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Parent training pays off for children with autism
“Referrals for parent training should now be considered the expected standard for medical practice,” said a member of the research team, Timothy B. Smith, PhD, a professor of psychology at Brigham Young University, Provo, Utah.
Programs that show parents how to teach functional skills and address maladaptive behaviors, also known as parent-mediated or parent-implemented interventions, offer an alternative to one-on-one professional services, which are in short supply, according to the paper, which was published in the Journal of Autism and Developmental Disorders.
Methods and results
The meta-analysis included 54 papers based on randomized clinical trials involving 2,895 children, which compared the effects of various parent interventions with professional treatment, treatment as usual, or being on a wait-list to receive an intervention.
Overall the research team reported “moderately strong” average benefits from the parent-mediated interventions (Hedges’ g, 0.553), indicating a medium effect size. Parent interventions had the greatest effect on outcomes involving positive behavior and social skills (0.603), followed by language and communication (0.545), maladaptive behavior (0.519), and life skills (0.239).
Similar benefits were observed regardless of a child’s age or sex or which parent or parents implemented an intervention. The effects also appeared to be consistent regardless of intervention characteristics, such as the number of training sessions parents received, although the researchers noted that many studies did not provide data on such details.
Paul Carbone, MD, a professor of pediatrics at the University of Utah, Salt Lake City, who was not involved in the review, said it demonstrates that such parental engagement is “vitally important” and pediatricians “should not hesitate to refer interested families.”
Dr. Carbone, who is the medical director of an assessment program for children with suspected developmental disabilities, said many training programs for parents have adopted telehealth, adding to their convenience. To make appropriate referrals, primary care clinicians should become acquainted with local programs and learn which outcomes they target, he said.
Dr. Smith noted that primary care physicians are “better trained now than ever” to identify autism spectrum disorder and therefore are among the first to identify those conditions and help parents understand “that their actions at home absolutely make a difference in the child’s development.”
Overcoming limitations, future research needs
The research team attempted to overcome limitations with previous reviews by using comprehensive search terms and other methods to identify relevant studies, including some that had not been published. They included only studies that reflect common practice of training multiple parents simultaneously, they wrote.
Dr. Smith noted that long-term outcomes data and further study to compare effects on children with mild, moderate, and severe autism are needed.
Although logic would suggest greater benefits for children with severe disease, there are no data to demonstrate that, he said.
The authors of the study and Dr. Carbone reported no relevant competing interests.
“Referrals for parent training should now be considered the expected standard for medical practice,” said a member of the research team, Timothy B. Smith, PhD, a professor of psychology at Brigham Young University, Provo, Utah.
Programs that show parents how to teach functional skills and address maladaptive behaviors, also known as parent-mediated or parent-implemented interventions, offer an alternative to one-on-one professional services, which are in short supply, according to the paper, which was published in the Journal of Autism and Developmental Disorders.
Methods and results
The meta-analysis included 54 papers based on randomized clinical trials involving 2,895 children, which compared the effects of various parent interventions with professional treatment, treatment as usual, or being on a wait-list to receive an intervention.
Overall the research team reported “moderately strong” average benefits from the parent-mediated interventions (Hedges’ g, 0.553), indicating a medium effect size. Parent interventions had the greatest effect on outcomes involving positive behavior and social skills (0.603), followed by language and communication (0.545), maladaptive behavior (0.519), and life skills (0.239).
Similar benefits were observed regardless of a child’s age or sex or which parent or parents implemented an intervention. The effects also appeared to be consistent regardless of intervention characteristics, such as the number of training sessions parents received, although the researchers noted that many studies did not provide data on such details.
Paul Carbone, MD, a professor of pediatrics at the University of Utah, Salt Lake City, who was not involved in the review, said it demonstrates that such parental engagement is “vitally important” and pediatricians “should not hesitate to refer interested families.”
Dr. Carbone, who is the medical director of an assessment program for children with suspected developmental disabilities, said many training programs for parents have adopted telehealth, adding to their convenience. To make appropriate referrals, primary care clinicians should become acquainted with local programs and learn which outcomes they target, he said.
Dr. Smith noted that primary care physicians are “better trained now than ever” to identify autism spectrum disorder and therefore are among the first to identify those conditions and help parents understand “that their actions at home absolutely make a difference in the child’s development.”
Overcoming limitations, future research needs
The research team attempted to overcome limitations with previous reviews by using comprehensive search terms and other methods to identify relevant studies, including some that had not been published. They included only studies that reflect common practice of training multiple parents simultaneously, they wrote.
Dr. Smith noted that long-term outcomes data and further study to compare effects on children with mild, moderate, and severe autism are needed.
Although logic would suggest greater benefits for children with severe disease, there are no data to demonstrate that, he said.
The authors of the study and Dr. Carbone reported no relevant competing interests.
“Referrals for parent training should now be considered the expected standard for medical practice,” said a member of the research team, Timothy B. Smith, PhD, a professor of psychology at Brigham Young University, Provo, Utah.
Programs that show parents how to teach functional skills and address maladaptive behaviors, also known as parent-mediated or parent-implemented interventions, offer an alternative to one-on-one professional services, which are in short supply, according to the paper, which was published in the Journal of Autism and Developmental Disorders.
Methods and results
The meta-analysis included 54 papers based on randomized clinical trials involving 2,895 children, which compared the effects of various parent interventions with professional treatment, treatment as usual, or being on a wait-list to receive an intervention.
Overall the research team reported “moderately strong” average benefits from the parent-mediated interventions (Hedges’ g, 0.553), indicating a medium effect size. Parent interventions had the greatest effect on outcomes involving positive behavior and social skills (0.603), followed by language and communication (0.545), maladaptive behavior (0.519), and life skills (0.239).
Similar benefits were observed regardless of a child’s age or sex or which parent or parents implemented an intervention. The effects also appeared to be consistent regardless of intervention characteristics, such as the number of training sessions parents received, although the researchers noted that many studies did not provide data on such details.
Paul Carbone, MD, a professor of pediatrics at the University of Utah, Salt Lake City, who was not involved in the review, said it demonstrates that such parental engagement is “vitally important” and pediatricians “should not hesitate to refer interested families.”
Dr. Carbone, who is the medical director of an assessment program for children with suspected developmental disabilities, said many training programs for parents have adopted telehealth, adding to their convenience. To make appropriate referrals, primary care clinicians should become acquainted with local programs and learn which outcomes they target, he said.
Dr. Smith noted that primary care physicians are “better trained now than ever” to identify autism spectrum disorder and therefore are among the first to identify those conditions and help parents understand “that their actions at home absolutely make a difference in the child’s development.”
Overcoming limitations, future research needs
The research team attempted to overcome limitations with previous reviews by using comprehensive search terms and other methods to identify relevant studies, including some that had not been published. They included only studies that reflect common practice of training multiple parents simultaneously, they wrote.
Dr. Smith noted that long-term outcomes data and further study to compare effects on children with mild, moderate, and severe autism are needed.
Although logic would suggest greater benefits for children with severe disease, there are no data to demonstrate that, he said.
The authors of the study and Dr. Carbone reported no relevant competing interests.
FROM JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS
Monkeypox virus found in asymptomatic people
The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.
It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”
In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”
Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.
That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
Research methods
For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.
During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.
The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.
In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.
At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
Clinical implications of findings are uncertain
Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.
Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”
Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.
She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”
However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
Non-vaccine interventions are also needed
Other experts stressed the need for nonvaccine interventions.
In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.
Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.
Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”
Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”
Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.
The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.
It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”
In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”
Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.
That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
Research methods
For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.
During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.
The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.
In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.
At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
Clinical implications of findings are uncertain
Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.
Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”
Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.
She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”
However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
Non-vaccine interventions are also needed
Other experts stressed the need for nonvaccine interventions.
In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.
Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.
Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”
Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”
Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.
The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.
It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”
In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”
Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.
That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
Research methods
For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.
During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.
The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.
In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.
At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
Clinical implications of findings are uncertain
Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.
Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”
Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.
She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”
However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
Non-vaccine interventions are also needed
Other experts stressed the need for nonvaccine interventions.
In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.
Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.
Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”
Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”
Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.
FROM ANNALS OF INTERNAL MEDICINE
Large study amplifies evidence of COVID vaccine safety in pregnancy
The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.
Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.
This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.
He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
Methods and results
For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.
Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.
Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).
Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).
The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).
A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.
“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.
Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
Stillbirth findings will be ‘very reassuring’ for patients
The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.
Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”
A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.
In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”
The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.
This study was supported by the Public Health Agency of Canada.
Dr. Fell and Dr. Ecker reported no competing financial interests.
The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.
Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.
This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.
He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
Methods and results
For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.
Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.
Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).
Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).
The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).
A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.
“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.
Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
Stillbirth findings will be ‘very reassuring’ for patients
The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.
Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”
A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.
In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”
The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.
This study was supported by the Public Health Agency of Canada.
Dr. Fell and Dr. Ecker reported no competing financial interests.
The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.
Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.
This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.
He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
Methods and results
For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.
Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.
Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).
Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).
The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).
A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.
“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.
Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
Stillbirth findings will be ‘very reassuring’ for patients
The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.
Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”
A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.
In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”
The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.
This study was supported by the Public Health Agency of Canada.
Dr. Fell and Dr. Ecker reported no competing financial interests.
FROM BMJ
Trials data on COPD leave primary care docs in the dark
Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.
As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.
Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.
“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”
, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.
The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.
Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
A window onto patient burden
According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.
The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.
Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.
Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.
Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.
Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.
Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.
The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”
Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.
At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.
Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.
Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.
Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.
Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.
Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.
Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.
According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.
“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”
The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.
A version of this article first appeared on Medscape.com.
Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.
As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.
Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.
“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”
, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.
The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.
Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
A window onto patient burden
According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.
The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.
Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.
Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.
Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.
Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.
Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.
The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”
Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.
At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.
Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.
Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.
Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.
Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.
Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.
Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.
According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.
“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”
The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.
A version of this article first appeared on Medscape.com.
Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.
As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.
Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.
“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”
, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.
The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.
Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
A window onto patient burden
According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.
The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.
Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.
Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.
Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.
Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.
Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.
The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”
Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.
At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.
Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.
Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.
Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.
Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.
Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.
Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.
According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.
“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”
The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.
A version of this article first appeared on Medscape.com.
Moms’ cooing swapped with morphine for newborns in withdrawal
Four years ago, Atrium Health, in Charlotte, N.C., embarked on a dramatic change in how it cares for newborns exposed to opioids in the womb.
Until then, most of the 700 or so babies who underwent opioid withdrawal each year in the hospital system spent their first weeks in a neonatal intensive care unit (NICU), isolated from their parents and treated with regular doses of morphine to ease their symptoms.
Now, most babies stay in the hospital for just a few days under a new approach called Eat, Sleep, Console. These young patients stay in private rooms where they can bond with their parents and volunteer caregivers. The usual course of treatment is no longer extended therapy with opioid replacements. Instead, mothers are encouraged to stay overnight and are taught how to sooth their babies with swaddling, rocking, and cooing.
As a result, the average length of stay for newborns with neonatal abstinence syndrome (NAS) has dropped from 12 days to 6. Use of morphine has fallen by 79%, from 2.25 to 0.45 mg/kg per stay, according to results of a quality improvement pilot project at one of Atrium’s community hospitals.
Similar outcomes from other hospitals around the country have led to widespread uptake of Eat, Sleep, Console since its advent in 2017. That year, according to federal data, seven newborns were diagnosed with NAS for every 1,000 births.
Advocates say the family-centric model helps parents feel less stigmatized and more confident in their ability to care for their babies, who can have symptoms such as irritability and difficulty feeding for months.
The approach “really empowers families to do what they do best, which is take care of each other,” Douglas Dodds, MD, a pediatrician who led the effort at Atrium, told this news organization.
Questioning the old protocols
Numerous state perinatal collaboratives, hospital associations, and health systems say the program is the new standard of care for infants with NAS and neonatal opioid withdrawal syndrome (NOWS).
Twenty-six hospitals have adopted Eat, Sleep, Console as part of a clinical trial sponsored by the National Institutes of Health and a program called Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). Researchers are comparing the approach to previous care protocols in regard to 12 outcomes, including time to medical readiness for discharge, frequency of opioid replacement therapy, and safety problems, such as seizures during treatment.
The transition has been swift. Less than a decade ago, most hospitals used the Finnegan Neonatal Abstinence Scoring System, which was developed in the 1970s to assess babies whose mothers had used heroin during pregnancy.
The Finnegan score entails monitoring babies every 3 hours for 21 symptoms, including high-pitched crying, sneezing, gastrointestinal problems, and yawning. If a baby scores an 8 or more three times in a row, most protocols using the traditional Finnegan approach recommend that providers move infants to an NICU, where they receive morphine or methadone. Once opioid replacement therapy is started, the protocols require a gradual weaning that lasts 3-4 weeks.
As the opioid epidemic grew and NICUs around the country began to fill with babies experiencing NAS or NOW, some clinicians began to question the Finnegan-driven approach.
“You have these miserable babies who are going through this really tough experience, and our first move is to separate them from their moms,” said Matthew Grossman, MD, a pediatric hospitalist at Yale New Haven Children’s Hospital, New Haven, Conn., who created Eat, Sleep, Console.
Dr. Grossman, associate professor and vice chair for quality in the department of pediatrics at Yale University, said he noticed that when mothers stayed overnight with their babies, the infants tended to have fewer withdrawal symptoms. Indeed, previous studies had demonstrated the benefits of breastfeeding and allowing mothers and babies to share a room.
“If you think of mom as a medicine, then you can’t put the baby in a unit where the mom can’t be there,” Dr. Grossman told this news organization. “It would be like taking a kid with pneumonia and putting him in a unit that doesn’t have antibiotics.”
Despite its prominence, the Finnegan score has never been validated for guiding the treatment of NAS. In addition, Finnegan scores can be inconsistent, and the assessment requires disturbing an infant to check signs such as its startle reflex, which, as Dr. Grossman and his fellow researchers pointed out, flies in the face of American Academy of Pediatrics’ recommendations to prioritize swaddling and minimize stimulation for infants with NAS.
By contrast, Eat, Sleep, Console offers a simplified assessment. Interventions are called for if a baby eats less than an ounce of food at a time/does not breastfeed, sleeps less than an hour at a stretch, or takes more than 10 minutes to be consoled. After nonpharmacologic interventions have been tried, doses of medication are used as needed. Babies who are doing well can be discharged in as few as 4 days.
Quashing bias against parents with substance abuse disorder
Even with the promise of shorter stays and better care, switching to nonpharmacologic care presents hurdles for hospitals. Among these is a lack of physical space for mothers to room with their babies in a quiet environment.
“In many community hospitals, the only place for infants to go is a neonatal intensive care unit, outside of the newborn nursery,” said Stephen Patrick, MD, MPH, associate professor and director of the Center for Child Health Policy at Vanderbilt University, Nashville, Tenn., who researches stigma associated with opioid use during pregnancy.
Administrators at SSM St. Mary’s Hospital in St. Louis initially balked at providing private rooms for mothers and their babies with NAS and NOWS, according to Kimberly Spence, MD, a neonatologist at SSM Health. She said the initial plan was to put the babies in a busy, brightly lit nursery.
But resistance waned as the hospital convinced health plans to pay for private rooms for the 5-7 days it typically takes a baby to go through withdrawal, said Dr. Spence, associate professor of pediatrics at Saint Louis University.
“We were able to provide enough data that this is evidence-based medicine and babies do better with their moms, and that ethically, this is the right thing to do, to reduce transfers to an NICU,” she said.
In addition, news stories about the family-centric approach and shorter stays for infants, along with SSM’s launch of an outpatient clinic to treat pregnant women with opioid use disorder, helped the system to attract more patients and increase its market share, said Dr. Spence.
Another challenge was getting physicians and nurses to set aside any judgments of parents with substance abuse disorder, according to Dr. Grossman and others.
“A lot of faculty and staff on the medical team didn’t feel like we should trust moms with their babies’ medical care” at SSM, Dr. Spence said.
Some hospitals conduct anti-bias training to teach providers that substance abuse is a disease that deserves proper medical treatment and not the moral failing of a patient. Such education may involve explaining that babies’ outcomes are improved when women undergo treatment with methadone or buprenorphine during pregnancy, even though use of those medications does pose a risk of NAS.
Creating a system that supports parents with substance abuse disorders may help to change perceptions. At Atrium Health, some staff members now enjoy working with these families because they can make a profound impact, Dr. Dodds said. He said they’ve learned that families suffering from substance abuse disorder “are not that different than any other family.”
Dr. Dodds, Dr. Patrick, Dr. Spence, and Dr. Grossman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Four years ago, Atrium Health, in Charlotte, N.C., embarked on a dramatic change in how it cares for newborns exposed to opioids in the womb.
Until then, most of the 700 or so babies who underwent opioid withdrawal each year in the hospital system spent their first weeks in a neonatal intensive care unit (NICU), isolated from their parents and treated with regular doses of morphine to ease their symptoms.
Now, most babies stay in the hospital for just a few days under a new approach called Eat, Sleep, Console. These young patients stay in private rooms where they can bond with their parents and volunteer caregivers. The usual course of treatment is no longer extended therapy with opioid replacements. Instead, mothers are encouraged to stay overnight and are taught how to sooth their babies with swaddling, rocking, and cooing.
As a result, the average length of stay for newborns with neonatal abstinence syndrome (NAS) has dropped from 12 days to 6. Use of morphine has fallen by 79%, from 2.25 to 0.45 mg/kg per stay, according to results of a quality improvement pilot project at one of Atrium’s community hospitals.
Similar outcomes from other hospitals around the country have led to widespread uptake of Eat, Sleep, Console since its advent in 2017. That year, according to federal data, seven newborns were diagnosed with NAS for every 1,000 births.
Advocates say the family-centric model helps parents feel less stigmatized and more confident in their ability to care for their babies, who can have symptoms such as irritability and difficulty feeding for months.
The approach “really empowers families to do what they do best, which is take care of each other,” Douglas Dodds, MD, a pediatrician who led the effort at Atrium, told this news organization.
Questioning the old protocols
Numerous state perinatal collaboratives, hospital associations, and health systems say the program is the new standard of care for infants with NAS and neonatal opioid withdrawal syndrome (NOWS).
Twenty-six hospitals have adopted Eat, Sleep, Console as part of a clinical trial sponsored by the National Institutes of Health and a program called Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). Researchers are comparing the approach to previous care protocols in regard to 12 outcomes, including time to medical readiness for discharge, frequency of opioid replacement therapy, and safety problems, such as seizures during treatment.
The transition has been swift. Less than a decade ago, most hospitals used the Finnegan Neonatal Abstinence Scoring System, which was developed in the 1970s to assess babies whose mothers had used heroin during pregnancy.
The Finnegan score entails monitoring babies every 3 hours for 21 symptoms, including high-pitched crying, sneezing, gastrointestinal problems, and yawning. If a baby scores an 8 or more three times in a row, most protocols using the traditional Finnegan approach recommend that providers move infants to an NICU, where they receive morphine or methadone. Once opioid replacement therapy is started, the protocols require a gradual weaning that lasts 3-4 weeks.
As the opioid epidemic grew and NICUs around the country began to fill with babies experiencing NAS or NOW, some clinicians began to question the Finnegan-driven approach.
“You have these miserable babies who are going through this really tough experience, and our first move is to separate them from their moms,” said Matthew Grossman, MD, a pediatric hospitalist at Yale New Haven Children’s Hospital, New Haven, Conn., who created Eat, Sleep, Console.
Dr. Grossman, associate professor and vice chair for quality in the department of pediatrics at Yale University, said he noticed that when mothers stayed overnight with their babies, the infants tended to have fewer withdrawal symptoms. Indeed, previous studies had demonstrated the benefits of breastfeeding and allowing mothers and babies to share a room.
“If you think of mom as a medicine, then you can’t put the baby in a unit where the mom can’t be there,” Dr. Grossman told this news organization. “It would be like taking a kid with pneumonia and putting him in a unit that doesn’t have antibiotics.”
Despite its prominence, the Finnegan score has never been validated for guiding the treatment of NAS. In addition, Finnegan scores can be inconsistent, and the assessment requires disturbing an infant to check signs such as its startle reflex, which, as Dr. Grossman and his fellow researchers pointed out, flies in the face of American Academy of Pediatrics’ recommendations to prioritize swaddling and minimize stimulation for infants with NAS.
By contrast, Eat, Sleep, Console offers a simplified assessment. Interventions are called for if a baby eats less than an ounce of food at a time/does not breastfeed, sleeps less than an hour at a stretch, or takes more than 10 minutes to be consoled. After nonpharmacologic interventions have been tried, doses of medication are used as needed. Babies who are doing well can be discharged in as few as 4 days.
Quashing bias against parents with substance abuse disorder
Even with the promise of shorter stays and better care, switching to nonpharmacologic care presents hurdles for hospitals. Among these is a lack of physical space for mothers to room with their babies in a quiet environment.
“In many community hospitals, the only place for infants to go is a neonatal intensive care unit, outside of the newborn nursery,” said Stephen Patrick, MD, MPH, associate professor and director of the Center for Child Health Policy at Vanderbilt University, Nashville, Tenn., who researches stigma associated with opioid use during pregnancy.
Administrators at SSM St. Mary’s Hospital in St. Louis initially balked at providing private rooms for mothers and their babies with NAS and NOWS, according to Kimberly Spence, MD, a neonatologist at SSM Health. She said the initial plan was to put the babies in a busy, brightly lit nursery.
But resistance waned as the hospital convinced health plans to pay for private rooms for the 5-7 days it typically takes a baby to go through withdrawal, said Dr. Spence, associate professor of pediatrics at Saint Louis University.
“We were able to provide enough data that this is evidence-based medicine and babies do better with their moms, and that ethically, this is the right thing to do, to reduce transfers to an NICU,” she said.
In addition, news stories about the family-centric approach and shorter stays for infants, along with SSM’s launch of an outpatient clinic to treat pregnant women with opioid use disorder, helped the system to attract more patients and increase its market share, said Dr. Spence.
Another challenge was getting physicians and nurses to set aside any judgments of parents with substance abuse disorder, according to Dr. Grossman and others.
“A lot of faculty and staff on the medical team didn’t feel like we should trust moms with their babies’ medical care” at SSM, Dr. Spence said.
Some hospitals conduct anti-bias training to teach providers that substance abuse is a disease that deserves proper medical treatment and not the moral failing of a patient. Such education may involve explaining that babies’ outcomes are improved when women undergo treatment with methadone or buprenorphine during pregnancy, even though use of those medications does pose a risk of NAS.
Creating a system that supports parents with substance abuse disorders may help to change perceptions. At Atrium Health, some staff members now enjoy working with these families because they can make a profound impact, Dr. Dodds said. He said they’ve learned that families suffering from substance abuse disorder “are not that different than any other family.”
Dr. Dodds, Dr. Patrick, Dr. Spence, and Dr. Grossman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Four years ago, Atrium Health, in Charlotte, N.C., embarked on a dramatic change in how it cares for newborns exposed to opioids in the womb.
Until then, most of the 700 or so babies who underwent opioid withdrawal each year in the hospital system spent their first weeks in a neonatal intensive care unit (NICU), isolated from their parents and treated with regular doses of morphine to ease their symptoms.
Now, most babies stay in the hospital for just a few days under a new approach called Eat, Sleep, Console. These young patients stay in private rooms where they can bond with their parents and volunteer caregivers. The usual course of treatment is no longer extended therapy with opioid replacements. Instead, mothers are encouraged to stay overnight and are taught how to sooth their babies with swaddling, rocking, and cooing.
As a result, the average length of stay for newborns with neonatal abstinence syndrome (NAS) has dropped from 12 days to 6. Use of morphine has fallen by 79%, from 2.25 to 0.45 mg/kg per stay, according to results of a quality improvement pilot project at one of Atrium’s community hospitals.
Similar outcomes from other hospitals around the country have led to widespread uptake of Eat, Sleep, Console since its advent in 2017. That year, according to federal data, seven newborns were diagnosed with NAS for every 1,000 births.
Advocates say the family-centric model helps parents feel less stigmatized and more confident in their ability to care for their babies, who can have symptoms such as irritability and difficulty feeding for months.
The approach “really empowers families to do what they do best, which is take care of each other,” Douglas Dodds, MD, a pediatrician who led the effort at Atrium, told this news organization.
Questioning the old protocols
Numerous state perinatal collaboratives, hospital associations, and health systems say the program is the new standard of care for infants with NAS and neonatal opioid withdrawal syndrome (NOWS).
Twenty-six hospitals have adopted Eat, Sleep, Console as part of a clinical trial sponsored by the National Institutes of Health and a program called Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). Researchers are comparing the approach to previous care protocols in regard to 12 outcomes, including time to medical readiness for discharge, frequency of opioid replacement therapy, and safety problems, such as seizures during treatment.
The transition has been swift. Less than a decade ago, most hospitals used the Finnegan Neonatal Abstinence Scoring System, which was developed in the 1970s to assess babies whose mothers had used heroin during pregnancy.
The Finnegan score entails monitoring babies every 3 hours for 21 symptoms, including high-pitched crying, sneezing, gastrointestinal problems, and yawning. If a baby scores an 8 or more three times in a row, most protocols using the traditional Finnegan approach recommend that providers move infants to an NICU, where they receive morphine or methadone. Once opioid replacement therapy is started, the protocols require a gradual weaning that lasts 3-4 weeks.
As the opioid epidemic grew and NICUs around the country began to fill with babies experiencing NAS or NOW, some clinicians began to question the Finnegan-driven approach.
“You have these miserable babies who are going through this really tough experience, and our first move is to separate them from their moms,” said Matthew Grossman, MD, a pediatric hospitalist at Yale New Haven Children’s Hospital, New Haven, Conn., who created Eat, Sleep, Console.
Dr. Grossman, associate professor and vice chair for quality in the department of pediatrics at Yale University, said he noticed that when mothers stayed overnight with their babies, the infants tended to have fewer withdrawal symptoms. Indeed, previous studies had demonstrated the benefits of breastfeeding and allowing mothers and babies to share a room.
“If you think of mom as a medicine, then you can’t put the baby in a unit where the mom can’t be there,” Dr. Grossman told this news organization. “It would be like taking a kid with pneumonia and putting him in a unit that doesn’t have antibiotics.”
Despite its prominence, the Finnegan score has never been validated for guiding the treatment of NAS. In addition, Finnegan scores can be inconsistent, and the assessment requires disturbing an infant to check signs such as its startle reflex, which, as Dr. Grossman and his fellow researchers pointed out, flies in the face of American Academy of Pediatrics’ recommendations to prioritize swaddling and minimize stimulation for infants with NAS.
By contrast, Eat, Sleep, Console offers a simplified assessment. Interventions are called for if a baby eats less than an ounce of food at a time/does not breastfeed, sleeps less than an hour at a stretch, or takes more than 10 minutes to be consoled. After nonpharmacologic interventions have been tried, doses of medication are used as needed. Babies who are doing well can be discharged in as few as 4 days.
Quashing bias against parents with substance abuse disorder
Even with the promise of shorter stays and better care, switching to nonpharmacologic care presents hurdles for hospitals. Among these is a lack of physical space for mothers to room with their babies in a quiet environment.
“In many community hospitals, the only place for infants to go is a neonatal intensive care unit, outside of the newborn nursery,” said Stephen Patrick, MD, MPH, associate professor and director of the Center for Child Health Policy at Vanderbilt University, Nashville, Tenn., who researches stigma associated with opioid use during pregnancy.
Administrators at SSM St. Mary’s Hospital in St. Louis initially balked at providing private rooms for mothers and their babies with NAS and NOWS, according to Kimberly Spence, MD, a neonatologist at SSM Health. She said the initial plan was to put the babies in a busy, brightly lit nursery.
But resistance waned as the hospital convinced health plans to pay for private rooms for the 5-7 days it typically takes a baby to go through withdrawal, said Dr. Spence, associate professor of pediatrics at Saint Louis University.
“We were able to provide enough data that this is evidence-based medicine and babies do better with their moms, and that ethically, this is the right thing to do, to reduce transfers to an NICU,” she said.
In addition, news stories about the family-centric approach and shorter stays for infants, along with SSM’s launch of an outpatient clinic to treat pregnant women with opioid use disorder, helped the system to attract more patients and increase its market share, said Dr. Spence.
Another challenge was getting physicians and nurses to set aside any judgments of parents with substance abuse disorder, according to Dr. Grossman and others.
“A lot of faculty and staff on the medical team didn’t feel like we should trust moms with their babies’ medical care” at SSM, Dr. Spence said.
Some hospitals conduct anti-bias training to teach providers that substance abuse is a disease that deserves proper medical treatment and not the moral failing of a patient. Such education may involve explaining that babies’ outcomes are improved when women undergo treatment with methadone or buprenorphine during pregnancy, even though use of those medications does pose a risk of NAS.
Creating a system that supports parents with substance abuse disorders may help to change perceptions. At Atrium Health, some staff members now enjoy working with these families because they can make a profound impact, Dr. Dodds said. He said they’ve learned that families suffering from substance abuse disorder “are not that different than any other family.”
Dr. Dodds, Dr. Patrick, Dr. Spence, and Dr. Grossman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Care gaps common after anal sphincter injuries from childbirth
Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.
In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.
“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”
The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.
Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.
For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.
Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.
Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.
However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.
Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.
The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.
Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
Not asked, not told
Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.
“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.
Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.
Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.
Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.
Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.
In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.
“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”
The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.
Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.
For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.
Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.
Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.
However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.
Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.
The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.
Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
Not asked, not told
Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.
“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.
Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.
Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.
Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.
Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.
In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.
“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”
The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.
Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.
For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.
Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.
Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.
However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.
Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.
The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.
Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
Not asked, not told
Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.
“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.
Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.
Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.
Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.
Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AUGS 2022
Surgeons may underestimate recovery from incontinence operation
Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.
The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.
“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.
Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.
The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”
Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”
Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.
For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.
Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.
As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.
The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.
Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
Essential information for patient planning
Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.
Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.
She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”
Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.
“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.
The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.
Dr. Wang and Dr. Boyd reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.
The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.
“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.
Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.
The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”
Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”
Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.
For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.
Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.
As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.
The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.
Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
Essential information for patient planning
Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.
Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.
She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”
Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.
“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.
The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.
Dr. Wang and Dr. Boyd reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.
The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.
“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.
Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.
The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”
Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”
Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.
For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.
Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.
As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.
The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.
Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
Essential information for patient planning
Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.
Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.
She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”
Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.
“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.
The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.
Dr. Wang and Dr. Boyd reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AUGS 2022
Up in smoke: Cannabis-related ED visits increased 18-fold for older Californians
Researchers in California found an 18-fold increase in the rate of cannabis-related trips to the ED visits among adults over age 65 in the state from 2005 to 2019.
Addressing potential harms of cannabis use among older adults, who face heightened risk for adverse reactions to the substance, “is urgently required,” the researchers reported at the annual meeting of the American Geriatrics Society.
The researchers advised doctors to discuss cannabis use with older patients and screen older adults for cannabis use. Those living with multiple chronic conditions and taking multiple medications are especially likely to be at risk for harm, coinvestigator Benjamin Han, MD, MPH, a geriatrician at the University of California, San Diego, said in an interview.
Dr. Han added that “very little” is understood about the risks and benefits of cannabis use in the elderly, and more studies are needed “so that clinicians can have data-informed discussions with their patients.”
California legalized medical marijuana in 1996 and recreational marijuana in 2016.
The researchers used diagnostic code data from California’s nonmilitary acute care hospitals, collected by the state’s Department of Healthcare Access and Information, to calculate annual rates of cannabis-related visits per 10,000 ED visits.
ED trips up sharply among older adults
Rates of cannabis-related visits increased significantly for all older adult age ranges (P < .001), according to the researchers. Among those aged 65-74 years, the rate increased about 15-fold, from 44.9 per 10,000 visits in 2005 to 714.5 per 100,000 in 2019; for ages 75-84, the rate increased about 22-fold, from 8.4 to 193.9 per 10,000; and for those 85 and older the rate jumped nearly 18-fold, from 2.1 to 39.2 per 10,000.
The greatest increase occurred in visits categorized in diagnostic codes as cannabis abuse and unspecified use. Cannabis dependence and cannabis poisoning accounted for only a small fraction of cases, the investigators found.
The researchers did not have data on specific reasons for a visit, or whether patients had smoked or ingested marijuana products. They also could not discern whether patients had used delta-9-tetrahydrocannabinol, which has psychoactive properties, or cannabidiol, which typically does not have the same mind-altering effects.
Dr. Han said the data may not present a full picture of marijuana-related ED visits. “It is important to recognize that older adults have lived through the very putative language around drug use – including cannabis – as part of the racist war on drugs,” which could lead them to omit having used drugs during the intake process.
A 2017 study linked cannabis use among older adults with more injuries, which in turn led to greater emergency department use. Brian Kaskie, PhD, associate professor in health management and policy at the University of Iowa, Iowa City, said in an interview that the new findings show a state-specific, but alarming trend, and that more research is needed.
“Were these first-time users who were not familiar with anxiety-inducing aspects of cannabis use and took high potency products? Did they complete any education about how to use cannabis?” said Dr. Kaskie, who was not involved in the new study. “Were the ER visits for relatively benign, nonemergent reasons or were these ... visits an outcome of a tragic, harmful event like a car accident or overdose?”
Dr. Han and Dr. Kaskie disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers in California found an 18-fold increase in the rate of cannabis-related trips to the ED visits among adults over age 65 in the state from 2005 to 2019.
Addressing potential harms of cannabis use among older adults, who face heightened risk for adverse reactions to the substance, “is urgently required,” the researchers reported at the annual meeting of the American Geriatrics Society.
The researchers advised doctors to discuss cannabis use with older patients and screen older adults for cannabis use. Those living with multiple chronic conditions and taking multiple medications are especially likely to be at risk for harm, coinvestigator Benjamin Han, MD, MPH, a geriatrician at the University of California, San Diego, said in an interview.
Dr. Han added that “very little” is understood about the risks and benefits of cannabis use in the elderly, and more studies are needed “so that clinicians can have data-informed discussions with their patients.”
California legalized medical marijuana in 1996 and recreational marijuana in 2016.
The researchers used diagnostic code data from California’s nonmilitary acute care hospitals, collected by the state’s Department of Healthcare Access and Information, to calculate annual rates of cannabis-related visits per 10,000 ED visits.
ED trips up sharply among older adults
Rates of cannabis-related visits increased significantly for all older adult age ranges (P < .001), according to the researchers. Among those aged 65-74 years, the rate increased about 15-fold, from 44.9 per 10,000 visits in 2005 to 714.5 per 100,000 in 2019; for ages 75-84, the rate increased about 22-fold, from 8.4 to 193.9 per 10,000; and for those 85 and older the rate jumped nearly 18-fold, from 2.1 to 39.2 per 10,000.
The greatest increase occurred in visits categorized in diagnostic codes as cannabis abuse and unspecified use. Cannabis dependence and cannabis poisoning accounted for only a small fraction of cases, the investigators found.
The researchers did not have data on specific reasons for a visit, or whether patients had smoked or ingested marijuana products. They also could not discern whether patients had used delta-9-tetrahydrocannabinol, which has psychoactive properties, or cannabidiol, which typically does not have the same mind-altering effects.
Dr. Han said the data may not present a full picture of marijuana-related ED visits. “It is important to recognize that older adults have lived through the very putative language around drug use – including cannabis – as part of the racist war on drugs,” which could lead them to omit having used drugs during the intake process.
A 2017 study linked cannabis use among older adults with more injuries, which in turn led to greater emergency department use. Brian Kaskie, PhD, associate professor in health management and policy at the University of Iowa, Iowa City, said in an interview that the new findings show a state-specific, but alarming trend, and that more research is needed.
“Were these first-time users who were not familiar with anxiety-inducing aspects of cannabis use and took high potency products? Did they complete any education about how to use cannabis?” said Dr. Kaskie, who was not involved in the new study. “Were the ER visits for relatively benign, nonemergent reasons or were these ... visits an outcome of a tragic, harmful event like a car accident or overdose?”
Dr. Han and Dr. Kaskie disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers in California found an 18-fold increase in the rate of cannabis-related trips to the ED visits among adults over age 65 in the state from 2005 to 2019.
Addressing potential harms of cannabis use among older adults, who face heightened risk for adverse reactions to the substance, “is urgently required,” the researchers reported at the annual meeting of the American Geriatrics Society.
The researchers advised doctors to discuss cannabis use with older patients and screen older adults for cannabis use. Those living with multiple chronic conditions and taking multiple medications are especially likely to be at risk for harm, coinvestigator Benjamin Han, MD, MPH, a geriatrician at the University of California, San Diego, said in an interview.
Dr. Han added that “very little” is understood about the risks and benefits of cannabis use in the elderly, and more studies are needed “so that clinicians can have data-informed discussions with their patients.”
California legalized medical marijuana in 1996 and recreational marijuana in 2016.
The researchers used diagnostic code data from California’s nonmilitary acute care hospitals, collected by the state’s Department of Healthcare Access and Information, to calculate annual rates of cannabis-related visits per 10,000 ED visits.
ED trips up sharply among older adults
Rates of cannabis-related visits increased significantly for all older adult age ranges (P < .001), according to the researchers. Among those aged 65-74 years, the rate increased about 15-fold, from 44.9 per 10,000 visits in 2005 to 714.5 per 100,000 in 2019; for ages 75-84, the rate increased about 22-fold, from 8.4 to 193.9 per 10,000; and for those 85 and older the rate jumped nearly 18-fold, from 2.1 to 39.2 per 10,000.
The greatest increase occurred in visits categorized in diagnostic codes as cannabis abuse and unspecified use. Cannabis dependence and cannabis poisoning accounted for only a small fraction of cases, the investigators found.
The researchers did not have data on specific reasons for a visit, or whether patients had smoked or ingested marijuana products. They also could not discern whether patients had used delta-9-tetrahydrocannabinol, which has psychoactive properties, or cannabidiol, which typically does not have the same mind-altering effects.
Dr. Han said the data may not present a full picture of marijuana-related ED visits. “It is important to recognize that older adults have lived through the very putative language around drug use – including cannabis – as part of the racist war on drugs,” which could lead them to omit having used drugs during the intake process.
A 2017 study linked cannabis use among older adults with more injuries, which in turn led to greater emergency department use. Brian Kaskie, PhD, associate professor in health management and policy at the University of Iowa, Iowa City, said in an interview that the new findings show a state-specific, but alarming trend, and that more research is needed.
“Were these first-time users who were not familiar with anxiety-inducing aspects of cannabis use and took high potency products? Did they complete any education about how to use cannabis?” said Dr. Kaskie, who was not involved in the new study. “Were the ER visits for relatively benign, nonemergent reasons or were these ... visits an outcome of a tragic, harmful event like a car accident or overdose?”
Dr. Han and Dr. Kaskie disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AGS 2022
Tool helps health system cut risky scripts for older adults
In the largest implementation yet of the tool, designed by the U.S. Department of Veterans Affairs to decrease the use of potentially inappropriate medications (PIMs), Lifespan, a nonprofit system whose partners include Brown University, Providence, R.I., reported a significant drop in the number of such prescriptions to older adults on discharge from the emergency department (ED).
The number of PIMs among monthly prescriptions fell by roughly 26% at Lifespan’s three adult acute care EDs after the system adopted EQUiPPED – Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department. The VA deployed a version of the tool in 2013 to address the lack of training most emergency clinicians receive in the management of geriatric medications.
The model “should be implemented in other states and, with greater replication, could shape national policy regarding quality of care for older adults,” according to the researchers, who reported the results May 12 at the American Geriatrics Society (AGS) 2022 Annual Scientific Meeting, Orlando.
Older adults are three times as likely as younger patients to wind up in an ED because of medication-related harms. This is in part due to the greater number of prescriptions U.S. adults older than 65 years take daily.
A key quality measure
Although the Centers for Medicare & Medicaid Services and other groups have deemed minimizing PIMs an important quality measure, most EDs lack an expert in geriatric prescribing, Elizabeth Goldberg, MD, an associate professor of emergency medicine at Brown University, told this news organization.
With EQUiPPED, clinicians receive access to geriatric medication order sets embedded in electronic health records, individualized benchmark reports, and education about medication safety in older adults. PIMs are defined by the American Geriatrics Society Beers Criteria and include drugs such as proton-pump inhibitors and antipsychotics.
Lifespan’s program involved 362 clinicians who treat about 230,000 patients annually – 40,000 of them aged 65 and older. Dr. Goldberg said implementing the program in such a large population could “really move the needle for older adults” by reducing falls, improving cognitive function, and preventing harm from the use of medication.
She and fellow researchers examined ED prescribing 13 months before and 16 months after they had implemented EQUiPPED, in August and September of 2019. Of clinicians who participated, 48% were attending physicians, 37% were residents, and 34% were advanced practice providers.
PIM prescribing dropped from 8.93% prior to implementation (95% confidence interval: 8.5%-9.36%) to 6.59% after (95% CI: 6.2%-6.98%; P < .001). Before implementation, 1,495 of 16,681 prescribed medications were considered inappropriate, compared with 1,044 of 15,818 medications after, according to the researchers. The biggest declines in prescribing involved antihistamines, muscle relaxants, and benzodiazepines.
Despite the improvements, the system did not meet a goal of reducing PIMs to less than 5%. Dr. Goldberg said educating the large number of clinicians, some of whom rotated in and out of the ED, proved particularly challenging. The COVID-19 pandemic also potentially diverted attention from the quality improvement project, she said.
In addition to its size, the project was notable because it was supported by Blue Cross & Blue Shield of Rhode Island. Dr. Goldberg said obtaining private funding proved to be a quicker and less competitive process than obtaining a government grant. Other institutions interested in running similar studies may need to find insurers that are in the Medicare Advantage market or that have a significant number of younger enrollees with chronic conditions, such as kidney disease, who may benefit from more careful prescribing practices, she said.
The new study builds on previous research, such as a 2017 study that showed that EQUiPPED reduced PIM prescribing at four VA hospitals. Findings from a more recent rollout at three academic health systems suggested that the model might also be effective in targeting the overuse of specific drugs in facilities in which PIM prescribing is already low.
A researcher in those earlier studies, Susan Nicole Hastings, MD, a geriatric medicine specialist at Duke University, Durham, N.C., and the Durham VA Health Care System, told this news organization that Lifespan’s experience supports the idea that “with the right attention to balancing fidelity and tailoring for the new setting, there is tremendous potential for moving successful programs from the VA to other health systems.”
Ann E. Vandenberg, PhD, MPH, a gerontologist at Emory University, Atlanta, said the fragmented nature of the American health care system makes it difficult to disseminate EQUiPPED widely, but interoperability applications that pull data from different electronic health records could help hospital systems to adopt the program without undergoing site-specific customization.
Dr. Hastings and Dr. Vandenberg have received research funding to study EQUiPPED from the Agency for Healthcare Research and Quality. Dr. Hastings also received research funding from the VA.
A version of this article first appeared on Medscape.com.
In the largest implementation yet of the tool, designed by the U.S. Department of Veterans Affairs to decrease the use of potentially inappropriate medications (PIMs), Lifespan, a nonprofit system whose partners include Brown University, Providence, R.I., reported a significant drop in the number of such prescriptions to older adults on discharge from the emergency department (ED).
The number of PIMs among monthly prescriptions fell by roughly 26% at Lifespan’s three adult acute care EDs after the system adopted EQUiPPED – Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department. The VA deployed a version of the tool in 2013 to address the lack of training most emergency clinicians receive in the management of geriatric medications.
The model “should be implemented in other states and, with greater replication, could shape national policy regarding quality of care for older adults,” according to the researchers, who reported the results May 12 at the American Geriatrics Society (AGS) 2022 Annual Scientific Meeting, Orlando.
Older adults are three times as likely as younger patients to wind up in an ED because of medication-related harms. This is in part due to the greater number of prescriptions U.S. adults older than 65 years take daily.
A key quality measure
Although the Centers for Medicare & Medicaid Services and other groups have deemed minimizing PIMs an important quality measure, most EDs lack an expert in geriatric prescribing, Elizabeth Goldberg, MD, an associate professor of emergency medicine at Brown University, told this news organization.
With EQUiPPED, clinicians receive access to geriatric medication order sets embedded in electronic health records, individualized benchmark reports, and education about medication safety in older adults. PIMs are defined by the American Geriatrics Society Beers Criteria and include drugs such as proton-pump inhibitors and antipsychotics.
Lifespan’s program involved 362 clinicians who treat about 230,000 patients annually – 40,000 of them aged 65 and older. Dr. Goldberg said implementing the program in such a large population could “really move the needle for older adults” by reducing falls, improving cognitive function, and preventing harm from the use of medication.
She and fellow researchers examined ED prescribing 13 months before and 16 months after they had implemented EQUiPPED, in August and September of 2019. Of clinicians who participated, 48% were attending physicians, 37% were residents, and 34% were advanced practice providers.
PIM prescribing dropped from 8.93% prior to implementation (95% confidence interval: 8.5%-9.36%) to 6.59% after (95% CI: 6.2%-6.98%; P < .001). Before implementation, 1,495 of 16,681 prescribed medications were considered inappropriate, compared with 1,044 of 15,818 medications after, according to the researchers. The biggest declines in prescribing involved antihistamines, muscle relaxants, and benzodiazepines.
Despite the improvements, the system did not meet a goal of reducing PIMs to less than 5%. Dr. Goldberg said educating the large number of clinicians, some of whom rotated in and out of the ED, proved particularly challenging. The COVID-19 pandemic also potentially diverted attention from the quality improvement project, she said.
In addition to its size, the project was notable because it was supported by Blue Cross & Blue Shield of Rhode Island. Dr. Goldberg said obtaining private funding proved to be a quicker and less competitive process than obtaining a government grant. Other institutions interested in running similar studies may need to find insurers that are in the Medicare Advantage market or that have a significant number of younger enrollees with chronic conditions, such as kidney disease, who may benefit from more careful prescribing practices, she said.
The new study builds on previous research, such as a 2017 study that showed that EQUiPPED reduced PIM prescribing at four VA hospitals. Findings from a more recent rollout at three academic health systems suggested that the model might also be effective in targeting the overuse of specific drugs in facilities in which PIM prescribing is already low.
A researcher in those earlier studies, Susan Nicole Hastings, MD, a geriatric medicine specialist at Duke University, Durham, N.C., and the Durham VA Health Care System, told this news organization that Lifespan’s experience supports the idea that “with the right attention to balancing fidelity and tailoring for the new setting, there is tremendous potential for moving successful programs from the VA to other health systems.”
Ann E. Vandenberg, PhD, MPH, a gerontologist at Emory University, Atlanta, said the fragmented nature of the American health care system makes it difficult to disseminate EQUiPPED widely, but interoperability applications that pull data from different electronic health records could help hospital systems to adopt the program without undergoing site-specific customization.
Dr. Hastings and Dr. Vandenberg have received research funding to study EQUiPPED from the Agency for Healthcare Research and Quality. Dr. Hastings also received research funding from the VA.
A version of this article first appeared on Medscape.com.
In the largest implementation yet of the tool, designed by the U.S. Department of Veterans Affairs to decrease the use of potentially inappropriate medications (PIMs), Lifespan, a nonprofit system whose partners include Brown University, Providence, R.I., reported a significant drop in the number of such prescriptions to older adults on discharge from the emergency department (ED).
The number of PIMs among monthly prescriptions fell by roughly 26% at Lifespan’s three adult acute care EDs after the system adopted EQUiPPED – Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department. The VA deployed a version of the tool in 2013 to address the lack of training most emergency clinicians receive in the management of geriatric medications.
The model “should be implemented in other states and, with greater replication, could shape national policy regarding quality of care for older adults,” according to the researchers, who reported the results May 12 at the American Geriatrics Society (AGS) 2022 Annual Scientific Meeting, Orlando.
Older adults are three times as likely as younger patients to wind up in an ED because of medication-related harms. This is in part due to the greater number of prescriptions U.S. adults older than 65 years take daily.
A key quality measure
Although the Centers for Medicare & Medicaid Services and other groups have deemed minimizing PIMs an important quality measure, most EDs lack an expert in geriatric prescribing, Elizabeth Goldberg, MD, an associate professor of emergency medicine at Brown University, told this news organization.
With EQUiPPED, clinicians receive access to geriatric medication order sets embedded in electronic health records, individualized benchmark reports, and education about medication safety in older adults. PIMs are defined by the American Geriatrics Society Beers Criteria and include drugs such as proton-pump inhibitors and antipsychotics.
Lifespan’s program involved 362 clinicians who treat about 230,000 patients annually – 40,000 of them aged 65 and older. Dr. Goldberg said implementing the program in such a large population could “really move the needle for older adults” by reducing falls, improving cognitive function, and preventing harm from the use of medication.
She and fellow researchers examined ED prescribing 13 months before and 16 months after they had implemented EQUiPPED, in August and September of 2019. Of clinicians who participated, 48% were attending physicians, 37% were residents, and 34% were advanced practice providers.
PIM prescribing dropped from 8.93% prior to implementation (95% confidence interval: 8.5%-9.36%) to 6.59% after (95% CI: 6.2%-6.98%; P < .001). Before implementation, 1,495 of 16,681 prescribed medications were considered inappropriate, compared with 1,044 of 15,818 medications after, according to the researchers. The biggest declines in prescribing involved antihistamines, muscle relaxants, and benzodiazepines.
Despite the improvements, the system did not meet a goal of reducing PIMs to less than 5%. Dr. Goldberg said educating the large number of clinicians, some of whom rotated in and out of the ED, proved particularly challenging. The COVID-19 pandemic also potentially diverted attention from the quality improvement project, she said.
In addition to its size, the project was notable because it was supported by Blue Cross & Blue Shield of Rhode Island. Dr. Goldberg said obtaining private funding proved to be a quicker and less competitive process than obtaining a government grant. Other institutions interested in running similar studies may need to find insurers that are in the Medicare Advantage market or that have a significant number of younger enrollees with chronic conditions, such as kidney disease, who may benefit from more careful prescribing practices, she said.
The new study builds on previous research, such as a 2017 study that showed that EQUiPPED reduced PIM prescribing at four VA hospitals. Findings from a more recent rollout at three academic health systems suggested that the model might also be effective in targeting the overuse of specific drugs in facilities in which PIM prescribing is already low.
A researcher in those earlier studies, Susan Nicole Hastings, MD, a geriatric medicine specialist at Duke University, Durham, N.C., and the Durham VA Health Care System, told this news organization that Lifespan’s experience supports the idea that “with the right attention to balancing fidelity and tailoring for the new setting, there is tremendous potential for moving successful programs from the VA to other health systems.”
Ann E. Vandenberg, PhD, MPH, a gerontologist at Emory University, Atlanta, said the fragmented nature of the American health care system makes it difficult to disseminate EQUiPPED widely, but interoperability applications that pull data from different electronic health records could help hospital systems to adopt the program without undergoing site-specific customization.
Dr. Hastings and Dr. Vandenberg have received research funding to study EQUiPPED from the Agency for Healthcare Research and Quality. Dr. Hastings also received research funding from the VA.
A version of this article first appeared on Medscape.com.
FROM AGS 2022
Colorado law would lift veil of secrecy on sperm donations
Legislation nearing passage in Colorado would lift a veil of secrecy around sperm donation and grant other protections to people conceived with donated gametes.
The bipartisan bill, which was passed by the state’s house of representatives May 10 after previous approval by the senate, would enable offspring to learn the identity of a sperm or egg donor when they turn 18 and receive a donor’s medical information prior to that. Fertility clinics would be required to update donors’ contact information and medical records every 3 years.
In addition, clinics would have to make “good-faith efforts” to track births to ensure that no more than 25 families conceive babies from a single donor’s sperm. Egg donors could donate up to six times, based on medical risk.
The bill would establish a minimum donor age of 21 years and require dissemination of educational materials to donors and prospective parents about the psychological needs of donor-conceived children.
The provisions would take effect with donations collected on or after Jan. 1, 2025. Violators would be subject to fines of up to $20,000 per day.
Advocates point out that in addition to the benefits of knowing one’s genetic identity, the anonymity of sperm donors has been scuttled by the availability of commercial genetic testing. (Egg donation has tended to be more open.)
Some sperm banks already have adopted systems in which adult offspring can learn the identity of donors if both parties agree. However, a survey by the United States Donor Conceived Council, an advocacy group, found “significant problems” with some of those policies, such as requirements that donor-conceived offspring sign nondisclosure agreements or sperm banks refusing to release information if a donor-conceived person’s parents never registered the child’s birth with the bank.
Some measures in the bill reflect the guidelines of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, although not all companies follow them, according to the council’s survey. For example, no sperm bank adheres to a recommendation that donors be at least 21 years old.
“The industry is shifting very fast, but there are definitely banks that I think need an extra push to protect the rights of the people that they’re producing,” Tiffany Gardner, a spokesperson for the council, told this news organization.
At a senate hearing, fertility care providers voiced concerns that the legislation would impose undue burdens on the industry and discourage men from donating sperm. In response, sponsors made several amendments, including capping a licensing fee for clinics and banks at $500 and increasing the family limit for each donor, which was originally set at 10.
Still, some in the industry said the bill, introduced April 22, was too rushed to receive adequate scrutiny. While everyone agreed that limiting the number of a person’s half siblings is a good thing, for example, the best way to go about it is unclear, they said.
“There wasn’t enough time to really get experts together to provide more formal, thoughtful, evidence-based feedback on what should be on this bill,” said Cassandra Roeca, MD, of Shady Grove Fertility, which has clinics in Denver and Colorado Springs. Dr. Roeca testified on behalf of Colorado Fertility Advocates, a nonprofit that promotes access to fertility care.
Gov. Jared Polis (D) is expected to sign the bill, an aide to one of the co-sponsors, Rep. Kerry Tipper (D-Lakewood), said in an interview.
Colorado is not the only state considering transparency for donor-conceived offspring. A New York bill would require fertility clinics to verify the medical, educational, and criminal histories of donors and allow donor-conceived people access to the information.
The New York measure is championed by the family of Steven Gunner, a 27-year-old man who died in May 2020 of an opioid overdose. The Wall Street Journal reported that Mr. Gunner’s family had been unaware of his biological father’s history of psychiatric problems.
A version of this article first appeared on Medscape.com.
Legislation nearing passage in Colorado would lift a veil of secrecy around sperm donation and grant other protections to people conceived with donated gametes.
The bipartisan bill, which was passed by the state’s house of representatives May 10 after previous approval by the senate, would enable offspring to learn the identity of a sperm or egg donor when they turn 18 and receive a donor’s medical information prior to that. Fertility clinics would be required to update donors’ contact information and medical records every 3 years.
In addition, clinics would have to make “good-faith efforts” to track births to ensure that no more than 25 families conceive babies from a single donor’s sperm. Egg donors could donate up to six times, based on medical risk.
The bill would establish a minimum donor age of 21 years and require dissemination of educational materials to donors and prospective parents about the psychological needs of donor-conceived children.
The provisions would take effect with donations collected on or after Jan. 1, 2025. Violators would be subject to fines of up to $20,000 per day.
Advocates point out that in addition to the benefits of knowing one’s genetic identity, the anonymity of sperm donors has been scuttled by the availability of commercial genetic testing. (Egg donation has tended to be more open.)
Some sperm banks already have adopted systems in which adult offspring can learn the identity of donors if both parties agree. However, a survey by the United States Donor Conceived Council, an advocacy group, found “significant problems” with some of those policies, such as requirements that donor-conceived offspring sign nondisclosure agreements or sperm banks refusing to release information if a donor-conceived person’s parents never registered the child’s birth with the bank.
Some measures in the bill reflect the guidelines of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, although not all companies follow them, according to the council’s survey. For example, no sperm bank adheres to a recommendation that donors be at least 21 years old.
“The industry is shifting very fast, but there are definitely banks that I think need an extra push to protect the rights of the people that they’re producing,” Tiffany Gardner, a spokesperson for the council, told this news organization.
At a senate hearing, fertility care providers voiced concerns that the legislation would impose undue burdens on the industry and discourage men from donating sperm. In response, sponsors made several amendments, including capping a licensing fee for clinics and banks at $500 and increasing the family limit for each donor, which was originally set at 10.
Still, some in the industry said the bill, introduced April 22, was too rushed to receive adequate scrutiny. While everyone agreed that limiting the number of a person’s half siblings is a good thing, for example, the best way to go about it is unclear, they said.
“There wasn’t enough time to really get experts together to provide more formal, thoughtful, evidence-based feedback on what should be on this bill,” said Cassandra Roeca, MD, of Shady Grove Fertility, which has clinics in Denver and Colorado Springs. Dr. Roeca testified on behalf of Colorado Fertility Advocates, a nonprofit that promotes access to fertility care.
Gov. Jared Polis (D) is expected to sign the bill, an aide to one of the co-sponsors, Rep. Kerry Tipper (D-Lakewood), said in an interview.
Colorado is not the only state considering transparency for donor-conceived offspring. A New York bill would require fertility clinics to verify the medical, educational, and criminal histories of donors and allow donor-conceived people access to the information.
The New York measure is championed by the family of Steven Gunner, a 27-year-old man who died in May 2020 of an opioid overdose. The Wall Street Journal reported that Mr. Gunner’s family had been unaware of his biological father’s history of psychiatric problems.
A version of this article first appeared on Medscape.com.
Legislation nearing passage in Colorado would lift a veil of secrecy around sperm donation and grant other protections to people conceived with donated gametes.
The bipartisan bill, which was passed by the state’s house of representatives May 10 after previous approval by the senate, would enable offspring to learn the identity of a sperm or egg donor when they turn 18 and receive a donor’s medical information prior to that. Fertility clinics would be required to update donors’ contact information and medical records every 3 years.
In addition, clinics would have to make “good-faith efforts” to track births to ensure that no more than 25 families conceive babies from a single donor’s sperm. Egg donors could donate up to six times, based on medical risk.
The bill would establish a minimum donor age of 21 years and require dissemination of educational materials to donors and prospective parents about the psychological needs of donor-conceived children.
The provisions would take effect with donations collected on or after Jan. 1, 2025. Violators would be subject to fines of up to $20,000 per day.
Advocates point out that in addition to the benefits of knowing one’s genetic identity, the anonymity of sperm donors has been scuttled by the availability of commercial genetic testing. (Egg donation has tended to be more open.)
Some sperm banks already have adopted systems in which adult offspring can learn the identity of donors if both parties agree. However, a survey by the United States Donor Conceived Council, an advocacy group, found “significant problems” with some of those policies, such as requirements that donor-conceived offspring sign nondisclosure agreements or sperm banks refusing to release information if a donor-conceived person’s parents never registered the child’s birth with the bank.
Some measures in the bill reflect the guidelines of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, although not all companies follow them, according to the council’s survey. For example, no sperm bank adheres to a recommendation that donors be at least 21 years old.
“The industry is shifting very fast, but there are definitely banks that I think need an extra push to protect the rights of the people that they’re producing,” Tiffany Gardner, a spokesperson for the council, told this news organization.
At a senate hearing, fertility care providers voiced concerns that the legislation would impose undue burdens on the industry and discourage men from donating sperm. In response, sponsors made several amendments, including capping a licensing fee for clinics and banks at $500 and increasing the family limit for each donor, which was originally set at 10.
Still, some in the industry said the bill, introduced April 22, was too rushed to receive adequate scrutiny. While everyone agreed that limiting the number of a person’s half siblings is a good thing, for example, the best way to go about it is unclear, they said.
“There wasn’t enough time to really get experts together to provide more formal, thoughtful, evidence-based feedback on what should be on this bill,” said Cassandra Roeca, MD, of Shady Grove Fertility, which has clinics in Denver and Colorado Springs. Dr. Roeca testified on behalf of Colorado Fertility Advocates, a nonprofit that promotes access to fertility care.
Gov. Jared Polis (D) is expected to sign the bill, an aide to one of the co-sponsors, Rep. Kerry Tipper (D-Lakewood), said in an interview.
Colorado is not the only state considering transparency for donor-conceived offspring. A New York bill would require fertility clinics to verify the medical, educational, and criminal histories of donors and allow donor-conceived people access to the information.
The New York measure is championed by the family of Steven Gunner, a 27-year-old man who died in May 2020 of an opioid overdose. The Wall Street Journal reported that Mr. Gunner’s family had been unaware of his biological father’s history of psychiatric problems.
A version of this article first appeared on Medscape.com.