Women's Health

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

Sports-related sudden cardiac arrest (Sr-SCA) appears to be extremely rare in women, compared with men, despite similar characteristics and circumstances of occurrence, data from three European population-based registries suggest.

“Our study shows that cardiac arrest during sports activities is up to 13 times less frequent in women, which means that the risk of sports-related cardiac arrest is substantially lower in women than in men. This tighter risk is consistent across all age subgroups and registries,” Orianne Weizman, MD, MPH, Université Paris Cité, said in an interview.

“Even if it is a nonconsensual suggestion, the question of risk-adapted screening in women must be asked,” Dr. Weizman and colleagues propose.

Their study was published online  in the Journal of the American College of Cardiology.
 

Annual incidence

Among 34,826 cases of SCA in the registries that occurred in adults between 2006 and 2017, 760 (2.2%) were related to sports, and the vast majority occurred in men (706, 92.9%). Only 54 (7.1%) occurred in women.

Viktor Cap/Thinkstock

Overall, the average annual incidence of Sr-SCA in women was 0.19 per million, compared with 2.63 per million in men (P < .0001).

When extrapolating to the total European population and accounting for age and sex, this translates into 98 expected cases of Sr-SCA each year in women versus 1,350 cases annually in men.

The average age of Sr-SCA was similar in women and men (59 years). Most cases occurred during moderate-vigorous physical activity, although data on the types of sports and time spent on sports per week or month were not defined.

However, the investigators note that women with Sr-SCA were more likely than men to be engaged in light or moderate physical activity at the time of arrest (17.5% vs. 4.2%) – suggesting a potential higher propensity for women to present with SCA at moderate workloads.

The incidence of Sr-SCA increased only slightly in postmenopausal women, while there was an 8-fold increase in men aged 60-74 years, relative to peers younger than 40 years.

History of heart disease was relatively uncommon in both men and women. Previous myocardial infarction was the most frequent preexisting condition in men (26.8%), whereas nonischemic heart disease (cardiomyopathy and valvular heart disease) was more frequent among women (29.0%).

Cardiovascular risk factors were frequently present in both men and women, with at least one factor present in two-thirds of the patients, regardless of sex.

Pulseless electrical activity and asystole were more common in women than in men (40.7% vs. 19.1%), as has been shown in previous studies of resuscitation from SCA in the general population. Ventricular tachycardia or fibrillation was the initial rhythm in 80.9% of men and 59.3% of women.

The cause of SCA was MI in 31.4% of women and 29.0% of men. Other cases were related to dilated cardiomyopathy (5.6% in women, 1.8% in men) or hypertrophic cardiomyopathy (1.9% in women, 1.3% in men). Electrical heart disease was found in two women (3.7%) and 15 men (2.1%).

In most cases (86%), one or more witnesses were present and assisted after the collapse. There was no significant difference between men and women in bystander response, time to defibrillation, and survival, which approached 60% at hospital discharge with early bystander cardiorespiratory resuscitation and automatic external defibrillator use.

A limitation of the study is a predominantly White European population, meaning that the findings may not be extrapolated to other populations.
 

Tailored screening?

“These findings raise questions about the causes of this extremely low risk, which are not yet clear, and the extent to which we should revise our pre-sport screening methods,” Dr. Weizman told this news organization.

“We suggest that extensive, routinely conducted screening in women would not be cost-effective because of the extremely rare incidence of serious events,” Dr. Weizman said.

What’s lacking, however, is sport-specific data on whether specific activities (endurance or resistance) would be more risky for women. Further information, particularly on the sports at highest risk for Sr-SCA in women, is needed to propose tailor-made screening algorithms, Dr. Weizman noted.

The value of preparticipation screening for occult heart disease beyond the history and physical examination has been debated, with some organizations recommending electrocardiogram in addition to baseline assessments.

But this can lead to false-positives, “with the anxiety and cost associated with additional testing,” Anne Curtis, MD, State University of New York at Buffalo, Buffalo General Medical Center, and Jan Tijssen, PhD, University of Amsterdam, write in a linked editorial.

Currently, the American Heart Association recommends screening before sports participation, with a focused personal and family history and physical examination.

Dr. Curtis told this news organization that the U.S. guidelines “should stay as they are, but if one were to change them, it would be important to recognize that male athletes are much more likely to suffer arrhythmic events during sports than female athletes.”

“That to me means that female athletes in particular should not need to have ECGs prior to sports participation unless the history and physical examination detects a potential problem that needs further investigation,” Dr. Curtis said.

“Both women and men should be screened for cardiovascular risk factors during routine primary care, with appropriate interventions for hypertension, hyperlipidemia, smoking, and other risk factors,” Dr. Curtis and Dr. Tijssen advise in their editorial.

“In asymptomatic individuals who wish to become more active, in most cases they should be given the green light to proceed, starting slow and increasing intensity/duration over time, without specific additional testing. This advice is particularly relevant for women, given the findings of the current and prior studies,” they add.

This research was funded by Horizon 2020 and COST Action PARQ, supported by the European Cooperation in Science and Technology. Additional support was provided by INSERM, University of Paris, Assistance Publique-Hôpitaux de Paris, Fondation Coeur et Artères, Global Heart Watch, Fédération Française de Cardiologie, Société Française de Cardiologie, Fondation Recherche Medicale, as well as unrestricted grants from industrial partners. The authors and Dr. Tijssen have declared no relevant financial relationships. Dr. Curtis has disclosed relationships with Janssen several pharmaceutical companies.

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

Sports-related sudden cardiac arrest (Sr-SCA) appears to be extremely rare in women, compared with men, despite similar characteristics and circumstances of occurrence, data from three European population-based registries suggest.

“Our study shows that cardiac arrest during sports activities is up to 13 times less frequent in women, which means that the risk of sports-related cardiac arrest is substantially lower in women than in men. This tighter risk is consistent across all age subgroups and registries,” Orianne Weizman, MD, MPH, Université Paris Cité, said in an interview.

“Even if it is a nonconsensual suggestion, the question of risk-adapted screening in women must be asked,” Dr. Weizman and colleagues propose.

Their study was published online  in the Journal of the American College of Cardiology.
 

Annual incidence

Among 34,826 cases of SCA in the registries that occurred in adults between 2006 and 2017, 760 (2.2%) were related to sports, and the vast majority occurred in men (706, 92.9%). Only 54 (7.1%) occurred in women.

Viktor Cap/Thinkstock

Overall, the average annual incidence of Sr-SCA in women was 0.19 per million, compared with 2.63 per million in men (P < .0001).

When extrapolating to the total European population and accounting for age and sex, this translates into 98 expected cases of Sr-SCA each year in women versus 1,350 cases annually in men.

The average age of Sr-SCA was similar in women and men (59 years). Most cases occurred during moderate-vigorous physical activity, although data on the types of sports and time spent on sports per week or month were not defined.

However, the investigators note that women with Sr-SCA were more likely than men to be engaged in light or moderate physical activity at the time of arrest (17.5% vs. 4.2%) – suggesting a potential higher propensity for women to present with SCA at moderate workloads.

The incidence of Sr-SCA increased only slightly in postmenopausal women, while there was an 8-fold increase in men aged 60-74 years, relative to peers younger than 40 years.

History of heart disease was relatively uncommon in both men and women. Previous myocardial infarction was the most frequent preexisting condition in men (26.8%), whereas nonischemic heart disease (cardiomyopathy and valvular heart disease) was more frequent among women (29.0%).

Cardiovascular risk factors were frequently present in both men and women, with at least one factor present in two-thirds of the patients, regardless of sex.

Pulseless electrical activity and asystole were more common in women than in men (40.7% vs. 19.1%), as has been shown in previous studies of resuscitation from SCA in the general population. Ventricular tachycardia or fibrillation was the initial rhythm in 80.9% of men and 59.3% of women.

The cause of SCA was MI in 31.4% of women and 29.0% of men. Other cases were related to dilated cardiomyopathy (5.6% in women, 1.8% in men) or hypertrophic cardiomyopathy (1.9% in women, 1.3% in men). Electrical heart disease was found in two women (3.7%) and 15 men (2.1%).

In most cases (86%), one or more witnesses were present and assisted after the collapse. There was no significant difference between men and women in bystander response, time to defibrillation, and survival, which approached 60% at hospital discharge with early bystander cardiorespiratory resuscitation and automatic external defibrillator use.

A limitation of the study is a predominantly White European population, meaning that the findings may not be extrapolated to other populations.
 

Tailored screening?

“These findings raise questions about the causes of this extremely low risk, which are not yet clear, and the extent to which we should revise our pre-sport screening methods,” Dr. Weizman told this news organization.

“We suggest that extensive, routinely conducted screening in women would not be cost-effective because of the extremely rare incidence of serious events,” Dr. Weizman said.

What’s lacking, however, is sport-specific data on whether specific activities (endurance or resistance) would be more risky for women. Further information, particularly on the sports at highest risk for Sr-SCA in women, is needed to propose tailor-made screening algorithms, Dr. Weizman noted.

The value of preparticipation screening for occult heart disease beyond the history and physical examination has been debated, with some organizations recommending electrocardiogram in addition to baseline assessments.

But this can lead to false-positives, “with the anxiety and cost associated with additional testing,” Anne Curtis, MD, State University of New York at Buffalo, Buffalo General Medical Center, and Jan Tijssen, PhD, University of Amsterdam, write in a linked editorial.

Currently, the American Heart Association recommends screening before sports participation, with a focused personal and family history and physical examination.

Dr. Curtis told this news organization that the U.S. guidelines “should stay as they are, but if one were to change them, it would be important to recognize that male athletes are much more likely to suffer arrhythmic events during sports than female athletes.”

“That to me means that female athletes in particular should not need to have ECGs prior to sports participation unless the history and physical examination detects a potential problem that needs further investigation,” Dr. Curtis said.

“Both women and men should be screened for cardiovascular risk factors during routine primary care, with appropriate interventions for hypertension, hyperlipidemia, smoking, and other risk factors,” Dr. Curtis and Dr. Tijssen advise in their editorial.

“In asymptomatic individuals who wish to become more active, in most cases they should be given the green light to proceed, starting slow and increasing intensity/duration over time, without specific additional testing. This advice is particularly relevant for women, given the findings of the current and prior studies,” they add.

This research was funded by Horizon 2020 and COST Action PARQ, supported by the European Cooperation in Science and Technology. Additional support was provided by INSERM, University of Paris, Assistance Publique-Hôpitaux de Paris, Fondation Coeur et Artères, Global Heart Watch, Fédération Française de Cardiologie, Société Française de Cardiologie, Fondation Recherche Medicale, as well as unrestricted grants from industrial partners. The authors and Dr. Tijssen have declared no relevant financial relationships. Dr. Curtis has disclosed relationships with Janssen several pharmaceutical companies.

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

Sports-related sudden cardiac arrest (Sr-SCA) appears to be extremely rare in women, compared with men, despite similar characteristics and circumstances of occurrence, data from three European population-based registries suggest.

“Our study shows that cardiac arrest during sports activities is up to 13 times less frequent in women, which means that the risk of sports-related cardiac arrest is substantially lower in women than in men. This tighter risk is consistent across all age subgroups and registries,” Orianne Weizman, MD, MPH, Université Paris Cité, said in an interview.

“Even if it is a nonconsensual suggestion, the question of risk-adapted screening in women must be asked,” Dr. Weizman and colleagues propose.

Their study was published online  in the Journal of the American College of Cardiology.
 

Annual incidence

Among 34,826 cases of SCA in the registries that occurred in adults between 2006 and 2017, 760 (2.2%) were related to sports, and the vast majority occurred in men (706, 92.9%). Only 54 (7.1%) occurred in women.

Viktor Cap/Thinkstock

Overall, the average annual incidence of Sr-SCA in women was 0.19 per million, compared with 2.63 per million in men (P < .0001).

When extrapolating to the total European population and accounting for age and sex, this translates into 98 expected cases of Sr-SCA each year in women versus 1,350 cases annually in men.

The average age of Sr-SCA was similar in women and men (59 years). Most cases occurred during moderate-vigorous physical activity, although data on the types of sports and time spent on sports per week or month were not defined.

However, the investigators note that women with Sr-SCA were more likely than men to be engaged in light or moderate physical activity at the time of arrest (17.5% vs. 4.2%) – suggesting a potential higher propensity for women to present with SCA at moderate workloads.

The incidence of Sr-SCA increased only slightly in postmenopausal women, while there was an 8-fold increase in men aged 60-74 years, relative to peers younger than 40 years.

History of heart disease was relatively uncommon in both men and women. Previous myocardial infarction was the most frequent preexisting condition in men (26.8%), whereas nonischemic heart disease (cardiomyopathy and valvular heart disease) was more frequent among women (29.0%).

Cardiovascular risk factors were frequently present in both men and women, with at least one factor present in two-thirds of the patients, regardless of sex.

Pulseless electrical activity and asystole were more common in women than in men (40.7% vs. 19.1%), as has been shown in previous studies of resuscitation from SCA in the general population. Ventricular tachycardia or fibrillation was the initial rhythm in 80.9% of men and 59.3% of women.

The cause of SCA was MI in 31.4% of women and 29.0% of men. Other cases were related to dilated cardiomyopathy (5.6% in women, 1.8% in men) or hypertrophic cardiomyopathy (1.9% in women, 1.3% in men). Electrical heart disease was found in two women (3.7%) and 15 men (2.1%).

In most cases (86%), one or more witnesses were present and assisted after the collapse. There was no significant difference between men and women in bystander response, time to defibrillation, and survival, which approached 60% at hospital discharge with early bystander cardiorespiratory resuscitation and automatic external defibrillator use.

A limitation of the study is a predominantly White European population, meaning that the findings may not be extrapolated to other populations.
 

Tailored screening?

“These findings raise questions about the causes of this extremely low risk, which are not yet clear, and the extent to which we should revise our pre-sport screening methods,” Dr. Weizman told this news organization.

“We suggest that extensive, routinely conducted screening in women would not be cost-effective because of the extremely rare incidence of serious events,” Dr. Weizman said.

What’s lacking, however, is sport-specific data on whether specific activities (endurance or resistance) would be more risky for women. Further information, particularly on the sports at highest risk for Sr-SCA in women, is needed to propose tailor-made screening algorithms, Dr. Weizman noted.

The value of preparticipation screening for occult heart disease beyond the history and physical examination has been debated, with some organizations recommending electrocardiogram in addition to baseline assessments.

But this can lead to false-positives, “with the anxiety and cost associated with additional testing,” Anne Curtis, MD, State University of New York at Buffalo, Buffalo General Medical Center, and Jan Tijssen, PhD, University of Amsterdam, write in a linked editorial.

Currently, the American Heart Association recommends screening before sports participation, with a focused personal and family history and physical examination.

Dr. Curtis told this news organization that the U.S. guidelines “should stay as they are, but if one were to change them, it would be important to recognize that male athletes are much more likely to suffer arrhythmic events during sports than female athletes.”

“That to me means that female athletes in particular should not need to have ECGs prior to sports participation unless the history and physical examination detects a potential problem that needs further investigation,” Dr. Curtis said.

“Both women and men should be screened for cardiovascular risk factors during routine primary care, with appropriate interventions for hypertension, hyperlipidemia, smoking, and other risk factors,” Dr. Curtis and Dr. Tijssen advise in their editorial.

“In asymptomatic individuals who wish to become more active, in most cases they should be given the green light to proceed, starting slow and increasing intensity/duration over time, without specific additional testing. This advice is particularly relevant for women, given the findings of the current and prior studies,” they add.

This research was funded by Horizon 2020 and COST Action PARQ, supported by the European Cooperation in Science and Technology. Additional support was provided by INSERM, University of Paris, Assistance Publique-Hôpitaux de Paris, Fondation Coeur et Artères, Global Heart Watch, Fédération Française de Cardiologie, Société Française de Cardiologie, Fondation Recherche Medicale, as well as unrestricted grants from industrial partners. The authors and Dr. Tijssen have declared no relevant financial relationships. Dr. Curtis has disclosed relationships with Janssen several pharmaceutical companies.

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

Intrauterine device (IUD) placement at 2-4 weeks postpartum was noninferior to placement at 6-8 weeks postpartum for complete expulsion, and carried only a slightly higher risk of partial expulsion. A randomized study of expulsion rates reports the risk of expulsion at these points may help patients and clinicians make informed choices about the timing of IUD insertion, wrote the study authors, led by Sarah H. Averbach, MD, MAS, an obstetrician-gynecologist at the University of California, San Diego. “We found that the risk of complete IUD expulsion was low at 2% after early IUD placement 2-4 weeks after delivery, and was noninferior to interval placement 6-8 weeks after delivery at 0%,” Dr. Averbach said in an interview.

Although the risks of partial expulsion and malposition were modestly greater after early placement, “the possibility of a small increase in the risk of IUD expulsion or malposition with early IUD placement should be weighed against the risk of undesired pregnancy and short-interval pregnancy by delaying placement.”

University of California, San Diego

The timing of IUD placement in the postpartum period should be guided by patients’ goals and preferences, she added. The early postpartum period 2-4 weeks after birth has the advantage of convenience since it coincides with early-postpartum or well-baby visits. The absolute risk differences observed between early and interval placement were small for both complete or partial expulsion at 3.8%, and the rate for complete expulsion after early placement was much lower than historical expulsion rates for immediate postpartum placement within in few days of delivery.

Last year, a large study showed an increase in expulsion risk with IUD insertion within 3 days of delivery. Current guidelines, however, support immediate insertion as a safe practice.

The study

Enrolling 404 participants from diverse settings during the period of 2018 to July 2021, researchers for the noninferiority trial randomly assigned 203 to early IUD placement 14-28 days postpartum and 201 to standard-interval placement at 42-56 days. Patients had a mean age of 29.9 years, 11.4% were Black, 56.4% were White, and 43.3% were Hispanic (some Hispanic participants self-identified as White and some as Black). By 6 months postpartum, 73% of the cohort had received an IUD and completed 6-months of follow-up, while 13% had never received an IUD and 14% were lost to follow-up. Complete expulsion rates were 3 of 149, or 2.0% (95% confidence interval [CI], 0.4-5.8) in the early group and 0 of 145, or 0% (95% CI, 0.0-2.5) in the standard group, for a between-group difference of 2.0 percentage points (95% CI, −0.5 to 5.7, P = .04). Two women chose to replace their IUDs.

Partial expulsion occurred in 14, or 9.4% (95% CI, 5.2-15.3) of patients in the early group and 11, or 7.6% (95% CI, 3.9-13.2) in the standard-interval group, for a between-group difference of 1.8 (95% CI, −4.8 to 8.6) percentage points (P = .22).

The small absolute increase in risk of partial expulsion in the early arm did not meet the prespecified criterion for noninferiority of 6%. Three pelvic infections occurred in the early placement arm.

There were 42 IUD removals: 25 in the early placement group and 17 in the standard interval group. Thirteen participants had their IUDs removed for symptoms such as cramping and bothersome vaginal bleeding.

No perforations were identified in either group at 6 months, suggesting that the rate of uterine perforations is low when IUDs are placed in the early and standard-interval postpartum periods. IUD use at 6 months remained comparable between arms: 69.5% in the early group vs. 67.2% in the standard-interval group.

Commenting on the trial but not involved in it, Maureen K. Baldwin, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland, said it provides further data on the prevalence of expulsion and malposition after placements using ultrasonography as needed. While two failures occurred with asymptomatic malposition, she added, “It should be noted that IUD position can change as a result of pregnancy, so it was not determined that malposition occurred prior to contraceptive failure.”

Oregon Health &amp; Science University

According to Dr. Baldwin, one strategy to reduce concerns is to use transvaginal ultrasonography at a later time or in the presence of unusual symptoms.

Overall, the study establishes that postpartum placement is an option equivalent to standard timing and it should be incorporated into patient preferences, she said. “Pain may be lowest at early placement compared to other timings, particularly for those who had vaginal birth.”

The study was supported by the Society of Family Planning research fund and the National Institutes of Health - National Institute of Child Health and Human Development. Dr. Averbach reported personal fees from Bayer Pharmaceuticals for advice on postpartum IUD placement as well as grants from the NIH outside of the submitted work. Dr. Baldwin disclosed no potential conflicts of interest with regard to her comments.

Intrauterine device (IUD) placement at 2-4 weeks postpartum was noninferior to placement at 6-8 weeks postpartum for complete expulsion, and carried only a slightly higher risk of partial expulsion. A randomized study of expulsion rates reports the risk of expulsion at these points may help patients and clinicians make informed choices about the timing of IUD insertion, wrote the study authors, led by Sarah H. Averbach, MD, MAS, an obstetrician-gynecologist at the University of California, San Diego. “We found that the risk of complete IUD expulsion was low at 2% after early IUD placement 2-4 weeks after delivery, and was noninferior to interval placement 6-8 weeks after delivery at 0%,” Dr. Averbach said in an interview.

Although the risks of partial expulsion and malposition were modestly greater after early placement, “the possibility of a small increase in the risk of IUD expulsion or malposition with early IUD placement should be weighed against the risk of undesired pregnancy and short-interval pregnancy by delaying placement.”

University of California, San Diego

The timing of IUD placement in the postpartum period should be guided by patients’ goals and preferences, she added. The early postpartum period 2-4 weeks after birth has the advantage of convenience since it coincides with early-postpartum or well-baby visits. The absolute risk differences observed between early and interval placement were small for both complete or partial expulsion at 3.8%, and the rate for complete expulsion after early placement was much lower than historical expulsion rates for immediate postpartum placement within in few days of delivery.

Last year, a large study showed an increase in expulsion risk with IUD insertion within 3 days of delivery. Current guidelines, however, support immediate insertion as a safe practice.

The study

Enrolling 404 participants from diverse settings during the period of 2018 to July 2021, researchers for the noninferiority trial randomly assigned 203 to early IUD placement 14-28 days postpartum and 201 to standard-interval placement at 42-56 days. Patients had a mean age of 29.9 years, 11.4% were Black, 56.4% were White, and 43.3% were Hispanic (some Hispanic participants self-identified as White and some as Black). By 6 months postpartum, 73% of the cohort had received an IUD and completed 6-months of follow-up, while 13% had never received an IUD and 14% were lost to follow-up. Complete expulsion rates were 3 of 149, or 2.0% (95% confidence interval [CI], 0.4-5.8) in the early group and 0 of 145, or 0% (95% CI, 0.0-2.5) in the standard group, for a between-group difference of 2.0 percentage points (95% CI, −0.5 to 5.7, P = .04). Two women chose to replace their IUDs.

Partial expulsion occurred in 14, or 9.4% (95% CI, 5.2-15.3) of patients in the early group and 11, or 7.6% (95% CI, 3.9-13.2) in the standard-interval group, for a between-group difference of 1.8 (95% CI, −4.8 to 8.6) percentage points (P = .22).

The small absolute increase in risk of partial expulsion in the early arm did not meet the prespecified criterion for noninferiority of 6%. Three pelvic infections occurred in the early placement arm.

There were 42 IUD removals: 25 in the early placement group and 17 in the standard interval group. Thirteen participants had their IUDs removed for symptoms such as cramping and bothersome vaginal bleeding.

No perforations were identified in either group at 6 months, suggesting that the rate of uterine perforations is low when IUDs are placed in the early and standard-interval postpartum periods. IUD use at 6 months remained comparable between arms: 69.5% in the early group vs. 67.2% in the standard-interval group.

Commenting on the trial but not involved in it, Maureen K. Baldwin, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland, said it provides further data on the prevalence of expulsion and malposition after placements using ultrasonography as needed. While two failures occurred with asymptomatic malposition, she added, “It should be noted that IUD position can change as a result of pregnancy, so it was not determined that malposition occurred prior to contraceptive failure.”

Oregon Health &amp; Science University

According to Dr. Baldwin, one strategy to reduce concerns is to use transvaginal ultrasonography at a later time or in the presence of unusual symptoms.

Overall, the study establishes that postpartum placement is an option equivalent to standard timing and it should be incorporated into patient preferences, she said. “Pain may be lowest at early placement compared to other timings, particularly for those who had vaginal birth.”

The study was supported by the Society of Family Planning research fund and the National Institutes of Health - National Institute of Child Health and Human Development. Dr. Averbach reported personal fees from Bayer Pharmaceuticals for advice on postpartum IUD placement as well as grants from the NIH outside of the submitted work. Dr. Baldwin disclosed no potential conflicts of interest with regard to her comments.

Intrauterine device (IUD) placement at 2-4 weeks postpartum was noninferior to placement at 6-8 weeks postpartum for complete expulsion, and carried only a slightly higher risk of partial expulsion. A randomized study of expulsion rates reports the risk of expulsion at these points may help patients and clinicians make informed choices about the timing of IUD insertion, wrote the study authors, led by Sarah H. Averbach, MD, MAS, an obstetrician-gynecologist at the University of California, San Diego. “We found that the risk of complete IUD expulsion was low at 2% after early IUD placement 2-4 weeks after delivery, and was noninferior to interval placement 6-8 weeks after delivery at 0%,” Dr. Averbach said in an interview.

Although the risks of partial expulsion and malposition were modestly greater after early placement, “the possibility of a small increase in the risk of IUD expulsion or malposition with early IUD placement should be weighed against the risk of undesired pregnancy and short-interval pregnancy by delaying placement.”

University of California, San Diego

The timing of IUD placement in the postpartum period should be guided by patients’ goals and preferences, she added. The early postpartum period 2-4 weeks after birth has the advantage of convenience since it coincides with early-postpartum or well-baby visits. The absolute risk differences observed between early and interval placement were small for both complete or partial expulsion at 3.8%, and the rate for complete expulsion after early placement was much lower than historical expulsion rates for immediate postpartum placement within in few days of delivery.

Last year, a large study showed an increase in expulsion risk with IUD insertion within 3 days of delivery. Current guidelines, however, support immediate insertion as a safe practice.

The study

Enrolling 404 participants from diverse settings during the period of 2018 to July 2021, researchers for the noninferiority trial randomly assigned 203 to early IUD placement 14-28 days postpartum and 201 to standard-interval placement at 42-56 days. Patients had a mean age of 29.9 years, 11.4% were Black, 56.4% were White, and 43.3% were Hispanic (some Hispanic participants self-identified as White and some as Black). By 6 months postpartum, 73% of the cohort had received an IUD and completed 6-months of follow-up, while 13% had never received an IUD and 14% were lost to follow-up. Complete expulsion rates were 3 of 149, or 2.0% (95% confidence interval [CI], 0.4-5.8) in the early group and 0 of 145, or 0% (95% CI, 0.0-2.5) in the standard group, for a between-group difference of 2.0 percentage points (95% CI, −0.5 to 5.7, P = .04). Two women chose to replace their IUDs.

Partial expulsion occurred in 14, or 9.4% (95% CI, 5.2-15.3) of patients in the early group and 11, or 7.6% (95% CI, 3.9-13.2) in the standard-interval group, for a between-group difference of 1.8 (95% CI, −4.8 to 8.6) percentage points (P = .22).

The small absolute increase in risk of partial expulsion in the early arm did not meet the prespecified criterion for noninferiority of 6%. Three pelvic infections occurred in the early placement arm.

There were 42 IUD removals: 25 in the early placement group and 17 in the standard interval group. Thirteen participants had their IUDs removed for symptoms such as cramping and bothersome vaginal bleeding.

No perforations were identified in either group at 6 months, suggesting that the rate of uterine perforations is low when IUDs are placed in the early and standard-interval postpartum periods. IUD use at 6 months remained comparable between arms: 69.5% in the early group vs. 67.2% in the standard-interval group.

Commenting on the trial but not involved in it, Maureen K. Baldwin, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland, said it provides further data on the prevalence of expulsion and malposition after placements using ultrasonography as needed. While two failures occurred with asymptomatic malposition, she added, “It should be noted that IUD position can change as a result of pregnancy, so it was not determined that malposition occurred prior to contraceptive failure.”

Oregon Health &amp; Science University

According to Dr. Baldwin, one strategy to reduce concerns is to use transvaginal ultrasonography at a later time or in the presence of unusual symptoms.

Overall, the study establishes that postpartum placement is an option equivalent to standard timing and it should be incorporated into patient preferences, she said. “Pain may be lowest at early placement compared to other timings, particularly for those who had vaginal birth.”

The study was supported by the Society of Family Planning research fund and the National Institutes of Health - National Institute of Child Health and Human Development. Dr. Averbach reported personal fees from Bayer Pharmaceuticals for advice on postpartum IUD placement as well as grants from the NIH outside of the submitted work. Dr. Baldwin disclosed no potential conflicts of interest with regard to her comments.

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

Dr. Amani Meaidi

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.

“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
 

The study

Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.

Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.

During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.

In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.

Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.

The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
 

An outsider’s perspective

Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.

Northwell Health

Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.

Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”

Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

Dr. Amani Meaidi

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.

“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
 

The study

Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.

Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.

During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.

In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.

Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.

The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
 

An outsider’s perspective

Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.

Northwell Health

Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.

Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”

Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

Dr. Amani Meaidi

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.

“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
 

The study

Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.

Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.

During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.

In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.

Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.

The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
 

An outsider’s perspective

Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.

Northwell Health

Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.

Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”

Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
 

Do android therapists dream of electric employees?

Robots. It can be tough to remember that, when they’re not dooming humanity to apocalypse or just telling you that you’re doomed, robots have real-world uses. There are actual robots in the world, and they can do things beyond bend girders, sing about science, or run the navy.

University of Cambridge

Look, we’ll stop with the pop-culture references when pop culture runs out of robots to reference. It may take a while.

Robots are indelibly rooted in the public consciousness, and that plays into our expectations when we encounter a real-life robot. This leads us into a recent study conducted by researchers at the University of Cambridge, who developed a robot-led mental well-being program that a tech company utilized for 4 weeks. Why choose a robot? Well, why spring for a qualified therapist who requires a salary when you could simply get a robot to do the job for free? Get with the capitalist agenda here. Surely it won’t backfire.

The 26 people enrolled in the study received coaching from one of two robots, both programmed identically to act like mental health coaches, based on interviews with human therapists. Both acted identically and had identical expressions. The only difference between the two was their appearance. QTRobot was nearly a meter tall and looked like a human child; Misty II was much smaller and looked like a toy.

People who received coaching from Misty II were better able to connect and had a better experience than those who received coaching from QTRobot. According to those in the QTRobot group, their expectations didn’t match reality. The robots are good coaches, but they don’t act human. This wasn’t a problem for Misty II, since it doesn’t look human, but for QTRobot, the participants were expecting “to hell with our orders,” but received “Daisy, Daisy, give me your answer do.” When you’ve been programmed to think of robots as metal humans, it can be off-putting to see them act as, well, robots.

That said, all participants found the exercises helpful and were open to receiving more robot-led therapy in the future. And while we’re sure the technology will advance to make robot therapists more empathetic and more human, hopefully scientists won’t go too far. We don’t need depressed robots.

Birthing experience is all in the mindset

Alexa, play Peer Gynt Suite No. 1, Op. 46 - I. Morning Mood.

Birth.

Giving birth is a common experience for many, if not most, female mammals, but wanting it to be a pleasurable one seems distinctly human. There are many methods and practices that may make giving birth an easier and enjoyable experience for the mother, but a new study suggests that the key could be in her mind.

joruba/Thinkstock

The mindset of the expectant mother during pregnancy, it seems, has some effect on how smooth or intervention-filled delivery is. If the mothers saw their experience as a natural process, they were less likely to need pain medication or a C-section, but mothers who viewed the experience as more of a “medical procedure” were more likely to require more medical supervision and intervention, according to investigators from the University of Bonn (Germany).

Now, the researchers wanted to be super clear in saying that there’s no right or wrong mindset to have. They just focused on the outcomes of those mindsets and whether they actually do have some effect on occurrences.

Apparently, yes.

“Mindsets can be understood as a kind of mental lense that guide our perception of the world around us and can influence our behavior,” Dr. Lisa Hoffmann said in a statement from the university. “The study highlights the importance of psychological factors in childbirth.”

The researchers surveyed 300 women with an online tool before and after delivery and found the effects of the natural process mindset lingered even after giving birth. They had lower rates of depression and posttraumatic stress, which may have a snowballing effect on mother-child bonding after childbirth.

Preparation for the big day, then, should be about more than gathering diapers and shopping for car seats. Women should prepare their minds as well. If it’s going to make giving birth better, why not?

Becoming a parent is going to create a psychological shift, no matter how you slice it.

Giant inflatable colon reported in Utah

Do not be alarmed! Yes, there is a giant inflatable colon currently at large in the Beehive State, but it will not harm you. The giant inflatable colon is in Utah as part of Intermountain Health’s “Let’s get to the bottom of colon cancer tour” and he only wants to help you.

Hiroshi Watanabe/Getty Images

The giant inflatable colon, whose name happens to be Collin, is 12 feet long and weighs 113 pounds. March is Colon Cancer Awareness Month, so Collin is traveling around Utah and Idaho to raise awareness about colon cancer and the various screening options. He is not going to change local weather patterns, eat small children, or take over local governments and raise your taxes.

Instead, Collin is planning to display “portions of a healthy colon, polyps or bumps on the colon, malignant polyps which look more vascular and have more redness, cancerous cells, advanced cancer cells, and Crohn’s disease,” KSL.com said.

Collin the colon is on loan to Intermountain Health from medical device manufacturer Boston Scientific and will be traveling to Spanish Fork, Provo, and Ogden, among other locations in Utah, as well as Burley and Meridian, Idaho, in the coming days.

Collin the colon’s participation in the tour has created some serious buzz in the Colin/Collin community:

• Colin Powell (four-star general and Secretary of State): “Back then, the second-most important topic among the Joint Chiefs of Staff was colon cancer screening. And the Navy guy – I can’t remember his name – was a huge fan of giant inflatable organs.”
• Colin Jost (comedian and Saturday Night Live “Weekend Update” cohost): “He’s funnier than Tucker Carlson and Pete Davidson combined.”

Do android therapists dream of electric employees?

Robots. It can be tough to remember that, when they’re not dooming humanity to apocalypse or just telling you that you’re doomed, robots have real-world uses. There are actual robots in the world, and they can do things beyond bend girders, sing about science, or run the navy.

University of Cambridge

Look, we’ll stop with the pop-culture references when pop culture runs out of robots to reference. It may take a while.

Robots are indelibly rooted in the public consciousness, and that plays into our expectations when we encounter a real-life robot. This leads us into a recent study conducted by researchers at the University of Cambridge, who developed a robot-led mental well-being program that a tech company utilized for 4 weeks. Why choose a robot? Well, why spring for a qualified therapist who requires a salary when you could simply get a robot to do the job for free? Get with the capitalist agenda here. Surely it won’t backfire.

The 26 people enrolled in the study received coaching from one of two robots, both programmed identically to act like mental health coaches, based on interviews with human therapists. Both acted identically and had identical expressions. The only difference between the two was their appearance. QTRobot was nearly a meter tall and looked like a human child; Misty II was much smaller and looked like a toy.

People who received coaching from Misty II were better able to connect and had a better experience than those who received coaching from QTRobot. According to those in the QTRobot group, their expectations didn’t match reality. The robots are good coaches, but they don’t act human. This wasn’t a problem for Misty II, since it doesn’t look human, but for QTRobot, the participants were expecting “to hell with our orders,” but received “Daisy, Daisy, give me your answer do.” When you’ve been programmed to think of robots as metal humans, it can be off-putting to see them act as, well, robots.

That said, all participants found the exercises helpful and were open to receiving more robot-led therapy in the future. And while we’re sure the technology will advance to make robot therapists more empathetic and more human, hopefully scientists won’t go too far. We don’t need depressed robots.

Birthing experience is all in the mindset

Alexa, play Peer Gynt Suite No. 1, Op. 46 - I. Morning Mood.

Birth.

Giving birth is a common experience for many, if not most, female mammals, but wanting it to be a pleasurable one seems distinctly human. There are many methods and practices that may make giving birth an easier and enjoyable experience for the mother, but a new study suggests that the key could be in her mind.

joruba/Thinkstock

The mindset of the expectant mother during pregnancy, it seems, has some effect on how smooth or intervention-filled delivery is. If the mothers saw their experience as a natural process, they were less likely to need pain medication or a C-section, but mothers who viewed the experience as more of a “medical procedure” were more likely to require more medical supervision and intervention, according to investigators from the University of Bonn (Germany).

Now, the researchers wanted to be super clear in saying that there’s no right or wrong mindset to have. They just focused on the outcomes of those mindsets and whether they actually do have some effect on occurrences.

Apparently, yes.

“Mindsets can be understood as a kind of mental lense that guide our perception of the world around us and can influence our behavior,” Dr. Lisa Hoffmann said in a statement from the university. “The study highlights the importance of psychological factors in childbirth.”

The researchers surveyed 300 women with an online tool before and after delivery and found the effects of the natural process mindset lingered even after giving birth. They had lower rates of depression and posttraumatic stress, which may have a snowballing effect on mother-child bonding after childbirth.

Preparation for the big day, then, should be about more than gathering diapers and shopping for car seats. Women should prepare their minds as well. If it’s going to make giving birth better, why not?

Becoming a parent is going to create a psychological shift, no matter how you slice it.

Giant inflatable colon reported in Utah

Do not be alarmed! Yes, there is a giant inflatable colon currently at large in the Beehive State, but it will not harm you. The giant inflatable colon is in Utah as part of Intermountain Health’s “Let’s get to the bottom of colon cancer tour” and he only wants to help you.

Hiroshi Watanabe/Getty Images

The giant inflatable colon, whose name happens to be Collin, is 12 feet long and weighs 113 pounds. March is Colon Cancer Awareness Month, so Collin is traveling around Utah and Idaho to raise awareness about colon cancer and the various screening options. He is not going to change local weather patterns, eat small children, or take over local governments and raise your taxes.

Instead, Collin is planning to display “portions of a healthy colon, polyps or bumps on the colon, malignant polyps which look more vascular and have more redness, cancerous cells, advanced cancer cells, and Crohn’s disease,” KSL.com said.

Collin the colon is on loan to Intermountain Health from medical device manufacturer Boston Scientific and will be traveling to Spanish Fork, Provo, and Ogden, among other locations in Utah, as well as Burley and Meridian, Idaho, in the coming days.

Collin the colon’s participation in the tour has created some serious buzz in the Colin/Collin community:

• Colin Powell (four-star general and Secretary of State): “Back then, the second-most important topic among the Joint Chiefs of Staff was colon cancer screening. And the Navy guy – I can’t remember his name – was a huge fan of giant inflatable organs.”
• Colin Jost (comedian and Saturday Night Live “Weekend Update” cohost): “He’s funnier than Tucker Carlson and Pete Davidson combined.”

Do android therapists dream of electric employees?

Robots. It can be tough to remember that, when they’re not dooming humanity to apocalypse or just telling you that you’re doomed, robots have real-world uses. There are actual robots in the world, and they can do things beyond bend girders, sing about science, or run the navy.

University of Cambridge

Look, we’ll stop with the pop-culture references when pop culture runs out of robots to reference. It may take a while.

Robots are indelibly rooted in the public consciousness, and that plays into our expectations when we encounter a real-life robot. This leads us into a recent study conducted by researchers at the University of Cambridge, who developed a robot-led mental well-being program that a tech company utilized for 4 weeks. Why choose a robot? Well, why spring for a qualified therapist who requires a salary when you could simply get a robot to do the job for free? Get with the capitalist agenda here. Surely it won’t backfire.

The 26 people enrolled in the study received coaching from one of two robots, both programmed identically to act like mental health coaches, based on interviews with human therapists. Both acted identically and had identical expressions. The only difference between the two was their appearance. QTRobot was nearly a meter tall and looked like a human child; Misty II was much smaller and looked like a toy.

People who received coaching from Misty II were better able to connect and had a better experience than those who received coaching from QTRobot. According to those in the QTRobot group, their expectations didn’t match reality. The robots are good coaches, but they don’t act human. This wasn’t a problem for Misty II, since it doesn’t look human, but for QTRobot, the participants were expecting “to hell with our orders,” but received “Daisy, Daisy, give me your answer do.” When you’ve been programmed to think of robots as metal humans, it can be off-putting to see them act as, well, robots.

That said, all participants found the exercises helpful and were open to receiving more robot-led therapy in the future. And while we’re sure the technology will advance to make robot therapists more empathetic and more human, hopefully scientists won’t go too far. We don’t need depressed robots.

Birthing experience is all in the mindset

Alexa, play Peer Gynt Suite No. 1, Op. 46 - I. Morning Mood.

Birth.

Giving birth is a common experience for many, if not most, female mammals, but wanting it to be a pleasurable one seems distinctly human. There are many methods and practices that may make giving birth an easier and enjoyable experience for the mother, but a new study suggests that the key could be in her mind.

joruba/Thinkstock

The mindset of the expectant mother during pregnancy, it seems, has some effect on how smooth or intervention-filled delivery is. If the mothers saw their experience as a natural process, they were less likely to need pain medication or a C-section, but mothers who viewed the experience as more of a “medical procedure” were more likely to require more medical supervision and intervention, according to investigators from the University of Bonn (Germany).

Now, the researchers wanted to be super clear in saying that there’s no right or wrong mindset to have. They just focused on the outcomes of those mindsets and whether they actually do have some effect on occurrences.

Apparently, yes.

“Mindsets can be understood as a kind of mental lense that guide our perception of the world around us and can influence our behavior,” Dr. Lisa Hoffmann said in a statement from the university. “The study highlights the importance of psychological factors in childbirth.”

The researchers surveyed 300 women with an online tool before and after delivery and found the effects of the natural process mindset lingered even after giving birth. They had lower rates of depression and posttraumatic stress, which may have a snowballing effect on mother-child bonding after childbirth.

Preparation for the big day, then, should be about more than gathering diapers and shopping for car seats. Women should prepare their minds as well. If it’s going to make giving birth better, why not?

Becoming a parent is going to create a psychological shift, no matter how you slice it.

Giant inflatable colon reported in Utah

Do not be alarmed! Yes, there is a giant inflatable colon currently at large in the Beehive State, but it will not harm you. The giant inflatable colon is in Utah as part of Intermountain Health’s “Let’s get to the bottom of colon cancer tour” and he only wants to help you.

Hiroshi Watanabe/Getty Images

The giant inflatable colon, whose name happens to be Collin, is 12 feet long and weighs 113 pounds. March is Colon Cancer Awareness Month, so Collin is traveling around Utah and Idaho to raise awareness about colon cancer and the various screening options. He is not going to change local weather patterns, eat small children, or take over local governments and raise your taxes.

Instead, Collin is planning to display “portions of a healthy colon, polyps or bumps on the colon, malignant polyps which look more vascular and have more redness, cancerous cells, advanced cancer cells, and Crohn’s disease,” KSL.com said.

Collin the colon is on loan to Intermountain Health from medical device manufacturer Boston Scientific and will be traveling to Spanish Fork, Provo, and Ogden, among other locations in Utah, as well as Burley and Meridian, Idaho, in the coming days.

Collin the colon’s participation in the tour has created some serious buzz in the Colin/Collin community:

• Colin Powell (four-star general and Secretary of State): “Back then, the second-most important topic among the Joint Chiefs of Staff was colon cancer screening. And the Navy guy – I can’t remember his name – was a huge fan of giant inflatable organs.”
• Colin Jost (comedian and Saturday Night Live “Weekend Update” cohost): “He’s funnier than Tucker Carlson and Pete Davidson combined.”

Opioid overdose and other preventable causes are important contributors to postpartum death rates, Medicaid claims data show, particularly in women who have a recent history of opioid use disorder (OUD), according to research published in Obstetrics and Gynecology.

Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
 

Nearly 5 million deliveries studied

Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.

They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.

Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).

Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
 

Medication significantly lowers death risk

The authors also documented the benefit of buprenorphine or methadone for OUD.

For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).

As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.

“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
 

Dismal numbers on ob.gyns. trained to prescribe medications

She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.

Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.

On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.

Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.

Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.

But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
 

Getting naloxone to patients, families

One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.

However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.

“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”

Still, naloxone can’t be seen as the answer, he said.

He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.

“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.

The best help, he says, will be continuation of treatment.

“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”

Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
 

Problem probably understated

He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.

“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.

Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.

In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.

“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”

Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
 

Opioid overdose and other preventable causes are important contributors to postpartum death rates, Medicaid claims data show, particularly in women who have a recent history of opioid use disorder (OUD), according to research published in Obstetrics and Gynecology.

Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
 

Nearly 5 million deliveries studied

Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.

They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.

Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).

Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
 

Medication significantly lowers death risk

The authors also documented the benefit of buprenorphine or methadone for OUD.

For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).

As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.

“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
 

Dismal numbers on ob.gyns. trained to prescribe medications

She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.

Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.

On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.

Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.

Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.

But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
 

Getting naloxone to patients, families

One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.

However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.

“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”

Still, naloxone can’t be seen as the answer, he said.

He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.

“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.

The best help, he says, will be continuation of treatment.

“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”

Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
 

Problem probably understated

He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.

“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.

Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.

In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.

“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”

Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
 

Opioid overdose and other preventable causes are important contributors to postpartum death rates, Medicaid claims data show, particularly in women who have a recent history of opioid use disorder (OUD), according to research published in Obstetrics and Gynecology.

Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
 

Nearly 5 million deliveries studied

Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.

They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.

Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).

Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
 

Medication significantly lowers death risk

The authors also documented the benefit of buprenorphine or methadone for OUD.

For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).

As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.

“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
 

Dismal numbers on ob.gyns. trained to prescribe medications

She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.

Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.

On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.

Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.

Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.

But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
 

Getting naloxone to patients, families

One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.

However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.

“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”

Still, naloxone can’t be seen as the answer, he said.

He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.

“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.

The best help, he says, will be continuation of treatment.

“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”

Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
 

Problem probably understated

He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.

“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.

Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.

In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.

“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”

Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
 

On average, children born following induced labor perform worse at school at age 12 years than their peers who were born after spontaneous onset of labor. This is the outcome of a report by Anita Ravelli, PhD, and her team of Dutch researchers in the department of obstetrics and gynecology of the Amsterdam University Medical Center, published in Acta Obstetricia et Gynecologica Scandinavica.

For the retrospective cohort study, the team analyzed data from almost 230,000 patients. According to these data, the likelihood of children reaching higher secondary school level is around 10% lower after elective induction of labor.
 

Labor induction frequent

These days in Germany, more than 20% of all births are induced. Sometimes this decision is made because of medical reasons, such as the woman’s having gestational diabetes, the presence of gestational toxicity, or the occurrence of a premature rupture of membranes. However, contractions are most often artificially triggered because the expected delivery date has passed.

Guidelines from the German Society of Gynecology and Obstetrics recommend inducing labor if there is a medical indication and if more than 10 days have passed since the expected delivery date. After 14 days, induction is strongly advised. This recommendation is based on studies that indicate that the child is at increased risk of disease and death once the expected delivery date is far exceeded.
 

Causal relationship unproven

It is still unclear whether and to what extent inducing labor affects a child’s neurologic development. Since the frequency of induced labor has increased greatly worldwide, Dr. Ravelli and her colleagues investigated this matter.

The study may have limited validity, however. “The outcome of the study only determines an association between spontaneous labor in mature children versus induced labor and a school performance test at 12 years of age,” said Maria Delius, MD, MPH, head of the Perinatal Center at the Clinic and Polyclinic for Obstetrics and Gynecology of the Ludwig Maximilian University of Munich. “The study is unable to prove any causality, even if it sounds that way in the abstract.”

This publication may in no way instigate a change in current practices, Dr. Delius emphasized. “There is a lot of potential for the wrong conclusions to be drawn from this study, and as a result – if it is presented and perceived in a subjective manner in public – to also cause harm to mothers and children,” she warned. The study also must not be associated with the drug misoprostol, since the various mechanical and medicinal methods of induction were not the topic of the Dutch investigation.
 

Gestational-week differences

The primary author of the study, Renee J. Burger, MD, PhD, of Dr. Ravelli’s UMC team, and her colleagues assessed the school performance of 226,684 children at age 12 years who were born in the 37th to 42nd week of gestation (WOG) between 2003 and 2008 in the Netherlands following an uncomplicated single pregnancy. They compared school performance, divided for each of the six WOG analyzed, between children whose birth was mechanically or medicinally induced and those who were born without intervention.

According to the report by the researchers, induced labor at every WOG up to the 41st week was associated with lower school performance in the children, compared with a spontaneous birth. In addition, fewer children whose birth was induced reached a higher secondary level of education. After 38 WOG, the figure stood at 48%, compared with 54% of children who were born without intervention. For 12-year-olds not born until the 42nd WOG, there were no significant differences between the two groups investigated.
 

Prospective studies pending

Dr. Burger and Dr. Ravelli emphasized that the results do not indicate that every child born after an induced labor will perform worse at school. This is a statistical correlation that cannot be transferred to a case-by-case basis. In addition, it is unlikely that all disruptive factors could be taken into consideration during the analyses. Nonetheless, the researchers conclude that the long-term effects of inducing labor should be considered during consultation and decision-making in the future.

In general, it is important that future randomized, controlled studies incorporate long-term measurements in their results and conclusions so that complete data on the present topic can be gathered. “Although the effect on the individual child is likely subtle, the impact on society due to the large number of early-term labor inductions should not be underestimated,” the authors wrote.
 

Unexamined disruptive factors

Sven Kehl, MD, PhD, senior physician of the department of obstetrics and gynecology and coordinator of the University Perinatal Center of Franconia at the University Hospital of Erlangen, Germany, is of a similar opinion. “Inducing labor causes birth to occur sooner and therefore for the pregnancy to finish prematurely,” said Dr. Kehl. Such premature births, not the mechanical or medicinal procedures for inducing labor, could affect the child’s cerebral development. “The results of this study suggest that inducing labor in uncomplicated pregnancies, in which there are no relevant medical indications, should be avoided,” said Dr. Kehl. In these cases, the mother should wait for a natural birth.

Some of the study’s strengths include the large quantity of data, the large number of participants, and the various disruptive factors taken into consideration, such as the mother’s level of education, according to Dr. Kehl. “But it is not a study from which causality can be derived,” he said.

Not all the potential disruptive factors could be found in the available data. For example, information regarding familial status, the father’s level of education, the parents’ smoking status, or the mother’s body mass index was missing. Also, only a small number of the possible indications for inducing labor was disclosed.
 

No elective inductions

The study is unlikely to have a major effect on practice in German maternity clinics, since the routine induction of labor from the 39th WOG has always been regarded critically in German-speaking countries, said Dr. Kehl. It is still true that if there are any risks, a risk-benefit analysis must be performed, and the risks to the mother or child must be evaluated when considering labor induction.

“If there are no medical reasons for inducing labor, the women must also be informed about the possible long-term consequences and not just about the short-term risks,” said Dr. Kehl.

His colleague in Berlin, Michael Abou-Dakn, MD, chief physician of gynecology and obstetrics at the St. Joseph’s Hospital, Berlin-Tempelhof, was more categorical. “It is right to criticize the fact that over 20% of births in Germany are induced,” he said. He is rather dubious, however, about the effects on school performance found in the study following induced labor. Still, the investigation is a reminder that inducing labor could involve side effects. “There should therefore be no elective inductions, or any without a clear indication,” said Dr. Abou-Dakn.

This article was translated from the Medscape German Edition and a version appeared on Medscape.com.

On average, children born following induced labor perform worse at school at age 12 years than their peers who were born after spontaneous onset of labor. This is the outcome of a report by Anita Ravelli, PhD, and her team of Dutch researchers in the department of obstetrics and gynecology of the Amsterdam University Medical Center, published in Acta Obstetricia et Gynecologica Scandinavica.

For the retrospective cohort study, the team analyzed data from almost 230,000 patients. According to these data, the likelihood of children reaching higher secondary school level is around 10% lower after elective induction of labor.
 

Labor induction frequent

These days in Germany, more than 20% of all births are induced. Sometimes this decision is made because of medical reasons, such as the woman’s having gestational diabetes, the presence of gestational toxicity, or the occurrence of a premature rupture of membranes. However, contractions are most often artificially triggered because the expected delivery date has passed.

Guidelines from the German Society of Gynecology and Obstetrics recommend inducing labor if there is a medical indication and if more than 10 days have passed since the expected delivery date. After 14 days, induction is strongly advised. This recommendation is based on studies that indicate that the child is at increased risk of disease and death once the expected delivery date is far exceeded.
 

Causal relationship unproven

It is still unclear whether and to what extent inducing labor affects a child’s neurologic development. Since the frequency of induced labor has increased greatly worldwide, Dr. Ravelli and her colleagues investigated this matter.

The study may have limited validity, however. “The outcome of the study only determines an association between spontaneous labor in mature children versus induced labor and a school performance test at 12 years of age,” said Maria Delius, MD, MPH, head of the Perinatal Center at the Clinic and Polyclinic for Obstetrics and Gynecology of the Ludwig Maximilian University of Munich. “The study is unable to prove any causality, even if it sounds that way in the abstract.”

This publication may in no way instigate a change in current practices, Dr. Delius emphasized. “There is a lot of potential for the wrong conclusions to be drawn from this study, and as a result – if it is presented and perceived in a subjective manner in public – to also cause harm to mothers and children,” she warned. The study also must not be associated with the drug misoprostol, since the various mechanical and medicinal methods of induction were not the topic of the Dutch investigation.
 

Gestational-week differences

The primary author of the study, Renee J. Burger, MD, PhD, of Dr. Ravelli’s UMC team, and her colleagues assessed the school performance of 226,684 children at age 12 years who were born in the 37th to 42nd week of gestation (WOG) between 2003 and 2008 in the Netherlands following an uncomplicated single pregnancy. They compared school performance, divided for each of the six WOG analyzed, between children whose birth was mechanically or medicinally induced and those who were born without intervention.

According to the report by the researchers, induced labor at every WOG up to the 41st week was associated with lower school performance in the children, compared with a spontaneous birth. In addition, fewer children whose birth was induced reached a higher secondary level of education. After 38 WOG, the figure stood at 48%, compared with 54% of children who were born without intervention. For 12-year-olds not born until the 42nd WOG, there were no significant differences between the two groups investigated.
 

Prospective studies pending

Dr. Burger and Dr. Ravelli emphasized that the results do not indicate that every child born after an induced labor will perform worse at school. This is a statistical correlation that cannot be transferred to a case-by-case basis. In addition, it is unlikely that all disruptive factors could be taken into consideration during the analyses. Nonetheless, the researchers conclude that the long-term effects of inducing labor should be considered during consultation and decision-making in the future.

In general, it is important that future randomized, controlled studies incorporate long-term measurements in their results and conclusions so that complete data on the present topic can be gathered. “Although the effect on the individual child is likely subtle, the impact on society due to the large number of early-term labor inductions should not be underestimated,” the authors wrote.
 

Unexamined disruptive factors

Sven Kehl, MD, PhD, senior physician of the department of obstetrics and gynecology and coordinator of the University Perinatal Center of Franconia at the University Hospital of Erlangen, Germany, is of a similar opinion. “Inducing labor causes birth to occur sooner and therefore for the pregnancy to finish prematurely,” said Dr. Kehl. Such premature births, not the mechanical or medicinal procedures for inducing labor, could affect the child’s cerebral development. “The results of this study suggest that inducing labor in uncomplicated pregnancies, in which there are no relevant medical indications, should be avoided,” said Dr. Kehl. In these cases, the mother should wait for a natural birth.

Some of the study’s strengths include the large quantity of data, the large number of participants, and the various disruptive factors taken into consideration, such as the mother’s level of education, according to Dr. Kehl. “But it is not a study from which causality can be derived,” he said.

Not all the potential disruptive factors could be found in the available data. For example, information regarding familial status, the father’s level of education, the parents’ smoking status, or the mother’s body mass index was missing. Also, only a small number of the possible indications for inducing labor was disclosed.
 

No elective inductions

The study is unlikely to have a major effect on practice in German maternity clinics, since the routine induction of labor from the 39th WOG has always been regarded critically in German-speaking countries, said Dr. Kehl. It is still true that if there are any risks, a risk-benefit analysis must be performed, and the risks to the mother or child must be evaluated when considering labor induction.

“If there are no medical reasons for inducing labor, the women must also be informed about the possible long-term consequences and not just about the short-term risks,” said Dr. Kehl.

His colleague in Berlin, Michael Abou-Dakn, MD, chief physician of gynecology and obstetrics at the St. Joseph’s Hospital, Berlin-Tempelhof, was more categorical. “It is right to criticize the fact that over 20% of births in Germany are induced,” he said. He is rather dubious, however, about the effects on school performance found in the study following induced labor. Still, the investigation is a reminder that inducing labor could involve side effects. “There should therefore be no elective inductions, or any without a clear indication,” said Dr. Abou-Dakn.

This article was translated from the Medscape German Edition and a version appeared on Medscape.com.

On average, children born following induced labor perform worse at school at age 12 years than their peers who were born after spontaneous onset of labor. This is the outcome of a report by Anita Ravelli, PhD, and her team of Dutch researchers in the department of obstetrics and gynecology of the Amsterdam University Medical Center, published in Acta Obstetricia et Gynecologica Scandinavica.

For the retrospective cohort study, the team analyzed data from almost 230,000 patients. According to these data, the likelihood of children reaching higher secondary school level is around 10% lower after elective induction of labor.
 

Labor induction frequent

These days in Germany, more than 20% of all births are induced. Sometimes this decision is made because of medical reasons, such as the woman’s having gestational diabetes, the presence of gestational toxicity, or the occurrence of a premature rupture of membranes. However, contractions are most often artificially triggered because the expected delivery date has passed.

Guidelines from the German Society of Gynecology and Obstetrics recommend inducing labor if there is a medical indication and if more than 10 days have passed since the expected delivery date. After 14 days, induction is strongly advised. This recommendation is based on studies that indicate that the child is at increased risk of disease and death once the expected delivery date is far exceeded.
 

Causal relationship unproven

It is still unclear whether and to what extent inducing labor affects a child’s neurologic development. Since the frequency of induced labor has increased greatly worldwide, Dr. Ravelli and her colleagues investigated this matter.

The study may have limited validity, however. “The outcome of the study only determines an association between spontaneous labor in mature children versus induced labor and a school performance test at 12 years of age,” said Maria Delius, MD, MPH, head of the Perinatal Center at the Clinic and Polyclinic for Obstetrics and Gynecology of the Ludwig Maximilian University of Munich. “The study is unable to prove any causality, even if it sounds that way in the abstract.”

This publication may in no way instigate a change in current practices, Dr. Delius emphasized. “There is a lot of potential for the wrong conclusions to be drawn from this study, and as a result – if it is presented and perceived in a subjective manner in public – to also cause harm to mothers and children,” she warned. The study also must not be associated with the drug misoprostol, since the various mechanical and medicinal methods of induction were not the topic of the Dutch investigation.
 

Gestational-week differences

The primary author of the study, Renee J. Burger, MD, PhD, of Dr. Ravelli’s UMC team, and her colleagues assessed the school performance of 226,684 children at age 12 years who were born in the 37th to 42nd week of gestation (WOG) between 2003 and 2008 in the Netherlands following an uncomplicated single pregnancy. They compared school performance, divided for each of the six WOG analyzed, between children whose birth was mechanically or medicinally induced and those who were born without intervention.

According to the report by the researchers, induced labor at every WOG up to the 41st week was associated with lower school performance in the children, compared with a spontaneous birth. In addition, fewer children whose birth was induced reached a higher secondary level of education. After 38 WOG, the figure stood at 48%, compared with 54% of children who were born without intervention. For 12-year-olds not born until the 42nd WOG, there were no significant differences between the two groups investigated.
 

Prospective studies pending

Dr. Burger and Dr. Ravelli emphasized that the results do not indicate that every child born after an induced labor will perform worse at school. This is a statistical correlation that cannot be transferred to a case-by-case basis. In addition, it is unlikely that all disruptive factors could be taken into consideration during the analyses. Nonetheless, the researchers conclude that the long-term effects of inducing labor should be considered during consultation and decision-making in the future.

In general, it is important that future randomized, controlled studies incorporate long-term measurements in their results and conclusions so that complete data on the present topic can be gathered. “Although the effect on the individual child is likely subtle, the impact on society due to the large number of early-term labor inductions should not be underestimated,” the authors wrote.
 

Unexamined disruptive factors

Sven Kehl, MD, PhD, senior physician of the department of obstetrics and gynecology and coordinator of the University Perinatal Center of Franconia at the University Hospital of Erlangen, Germany, is of a similar opinion. “Inducing labor causes birth to occur sooner and therefore for the pregnancy to finish prematurely,” said Dr. Kehl. Such premature births, not the mechanical or medicinal procedures for inducing labor, could affect the child’s cerebral development. “The results of this study suggest that inducing labor in uncomplicated pregnancies, in which there are no relevant medical indications, should be avoided,” said Dr. Kehl. In these cases, the mother should wait for a natural birth.

Some of the study’s strengths include the large quantity of data, the large number of participants, and the various disruptive factors taken into consideration, such as the mother’s level of education, according to Dr. Kehl. “But it is not a study from which causality can be derived,” he said.

Not all the potential disruptive factors could be found in the available data. For example, information regarding familial status, the father’s level of education, the parents’ smoking status, or the mother’s body mass index was missing. Also, only a small number of the possible indications for inducing labor was disclosed.
 

No elective inductions

The study is unlikely to have a major effect on practice in German maternity clinics, since the routine induction of labor from the 39th WOG has always been regarded critically in German-speaking countries, said Dr. Kehl. It is still true that if there are any risks, a risk-benefit analysis must be performed, and the risks to the mother or child must be evaluated when considering labor induction.

“If there are no medical reasons for inducing labor, the women must also be informed about the possible long-term consequences and not just about the short-term risks,” said Dr. Kehl.

His colleague in Berlin, Michael Abou-Dakn, MD, chief physician of gynecology and obstetrics at the St. Joseph’s Hospital, Berlin-Tempelhof, was more categorical. “It is right to criticize the fact that over 20% of births in Germany are induced,” he said. He is rather dubious, however, about the effects on school performance found in the study following induced labor. Still, the investigation is a reminder that inducing labor could involve side effects. “There should therefore be no elective inductions, or any without a clear indication,” said Dr. Abou-Dakn.

This article was translated from the Medscape German Edition and a version appeared on Medscape.com.

The Food and Drug Administration has made changes to existing mammography regulations.

A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.

The rule requires implementation of the changes within 18 months.

According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.

For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

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

The Food and Drug Administration has made changes to existing mammography regulations.

A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.

The rule requires implementation of the changes within 18 months.

According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.

For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

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

The Food and Drug Administration has made changes to existing mammography regulations.

A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.

The rule requires implementation of the changes within 18 months.

According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.

For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

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

Use of asthma medication by pregnant women was not associated with an increased risk of autism, attention-deficit/hyperactivity disorder, or Tourette syndrome for their children, a new study shows.

The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.

“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.

However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.

“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.

To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.

The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.

The findings were published in a research letter in JAMA Network Open.

In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).

After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).

Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.

The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.

The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.

“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.

The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.

Use of asthma medication by pregnant women was not associated with an increased risk of autism, attention-deficit/hyperactivity disorder, or Tourette syndrome for their children, a new study shows.

The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.

“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.

However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.

“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.

To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.

The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.

The findings were published in a research letter in JAMA Network Open.

In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).

After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).

Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.

The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.

The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.

“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.

The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.

Use of asthma medication by pregnant women was not associated with an increased risk of autism, attention-deficit/hyperactivity disorder, or Tourette syndrome for their children, a new study shows.

The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.

“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.

However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.

“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.

To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.

The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.

The findings were published in a research letter in JAMA Network Open.

In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).

After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).

Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.

The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.

The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.

“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.

The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.