after birth.

Dr. Krishna reiterated that postpartum patients should ideally have an initial follow-up within 3 weeks of giving birth, which the rapid expansion of telehealth has made more viable for both clinicians and mothers.

The authors similarly noted that telehealth and home visits “are promising options to promote early and consistent health care contact and reduce known barriers to postpartum care seeking such as fatigue, lack of transportation, and child care.” Predischarge guidance may also help meet postpartum patients’ health care needs.

“Health care professionals also may be able to reduce the escalation of common early postpartum problems identified in this study (e.g., respiratory problems, pain, urinary tract infections) with anticipatory postpartum counseling and care before hospital discharge such as ensuring that women have inhalers at home, developing a pain management plan, and screening for signs of urinary tract infection,” the authors wrote.

Dr. Krishna also pointed out the need to address racial inequalities in health care and material mortality.

“Black women have a maternal mortality rate two times the rate of non-Hispanic White women,” Dr. Krishna said. “One way to address health disparities between commercially insured and uninsured women is improving access to health care through Medicaid expansion for at least 1 year post partum. States that participated in the Affordable Care Acts Medicaid expansion have noted improvement in maternal mortality and a decrease in racial/ethnic inequities.”

The research was funded by the Robert Wood Johnson Foundation and the National Institutes of Health. Data was provided by Aetna, Humana, Kaiser Permanente and UnitedHealthcare. The authors and Dr. Krishna reported no disclosures.

Postpartum women with commercial health insurance use substantially more inpatient and outpatient care than nonpostpartum women, particularly in the first 2 months after giving birth, according to a retrospective cohort study published in the May 2021 issue of Obstetrics & Gynecology.

“These findings are consistent with previous studies that have documented elevated postpartum ED and hospitalization rates, and we contribute new evidence that indicates postpartum health care utilization rates are significantly higher than rates of health care utilization in the general population of reproductive aged women when they are not pregnant or postpartum,” Maria W. Steenland, ScD, of Brown University, Providence, R.I., and colleagues wrote. “Most notably, postpartum women were more than three times more likely to have an ED visit and eight times more likely to be hospitalized than nonpostpartum women in the early postpartum period.”

Approximately one-third of maternal deaths occur between 1 week and 1 year post partum, the authors noted in their background information. The overall U.S. maternal mortality rate was 17.4 per 100,000 live births in 2018, according to the Centers for Disease Control and Prevention.

“This study underscores the importance of access to health care for women, in particular in the postpartum period,” Iris Krishna, MD, MPH, an assistant professor of maternal-fetal medicine at Emory University, Atlanta, said in an interview. “Maternal mortality is a public health crisis. The majority of maternal deaths are preventable and occur up to 1 year postpartum. Studies such as these are needed as the postpartum period is a critical time in the care of reproductive age women that is often overlooked.”

Using data from a large national commercial claims database, the researchers analyzed data from 149,563 women aged 18-44 years who gave birth in 2016 and from 2,048,831 women who were neither pregnant nor post partum during the same study period. In postpartum women, the researchers specifically looked at hospitalization, preventive visits, problem visits, and ED visits during three periods for postpartum women: early postpartum, defined as within 21 days of giving birth; postpartum, defined as 21-60 days after birth; and extended postpartum, defined as 61 days to 1 year after birth. These data were then compared with equivalent periods in nonpostpartum women.

“For the comparison group, we created a random start date of follow-up by generating a random variable between 0 and 365 and adding this integer to Jan. 1, 2016,” the authors explained. “These start dates correspond to the range of possible follow-up start dates among postpartum women who gave birth in 2016.”

The groups differed in age composition: 62% of the postpartum women were between 25 and 34 years old while the nonpostpartum women were more evenly distributed across the age range. A higher proportion of nonpostpartum women had a chronic disease, but median income and geographic region were similar between the groups. Just over a third of the postpartum women (36%) had a cesarean delivery, higher than the 2016 national average of 32%.

Nearly a quarter (23.7%) of postpartum women had a problem visit in the early postpartum period, compared with one in five (19.7%) nonpostpartum women in the equivalent period. This 4-point difference increased to an 4.8-point difference after adjustment for age group, chronic disease, geographic region, income, and month when follow-up began.

Postpartum women were also three times more likely to have an ED visit (3.2%) in the early postpartum period than nonpostpartum women (1%). Postpartum women’s problem visits and ED visits were most prevalent in the first 2 weeks after childbirth: 12.4% in the first week and 10.4% in the second. Complaints for these visits primarily included urinary tract infections and other genitourinary issues, hypertension, breast or breastfeeding issues, and respiratory issues, such as shortness of breath or chest pain. Hospitalization rates were also higher in the early postpartum period for postpartum women (0.8%) than nonpostpartum women (0.1%).

Problem visits showed a similar pattern during the postpartum period from 21 to 60 days after birth: 39.4% of postpartum women, compared with 30.2% of nonpostpartum women. Rate differences were narrower for ED visits (2% post partum vs. 1.9% non–post partum) and hospitalization (0.3% post partum vs. 0.2% non–post partum), but the differences remained significant, and ED visits were still 0.3 points higher after adjustment.

The biggest differences between the groups in the first 2 months occurred with preventive care. In the early postpartum period, 15% of postpartum women had a preventive visit, compared with 3.3% of nonpostpartum women. Similarly, the rates were 28.2% in postpartum women and 6.5% in nonpostpartum women in the postpartum period.

Differences between the groups evened out in the extended postpartum period, when postpartum women had slightly fewer preventive visits (42.5%) than nonpostpartum women (42.7%). ED rates (11.2% postpartum vs 11.1%) and hospitalization rates (1.4% postpartum vs. 1.6%) were similar, but postpartum women were significantly more likely to have problem visits (79.2%) in the year after childbirth than nonpostpartum women (72.8%).

“Compared with postpartum women overall, postpartum women with chronic disease, pregnancy complications, and cesarean births were more likely to receive health care of all types in the early postpartum period,” the researchers reported. “Of the three subgroups, health care use was highest among postpartum women with chronic disease, among whom 35% had at least one outpatient problem visit, 5% had an ED visit, and 1.3% were hospitalized within the first 20 days of childbirth.”

These findings as a whole point to an increased need for health care not only in the first 3 weeks after women give birth but “beyond the traditional 6-week postpartum period, which adds to the argument that the way we care for women in the postpartum period should be revised,” Dr. Krishna said.

The American College of Obstetricians and Gynecologists updated their postpartum recommendations in 2018 to advise that all postpartum women have a follow-up visit in the first 3 weeks after birth.

Dr. Krishna reiterated that postpartum patients should ideally have an initial follow-up within 3 weeks of giving birth, which the rapid expansion of telehealth has made more viable for both clinicians and mothers.

The authors similarly noted that telehealth and home visits “are promising options to promote early and consistent health care contact and reduce known barriers to postpartum care seeking such as fatigue, lack of transportation, and child care.” Predischarge guidance may also help meet postpartum patients’ health care needs.

“Health care professionals also may be able to reduce the escalation of common early postpartum problems identified in this study (e.g., respiratory problems, pain, urinary tract infections) with anticipatory postpartum counseling and care before hospital discharge such as ensuring that women have inhalers at home, developing a pain management plan, and screening for signs of urinary tract infection,” the authors wrote.

Dr. Krishna also pointed out the need to address racial inequalities in health care and material mortality.

“Black women have a maternal mortality rate two times the rate of non-Hispanic White women,” Dr. Krishna said. “One way to address health disparities between commercially insured and uninsured women is improving access to health care through Medicaid expansion for at least 1 year post partum. States that participated in the Affordable Care Acts Medicaid expansion have noted improvement in maternal mortality and a decrease in racial/ethnic inequities.”

The research was funded by the Robert Wood Johnson Foundation and the National Institutes of Health. Data was provided by Aetna, Humana, Kaiser Permanente and UnitedHealthcare. The authors and Dr. Krishna reported no disclosures.

Results from a phase 3 trial indicate that removing cyclophosphamide from standard chemotherapy can improve fertility without compromising survival in women with breast cancer.

Researchers found that omitting cyclophosphamide from a regimen of epirubicin and paclitaxel increased the likelihood of an early return of menses, and there was a trend toward improved disease-free survival.

The phase 3 SPECTRUM trial involved 521 women with estrogen receptor–positive, HER2-negative breast cancer who had undergone definitive surgery at one of eight institutions in China. The average age of the patients was 34 years.

Cyclophosphamide is a standard component of adjuvant chemotherapy, but it’s strongly associated with premature ovarian failure and infertility.

“For the first time, we demonstrate that a cyclophosphamide-free regimen [can] increase the rate of menses recovery without compromising survival,” said the researchers, led by Ke-Da Yu, MD, PhD, of the Fudan University Shanghai (China) Cancer Center.

They also reported that, among the women who tried to conceive at a later date, there was a higher pregnancy success rate among those who did not take cyclophosphamide.

“Our findings can be extrapolated to patients with other subtypes of breast cancer, such as triple-negative or HER2-enriched, because the effect of paclitaxel and cyclophosphamide on menstrual resumption is not subtype specific,” the investigators commented.

The results were published online in the Journal of the National Cancer Institute.

This is the first prospective trial specifically designed to find an adjuvant breast cancer regimen less toxic to the ovaries. The “investigators ... should be applauded,” wrote Matteo Lambertini, MD, PhD, of the University of Genova (Italy), and Ann Partridge, MD, of the Dana-Farber Cancer Institute in Boston, in an accompanying editorial.

Although promising, there are a few caveats, the editorialists wrote. In a past trial of doxorubicin and docetaxel in lieu of a cyclophosphamide regimen, disease outcomes were inferior. There is also a question as to whether the SPECTRUM results apply to non-Asian women.

The editorialists also noted that enrollment in this trial ended in 2016, before it was recommended that ovarian suppression be used in conjunction with adjuvant chemotherapy to prevent premature menopause.

“[It’s] notable that the absolute benefit in reducing [premature ovarian insufficiency] rates with the use of a cyclophosphamide-free regimen is similar to the effect demonstrated with the administration of a gonadotropin-releasing hormone agonist during cyclophosphamide-based chemotherapy,” they commented. It’s possible that combining the two approaches might have an additive effect, but for now the possibility remains unknown.

In addition, the SPECTRUM trial predates the widespread use of genetic testing to guide treatment, the editorialists pointed out.

“Therefore, caution should be taken in adopting wholesale such regimens,” Dr. Lambertini and Dr. Partridge said.
 

Switch to paclitaxel

The research team was inspired by previous reports that swapping out cyclophosphamide for paclitaxel did not reduce adjuvant efficacy in the general breast cancer population.

The SPECTRUM trial randomly assigned 260 women to receive a cyclophosphamide-free regimen of epirubicin (75 mg/m²) and paclitaxel (175 mg/m²) every 3 weeks for four cycles followed by weekly paclitaxel (80 mg/m²) for 12 weeks.

Another 261 women were randomly assigned to receive cyclophosphamide (600 mg/m²) and epirubicin (75 mg/m²) every 3 weeks for four cycles followed by weekly paclitaxel (80 mg/m²) for 12 weeks. These patients constituted the control group.

A year after completing chemotherapy, 63.1% of the cyclophosphamide-free arm versus 48.3% of the control group, had resumed menses, defined as having two consecutive menstrual cycles or one cycle but with premenopausal levels of estradiol and follicle-stimulating hormone (P < .001).

Another caveat of the study is that assessments of women who resumed menses were conducted at the 1-year point; rates may have been higher in the cyclophosphamide arm had the investigators conducted the assessments at 2 years, the editorialists said.

The 5-year disease-free survival was 84.7% in the cyclophosphamide-free arm versus 78.3% in the control group, an absolute difference of 14.8% (P = .07).

Patients with node-positive disease appeared to benefit the most from cyclophosphamide sparing.

There were no statistically significant differences in overall or distant disease-free survival.
 

Higher pregnancy rates

Almost 18% of women in the experimental arm reported trying to conceive, and 9.6% of them did so. About 10% of women in the cyclophosphamide arm tried to conceive, and 2.7% did so (P = .03).

The median interval between randomization and pregnancy was 42 months.

For all of the women who became pregnant, endocrine therapy was interrupted. “Women who temporarily interrupt endocrine therapy due to pregnancy should be reminded to resume endocrine therapy following attempted or successful pregnancy,” the investigators wrote.

The patients were taking tamoxifen at least 5 years after receiving chemotherapy, most often as monotherapy. About 5% of the patients underwent up-front ovarian suppression with an aromatase inhibitor, which is a current standard option.

The study was supported by the National Natural Science Foundation of China and other organizations. The investigators and Dr. Partridge disclosed no relevant financial relationships. Dr. Lambertini has consulted for and/or has received speakers fees from Roche, AstraZeneca, Lilly, Novartis, and other companies.

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

Results from a phase 3 trial indicate that removing cyclophosphamide from standard chemotherapy can improve fertility without compromising survival in women with breast cancer.

Researchers found that omitting cyclophosphamide from a regimen of epirubicin and paclitaxel increased the likelihood of an early return of menses, and there was a trend toward improved disease-free survival.

The phase 3 SPECTRUM trial involved 521 women with estrogen receptor–positive, HER2-negative breast cancer who had undergone definitive surgery at one of eight institutions in China. The average age of the patients was 34 years.

Cyclophosphamide is a standard component of adjuvant chemotherapy, but it’s strongly associated with premature ovarian failure and infertility.

“For the first time, we demonstrate that a cyclophosphamide-free regimen [can] increase the rate of menses recovery without compromising survival,” said the researchers, led by Ke-Da Yu, MD, PhD, of the Fudan University Shanghai (China) Cancer Center.

They also reported that, among the women who tried to conceive at a later date, there was a higher pregnancy success rate among those who did not take cyclophosphamide.

“Our findings can be extrapolated to patients with other subtypes of breast cancer, such as triple-negative or HER2-enriched, because the effect of paclitaxel and cyclophosphamide on menstrual resumption is not subtype specific,” the investigators commented.

The results were published online in the Journal of the National Cancer Institute.

This is the first prospective trial specifically designed to find an adjuvant breast cancer regimen less toxic to the ovaries. The “investigators ... should be applauded,” wrote Matteo Lambertini, MD, PhD, of the University of Genova (Italy), and Ann Partridge, MD, of the Dana-Farber Cancer Institute in Boston, in an accompanying editorial.

Although promising, there are a few caveats, the editorialists wrote. In a past trial of doxorubicin and docetaxel in lieu of a cyclophosphamide regimen, disease outcomes were inferior. There is also a question as to whether the SPECTRUM results apply to non-Asian women.

The editorialists also noted that enrollment in this trial ended in 2016, before it was recommended that ovarian suppression be used in conjunction with adjuvant chemotherapy to prevent premature menopause.

“[It’s] notable that the absolute benefit in reducing [premature ovarian insufficiency] rates with the use of a cyclophosphamide-free regimen is similar to the effect demonstrated with the administration of a gonadotropin-releasing hormone agonist during cyclophosphamide-based chemotherapy,” they commented. It’s possible that combining the two approaches might have an additive effect, but for now the possibility remains unknown.

In addition, the SPECTRUM trial predates the widespread use of genetic testing to guide treatment, the editorialists pointed out.

“Therefore, caution should be taken in adopting wholesale such regimens,” Dr. Lambertini and Dr. Partridge said.
 

Switch to paclitaxel

The research team was inspired by previous reports that swapping out cyclophosphamide for paclitaxel did not reduce adjuvant efficacy in the general breast cancer population.

The SPECTRUM trial randomly assigned 260 women to receive a cyclophosphamide-free regimen of epirubicin (75 mg/m²) and paclitaxel (175 mg/m²) every 3 weeks for four cycles followed by weekly paclitaxel (80 mg/m²) for 12 weeks.

Another 261 women were randomly assigned to receive cyclophosphamide (600 mg/m²) and epirubicin (75 mg/m²) every 3 weeks for four cycles followed by weekly paclitaxel (80 mg/m²) for 12 weeks. These patients constituted the control group.

A year after completing chemotherapy, 63.1% of the cyclophosphamide-free arm versus 48.3% of the control group, had resumed menses, defined as having two consecutive menstrual cycles or one cycle but with premenopausal levels of estradiol and follicle-stimulating hormone (P < .001).

Another caveat of the study is that assessments of women who resumed menses were conducted at the 1-year point; rates may have been higher in the cyclophosphamide arm had the investigators conducted the assessments at 2 years, the editorialists said.

The 5-year disease-free survival was 84.7% in the cyclophosphamide-free arm versus 78.3% in the control group, an absolute difference of 14.8% (P = .07).

Patients with node-positive disease appeared to benefit the most from cyclophosphamide sparing.

There were no statistically significant differences in overall or distant disease-free survival.
 

Higher pregnancy rates

Almost 18% of women in the experimental arm reported trying to conceive, and 9.6% of them did so. About 10% of women in the cyclophosphamide arm tried to conceive, and 2.7% did so (P = .03).

The median interval between randomization and pregnancy was 42 months.

For all of the women who became pregnant, endocrine therapy was interrupted. “Women who temporarily interrupt endocrine therapy due to pregnancy should be reminded to resume endocrine therapy following attempted or successful pregnancy,” the investigators wrote.

The patients were taking tamoxifen at least 5 years after receiving chemotherapy, most often as monotherapy. About 5% of the patients underwent up-front ovarian suppression with an aromatase inhibitor, which is a current standard option.

The study was supported by the National Natural Science Foundation of China and other organizations. The investigators and Dr. Partridge disclosed no relevant financial relationships. Dr. Lambertini has consulted for and/or has received speakers fees from Roche, AstraZeneca, Lilly, Novartis, and other companies.

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

Results from a phase 3 trial indicate that removing cyclophosphamide from standard chemotherapy can improve fertility without compromising survival in women with breast cancer.

Researchers found that omitting cyclophosphamide from a regimen of epirubicin and paclitaxel increased the likelihood of an early return of menses, and there was a trend toward improved disease-free survival.

The phase 3 SPECTRUM trial involved 521 women with estrogen receptor–positive, HER2-negative breast cancer who had undergone definitive surgery at one of eight institutions in China. The average age of the patients was 34 years.

Cyclophosphamide is a standard component of adjuvant chemotherapy, but it’s strongly associated with premature ovarian failure and infertility.

“For the first time, we demonstrate that a cyclophosphamide-free regimen [can] increase the rate of menses recovery without compromising survival,” said the researchers, led by Ke-Da Yu, MD, PhD, of the Fudan University Shanghai (China) Cancer Center.

They also reported that, among the women who tried to conceive at a later date, there was a higher pregnancy success rate among those who did not take cyclophosphamide.

“Our findings can be extrapolated to patients with other subtypes of breast cancer, such as triple-negative or HER2-enriched, because the effect of paclitaxel and cyclophosphamide on menstrual resumption is not subtype specific,” the investigators commented.

The results were published online in the Journal of the National Cancer Institute.

This is the first prospective trial specifically designed to find an adjuvant breast cancer regimen less toxic to the ovaries. The “investigators ... should be applauded,” wrote Matteo Lambertini, MD, PhD, of the University of Genova (Italy), and Ann Partridge, MD, of the Dana-Farber Cancer Institute in Boston, in an accompanying editorial.

Although promising, there are a few caveats, the editorialists wrote. In a past trial of doxorubicin and docetaxel in lieu of a cyclophosphamide regimen, disease outcomes were inferior. There is also a question as to whether the SPECTRUM results apply to non-Asian women.

The editorialists also noted that enrollment in this trial ended in 2016, before it was recommended that ovarian suppression be used in conjunction with adjuvant chemotherapy to prevent premature menopause.

“[It’s] notable that the absolute benefit in reducing [premature ovarian insufficiency] rates with the use of a cyclophosphamide-free regimen is similar to the effect demonstrated with the administration of a gonadotropin-releasing hormone agonist during cyclophosphamide-based chemotherapy,” they commented. It’s possible that combining the two approaches might have an additive effect, but for now the possibility remains unknown.

In addition, the SPECTRUM trial predates the widespread use of genetic testing to guide treatment, the editorialists pointed out.

“Therefore, caution should be taken in adopting wholesale such regimens,” Dr. Lambertini and Dr. Partridge said.
 

Switch to paclitaxel

The research team was inspired by previous reports that swapping out cyclophosphamide for paclitaxel did not reduce adjuvant efficacy in the general breast cancer population.

The SPECTRUM trial randomly assigned 260 women to receive a cyclophosphamide-free regimen of epirubicin (75 mg/m²) and paclitaxel (175 mg/m²) every 3 weeks for four cycles followed by weekly paclitaxel (80 mg/m²) for 12 weeks.

Another 261 women were randomly assigned to receive cyclophosphamide (600 mg/m²) and epirubicin (75 mg/m²) every 3 weeks for four cycles followed by weekly paclitaxel (80 mg/m²) for 12 weeks. These patients constituted the control group.

A year after completing chemotherapy, 63.1% of the cyclophosphamide-free arm versus 48.3% of the control group, had resumed menses, defined as having two consecutive menstrual cycles or one cycle but with premenopausal levels of estradiol and follicle-stimulating hormone (P < .001).

Another caveat of the study is that assessments of women who resumed menses were conducted at the 1-year point; rates may have been higher in the cyclophosphamide arm had the investigators conducted the assessments at 2 years, the editorialists said.

The 5-year disease-free survival was 84.7% in the cyclophosphamide-free arm versus 78.3% in the control group, an absolute difference of 14.8% (P = .07).

Patients with node-positive disease appeared to benefit the most from cyclophosphamide sparing.

There were no statistically significant differences in overall or distant disease-free survival.
 

Higher pregnancy rates

Almost 18% of women in the experimental arm reported trying to conceive, and 9.6% of them did so. About 10% of women in the cyclophosphamide arm tried to conceive, and 2.7% did so (P = .03).

The median interval between randomization and pregnancy was 42 months.

For all of the women who became pregnant, endocrine therapy was interrupted. “Women who temporarily interrupt endocrine therapy due to pregnancy should be reminded to resume endocrine therapy following attempted or successful pregnancy,” the investigators wrote.

The patients were taking tamoxifen at least 5 years after receiving chemotherapy, most often as monotherapy. About 5% of the patients underwent up-front ovarian suppression with an aromatase inhibitor, which is a current standard option.

The study was supported by the National Natural Science Foundation of China and other organizations. The investigators and Dr. Partridge disclosed no relevant financial relationships. Dr. Lambertini has consulted for and/or has received speakers fees from Roche, AstraZeneca, Lilly, Novartis, and other companies.

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

Dr. Ben-a-bo?

Nope.

Ben-nabi?

Nope.

Ben-NO-bo?

Also no.

My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.

We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)

However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.

Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.

First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)

If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.

It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. Making an effort to pronounce every patients’ name correctly I believe is a simple act we can all do to move us closer to mitigating racial biases and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.

Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.

Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.

Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Dr. Ben-a-bo?

Nope.

Ben-nabi?

Nope.

Ben-NO-bo?

Also no.

My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.

We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)

However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.

Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.

First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)

If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.

It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. Making an effort to pronounce every patients’ name correctly I believe is a simple act we can all do to move us closer to mitigating racial biases and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.

Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.

Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.

Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Dr. Ben-a-bo?

Nope.

Ben-nabi?

Nope.

Ben-NO-bo?

Also no.

My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.

We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)

However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.

Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.

First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)

If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.

It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. Making an effort to pronounce every patients’ name correctly I believe is a simple act we can all do to move us closer to mitigating racial biases and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.

Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.

Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.

Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

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

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

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

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

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

The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.

Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.

Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.

“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.

Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.

Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.

However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.

States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.

“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.

Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.

In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.

Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.

Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

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

The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.

Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.

Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.

“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.

Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.

Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.

However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.

States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.

“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.

Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.

In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.

Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.

Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

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

The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.

Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.

Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.

“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.

Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.

Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.

However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.

States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.

“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.

Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.

In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.

Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.

Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

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

For intrapartum fetal surveillance, the old way may be the best way, according to a meta-analysis involving more than 118,000 patients.

Intermittent auscultation with a Pinard stethoscope and handheld Doppler was associated with a significantly lower risk of emergency cesarean deliveries than newer monitoring techniques without jeopardizing maternal or neonatal outcomes, reported lead author Bassel H. Al Wattar, MD, PhD, of University of Warwick, Coventry, England, and University College London Hospitals, and colleagues.

“Over the last 50 years, several newer surveillance methods have been evaluated, with varied uptake in practice,” the investigators wrote in the Canadian Medical Association Journal, noting that cardiotocography (CTG) is the most common method for high-risk pregnancies, typically coupled with at least one other modality, such as fetal scalp pH analysis (FBS), fetal pulse oximetry (FPO), or fetal heart electrocardiogram (STAN).

“Despite extensive investment in clinical research, the overall effectiveness of such methods in improving maternal and neonatal outcomes remains debatable as stillbirth rates have plateaued worldwide, while cesarean delivery rates continue to rise,” the investigators wrote. Previous meta-analyses have relied upon head-to-head comparisons of monitoring techniques and did not take into account effects on maternal and neonatal outcomes.

To address this knowledge gap, Dr. Al Wattar and colleagues conducted the present systematic review and meta-analysis, ultimately including 33 trials with 118,863 women who underwent intrapartum fetal surveillance, dating back to 1976. Ten surveillance types were evaluated, including intermittent auscultation with Pinard stethoscope and handheld Doppler, CTG with or without computer-aided decision models (cCTG), and CTG or cCTG combined with one or two other techniques, such as FBS, FPO, and STAN.

This revealed that intermittent auscultation outperformed all other techniques in terms of emergency cesarean deliveries and emergency cesarean deliveries because of fetal distress.

Specifically, intermittent auscultation significantly reduced risk of emergency cesarean deliveries, compared with CTG (relative risk, 0.83; 95% confidence interval, 0.72-0.97), CTG-FBS (RR, 0.71; 95% CI, 0.63-0.80), CTG-lactate (RR, 0.77; 95% CI, 0.64-0.92), and FPO-CTG-FBS (RR, 0.81; 95% CI, 0.67-0.99). Conversely, compared with IA, STAN-CTG-FBS and cCTG-FBS raised risk of emergency cesarean deliveries by 17% and 21%, respectively.

Compared with other modalities, the superiority of intermittent auscultation was even more pronounced in terms of emergency cesarean deliveries because of fetal distress. Intermittent auscultation reduced risk by 43%, compared with CTG, 66% compared with CTG-FBS, 58%, compared with FPO-CTG, and 17%, compared with FPO-CTG-FBS. Conversely, compared with intermittent auscultation, STAN-CTG and cCTG-FBS increased risk of emergency cesarean deliveries because of fetal distress by 39% and 80%, respectively.

Further analysis showed that all types of surveillance had similar effects on neonatal outcomes, such as admission to neonatal unit and neonatal acidemia. Although a combination of STAN or FPO with CTG-FBS “seemed to improve the likelihood of reducing adverse neonatal outcomes,” the investigators noted that these differences were not significant in network meta­-analysis.

“New fetal surveillance methods did not improve neonatal outcomes or reduce unnecessary maternal interventions,” Dr. Al Wattar and colleagues concluded. “Further evidence is needed to evaluate the effects of fetal pulse oximetry and fetal heart electrocardiography in labor.”

Courtney Rhoades, DO, MBA, FACOG, medical director of labor and delivery and assistant professor of obstetrics and gynecology at the University of Florida, Jacksonville, suggested that the meta-analysis supports the safety of intermittent auscultation, but the results may not be entirely applicable to real-world practice.

“It is hard, in practice, to draw the same conclusion that they do in the study that the newer methods may cause too many emergency C-sections because our fetal monitoring equipment, methodology for interpretation, ability to do emergency C-sections and maternal risk factors have changed in the last 50 years,” Dr. Rhoades said. “Continuous fetal monitoring gives more data points during labor, and with more data points, there are more opportunities to interpret and act – either correctly or incorrectly. As they state in the study, the decision to do a C-section is multifactorial.”

Dr. Rhoades, who recently authored a textbook chapter on intrapartum monitoring and fetal assessment, recommended that intermittent auscultation be reserved for low-risk patients.

“The American College of Obstetricians and Gynecologists has endorsed intermittent auscultation for low-risk pregnancies and this study affirms their support,” Dr. Rhoades said. “Women with a low-risk pregnancy can benefit from intermittent auscultation because it allows them more autonomy and movement during labor so it should be offered to our low-risk patients.”

Dr. Al Wattar reported a personal Academic Clinical Lectureship from the U.K. National Health Institute of Research. Dr. Khan disclosed funding from the Beatriz Galindo Program Grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government.

For intrapartum fetal surveillance, the old way may be the best way, according to a meta-analysis involving more than 118,000 patients.

Intermittent auscultation with a Pinard stethoscope and handheld Doppler was associated with a significantly lower risk of emergency cesarean deliveries than newer monitoring techniques without jeopardizing maternal or neonatal outcomes, reported lead author Bassel H. Al Wattar, MD, PhD, of University of Warwick, Coventry, England, and University College London Hospitals, and colleagues.

“Over the last 50 years, several newer surveillance methods have been evaluated, with varied uptake in practice,” the investigators wrote in the Canadian Medical Association Journal, noting that cardiotocography (CTG) is the most common method for high-risk pregnancies, typically coupled with at least one other modality, such as fetal scalp pH analysis (FBS), fetal pulse oximetry (FPO), or fetal heart electrocardiogram (STAN).

“Despite extensive investment in clinical research, the overall effectiveness of such methods in improving maternal and neonatal outcomes remains debatable as stillbirth rates have plateaued worldwide, while cesarean delivery rates continue to rise,” the investigators wrote. Previous meta-analyses have relied upon head-to-head comparisons of monitoring techniques and did not take into account effects on maternal and neonatal outcomes.

To address this knowledge gap, Dr. Al Wattar and colleagues conducted the present systematic review and meta-analysis, ultimately including 33 trials with 118,863 women who underwent intrapartum fetal surveillance, dating back to 1976. Ten surveillance types were evaluated, including intermittent auscultation with Pinard stethoscope and handheld Doppler, CTG with or without computer-aided decision models (cCTG), and CTG or cCTG combined with one or two other techniques, such as FBS, FPO, and STAN.

This revealed that intermittent auscultation outperformed all other techniques in terms of emergency cesarean deliveries and emergency cesarean deliveries because of fetal distress.

Specifically, intermittent auscultation significantly reduced risk of emergency cesarean deliveries, compared with CTG (relative risk, 0.83; 95% confidence interval, 0.72-0.97), CTG-FBS (RR, 0.71; 95% CI, 0.63-0.80), CTG-lactate (RR, 0.77; 95% CI, 0.64-0.92), and FPO-CTG-FBS (RR, 0.81; 95% CI, 0.67-0.99). Conversely, compared with IA, STAN-CTG-FBS and cCTG-FBS raised risk of emergency cesarean deliveries by 17% and 21%, respectively.

Compared with other modalities, the superiority of intermittent auscultation was even more pronounced in terms of emergency cesarean deliveries because of fetal distress. Intermittent auscultation reduced risk by 43%, compared with CTG, 66% compared with CTG-FBS, 58%, compared with FPO-CTG, and 17%, compared with FPO-CTG-FBS. Conversely, compared with intermittent auscultation, STAN-CTG and cCTG-FBS increased risk of emergency cesarean deliveries because of fetal distress by 39% and 80%, respectively.

Further analysis showed that all types of surveillance had similar effects on neonatal outcomes, such as admission to neonatal unit and neonatal acidemia. Although a combination of STAN or FPO with CTG-FBS “seemed to improve the likelihood of reducing adverse neonatal outcomes,” the investigators noted that these differences were not significant in network meta­-analysis.

“New fetal surveillance methods did not improve neonatal outcomes or reduce unnecessary maternal interventions,” Dr. Al Wattar and colleagues concluded. “Further evidence is needed to evaluate the effects of fetal pulse oximetry and fetal heart electrocardiography in labor.”

Courtney Rhoades, DO, MBA, FACOG, medical director of labor and delivery and assistant professor of obstetrics and gynecology at the University of Florida, Jacksonville, suggested that the meta-analysis supports the safety of intermittent auscultation, but the results may not be entirely applicable to real-world practice.

“It is hard, in practice, to draw the same conclusion that they do in the study that the newer methods may cause too many emergency C-sections because our fetal monitoring equipment, methodology for interpretation, ability to do emergency C-sections and maternal risk factors have changed in the last 50 years,” Dr. Rhoades said. “Continuous fetal monitoring gives more data points during labor, and with more data points, there are more opportunities to interpret and act – either correctly or incorrectly. As they state in the study, the decision to do a C-section is multifactorial.”

Dr. Rhoades, who recently authored a textbook chapter on intrapartum monitoring and fetal assessment, recommended that intermittent auscultation be reserved for low-risk patients.

“The American College of Obstetricians and Gynecologists has endorsed intermittent auscultation for low-risk pregnancies and this study affirms their support,” Dr. Rhoades said. “Women with a low-risk pregnancy can benefit from intermittent auscultation because it allows them more autonomy and movement during labor so it should be offered to our low-risk patients.”

Dr. Al Wattar reported a personal Academic Clinical Lectureship from the U.K. National Health Institute of Research. Dr. Khan disclosed funding from the Beatriz Galindo Program Grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government.

For intrapartum fetal surveillance, the old way may be the best way, according to a meta-analysis involving more than 118,000 patients.

Intermittent auscultation with a Pinard stethoscope and handheld Doppler was associated with a significantly lower risk of emergency cesarean deliveries than newer monitoring techniques without jeopardizing maternal or neonatal outcomes, reported lead author Bassel H. Al Wattar, MD, PhD, of University of Warwick, Coventry, England, and University College London Hospitals, and colleagues.

“Over the last 50 years, several newer surveillance methods have been evaluated, with varied uptake in practice,” the investigators wrote in the Canadian Medical Association Journal, noting that cardiotocography (CTG) is the most common method for high-risk pregnancies, typically coupled with at least one other modality, such as fetal scalp pH analysis (FBS), fetal pulse oximetry (FPO), or fetal heart electrocardiogram (STAN).

“Despite extensive investment in clinical research, the overall effectiveness of such methods in improving maternal and neonatal outcomes remains debatable as stillbirth rates have plateaued worldwide, while cesarean delivery rates continue to rise,” the investigators wrote. Previous meta-analyses have relied upon head-to-head comparisons of monitoring techniques and did not take into account effects on maternal and neonatal outcomes.

To address this knowledge gap, Dr. Al Wattar and colleagues conducted the present systematic review and meta-analysis, ultimately including 33 trials with 118,863 women who underwent intrapartum fetal surveillance, dating back to 1976. Ten surveillance types were evaluated, including intermittent auscultation with Pinard stethoscope and handheld Doppler, CTG with or without computer-aided decision models (cCTG), and CTG or cCTG combined with one or two other techniques, such as FBS, FPO, and STAN.

This revealed that intermittent auscultation outperformed all other techniques in terms of emergency cesarean deliveries and emergency cesarean deliveries because of fetal distress.

Specifically, intermittent auscultation significantly reduced risk of emergency cesarean deliveries, compared with CTG (relative risk, 0.83; 95% confidence interval, 0.72-0.97), CTG-FBS (RR, 0.71; 95% CI, 0.63-0.80), CTG-lactate (RR, 0.77; 95% CI, 0.64-0.92), and FPO-CTG-FBS (RR, 0.81; 95% CI, 0.67-0.99). Conversely, compared with IA, STAN-CTG-FBS and cCTG-FBS raised risk of emergency cesarean deliveries by 17% and 21%, respectively.

Compared with other modalities, the superiority of intermittent auscultation was even more pronounced in terms of emergency cesarean deliveries because of fetal distress. Intermittent auscultation reduced risk by 43%, compared with CTG, 66% compared with CTG-FBS, 58%, compared with FPO-CTG, and 17%, compared with FPO-CTG-FBS. Conversely, compared with intermittent auscultation, STAN-CTG and cCTG-FBS increased risk of emergency cesarean deliveries because of fetal distress by 39% and 80%, respectively.

Further analysis showed that all types of surveillance had similar effects on neonatal outcomes, such as admission to neonatal unit and neonatal acidemia. Although a combination of STAN or FPO with CTG-FBS “seemed to improve the likelihood of reducing adverse neonatal outcomes,” the investigators noted that these differences were not significant in network meta­-analysis.

“New fetal surveillance methods did not improve neonatal outcomes or reduce unnecessary maternal interventions,” Dr. Al Wattar and colleagues concluded. “Further evidence is needed to evaluate the effects of fetal pulse oximetry and fetal heart electrocardiography in labor.”

Courtney Rhoades, DO, MBA, FACOG, medical director of labor and delivery and assistant professor of obstetrics and gynecology at the University of Florida, Jacksonville, suggested that the meta-analysis supports the safety of intermittent auscultation, but the results may not be entirely applicable to real-world practice.

“It is hard, in practice, to draw the same conclusion that they do in the study that the newer methods may cause too many emergency C-sections because our fetal monitoring equipment, methodology for interpretation, ability to do emergency C-sections and maternal risk factors have changed in the last 50 years,” Dr. Rhoades said. “Continuous fetal monitoring gives more data points during labor, and with more data points, there are more opportunities to interpret and act – either correctly or incorrectly. As they state in the study, the decision to do a C-section is multifactorial.”

Dr. Rhoades, who recently authored a textbook chapter on intrapartum monitoring and fetal assessment, recommended that intermittent auscultation be reserved for low-risk patients.

“The American College of Obstetricians and Gynecologists has endorsed intermittent auscultation for low-risk pregnancies and this study affirms their support,” Dr. Rhoades said. “Women with a low-risk pregnancy can benefit from intermittent auscultation because it allows them more autonomy and movement during labor so it should be offered to our low-risk patients.”

Dr. Al Wattar reported a personal Academic Clinical Lectureship from the U.K. National Health Institute of Research. Dr. Khan disclosed funding from the Beatriz Galindo Program Grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government.

The recommended pause in use of the Johnson & Johnson COVID-19 vaccine will last at least another week after a Centers for Disease Control and Prevention advisory committee on April 14 decided not to take action.

Johnson &amp; Johnson

The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.

The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.

A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”

At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.

Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.

Committee member Camiile Kotton, MD, described the pause as “devastating.”

“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”

Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
 

What is known, not known

Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.

Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.

No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.

In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.

She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.

Approximately 13 million J&J doses are available to order or are already at administration sites, she said.

But much more is unknown, she said.

“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.

Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.

Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”

“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.

“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”

He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.

“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.

ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.

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

The recommended pause in use of the Johnson & Johnson COVID-19 vaccine will last at least another week after a Centers for Disease Control and Prevention advisory committee on April 14 decided not to take action.

Johnson &amp; Johnson

The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.

The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.

A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”

At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.

Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.

Committee member Camiile Kotton, MD, described the pause as “devastating.”

“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”

Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
 

What is known, not known

Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.

Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.

No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.

In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.

She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.

Approximately 13 million J&J doses are available to order or are already at administration sites, she said.

But much more is unknown, she said.

“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.

Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.

Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”

“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.

“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”

He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.

“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.

ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.

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

The recommended pause in use of the Johnson & Johnson COVID-19 vaccine will last at least another week after a Centers for Disease Control and Prevention advisory committee on April 14 decided not to take action.

Johnson &amp; Johnson

The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.

The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.

A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”

At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.

Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.

Committee member Camiile Kotton, MD, described the pause as “devastating.”

“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”

Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
 

What is known, not known

Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.

Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.

No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.

In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.

She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.

Approximately 13 million J&J doses are available to order or are already at administration sites, she said.

But much more is unknown, she said.

“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.

Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.

Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”

“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.

“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”

He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.

“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.

ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.

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

An advisory committee to the Centers for Disease Control and Prevention is addressing the safety of the Johnson & Johnson COVID-19 vaccine on April 14, 2021, after the CDC and Food and Drug Administration recommended that states hold off on using it pending a detailed review of six cases of the same kind of rare but serious event – a blood clot in the vessels that drain blood from the brain combined with a large drop in platelets, which increases the risk for bleeding.

This combination can lead to severe strokes that can lead to brain damage or death. Among the six cases reported, which came to light over the past 3 weeks, one person died, according to the CDC. All six were women and ranged in age from 18 to 48 years.

According to a report from the Vaccine Adverse Event Reporting System (VAERS), which is maintained by the Department of Health & Human Services, the woman who died was 45. She developed a gradually worsening headache about a week after receiving the Johnson & Johnson vaccine.

On March 17, the day she came to the hospital, she was dry heaving. Her headache had suddenly gotten much worse, and the left side of her body was weak, which are signs of a stroke. A CT scan revealed both bleeding in her brain and a clot in her cortical vein. She died the following day.

In addition to VAERS, which accepts reports from anyone, the CDC and FDA are monitoring at least eight other safety systems maintained by hospitals, research centers, long-term care facilities, and insurance companies for signs of trouble with the vaccines. VAERS data is searchable and open to the public. Most of these systems are not publicly available to protect patient privacy. It’s unclear which systems detected the six cases cited by federal regulators.

“These are very serious and potentially fatal problems occurring in a healthy young adult. It’s serious and we need to get to the bottom of it,” said Ed Belongia, MD, director of the Center for Clinical Epidemiology and Population Health at the Marshfield (Wis.) Clinic Research Institute. Dr. Belongia leads a research team that helps the CDC monitor vaccine safety and effectiveness. 

“Safety is always the highest priority, and I think what we’ve seen here in the past 24 hours is our vaccine safety monitoring system is working,” he said.

Others agree. “I think what CDC and FDA have detected is a rare, but likely real adverse event associated with this vaccine,” said Paul Offit, MD, director of vaccine education at Children’s Hospital of Philadelphia.

Although much is still unknown about these events, they follow a similar pattern of blood clots reported with the AstraZeneca vaccine in Europe. That vaccine is now sold under the brand name Vaxzevria. 

This has experts questioning whether all vaccines of this type may cause these rare clots.

“I think it’s likely a class effect,” said Dr. Offit, who was a member of the FDA advisory committee that reviewed clinical trial data on the J&J vaccine before it was authorized for use.
 

Adenovirus vaccines scrutinized

Both the Johnson & Johnson and Vaxzevria vaccines use an adenovirus to ferry genetic instructions for making the coronaviruses spike protein into our cells.

Adenoviruses are common, relatively simple viruses that normally cause mild cold or flu symptoms. The ones used in the vaccine are disabled so they can’t make us sick. They’re more like Trojan horses. 

Once inside our cells, they release the DNA instructions they carry to make the spike protein of the new coronavirus. Those cells then crank out copies of the spike protein, which then get displayed on the outer surface of the cell membrane where they are recognized by the immune system. 

The immune system then makes antibodies and other defenses against the spike so that, when the real coronavirus comes along, our bodies are ready to fight the infection.

There’s no question the vaccine works. In clinical trials, the Johnson & Johnson vaccine was 66% percent effective at preventing against moderate to severe COVID-19 infection, and none of the patients who got COVID-19 after vaccination had to be admitted to the hospital or died.

The idea behind using adenoviruses in vaccines isn’t a new one. In a kind of fight-fire-with-fire approach, the idea is to use a virus, which is good at infecting us, to fight a different kind of virus.

Researchers have been working on the concept for about 10 years, but the COVID-19 vaccines that use this technology are some of the first adenovirus-vector vaccines deployed in humans. 

Only one other adenovirus vaccine, for Ebola, has been approved for use in humans. It was approved in Europe last year. Before the Johnson & Johnson vaccine, no other adenovirus vector has been available for use in humans in the United States.

There are six adenovirus-vector vaccines for COVID-19. In addition to AstraZeneca and Johnson & Johnson, there’s the Russian-developed vaccine Sputnik V, along with CanSino from China, and the Covishield vaccine in India.

Adenovirus vaccines are more stable than the mRNA vaccines. That makes them easier to store and transport. 

But they have a significant downside, too. Because adenoviruses infect humans out in the world, we already make antibodies against them. So there’s always a danger that our immune systems might recognize and react to the vaccine, rendering it ineffective. For that reason, scientists try to carefully select the adenovirus vectors, or carriers, they use.

The two vaccines under investigation for blood clots are slightly different. The Johnson & Johnson vaccine uses the vector AD26, because most of the population lacks preexisting immunity to it. Vaxzevria uses an adenovirus that infects chimpanzees, called ChAdOx1. 

Vaxzevria has been widely used in Europe but has not yet been authorized in the United States.

On April 7, the European Medicines Agency, Europe’s counterpart to the FDA, ruled that unusual blood clots with low blood platelets should be listed as rare side effects on the Vaxzevria vaccine.

The decision came after reviewing 62 cases of cerebral venous sinus thrombosis (CVST) linked to the vaccine and 25 cases of another rare type of clot, called a splanchnic vein thrombosis. Splanchnic veins drain blood from the major organs in the digestive system, including the stomach, liver, and intestines; 18 of those events were fatal.

The reports were culled from reporting in Europe and the United Kingdom, where around 25 million people have received the Vaxzevria vaccine, making these clots exceptionally rare, but serious.

So far, six cases of CVST have been reported in the United States, after more than 7 million doses of the Johnson & Johnson vaccines have been administered.

A key question for U.S. regulators will be the background rate for these types of rare combinations of clots and deplenished platelets. The background rate is the number of events that would be expected to occur naturally in a population of unvaccinated people. On a press call on April 13, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, was asked about the frequency of this dangerous combination. He said the combination of low platelets and clots was so rare that it was hard to pinpoint, but might be somewhere between 2 and 14 cases per million people over the course of a year.

The first Johnson & Johnson doses were given in early March. That means the six cases came to light within the first few weeks of use of the vaccine in the United States, a very short amount of time.

“These were six cases per million people for 2 weeks, which is the same thing as 25 million per year, so it’s clearly above the background rate,” Dr. Offit said.
 

Studies suggest possible mechanism

On April 9, the New England Journal of Medicine published a detailed evaluation of the 11 patients in Germany and Austria who developed the rare clots after their Vaxzevria vaccines.

The study detected rare antibodies to a signaling protein called platelet factor 4, which helps to coordinate clot formation.

These same type of antibodies form in some people given the blood thinning drug heparin. In those reactions, which are also exceptionally rare, the same type of syndrome develops, leading to large, devastating clots that consume circulating platelets.

It’s not yet clear whether people who develop reactions to the vaccines already have some platelet factor 4 antibodies before they are vaccinated, or whether the vaccines somehow spur the body to make these antibodies, which then launch a kind of autoimmune attack.

The researchers on the paper gave the syndrome a name, vaccine-induced thrombotic thrombocytopenia (VITT).

It’s also not clear why more cases seem to be in women than in men. Andrew Eisenberger, MD, an associate professor of hematology and oncology at Columbia University, New York, said the most common causes of cerebral venous sinus thrombosis have to do with conditions that raise estrogen levels, like pregnancy and hormonal contraception.

“Estrogen naturally leads to changes in several clotting proteins in the blood that may predispose to abnormal blood clotting in a few different sites in the body,” he said. “The clotting changes we are encountering with some of COVID-19 vaccines are likely to be synergistic with the effects of estrogen on the blood.”

No matter the cause, the CDC on April 13 alerted doctors to keep a high index of suspicion for VITT in patients who have received the Johnson & Johnson vaccination within the last 2 weeks. In those patients, the usual course of treatment with blood thinning drugs like heparin may be harmful.

Symptoms to watch for include severe headache or backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin, or easy bruising.