Heidi Splete

Nurses were less likely than clinicians to be sympathetic to pregnant women using opioids, based on data from 119 surveys.

University of Illinois, Chicago

Opioid use disorder among pregnant women continues to rise, and untreated opioid use is associated with complications including preterm delivery, placental abruption, and stillbirth, wrote Alexis Braverman, MD, of the University of Illinois, Chicago, and colleagues. However, many perinatal women who seek care and medications for opioid use disorder (OUD) report stigma that limits their ability to reduce these risks.

In a study published in the American Journal on Addictions , the researchers conducted an anonymous survey of 132 health care workers at six outpatient locations and a main hospital of an urban medical center. The survey was designed to assess attitudes toward pregnant women who were using opioids. The 119 complete responses in the final analysis included 40 nurses and 79 clinicians across ob.gyn., family medicine, and pediatrics. A total of 19 respondents were waivered to prescribe outpatient buprenorphine for OUD.

Nurses were significantly less likely than clinicians to agree that OUD is a chronic illness, to feel sympathy for women who use opioids during pregnancy, and to see pregnancy as an opportunity for behavior change (P = .000, P = .003, and P = .001, respectively).

Overall, family medicine providers and clinicians with 11-20 years of practice experience were significantly more sympathetic to pregnant women who used opioids, compared with providers from other departments and with fewer years of practice (P = .025 and P = .039, respectively).

Providers in pediatrics departments were significantly more likely than those from other departments to agree strongly with feeling anger at pregnant women who use opioids (P = .009), and that these women should not be allowed to parent (P = .013). However, providers in pediatrics were significantly more comfortable than those in other departments with discussing the involvement of social services in patient care (P = .020) and with counseling patients on neonatal opioid withdrawal syndrome, known as NOWS (P = .027).

“We hypothesize that nurses who perform more acute, inpatient work rather than outpatient work may not be exposed as frequently to a patient’s personal progress on their journey with OUD,” and therefore might not be exposed to the rewarding experiences and progress made by patients, the researchers wrote in their discussion.

However, the overall low level of comfort in discussing NOWS and social service involvement across provider groups (one-quarter for pediatrics, one-fifth for ob.gyn, and one-sixth for family medicine) highlights the need for further training in this area, they said.

The findings were limited by several factors, including the potential for responder bias; however, the results identify a need for greater training in stigma reduction and in counseling families on issues related to OUD, the researchers said. More studies are needed to examine attitude changes after the implementation of stigma reduction strategies, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Nurses were less likely than clinicians to be sympathetic to pregnant women using opioids, based on data from 119 surveys.

University of Illinois, Chicago

Opioid use disorder among pregnant women continues to rise, and untreated opioid use is associated with complications including preterm delivery, placental abruption, and stillbirth, wrote Alexis Braverman, MD, of the University of Illinois, Chicago, and colleagues. However, many perinatal women who seek care and medications for opioid use disorder (OUD) report stigma that limits their ability to reduce these risks.

In a study published in the American Journal on Addictions , the researchers conducted an anonymous survey of 132 health care workers at six outpatient locations and a main hospital of an urban medical center. The survey was designed to assess attitudes toward pregnant women who were using opioids. The 119 complete responses in the final analysis included 40 nurses and 79 clinicians across ob.gyn., family medicine, and pediatrics. A total of 19 respondents were waivered to prescribe outpatient buprenorphine for OUD.

Nurses were significantly less likely than clinicians to agree that OUD is a chronic illness, to feel sympathy for women who use opioids during pregnancy, and to see pregnancy as an opportunity for behavior change (P = .000, P = .003, and P = .001, respectively).

Overall, family medicine providers and clinicians with 11-20 years of practice experience were significantly more sympathetic to pregnant women who used opioids, compared with providers from other departments and with fewer years of practice (P = .025 and P = .039, respectively).

Providers in pediatrics departments were significantly more likely than those from other departments to agree strongly with feeling anger at pregnant women who use opioids (P = .009), and that these women should not be allowed to parent (P = .013). However, providers in pediatrics were significantly more comfortable than those in other departments with discussing the involvement of social services in patient care (P = .020) and with counseling patients on neonatal opioid withdrawal syndrome, known as NOWS (P = .027).

“We hypothesize that nurses who perform more acute, inpatient work rather than outpatient work may not be exposed as frequently to a patient’s personal progress on their journey with OUD,” and therefore might not be exposed to the rewarding experiences and progress made by patients, the researchers wrote in their discussion.

However, the overall low level of comfort in discussing NOWS and social service involvement across provider groups (one-quarter for pediatrics, one-fifth for ob.gyn, and one-sixth for family medicine) highlights the need for further training in this area, they said.

The findings were limited by several factors, including the potential for responder bias; however, the results identify a need for greater training in stigma reduction and in counseling families on issues related to OUD, the researchers said. More studies are needed to examine attitude changes after the implementation of stigma reduction strategies, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Nurses were less likely than clinicians to be sympathetic to pregnant women using opioids, based on data from 119 surveys.

University of Illinois, Chicago

Opioid use disorder among pregnant women continues to rise, and untreated opioid use is associated with complications including preterm delivery, placental abruption, and stillbirth, wrote Alexis Braverman, MD, of the University of Illinois, Chicago, and colleagues. However, many perinatal women who seek care and medications for opioid use disorder (OUD) report stigma that limits their ability to reduce these risks.

In a study published in the American Journal on Addictions , the researchers conducted an anonymous survey of 132 health care workers at six outpatient locations and a main hospital of an urban medical center. The survey was designed to assess attitudes toward pregnant women who were using opioids. The 119 complete responses in the final analysis included 40 nurses and 79 clinicians across ob.gyn., family medicine, and pediatrics. A total of 19 respondents were waivered to prescribe outpatient buprenorphine for OUD.

Nurses were significantly less likely than clinicians to agree that OUD is a chronic illness, to feel sympathy for women who use opioids during pregnancy, and to see pregnancy as an opportunity for behavior change (P = .000, P = .003, and P = .001, respectively).

Overall, family medicine providers and clinicians with 11-20 years of practice experience were significantly more sympathetic to pregnant women who used opioids, compared with providers from other departments and with fewer years of practice (P = .025 and P = .039, respectively).

Providers in pediatrics departments were significantly more likely than those from other departments to agree strongly with feeling anger at pregnant women who use opioids (P = .009), and that these women should not be allowed to parent (P = .013). However, providers in pediatrics were significantly more comfortable than those in other departments with discussing the involvement of social services in patient care (P = .020) and with counseling patients on neonatal opioid withdrawal syndrome, known as NOWS (P = .027).

“We hypothesize that nurses who perform more acute, inpatient work rather than outpatient work may not be exposed as frequently to a patient’s personal progress on their journey with OUD,” and therefore might not be exposed to the rewarding experiences and progress made by patients, the researchers wrote in their discussion.

However, the overall low level of comfort in discussing NOWS and social service involvement across provider groups (one-quarter for pediatrics, one-fifth for ob.gyn, and one-sixth for family medicine) highlights the need for further training in this area, they said.

The findings were limited by several factors, including the potential for responder bias; however, the results identify a need for greater training in stigma reduction and in counseling families on issues related to OUD, the researchers said. More studies are needed to examine attitude changes after the implementation of stigma reduction strategies, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Smokers who followed an adaptive treatment regimen with drug patches had greater smoking abstinence after 12 weeks than did those who followed a standard regimen, based on data from 188 individuals.

Adaptive pharmacotherapy is a common strategy across many medical conditions, but its use in smoking cessation treatments involving skin patches has not been examined, wrote James M. Davis, MD, of Duke University, Durham, N.C., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 188 adults who sought smoking cessation treatment at a university health system between February 2018 and May 2020. The researchers planned to enroll 300 adults, but enrollment was truncated because of the COVID-19 pandemic.

Participants chose between varenicline or nicotine patches, and then were randomized to an adaptive or standard treatment regimen. All participants started their medication 4 weeks before their target quit smoking day.

A total of 127 participants chose varenicline, with 64 randomized to adaptive treatment and 63 randomized to standard treatment; 61 participants chose nicotine patches, with 31 randomized to adaptive treatment and 30 randomized to standard treatment. Overall, participants smoked a mean of 15.4 cigarettes per day at baseline. The mean age of the participants was 49.1 years; 54% were female, 52% were White, and 48% were Black. Baseline demographics were similar between the groups.

The primary outcome was 30-day continuous abstinence from smoking (biochemically verified) at 12 weeks after each participant’s target quit date.

After 2 weeks (2 weeks before the target quit smoking day), all participants were assessed for treatment response. Those in the adaptive group who were deemed responders, defined as a reduction in daily cigarettes of at least 50%, received placebo bupropion. Those in the adaptive group deemed nonresponders received 150 mg bupropion twice daily in addition to their patch regimen. The standard treatment group also received placebo bupropion.

At 12 weeks after the target quit day, 24% of the adaptive group demonstrated 30-day continuous smoking abstinence, compared with 9% of the standard group (odds ratio, 3.38; P = .004). Smoking abstinence was higher in the adaptive vs. placebo groups for those who used varenicline patches (28% vs. 8%; OR, 4.54) and for those who used nicotine patches (16% vs. 10%; OR, 1.73).

In addition, 7-day smoking abstinence measured at a 2-week postquit day visit was three times higher in the adaptive group compared with the standard treatment group (32% vs. 11%; OR, 3.30).

No incidents of death, life-threatening events, hospitalization, or persistent or significant disability or incapacity related to the study were reported; one death in the varenicline group was attributable to stage 4 cancer.

The findings were limited by several factors including the few or no participants of Alaska Native, American Indian, Hispanic, or Pacific Islander ethnicities, or those who were multiracial. The free medication and modest compensation for study visits further reduce generalizability, the researchers noted. Other limitations included the smaller-than-intended sample size and inability to assess individual components of adaptive treatment, they said.

However, the results support the value of adaptive treatment and suggest that adaptive treatment with precessation varenicline or nicotine patches followed by bupropion for nonresponders is more effective than standard treatment for smoking cessation.

The study was supported by the National Institute on Drug Abuse; the varenicline was provided by Pfizer. Dr. Davis had no financial conflicts to disclose.

Smokers who followed an adaptive treatment regimen with drug patches had greater smoking abstinence after 12 weeks than did those who followed a standard regimen, based on data from 188 individuals.

Adaptive pharmacotherapy is a common strategy across many medical conditions, but its use in smoking cessation treatments involving skin patches has not been examined, wrote James M. Davis, MD, of Duke University, Durham, N.C., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 188 adults who sought smoking cessation treatment at a university health system between February 2018 and May 2020. The researchers planned to enroll 300 adults, but enrollment was truncated because of the COVID-19 pandemic.

Participants chose between varenicline or nicotine patches, and then were randomized to an adaptive or standard treatment regimen. All participants started their medication 4 weeks before their target quit smoking day.

A total of 127 participants chose varenicline, with 64 randomized to adaptive treatment and 63 randomized to standard treatment; 61 participants chose nicotine patches, with 31 randomized to adaptive treatment and 30 randomized to standard treatment. Overall, participants smoked a mean of 15.4 cigarettes per day at baseline. The mean age of the participants was 49.1 years; 54% were female, 52% were White, and 48% were Black. Baseline demographics were similar between the groups.

The primary outcome was 30-day continuous abstinence from smoking (biochemically verified) at 12 weeks after each participant’s target quit date.

After 2 weeks (2 weeks before the target quit smoking day), all participants were assessed for treatment response. Those in the adaptive group who were deemed responders, defined as a reduction in daily cigarettes of at least 50%, received placebo bupropion. Those in the adaptive group deemed nonresponders received 150 mg bupropion twice daily in addition to their patch regimen. The standard treatment group also received placebo bupropion.

At 12 weeks after the target quit day, 24% of the adaptive group demonstrated 30-day continuous smoking abstinence, compared with 9% of the standard group (odds ratio, 3.38; P = .004). Smoking abstinence was higher in the adaptive vs. placebo groups for those who used varenicline patches (28% vs. 8%; OR, 4.54) and for those who used nicotine patches (16% vs. 10%; OR, 1.73).

In addition, 7-day smoking abstinence measured at a 2-week postquit day visit was three times higher in the adaptive group compared with the standard treatment group (32% vs. 11%; OR, 3.30).

No incidents of death, life-threatening events, hospitalization, or persistent or significant disability or incapacity related to the study were reported; one death in the varenicline group was attributable to stage 4 cancer.

The findings were limited by several factors including the few or no participants of Alaska Native, American Indian, Hispanic, or Pacific Islander ethnicities, or those who were multiracial. The free medication and modest compensation for study visits further reduce generalizability, the researchers noted. Other limitations included the smaller-than-intended sample size and inability to assess individual components of adaptive treatment, they said.

However, the results support the value of adaptive treatment and suggest that adaptive treatment with precessation varenicline or nicotine patches followed by bupropion for nonresponders is more effective than standard treatment for smoking cessation.

The study was supported by the National Institute on Drug Abuse; the varenicline was provided by Pfizer. Dr. Davis had no financial conflicts to disclose.

Smokers who followed an adaptive treatment regimen with drug patches had greater smoking abstinence after 12 weeks than did those who followed a standard regimen, based on data from 188 individuals.

Adaptive pharmacotherapy is a common strategy across many medical conditions, but its use in smoking cessation treatments involving skin patches has not been examined, wrote James M. Davis, MD, of Duke University, Durham, N.C., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 188 adults who sought smoking cessation treatment at a university health system between February 2018 and May 2020. The researchers planned to enroll 300 adults, but enrollment was truncated because of the COVID-19 pandemic.

Participants chose between varenicline or nicotine patches, and then were randomized to an adaptive or standard treatment regimen. All participants started their medication 4 weeks before their target quit smoking day.

A total of 127 participants chose varenicline, with 64 randomized to adaptive treatment and 63 randomized to standard treatment; 61 participants chose nicotine patches, with 31 randomized to adaptive treatment and 30 randomized to standard treatment. Overall, participants smoked a mean of 15.4 cigarettes per day at baseline. The mean age of the participants was 49.1 years; 54% were female, 52% were White, and 48% were Black. Baseline demographics were similar between the groups.

The primary outcome was 30-day continuous abstinence from smoking (biochemically verified) at 12 weeks after each participant’s target quit date.

After 2 weeks (2 weeks before the target quit smoking day), all participants were assessed for treatment response. Those in the adaptive group who were deemed responders, defined as a reduction in daily cigarettes of at least 50%, received placebo bupropion. Those in the adaptive group deemed nonresponders received 150 mg bupropion twice daily in addition to their patch regimen. The standard treatment group also received placebo bupropion.

At 12 weeks after the target quit day, 24% of the adaptive group demonstrated 30-day continuous smoking abstinence, compared with 9% of the standard group (odds ratio, 3.38; P = .004). Smoking abstinence was higher in the adaptive vs. placebo groups for those who used varenicline patches (28% vs. 8%; OR, 4.54) and for those who used nicotine patches (16% vs. 10%; OR, 1.73).

In addition, 7-day smoking abstinence measured at a 2-week postquit day visit was three times higher in the adaptive group compared with the standard treatment group (32% vs. 11%; OR, 3.30).

No incidents of death, life-threatening events, hospitalization, or persistent or significant disability or incapacity related to the study were reported; one death in the varenicline group was attributable to stage 4 cancer.

The findings were limited by several factors including the few or no participants of Alaska Native, American Indian, Hispanic, or Pacific Islander ethnicities, or those who were multiracial. The free medication and modest compensation for study visits further reduce generalizability, the researchers noted. Other limitations included the smaller-than-intended sample size and inability to assess individual components of adaptive treatment, they said.

However, the results support the value of adaptive treatment and suggest that adaptive treatment with precessation varenicline or nicotine patches followed by bupropion for nonresponders is more effective than standard treatment for smoking cessation.

The study was supported by the National Institute on Drug Abuse; the varenicline was provided by Pfizer. Dr. Davis had no financial conflicts to disclose.

TOPLINE:

Opioid use, older age, and fracture history increase the risk for fractures in older adults with ankylosing spondylitis (AS) based on a review of registry and Medicare claims data.

METHODOLOGY:

• Rheumatology Informatics System for Effectiveness (RISE) registry data were linked to Medicare claims from 2016 to 2018; each patient had two AS International Classification of Diseases–9 and –10 codes at least 30 days apart.
• The study population included 1426 adults with AS (mean age, 69.4 years) who had continuous Medicare enrollment (Parts A and B) for the entire follow-up period but did not have Medicare Advantage Plan (Part C).
• The researchers used a logistic regression analysis to identify factors associated with fractures including age, sex, and body mass index.

TAKEAWAYS:

• The overall incidence of fractures was 76.7 per 1,000 person-years.
• Older age, history of fracture, and opioid use at a morphine-equivalent dose > 30 mg (at least one prescription 30 or more days prior to the index date) were significantly associated with increased risk for fracture (odds ratios, 2.8, 5.24, and 1.86, respectively).
• Fracture risk was equally likely for men and women.

IN PRACTICE:

The study supports fracture risk-reduction strategies for men and women with AS and a fracture history, with added attention to opioid users.

SOURCE:

The first author of the study was Rachael Stovall, MD, of the University of California, San Francisco. The study was published Aug. 22, 2023, in Arthritis Care & Research.

LIMITATIONS:

The study does not include individuals younger than 65 years and references only first fractures. Some EHR data on variables including race, body mass index, national area deprivation index, and smoking status are incomplete.

DISCLOSURES:

The study was supported by various grants from the National Center for Advancing Translational Sciences, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Rheumatology Research Foundation.

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

TOPLINE:

Opioid use, older age, and fracture history increase the risk for fractures in older adults with ankylosing spondylitis (AS) based on a review of registry and Medicare claims data.

METHODOLOGY:

• Rheumatology Informatics System for Effectiveness (RISE) registry data were linked to Medicare claims from 2016 to 2018; each patient had two AS International Classification of Diseases–9 and –10 codes at least 30 days apart.
• The study population included 1426 adults with AS (mean age, 69.4 years) who had continuous Medicare enrollment (Parts A and B) for the entire follow-up period but did not have Medicare Advantage Plan (Part C).
• The researchers used a logistic regression analysis to identify factors associated with fractures including age, sex, and body mass index.

TAKEAWAYS:

• The overall incidence of fractures was 76.7 per 1,000 person-years.
• Older age, history of fracture, and opioid use at a morphine-equivalent dose > 30 mg (at least one prescription 30 or more days prior to the index date) were significantly associated with increased risk for fracture (odds ratios, 2.8, 5.24, and 1.86, respectively).
• Fracture risk was equally likely for men and women.

IN PRACTICE:

The study supports fracture risk-reduction strategies for men and women with AS and a fracture history, with added attention to opioid users.

SOURCE:

The first author of the study was Rachael Stovall, MD, of the University of California, San Francisco. The study was published Aug. 22, 2023, in Arthritis Care & Research.

LIMITATIONS:

The study does not include individuals younger than 65 years and references only first fractures. Some EHR data on variables including race, body mass index, national area deprivation index, and smoking status are incomplete.

DISCLOSURES:

The study was supported by various grants from the National Center for Advancing Translational Sciences, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Rheumatology Research Foundation.

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

TOPLINE:

Opioid use, older age, and fracture history increase the risk for fractures in older adults with ankylosing spondylitis (AS) based on a review of registry and Medicare claims data.

METHODOLOGY:

• Rheumatology Informatics System for Effectiveness (RISE) registry data were linked to Medicare claims from 2016 to 2018; each patient had two AS International Classification of Diseases–9 and –10 codes at least 30 days apart.
• The study population included 1426 adults with AS (mean age, 69.4 years) who had continuous Medicare enrollment (Parts A and B) for the entire follow-up period but did not have Medicare Advantage Plan (Part C).
• The researchers used a logistic regression analysis to identify factors associated with fractures including age, sex, and body mass index.

TAKEAWAYS:

• The overall incidence of fractures was 76.7 per 1,000 person-years.
• Older age, history of fracture, and opioid use at a morphine-equivalent dose > 30 mg (at least one prescription 30 or more days prior to the index date) were significantly associated with increased risk for fracture (odds ratios, 2.8, 5.24, and 1.86, respectively).
• Fracture risk was equally likely for men and women.

IN PRACTICE:

The study supports fracture risk-reduction strategies for men and women with AS and a fracture history, with added attention to opioid users.

SOURCE:

The first author of the study was Rachael Stovall, MD, of the University of California, San Francisco. The study was published Aug. 22, 2023, in Arthritis Care & Research.

LIMITATIONS:

The study does not include individuals younger than 65 years and references only first fractures. Some EHR data on variables including race, body mass index, national area deprivation index, and smoking status are incomplete.

DISCLOSURES:

The study was supported by various grants from the National Center for Advancing Translational Sciences, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Rheumatology Research Foundation.

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

Eating disorders are a common comorbidity in bipolar disorder patients, especially those with type II, based on data from more than 2,000 individuals.

Previous research of bipolar disorder (BD) shows a high rate of comorbidities with other psychiatric disorders, including eating disorders (EDs), Valentin Flaudias, PhD, of Nantes (France) University and colleagues wrote.

Valentin Flaudias

“There is growing evidence that, compared with individuals with BD alone, individuals with both BD and EDs have a more severe clinical profile, including increased mood instability, alcohol use disorders, anxiety disorders, more depressive episodes, more rapid cycling, increased suicidality, and poorer response to medication,” but studies of BD type-specific ED prevalence have been inconsistent, they said.

In a study published in the Journal of Affective Disorders, the researchers reviewed data from 2,929 outpatients who underwent assessments for BD at 1 of 12 psychiatric centers in France. Of these, 1,505 met criteria for type I and 1,424 met criteria for type II. The post hoc analysis included identification of lifetime prevalence of ED. Diagnosis was based on the DSM-4-TR and the researchers considered three ED types: anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). Subtypes of BD were type I and type II. DSM not otherwise specified diagnoses for BD and EDs were excluded. The mean age of the participants was 40.5 years, and 61% were women.

A total of 479 individuals met criteria for comorbid EDs (16.4%). ED prevalence was significantly higher in BD type II patients than in BD type I patients (20.6 % vs. 12.4 %, P < .001). The overall breakdown according to ED subtype was 30% for AN, 13% for BN, and 56% for BED. The researchers found no significant differences in patients with AN, BN, or BED according to BD subtype.

In a multivariate analysis, BD patients with ED were more likely than those without ED to be women (77% vs. 55%), especially those with AN (95% vs. 82%).

BD patients with ED also tended to be younger than those without ED (37 years vs. 41 years) and reported more frequent suicide attempts (50% vs. 35%). Younger age and more frequent suicide attempts were further significant among BD patients with AN, compared with those with BED, but BD patients with BED reported higher levels of childhood trauma.

BD patients with ED also reported higher levels of depressive symptoms than those without ED, although history of psychosis was less frequent among BD patients with AN and BED compared with BD patients without EDs.

Overall, “after controlling for other variables, the independent factors differentiating BD patients with versus without ED were primarily younger age, female gender, abnormal BMI, increased affective lability and higher comorbidity with anxiety disorders,” the researchers wrote. In addition, presence of EDs except for AN was associated with decreased current functioning.

The findings were limited by several factors including the cross-sectional design, lack of a control group of non-BD individuals, and the consideration of ED over a lifetime, and small number of BN cases, the researchers noted.

However, the results suggest a high prevalence of ED in BD patients and highlight the need to screen BD patients for ED and provide integrated care. More research is needed to explore the evolution of the two conditions as comorbidities and to examine subtypes and of both conditions and their interactions, they concluded.

The study was supported by the FondaMental Foundation, French National Institute for Health and Medical Research, Public Hospitals of Paris, and the French National Research Agency’s Investment for the Future program. The researchers had no financial conflicts to disclose.

Eating disorders are a common comorbidity in bipolar disorder patients, especially those with type II, based on data from more than 2,000 individuals.

Previous research of bipolar disorder (BD) shows a high rate of comorbidities with other psychiatric disorders, including eating disorders (EDs), Valentin Flaudias, PhD, of Nantes (France) University and colleagues wrote.

Valentin Flaudias

“There is growing evidence that, compared with individuals with BD alone, individuals with both BD and EDs have a more severe clinical profile, including increased mood instability, alcohol use disorders, anxiety disorders, more depressive episodes, more rapid cycling, increased suicidality, and poorer response to medication,” but studies of BD type-specific ED prevalence have been inconsistent, they said.

In a study published in the Journal of Affective Disorders, the researchers reviewed data from 2,929 outpatients who underwent assessments for BD at 1 of 12 psychiatric centers in France. Of these, 1,505 met criteria for type I and 1,424 met criteria for type II. The post hoc analysis included identification of lifetime prevalence of ED. Diagnosis was based on the DSM-4-TR and the researchers considered three ED types: anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). Subtypes of BD were type I and type II. DSM not otherwise specified diagnoses for BD and EDs were excluded. The mean age of the participants was 40.5 years, and 61% were women.

A total of 479 individuals met criteria for comorbid EDs (16.4%). ED prevalence was significantly higher in BD type II patients than in BD type I patients (20.6 % vs. 12.4 %, P < .001). The overall breakdown according to ED subtype was 30% for AN, 13% for BN, and 56% for BED. The researchers found no significant differences in patients with AN, BN, or BED according to BD subtype.

In a multivariate analysis, BD patients with ED were more likely than those without ED to be women (77% vs. 55%), especially those with AN (95% vs. 82%).

BD patients with ED also tended to be younger than those without ED (37 years vs. 41 years) and reported more frequent suicide attempts (50% vs. 35%). Younger age and more frequent suicide attempts were further significant among BD patients with AN, compared with those with BED, but BD patients with BED reported higher levels of childhood trauma.

BD patients with ED also reported higher levels of depressive symptoms than those without ED, although history of psychosis was less frequent among BD patients with AN and BED compared with BD patients without EDs.

Overall, “after controlling for other variables, the independent factors differentiating BD patients with versus without ED were primarily younger age, female gender, abnormal BMI, increased affective lability and higher comorbidity with anxiety disorders,” the researchers wrote. In addition, presence of EDs except for AN was associated with decreased current functioning.

The findings were limited by several factors including the cross-sectional design, lack of a control group of non-BD individuals, and the consideration of ED over a lifetime, and small number of BN cases, the researchers noted.

However, the results suggest a high prevalence of ED in BD patients and highlight the need to screen BD patients for ED and provide integrated care. More research is needed to explore the evolution of the two conditions as comorbidities and to examine subtypes and of both conditions and their interactions, they concluded.

The study was supported by the FondaMental Foundation, French National Institute for Health and Medical Research, Public Hospitals of Paris, and the French National Research Agency’s Investment for the Future program. The researchers had no financial conflicts to disclose.

Eating disorders are a common comorbidity in bipolar disorder patients, especially those with type II, based on data from more than 2,000 individuals.

Previous research of bipolar disorder (BD) shows a high rate of comorbidities with other psychiatric disorders, including eating disorders (EDs), Valentin Flaudias, PhD, of Nantes (France) University and colleagues wrote.

Valentin Flaudias

“There is growing evidence that, compared with individuals with BD alone, individuals with both BD and EDs have a more severe clinical profile, including increased mood instability, alcohol use disorders, anxiety disorders, more depressive episodes, more rapid cycling, increased suicidality, and poorer response to medication,” but studies of BD type-specific ED prevalence have been inconsistent, they said.

In a study published in the Journal of Affective Disorders, the researchers reviewed data from 2,929 outpatients who underwent assessments for BD at 1 of 12 psychiatric centers in France. Of these, 1,505 met criteria for type I and 1,424 met criteria for type II. The post hoc analysis included identification of lifetime prevalence of ED. Diagnosis was based on the DSM-4-TR and the researchers considered three ED types: anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). Subtypes of BD were type I and type II. DSM not otherwise specified diagnoses for BD and EDs were excluded. The mean age of the participants was 40.5 years, and 61% were women.

A total of 479 individuals met criteria for comorbid EDs (16.4%). ED prevalence was significantly higher in BD type II patients than in BD type I patients (20.6 % vs. 12.4 %, P < .001). The overall breakdown according to ED subtype was 30% for AN, 13% for BN, and 56% for BED. The researchers found no significant differences in patients with AN, BN, or BED according to BD subtype.

In a multivariate analysis, BD patients with ED were more likely than those without ED to be women (77% vs. 55%), especially those with AN (95% vs. 82%).

BD patients with ED also tended to be younger than those without ED (37 years vs. 41 years) and reported more frequent suicide attempts (50% vs. 35%). Younger age and more frequent suicide attempts were further significant among BD patients with AN, compared with those with BED, but BD patients with BED reported higher levels of childhood trauma.

BD patients with ED also reported higher levels of depressive symptoms than those without ED, although history of psychosis was less frequent among BD patients with AN and BED compared with BD patients without EDs.

Overall, “after controlling for other variables, the independent factors differentiating BD patients with versus without ED were primarily younger age, female gender, abnormal BMI, increased affective lability and higher comorbidity with anxiety disorders,” the researchers wrote. In addition, presence of EDs except for AN was associated with decreased current functioning.

The findings were limited by several factors including the cross-sectional design, lack of a control group of non-BD individuals, and the consideration of ED over a lifetime, and small number of BN cases, the researchers noted.

However, the results suggest a high prevalence of ED in BD patients and highlight the need to screen BD patients for ED and provide integrated care. More research is needed to explore the evolution of the two conditions as comorbidities and to examine subtypes and of both conditions and their interactions, they concluded.

The study was supported by the FondaMental Foundation, French National Institute for Health and Medical Research, Public Hospitals of Paris, and the French National Research Agency’s Investment for the Future program. The researchers had no financial conflicts to disclose.

Women tested for vaginitis using a nucleic amplification test were significantly more likely to be cotested for Chlamydia trachomatis and Neissaria gonorrhoeae than women who were diagnosed based on other test types, based on data from more than 1.3 million individuals.

Penn State University

Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.

The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.

Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.

Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).

Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.

“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.

The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.

However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.

The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.

Women tested for vaginitis using a nucleic amplification test were significantly more likely to be cotested for Chlamydia trachomatis and Neissaria gonorrhoeae than women who were diagnosed based on other test types, based on data from more than 1.3 million individuals.

Penn State University

Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.

The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.

Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.

Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).

Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.

“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.

The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.

However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.

The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.

Women tested for vaginitis using a nucleic amplification test were significantly more likely to be cotested for Chlamydia trachomatis and Neissaria gonorrhoeae than women who were diagnosed based on other test types, based on data from more than 1.3 million individuals.

Penn State University

Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.

The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.

Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.

Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).

Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.

“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.

The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.

However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.

The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.

Adults with asthma who were newly prescribed mepolizumab showed significant improvement in symptoms after 1 year regardless of comorbidities, based on data from 822 individuals.

Comorbidities including chronic rhinosinusitis with polyps (CRSwNP), gastroesophageal reflux disease GERD), anxiety and depression, and chronic obstructive pulmonary disorder (COPD) are common in patients with severe asthma and add to the disease burden, wrote Mark C. Liu, MD, of Johns Hopkins University, Baltimore, and colleagues.

“Some comorbidities, such as CRSwNP, share pathophysiological mechanisms with severe asthma, with interleukin-5 (IL-5),” and treatments targeting IL-5 could improve outcomes, they said.

In the real-world REALITI-A study, mepolizumab, a humanized monoclonal antibody that targets IL-5, significantly reduced asthma exacerbation and oral corticosteroid use in severe asthma patients, they said.

To assess the impact of mepolizumab on patients with comorbidities, the researchers conducted a post hoc analysis of 822 adults with severe asthma, including 321 with CRSwNP, 309 with GERD, 203 with depression/anxiety, and 81 with COPD. The findings were published in the Journal of Allergy and Clinical Immunology: In Practice.

The main outcomes were the rate of clinically significant asthma exacerbations (CSEs) between the 12 months before and after mepolizumab initiation, and the changes from baseline in the daily maintenance use of oral corticosteroids (OCS).

Across all comorbidities, the rate of CSEs decreased significantly from the pretreatment period to the follow-up period, from 4.28 events per year to 1.23 events per year.

“A numerically greater reduction in the rate of CSEs was reported for patients with versus without CRSwNP, whereas the reverse was reported for patients with versus without COPD and depression/anxiety, although the confidence intervals were large for the with COPD subgroup,” the researchers wrote.

The median maintenance dose of oral corticosteroids decreased by at least 50% across all comorbidities after mepolizumab treatment; patients with CRSwNP had the greatest reduction (83%).

In addition, scores on the Asthma Control Questionnaire–5 decreased by at least 0.63 points, and least squared (LS) mean changes in forced expiratory volume per second (FEV₁) increased from baseline across all comorbidities after mepolizumab treatment by at least 74 mL.

Although patients with versus without CRSwNP had greater improvements, patients without GERD, depression/anxiety, and COPD had greater improvements than did those without the respective conditions with the exception of greater FEV₁ improvement in patients with vs. without COPD.

“Patients with severe asthma and comorbid CRSwNP are recognized as having a high disease burden, as demonstrated by more frequent exacerbations,” the researchers wrote in their discussion. “Mepolizumab may serve to reduce the disease burden of this high-risk group by targeting the common pathophysiological pathway of IL-5 and eosinophilic-driven inflammation because it has proven clinical benefits in treating asthma and CRSwNP separately and together,” and the current study findings support the use of mepolizumab for this population in particular, they said.

The findings were limited by several factors including the incomplete data for voluntary assessments, the post hoc design and relatively small numbers of patients in various subgroups, notably COPD, and the potential inaccurate diagnosis of COPD, the researchers noted.

“Nevertheless, because the amount of improvement in each outcome following mepolizumab treatment differed depending on the comorbidity in question, our findings highlight the impact that comorbidities and their prevalence and severity have on outcomes,” and the overall success of mepolizumab across clinical characteristics and comorbidities supports the generalizability of the findings to the larger population of adults with severe asthma, they concluded.

The study was supported by GlaxoSmithKline. Dr. Liu disclosed research funding from GSK, Boehringer Ingelheim, and Gossamer Bio, and participation on advisory boards for AstraZeneca, GSK, and Gossamer Bio.

Adults with asthma who were newly prescribed mepolizumab showed significant improvement in symptoms after 1 year regardless of comorbidities, based on data from 822 individuals.

Comorbidities including chronic rhinosinusitis with polyps (CRSwNP), gastroesophageal reflux disease GERD), anxiety and depression, and chronic obstructive pulmonary disorder (COPD) are common in patients with severe asthma and add to the disease burden, wrote Mark C. Liu, MD, of Johns Hopkins University, Baltimore, and colleagues.

“Some comorbidities, such as CRSwNP, share pathophysiological mechanisms with severe asthma, with interleukin-5 (IL-5),” and treatments targeting IL-5 could improve outcomes, they said.

In the real-world REALITI-A study, mepolizumab, a humanized monoclonal antibody that targets IL-5, significantly reduced asthma exacerbation and oral corticosteroid use in severe asthma patients, they said.

To assess the impact of mepolizumab on patients with comorbidities, the researchers conducted a post hoc analysis of 822 adults with severe asthma, including 321 with CRSwNP, 309 with GERD, 203 with depression/anxiety, and 81 with COPD. The findings were published in the Journal of Allergy and Clinical Immunology: In Practice.

The main outcomes were the rate of clinically significant asthma exacerbations (CSEs) between the 12 months before and after mepolizumab initiation, and the changes from baseline in the daily maintenance use of oral corticosteroids (OCS).

Across all comorbidities, the rate of CSEs decreased significantly from the pretreatment period to the follow-up period, from 4.28 events per year to 1.23 events per year.

“A numerically greater reduction in the rate of CSEs was reported for patients with versus without CRSwNP, whereas the reverse was reported for patients with versus without COPD and depression/anxiety, although the confidence intervals were large for the with COPD subgroup,” the researchers wrote.

The median maintenance dose of oral corticosteroids decreased by at least 50% across all comorbidities after mepolizumab treatment; patients with CRSwNP had the greatest reduction (83%).

In addition, scores on the Asthma Control Questionnaire–5 decreased by at least 0.63 points, and least squared (LS) mean changes in forced expiratory volume per second (FEV₁) increased from baseline across all comorbidities after mepolizumab treatment by at least 74 mL.

Although patients with versus without CRSwNP had greater improvements, patients without GERD, depression/anxiety, and COPD had greater improvements than did those without the respective conditions with the exception of greater FEV₁ improvement in patients with vs. without COPD.

“Patients with severe asthma and comorbid CRSwNP are recognized as having a high disease burden, as demonstrated by more frequent exacerbations,” the researchers wrote in their discussion. “Mepolizumab may serve to reduce the disease burden of this high-risk group by targeting the common pathophysiological pathway of IL-5 and eosinophilic-driven inflammation because it has proven clinical benefits in treating asthma and CRSwNP separately and together,” and the current study findings support the use of mepolizumab for this population in particular, they said.

The findings were limited by several factors including the incomplete data for voluntary assessments, the post hoc design and relatively small numbers of patients in various subgroups, notably COPD, and the potential inaccurate diagnosis of COPD, the researchers noted.

“Nevertheless, because the amount of improvement in each outcome following mepolizumab treatment differed depending on the comorbidity in question, our findings highlight the impact that comorbidities and their prevalence and severity have on outcomes,” and the overall success of mepolizumab across clinical characteristics and comorbidities supports the generalizability of the findings to the larger population of adults with severe asthma, they concluded.

The study was supported by GlaxoSmithKline. Dr. Liu disclosed research funding from GSK, Boehringer Ingelheim, and Gossamer Bio, and participation on advisory boards for AstraZeneca, GSK, and Gossamer Bio.

Adults with asthma who were newly prescribed mepolizumab showed significant improvement in symptoms after 1 year regardless of comorbidities, based on data from 822 individuals.

Comorbidities including chronic rhinosinusitis with polyps (CRSwNP), gastroesophageal reflux disease GERD), anxiety and depression, and chronic obstructive pulmonary disorder (COPD) are common in patients with severe asthma and add to the disease burden, wrote Mark C. Liu, MD, of Johns Hopkins University, Baltimore, and colleagues.

“Some comorbidities, such as CRSwNP, share pathophysiological mechanisms with severe asthma, with interleukin-5 (IL-5),” and treatments targeting IL-5 could improve outcomes, they said.

In the real-world REALITI-A study, mepolizumab, a humanized monoclonal antibody that targets IL-5, significantly reduced asthma exacerbation and oral corticosteroid use in severe asthma patients, they said.

To assess the impact of mepolizumab on patients with comorbidities, the researchers conducted a post hoc analysis of 822 adults with severe asthma, including 321 with CRSwNP, 309 with GERD, 203 with depression/anxiety, and 81 with COPD. The findings were published in the Journal of Allergy and Clinical Immunology: In Practice.

The main outcomes were the rate of clinically significant asthma exacerbations (CSEs) between the 12 months before and after mepolizumab initiation, and the changes from baseline in the daily maintenance use of oral corticosteroids (OCS).

Across all comorbidities, the rate of CSEs decreased significantly from the pretreatment period to the follow-up period, from 4.28 events per year to 1.23 events per year.

“A numerically greater reduction in the rate of CSEs was reported for patients with versus without CRSwNP, whereas the reverse was reported for patients with versus without COPD and depression/anxiety, although the confidence intervals were large for the with COPD subgroup,” the researchers wrote.

The median maintenance dose of oral corticosteroids decreased by at least 50% across all comorbidities after mepolizumab treatment; patients with CRSwNP had the greatest reduction (83%).

In addition, scores on the Asthma Control Questionnaire–5 decreased by at least 0.63 points, and least squared (LS) mean changes in forced expiratory volume per second (FEV₁) increased from baseline across all comorbidities after mepolizumab treatment by at least 74 mL.

Although patients with versus without CRSwNP had greater improvements, patients without GERD, depression/anxiety, and COPD had greater improvements than did those without the respective conditions with the exception of greater FEV₁ improvement in patients with vs. without COPD.

“Patients with severe asthma and comorbid CRSwNP are recognized as having a high disease burden, as demonstrated by more frequent exacerbations,” the researchers wrote in their discussion. “Mepolizumab may serve to reduce the disease burden of this high-risk group by targeting the common pathophysiological pathway of IL-5 and eosinophilic-driven inflammation because it has proven clinical benefits in treating asthma and CRSwNP separately and together,” and the current study findings support the use of mepolizumab for this population in particular, they said.

The findings were limited by several factors including the incomplete data for voluntary assessments, the post hoc design and relatively small numbers of patients in various subgroups, notably COPD, and the potential inaccurate diagnosis of COPD, the researchers noted.

“Nevertheless, because the amount of improvement in each outcome following mepolizumab treatment differed depending on the comorbidity in question, our findings highlight the impact that comorbidities and their prevalence and severity have on outcomes,” and the overall success of mepolizumab across clinical characteristics and comorbidities supports the generalizability of the findings to the larger population of adults with severe asthma, they concluded.

The study was supported by GlaxoSmithKline. Dr. Liu disclosed research funding from GSK, Boehringer Ingelheim, and Gossamer Bio, and participation on advisory boards for AstraZeneca, GSK, and Gossamer Bio.

Weight loss of at least 5% over a 3-year period was associated with significantly increased mortality in women at age 90, 95, and 100 years compared with those whose weight remained stable, based on data from more than 50,000 individuals.

Previous studies of later-life weight changes and mortality have yielded inconsistent results driven by considerations of weight loss intentionality, and data on older adults in particular are limited, wrote Aladdin H. Shadyab, PhD, of the University of California, San Diego, and colleagues.

In a study published in the Journals of Gerontology: Medical Sciences, the researchers reviewed data from the Women’s Health Initiative, a prospective study of factors affecting chronic disease development in postmenopausal women. The study population included 54,437 women who entered the WHI between 1993 and 1998 at ages 50-79 years. The mean baseline age was 69.8 years; 89.5% of the participants were White, 5.7% were Black, 2.7% were Asian, 2.5% were Hispanic/Latino, and the remaining 1.0% were multiracial, American Indian/Alaskan Native, Native Hawaiian/Other Pacific Islander, or unknown.

The primary outcomes were the associations of short-term (3-year) and long-term (10-year) weight changes with survival to ages 90, 95, and 100 years.

A total of 30,647 women survived to at least 90 years (56.3%).

Overall, women with a short-term weight loss of 5% or more of body weight were 33% less likely to survive to age 90 years, 35% less likely to survive to age 95 years, and 38% less likely to survive to age 100 years than were those whose weight remained stable (odds ratios, 0.67, 0.65, and 0.62, respectively).

The associations were stronger in cases of unintentional short-term weight loss. Intentional weight loss from baseline to year 3 was associated with 17% lower odds of survival to age 90 compared to stable weight (OR, 0.83), but unintentional weight loss was associated with 51% lower odds of survival to age 90 (OR, 0.49).

Similarly, women with 10-year weight loss of at least 5% were 40% less likely to survive to 90 years and 49% less likely to survive to 95 years (OR, 0.60 and OR, 0.51, respectively). The sample size was too small to assess the relation of 10-year weight loss with survival to 100 years, and intentionality was not assessed for 10-year weight changes.

By contrast, weight gain of at least 5% had no significant effect on survival to ages 90, 95, or 100 years, but stable weight over time increased the odds of living to ages 90 to 100 years by 1.2-fold to 2-fold compared to either intentional or unintentional weight loss of at least 5%.

The trends in results were similar across body weight categories (normal weight, overweight, and obese as defined by body mass index). Baseline age and smoking status had no significant effect on the results.

Some of the proportion of self-reported intentional weight loss in the study population may have been unintentional, the researchers wrote in their discussion.

“It is important to note that perceived intentionality of weight loss may be influenced by the many societal pressures to lose weight, especially among women, and therefore overestimate the behavioral changes underlying experienced weight loss in older adults,” they said.

The findings were limited by several factors including the potential for inaccurate self-reported weight loss intention, and the likelihood that the mean older age of the population at baseline (older than 60 years) meant that they were more likely to live longer regardless of weight changes, the researchers noted. Other limitations included the primarily White study population, and other residual confounding factors such as ill health that might drive weight loss, the researchers noted.

However, the results were strengthened by the large sample size and long follow-up period, and suggest that “blanket recommendations for weight loss in older women are unlikely to lead to better survival at advanced ages,” they concluded.
 

Data support weight monitoring

The investigators acknowledged that their data do not affect clinical recommendations for moderate weight loss in older women to improve health outcomes, especially in those with overweight or obesity, but instead “support close monitoring of the amount and speed of weight loss, particularly when unintentional, as an indicator of underlying poor health and predictor of decreased lifespan in older women.”

Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, agreed with this conclusion. The current study suggests that when older women lose a significant amount of weight unintentionally, it could be a sign of failing health, he said.

Weight gain or loss in old age is very different from weight issues in younger people, where clinicians may be encouraging weight loss to improve health outcomes, Dr. Skolnik said in an interview.

A key take-home message for clinicians, in addition to monitoring weight in older patients, is to emphasize nutrition for individuals in their 80s, 90s, and beyond, he said.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Shadyab had no financial conflicts to disclose. Dr. Skolnik had no financial conflicts to disclose and serves on the editorial advisory board of Family Practice News.

Weight loss of at least 5% over a 3-year period was associated with significantly increased mortality in women at age 90, 95, and 100 years compared with those whose weight remained stable, based on data from more than 50,000 individuals.

Previous studies of later-life weight changes and mortality have yielded inconsistent results driven by considerations of weight loss intentionality, and data on older adults in particular are limited, wrote Aladdin H. Shadyab, PhD, of the University of California, San Diego, and colleagues.

In a study published in the Journals of Gerontology: Medical Sciences, the researchers reviewed data from the Women’s Health Initiative, a prospective study of factors affecting chronic disease development in postmenopausal women. The study population included 54,437 women who entered the WHI between 1993 and 1998 at ages 50-79 years. The mean baseline age was 69.8 years; 89.5% of the participants were White, 5.7% were Black, 2.7% were Asian, 2.5% were Hispanic/Latino, and the remaining 1.0% were multiracial, American Indian/Alaskan Native, Native Hawaiian/Other Pacific Islander, or unknown.

The primary outcomes were the associations of short-term (3-year) and long-term (10-year) weight changes with survival to ages 90, 95, and 100 years.

A total of 30,647 women survived to at least 90 years (56.3%).

Overall, women with a short-term weight loss of 5% or more of body weight were 33% less likely to survive to age 90 years, 35% less likely to survive to age 95 years, and 38% less likely to survive to age 100 years than were those whose weight remained stable (odds ratios, 0.67, 0.65, and 0.62, respectively).

The associations were stronger in cases of unintentional short-term weight loss. Intentional weight loss from baseline to year 3 was associated with 17% lower odds of survival to age 90 compared to stable weight (OR, 0.83), but unintentional weight loss was associated with 51% lower odds of survival to age 90 (OR, 0.49).

Similarly, women with 10-year weight loss of at least 5% were 40% less likely to survive to 90 years and 49% less likely to survive to 95 years (OR, 0.60 and OR, 0.51, respectively). The sample size was too small to assess the relation of 10-year weight loss with survival to 100 years, and intentionality was not assessed for 10-year weight changes.

By contrast, weight gain of at least 5% had no significant effect on survival to ages 90, 95, or 100 years, but stable weight over time increased the odds of living to ages 90 to 100 years by 1.2-fold to 2-fold compared to either intentional or unintentional weight loss of at least 5%.

The trends in results were similar across body weight categories (normal weight, overweight, and obese as defined by body mass index). Baseline age and smoking status had no significant effect on the results.

Some of the proportion of self-reported intentional weight loss in the study population may have been unintentional, the researchers wrote in their discussion.

“It is important to note that perceived intentionality of weight loss may be influenced by the many societal pressures to lose weight, especially among women, and therefore overestimate the behavioral changes underlying experienced weight loss in older adults,” they said.

The findings were limited by several factors including the potential for inaccurate self-reported weight loss intention, and the likelihood that the mean older age of the population at baseline (older than 60 years) meant that they were more likely to live longer regardless of weight changes, the researchers noted. Other limitations included the primarily White study population, and other residual confounding factors such as ill health that might drive weight loss, the researchers noted.

However, the results were strengthened by the large sample size and long follow-up period, and suggest that “blanket recommendations for weight loss in older women are unlikely to lead to better survival at advanced ages,” they concluded.
 

Data support weight monitoring

The investigators acknowledged that their data do not affect clinical recommendations for moderate weight loss in older women to improve health outcomes, especially in those with overweight or obesity, but instead “support close monitoring of the amount and speed of weight loss, particularly when unintentional, as an indicator of underlying poor health and predictor of decreased lifespan in older women.”

Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, agreed with this conclusion. The current study suggests that when older women lose a significant amount of weight unintentionally, it could be a sign of failing health, he said.

Weight gain or loss in old age is very different from weight issues in younger people, where clinicians may be encouraging weight loss to improve health outcomes, Dr. Skolnik said in an interview.

A key take-home message for clinicians, in addition to monitoring weight in older patients, is to emphasize nutrition for individuals in their 80s, 90s, and beyond, he said.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Shadyab had no financial conflicts to disclose. Dr. Skolnik had no financial conflicts to disclose and serves on the editorial advisory board of Family Practice News.

Weight loss of at least 5% over a 3-year period was associated with significantly increased mortality in women at age 90, 95, and 100 years compared with those whose weight remained stable, based on data from more than 50,000 individuals.

Previous studies of later-life weight changes and mortality have yielded inconsistent results driven by considerations of weight loss intentionality, and data on older adults in particular are limited, wrote Aladdin H. Shadyab, PhD, of the University of California, San Diego, and colleagues.

In a study published in the Journals of Gerontology: Medical Sciences, the researchers reviewed data from the Women’s Health Initiative, a prospective study of factors affecting chronic disease development in postmenopausal women. The study population included 54,437 women who entered the WHI between 1993 and 1998 at ages 50-79 years. The mean baseline age was 69.8 years; 89.5% of the participants were White, 5.7% were Black, 2.7% were Asian, 2.5% were Hispanic/Latino, and the remaining 1.0% were multiracial, American Indian/Alaskan Native, Native Hawaiian/Other Pacific Islander, or unknown.

The primary outcomes were the associations of short-term (3-year) and long-term (10-year) weight changes with survival to ages 90, 95, and 100 years.

A total of 30,647 women survived to at least 90 years (56.3%).

Overall, women with a short-term weight loss of 5% or more of body weight were 33% less likely to survive to age 90 years, 35% less likely to survive to age 95 years, and 38% less likely to survive to age 100 years than were those whose weight remained stable (odds ratios, 0.67, 0.65, and 0.62, respectively).

The associations were stronger in cases of unintentional short-term weight loss. Intentional weight loss from baseline to year 3 was associated with 17% lower odds of survival to age 90 compared to stable weight (OR, 0.83), but unintentional weight loss was associated with 51% lower odds of survival to age 90 (OR, 0.49).

Similarly, women with 10-year weight loss of at least 5% were 40% less likely to survive to 90 years and 49% less likely to survive to 95 years (OR, 0.60 and OR, 0.51, respectively). The sample size was too small to assess the relation of 10-year weight loss with survival to 100 years, and intentionality was not assessed for 10-year weight changes.

By contrast, weight gain of at least 5% had no significant effect on survival to ages 90, 95, or 100 years, but stable weight over time increased the odds of living to ages 90 to 100 years by 1.2-fold to 2-fold compared to either intentional or unintentional weight loss of at least 5%.

The trends in results were similar across body weight categories (normal weight, overweight, and obese as defined by body mass index). Baseline age and smoking status had no significant effect on the results.

Some of the proportion of self-reported intentional weight loss in the study population may have been unintentional, the researchers wrote in their discussion.

“It is important to note that perceived intentionality of weight loss may be influenced by the many societal pressures to lose weight, especially among women, and therefore overestimate the behavioral changes underlying experienced weight loss in older adults,” they said.

The findings were limited by several factors including the potential for inaccurate self-reported weight loss intention, and the likelihood that the mean older age of the population at baseline (older than 60 years) meant that they were more likely to live longer regardless of weight changes, the researchers noted. Other limitations included the primarily White study population, and other residual confounding factors such as ill health that might drive weight loss, the researchers noted.

However, the results were strengthened by the large sample size and long follow-up period, and suggest that “blanket recommendations for weight loss in older women are unlikely to lead to better survival at advanced ages,” they concluded.
 

Data support weight monitoring

The investigators acknowledged that their data do not affect clinical recommendations for moderate weight loss in older women to improve health outcomes, especially in those with overweight or obesity, but instead “support close monitoring of the amount and speed of weight loss, particularly when unintentional, as an indicator of underlying poor health and predictor of decreased lifespan in older women.”

Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, agreed with this conclusion. The current study suggests that when older women lose a significant amount of weight unintentionally, it could be a sign of failing health, he said.

Weight gain or loss in old age is very different from weight issues in younger people, where clinicians may be encouraging weight loss to improve health outcomes, Dr. Skolnik said in an interview.

A key take-home message for clinicians, in addition to monitoring weight in older patients, is to emphasize nutrition for individuals in their 80s, 90s, and beyond, he said.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Shadyab had no financial conflicts to disclose. Dr. Skolnik had no financial conflicts to disclose and serves on the editorial advisory board of Family Practice News.

Systemic sclerosis patients with both interstitial lung disease and pulmonary hypertension had worse survival than those without both conditions, based on data from more than 3,000 individuals.

Pulmonary complications are now the most common causes of death in adults with systemic sclerosis (SSc), but the impact of patient characteristics and risk factors such as interstitial lung disease (ILD) and pulmonary hypertension (PH) on SSc outcomes remains unclear, wrote Pia Moinzadeh, MD, of University Hospital Cologne (Germany) and colleagues.

Although the role of ILD and PH in different SSc subtypes has been studied, larger studies of the effects of ILD and combining ILD and PH on outcomes are needed, since survival rates can change over time with new classification criteria, diagnostic tools, and improved therapies, they said.

In a study published in the journal Chest, the researchers reviewed data from 3,257 adults aged 18 years and older with SSc over a mean follow-up of 3.45 years. Participants were part of the German Network for Systemic Sclerosis (DNSS) that included 25 clinical centers in Germany. The participants were divided into SSc subsets: 54.2% with limited cutaneous SSc (lcSSc), 31.4% with diffuse cutaneous SSc (dcSSc), and 14.4% SSc overlapping syndromes.

The baseline prevalence of ILD was 34.5%, including 200 patients with ILD-PH and 923 with ILD but without PH. The baseline prevalence of PH without ILD was 4.5%. ILD was defined as SSc associated when other causes were excluded. PH was defined as an increase in mean arterial pressure of at least 25 mm Hg at rest, and also was defined by an estimated right ventricular systolic pressure greater than 35 mm Hg based on echocardiography.

By the end of the study period, 47.6% of SSc patients had ILD, 15.2% had ILD-PH, and 6.5% had pulmonary arterial hypertension (PAH). Of the SSc patients with ILD, 57.3% had dcSSc; the prevalence of PAH was not significantly different between the SSc subtypes. Patients with dcSSc were more likely to develop ILD-PH (52.2%) and ILD without PH (52.1%); patients with lcSSc were more likely to have PAH (64.9%) or no pulmonary involvement (64.1%).

“For all subsets, a significant increase in the frequency of SSc-ILD was observed during follow-ups,” the researchers noted.

Overall survival at 5 years was worst for patients with both ILD and PH (79.1%). Five-year OS for patients with PAH was 85.0%. OS at 5 years was significantly better for patients with ILD without PH (92.8%) and those with no pulmonary involvement (96.4%), compared with the ILD and PH patients (P < 0.001).

In a multivariate analysis, the risk of death was more than five times higher for patients with ILD-PH, compared with the reference group of patients without pulmonary involvement (hazard ratio, 5.3). Factors associated with reduced risk of death included female sex (HR, 0.3), higher body mass index (HR, 0.9), and higher diffusing capacity of the lung for carbon monoxide (HR, 0.98).

The findings were limited by several factors including the incomplete data for patients enrolled early in the registry, lack of complete radiology data, and the inability to determine whether the association between pulmonary involvement and survival was related to ILD or to pulmonary vascular disease, the researchers noted.

However, the results suggest that a combination of ILD and PH is the main predictor of death in patients with SSc and ILD, although the overall survival for SSc patients with and without pulmonary involvement has improved in recent decades thanks to improved therapies, multidisciplinary care, and greater attention to the disease worldwide, they concluded.

The study received no outside funding. Dr. Moinzadeh disclosed lecture fees from Boehringer Ingelheim.

Systemic sclerosis patients with both interstitial lung disease and pulmonary hypertension had worse survival than those without both conditions, based on data from more than 3,000 individuals.

Pulmonary complications are now the most common causes of death in adults with systemic sclerosis (SSc), but the impact of patient characteristics and risk factors such as interstitial lung disease (ILD) and pulmonary hypertension (PH) on SSc outcomes remains unclear, wrote Pia Moinzadeh, MD, of University Hospital Cologne (Germany) and colleagues.

Although the role of ILD and PH in different SSc subtypes has been studied, larger studies of the effects of ILD and combining ILD and PH on outcomes are needed, since survival rates can change over time with new classification criteria, diagnostic tools, and improved therapies, they said.

In a study published in the journal Chest, the researchers reviewed data from 3,257 adults aged 18 years and older with SSc over a mean follow-up of 3.45 years. Participants were part of the German Network for Systemic Sclerosis (DNSS) that included 25 clinical centers in Germany. The participants were divided into SSc subsets: 54.2% with limited cutaneous SSc (lcSSc), 31.4% with diffuse cutaneous SSc (dcSSc), and 14.4% SSc overlapping syndromes.

The baseline prevalence of ILD was 34.5%, including 200 patients with ILD-PH and 923 with ILD but without PH. The baseline prevalence of PH without ILD was 4.5%. ILD was defined as SSc associated when other causes were excluded. PH was defined as an increase in mean arterial pressure of at least 25 mm Hg at rest, and also was defined by an estimated right ventricular systolic pressure greater than 35 mm Hg based on echocardiography.

By the end of the study period, 47.6% of SSc patients had ILD, 15.2% had ILD-PH, and 6.5% had pulmonary arterial hypertension (PAH). Of the SSc patients with ILD, 57.3% had dcSSc; the prevalence of PAH was not significantly different between the SSc subtypes. Patients with dcSSc were more likely to develop ILD-PH (52.2%) and ILD without PH (52.1%); patients with lcSSc were more likely to have PAH (64.9%) or no pulmonary involvement (64.1%).

“For all subsets, a significant increase in the frequency of SSc-ILD was observed during follow-ups,” the researchers noted.

Overall survival at 5 years was worst for patients with both ILD and PH (79.1%). Five-year OS for patients with PAH was 85.0%. OS at 5 years was significantly better for patients with ILD without PH (92.8%) and those with no pulmonary involvement (96.4%), compared with the ILD and PH patients (P < 0.001).

In a multivariate analysis, the risk of death was more than five times higher for patients with ILD-PH, compared with the reference group of patients without pulmonary involvement (hazard ratio, 5.3). Factors associated with reduced risk of death included female sex (HR, 0.3), higher body mass index (HR, 0.9), and higher diffusing capacity of the lung for carbon monoxide (HR, 0.98).

The findings were limited by several factors including the incomplete data for patients enrolled early in the registry, lack of complete radiology data, and the inability to determine whether the association between pulmonary involvement and survival was related to ILD or to pulmonary vascular disease, the researchers noted.

However, the results suggest that a combination of ILD and PH is the main predictor of death in patients with SSc and ILD, although the overall survival for SSc patients with and without pulmonary involvement has improved in recent decades thanks to improved therapies, multidisciplinary care, and greater attention to the disease worldwide, they concluded.

The study received no outside funding. Dr. Moinzadeh disclosed lecture fees from Boehringer Ingelheim.

Systemic sclerosis patients with both interstitial lung disease and pulmonary hypertension had worse survival than those without both conditions, based on data from more than 3,000 individuals.

Pulmonary complications are now the most common causes of death in adults with systemic sclerosis (SSc), but the impact of patient characteristics and risk factors such as interstitial lung disease (ILD) and pulmonary hypertension (PH) on SSc outcomes remains unclear, wrote Pia Moinzadeh, MD, of University Hospital Cologne (Germany) and colleagues.

Although the role of ILD and PH in different SSc subtypes has been studied, larger studies of the effects of ILD and combining ILD and PH on outcomes are needed, since survival rates can change over time with new classification criteria, diagnostic tools, and improved therapies, they said.

In a study published in the journal Chest, the researchers reviewed data from 3,257 adults aged 18 years and older with SSc over a mean follow-up of 3.45 years. Participants were part of the German Network for Systemic Sclerosis (DNSS) that included 25 clinical centers in Germany. The participants were divided into SSc subsets: 54.2% with limited cutaneous SSc (lcSSc), 31.4% with diffuse cutaneous SSc (dcSSc), and 14.4% SSc overlapping syndromes.

The baseline prevalence of ILD was 34.5%, including 200 patients with ILD-PH and 923 with ILD but without PH. The baseline prevalence of PH without ILD was 4.5%. ILD was defined as SSc associated when other causes were excluded. PH was defined as an increase in mean arterial pressure of at least 25 mm Hg at rest, and also was defined by an estimated right ventricular systolic pressure greater than 35 mm Hg based on echocardiography.

By the end of the study period, 47.6% of SSc patients had ILD, 15.2% had ILD-PH, and 6.5% had pulmonary arterial hypertension (PAH). Of the SSc patients with ILD, 57.3% had dcSSc; the prevalence of PAH was not significantly different between the SSc subtypes. Patients with dcSSc were more likely to develop ILD-PH (52.2%) and ILD without PH (52.1%); patients with lcSSc were more likely to have PAH (64.9%) or no pulmonary involvement (64.1%).

“For all subsets, a significant increase in the frequency of SSc-ILD was observed during follow-ups,” the researchers noted.

Overall survival at 5 years was worst for patients with both ILD and PH (79.1%). Five-year OS for patients with PAH was 85.0%. OS at 5 years was significantly better for patients with ILD without PH (92.8%) and those with no pulmonary involvement (96.4%), compared with the ILD and PH patients (P < 0.001).

In a multivariate analysis, the risk of death was more than five times higher for patients with ILD-PH, compared with the reference group of patients without pulmonary involvement (hazard ratio, 5.3). Factors associated with reduced risk of death included female sex (HR, 0.3), higher body mass index (HR, 0.9), and higher diffusing capacity of the lung for carbon monoxide (HR, 0.98).

The findings were limited by several factors including the incomplete data for patients enrolled early in the registry, lack of complete radiology data, and the inability to determine whether the association between pulmonary involvement and survival was related to ILD or to pulmonary vascular disease, the researchers noted.

However, the results suggest that a combination of ILD and PH is the main predictor of death in patients with SSc and ILD, although the overall survival for SSc patients with and without pulmonary involvement has improved in recent decades thanks to improved therapies, multidisciplinary care, and greater attention to the disease worldwide, they concluded.

The study received no outside funding. Dr. Moinzadeh disclosed lecture fees from Boehringer Ingelheim.

One in five women in the United States undergoing maternity care experiences mistreatment from health care providers, based on survey data from more than 2,000 individuals.

“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.

Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.

Dr. Mohamoud

“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.

In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.

The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.

Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”

Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.

Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).

However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.

When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).

Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).

With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.

In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).

The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.

However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.

In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.

Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.

The study received no outside funding. The researchers had no financial conflicts to disclose.

One in five women in the United States undergoing maternity care experiences mistreatment from health care providers, based on survey data from more than 2,000 individuals.

“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.

Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.

Dr. Mohamoud

“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.

In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.

The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.

Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”

Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.

Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).

However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.

When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).

Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).

With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.

In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).

The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.

However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.

In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.

Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.

The study received no outside funding. The researchers had no financial conflicts to disclose.

One in five women in the United States undergoing maternity care experiences mistreatment from health care providers, based on survey data from more than 2,000 individuals.

“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.

Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.

Dr. Mohamoud

“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.

In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.

The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.

Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”

Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.

Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).

However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.

When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).

Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).

With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.

In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).

The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.

However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.

In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.

Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.