Heidi Splete

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

obnews@mdedge.com

Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

obnews@mdedge.com

Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

obnews@mdedge.com

Adults with severe asthma (SA) experienced significantly fewer exacerbations on biologic therapies, compared with those who did not use biologics, based on data from more than 2,000 individuals.

The development of biologics to target specific inflammatory pathways “has transformed the management of uncontrolled SA,” but data on the real-world use of biologics in severe asthma patients treated by subspecialists are limited, wrote Reynold A. Panettieri, Jr., MD, of Rutgers, State University of New Jersey, New Brunswick, and colleagues.

In a study published in the Annals of Allergy, Asthma & Immunology, the researchers reviewed data from CHRONICLE, an ongoing, prospective, real-world noninterventional study of adults aged 18 years and older with severe asthma in the United States.

The study population included 2,847 patients enrolled in the CHRONICLE study between February 2018 and February 2021; 68.8% were women, 74.6% were White. The patients ranged in age from 18 to 89 years, with a mean age of 54.2 years.

Biologic use was defined as patients who started or had ongoing use of biologics between 12 months before enrollment and the patient’s most recent data collection. Switches were defined as stopping one biologic and starting another within 6 months; stops were defined as discontinuing a biologic without switching to another within 6 months. A total of 66% of the patients were using biologics at the time of study enrollment. The most common biologic was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), and dupilumab (18%).

Overall, 89% of the patients had ongoing biologic use, 16% had biologic switches, and 13% had stops.

Patients who started biologics or switched biologics had significant reductions in asthma exacerbations at 6 months, compared with nonbiologic users of 58% (1.80 vs. 0.76 per patient-year) and 49% (1.47 vs. 0.75 per patient-year), respectively (P < .001 for both). Asthma exacerbations declined by 70% among biologics users for whom data were available for 12 months before and 12 months after starting biologics.

Exacerbations decreased at 6 months after biologic initiation across all subgroups of patients, notably patients with pre-biologic FEV₁ < 80% and patients with FEV₁ ≥ 80% (66% and 53%, respectively); never smokers and current/former smokers (63% and 50%, respectively); and patients with COPD and without COPD (58% and 52%, respectively).

The researchers also found a greater reduction in exacerbations among patients who switched from anti-IgE therapy to anti–IL-5/IL-5R/IL-4R therapy, compared with those who switched among anti–IL-5/IL-5R/IL-4R therapies (58% vs. 46%).

Patients who stopped or switched biologics appeared to have more severe or treatment-refractory disease than those with ongoing biologic use, the researchers noted. The most common reason for stopping or switching was worsening symptoms.

The study findings were limited by several factors, including the focus only on adults in the United States with subspecialist-treated SA, which may limit generalizability to children or other populations, the researchers noted. Other limitations included the variation in clinical decisions and insurance coverage and the inability to conduct longitudinal assessments, they said.

The results demonstrate that starting or switching biologics was consistently associated with fewer exacerbations in severe asthma. However, more research is needed to determine why some patients were not receiving biologics because they were not considered clinically eligible by their subspecialist health care providers, the researchers concluded.

The current study and the CHRONICLE study were supported by AstraZeneca. Lead author Dr. Panettieri disclosed serving on the advisory boards for and receiving grant support from AstraZeneca, Sanofi, Genentech, Regeneron, and Novartis.

Adults with severe asthma (SA) experienced significantly fewer exacerbations on biologic therapies, compared with those who did not use biologics, based on data from more than 2,000 individuals.

The development of biologics to target specific inflammatory pathways “has transformed the management of uncontrolled SA,” but data on the real-world use of biologics in severe asthma patients treated by subspecialists are limited, wrote Reynold A. Panettieri, Jr., MD, of Rutgers, State University of New Jersey, New Brunswick, and colleagues.

In a study published in the Annals of Allergy, Asthma & Immunology, the researchers reviewed data from CHRONICLE, an ongoing, prospective, real-world noninterventional study of adults aged 18 years and older with severe asthma in the United States.

The study population included 2,847 patients enrolled in the CHRONICLE study between February 2018 and February 2021; 68.8% were women, 74.6% were White. The patients ranged in age from 18 to 89 years, with a mean age of 54.2 years.

Biologic use was defined as patients who started or had ongoing use of biologics between 12 months before enrollment and the patient’s most recent data collection. Switches were defined as stopping one biologic and starting another within 6 months; stops were defined as discontinuing a biologic without switching to another within 6 months. A total of 66% of the patients were using biologics at the time of study enrollment. The most common biologic was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), and dupilumab (18%).

Overall, 89% of the patients had ongoing biologic use, 16% had biologic switches, and 13% had stops.

Patients who started biologics or switched biologics had significant reductions in asthma exacerbations at 6 months, compared with nonbiologic users of 58% (1.80 vs. 0.76 per patient-year) and 49% (1.47 vs. 0.75 per patient-year), respectively (P < .001 for both). Asthma exacerbations declined by 70% among biologics users for whom data were available for 12 months before and 12 months after starting biologics.

Exacerbations decreased at 6 months after biologic initiation across all subgroups of patients, notably patients with pre-biologic FEV₁ < 80% and patients with FEV₁ ≥ 80% (66% and 53%, respectively); never smokers and current/former smokers (63% and 50%, respectively); and patients with COPD and without COPD (58% and 52%, respectively).

The researchers also found a greater reduction in exacerbations among patients who switched from anti-IgE therapy to anti–IL-5/IL-5R/IL-4R therapy, compared with those who switched among anti–IL-5/IL-5R/IL-4R therapies (58% vs. 46%).

Patients who stopped or switched biologics appeared to have more severe or treatment-refractory disease than those with ongoing biologic use, the researchers noted. The most common reason for stopping or switching was worsening symptoms.

The study findings were limited by several factors, including the focus only on adults in the United States with subspecialist-treated SA, which may limit generalizability to children or other populations, the researchers noted. Other limitations included the variation in clinical decisions and insurance coverage and the inability to conduct longitudinal assessments, they said.

The results demonstrate that starting or switching biologics was consistently associated with fewer exacerbations in severe asthma. However, more research is needed to determine why some patients were not receiving biologics because they were not considered clinically eligible by their subspecialist health care providers, the researchers concluded.

The current study and the CHRONICLE study were supported by AstraZeneca. Lead author Dr. Panettieri disclosed serving on the advisory boards for and receiving grant support from AstraZeneca, Sanofi, Genentech, Regeneron, and Novartis.

Adults with severe asthma (SA) experienced significantly fewer exacerbations on biologic therapies, compared with those who did not use biologics, based on data from more than 2,000 individuals.

The development of biologics to target specific inflammatory pathways “has transformed the management of uncontrolled SA,” but data on the real-world use of biologics in severe asthma patients treated by subspecialists are limited, wrote Reynold A. Panettieri, Jr., MD, of Rutgers, State University of New Jersey, New Brunswick, and colleagues.

In a study published in the Annals of Allergy, Asthma & Immunology, the researchers reviewed data from CHRONICLE, an ongoing, prospective, real-world noninterventional study of adults aged 18 years and older with severe asthma in the United States.

The study population included 2,847 patients enrolled in the CHRONICLE study between February 2018 and February 2021; 68.8% were women, 74.6% were White. The patients ranged in age from 18 to 89 years, with a mean age of 54.2 years.

Biologic use was defined as patients who started or had ongoing use of biologics between 12 months before enrollment and the patient’s most recent data collection. Switches were defined as stopping one biologic and starting another within 6 months; stops were defined as discontinuing a biologic without switching to another within 6 months. A total of 66% of the patients were using biologics at the time of study enrollment. The most common biologic was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), and dupilumab (18%).

Overall, 89% of the patients had ongoing biologic use, 16% had biologic switches, and 13% had stops.

Patients who started biologics or switched biologics had significant reductions in asthma exacerbations at 6 months, compared with nonbiologic users of 58% (1.80 vs. 0.76 per patient-year) and 49% (1.47 vs. 0.75 per patient-year), respectively (P < .001 for both). Asthma exacerbations declined by 70% among biologics users for whom data were available for 12 months before and 12 months after starting biologics.

Exacerbations decreased at 6 months after biologic initiation across all subgroups of patients, notably patients with pre-biologic FEV₁ < 80% and patients with FEV₁ ≥ 80% (66% and 53%, respectively); never smokers and current/former smokers (63% and 50%, respectively); and patients with COPD and without COPD (58% and 52%, respectively).

The researchers also found a greater reduction in exacerbations among patients who switched from anti-IgE therapy to anti–IL-5/IL-5R/IL-4R therapy, compared with those who switched among anti–IL-5/IL-5R/IL-4R therapies (58% vs. 46%).

Patients who stopped or switched biologics appeared to have more severe or treatment-refractory disease than those with ongoing biologic use, the researchers noted. The most common reason for stopping or switching was worsening symptoms.

The study findings were limited by several factors, including the focus only on adults in the United States with subspecialist-treated SA, which may limit generalizability to children or other populations, the researchers noted. Other limitations included the variation in clinical decisions and insurance coverage and the inability to conduct longitudinal assessments, they said.

The results demonstrate that starting or switching biologics was consistently associated with fewer exacerbations in severe asthma. However, more research is needed to determine why some patients were not receiving biologics because they were not considered clinically eligible by their subspecialist health care providers, the researchers concluded.

The current study and the CHRONICLE study were supported by AstraZeneca. Lead author Dr. Panettieri disclosed serving on the advisory boards for and receiving grant support from AstraZeneca, Sanofi, Genentech, Regeneron, and Novartis.

Chronic obstructive pulmonary disease (COPD) was among the significant predictors of hospital readmission in older adults with fractures, based on data from nearly 400 individuals.

Fractures in the elderly remain a major health concern, and readmissions are common; however, “The predictive factors for hospital readmission of elderly people with fractures are multifactorial and complex,” Lara Cristina da Cunha Guimarães, MSN, of State School of Public Health Candido Santiago, State Department of Health of Goiás (Brazil), and colleagues wrote.

Previous research suggests that readmissions risk may be greater in patients with preadmission conditions including pulmonary and cardiac disease, history of stroke and other neurological conditions, and other factors associated with aging in general, they said.

In a study published in the journal Injury , the researchers reviewed data from 376 adults aged 60 years and older in a trauma referral hospital in Brazil who had suffered fractures and were hospitalized between Sept. 1, 2016, and Feb. 28, 2017. The primary outcome was readmission up to one year after discharge from the initial hospitalization for fracture.

Approximately half of the patients experienced femur fractures (53.2%), and the most frequent cause was falling from standing height (72.9%). The overall incidence of readmission was 20.7%. A total of 30.5% of readmissions were related to the fracture, and surgical-site infections were the most common cause of fracture-related complications.

More than half (58.3%) of the readmissions were related to clinical complications.

In a multivariate analysis, several clinical factors not related to fractures were independently associated with readmission, including a previous diagnosis of COPD, age between 60 and 69 years, a fracture of the femur, and delirium at the time of the first hospitalization for fracture.

Pneumonia was the most frequent cause of clinical complications, reflecting data from other recent studies, the researchers noted. “Elderly people with COPD are more susceptible to infections, such as pneumonia, which was a cause of frequent readmissions in the population studied. The presence of COPD can contribute to imbalance in the pulmonary microbiome, mucus production and persistent inflammation of the airways, and structural damage, which increases exposure of the pulmonary mucosa to pathogens.” COPD also can be associated with cardiovascular, mental, and musculoskeletal diseases that can further complicate and delay recovery from fractures.

The study findings were limited by the potential for incomplete information in medical records. However, the results indicate a range of causes and conditions associated with hospital readmission after fractures in older adults, they said. Recognizing these factors can guide plans for transitions from hospital to home care to reduce complications and readmissions.

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

Chronic obstructive pulmonary disease (COPD) was among the significant predictors of hospital readmission in older adults with fractures, based on data from nearly 400 individuals.

Fractures in the elderly remain a major health concern, and readmissions are common; however, “The predictive factors for hospital readmission of elderly people with fractures are multifactorial and complex,” Lara Cristina da Cunha Guimarães, MSN, of State School of Public Health Candido Santiago, State Department of Health of Goiás (Brazil), and colleagues wrote.

Previous research suggests that readmissions risk may be greater in patients with preadmission conditions including pulmonary and cardiac disease, history of stroke and other neurological conditions, and other factors associated with aging in general, they said.

In a study published in the journal Injury , the researchers reviewed data from 376 adults aged 60 years and older in a trauma referral hospital in Brazil who had suffered fractures and were hospitalized between Sept. 1, 2016, and Feb. 28, 2017. The primary outcome was readmission up to one year after discharge from the initial hospitalization for fracture.

Approximately half of the patients experienced femur fractures (53.2%), and the most frequent cause was falling from standing height (72.9%). The overall incidence of readmission was 20.7%. A total of 30.5% of readmissions were related to the fracture, and surgical-site infections were the most common cause of fracture-related complications.

More than half (58.3%) of the readmissions were related to clinical complications.

In a multivariate analysis, several clinical factors not related to fractures were independently associated with readmission, including a previous diagnosis of COPD, age between 60 and 69 years, a fracture of the femur, and delirium at the time of the first hospitalization for fracture.

Pneumonia was the most frequent cause of clinical complications, reflecting data from other recent studies, the researchers noted. “Elderly people with COPD are more susceptible to infections, such as pneumonia, which was a cause of frequent readmissions in the population studied. The presence of COPD can contribute to imbalance in the pulmonary microbiome, mucus production and persistent inflammation of the airways, and structural damage, which increases exposure of the pulmonary mucosa to pathogens.” COPD also can be associated with cardiovascular, mental, and musculoskeletal diseases that can further complicate and delay recovery from fractures.

The study findings were limited by the potential for incomplete information in medical records. However, the results indicate a range of causes and conditions associated with hospital readmission after fractures in older adults, they said. Recognizing these factors can guide plans for transitions from hospital to home care to reduce complications and readmissions.

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

Chronic obstructive pulmonary disease (COPD) was among the significant predictors of hospital readmission in older adults with fractures, based on data from nearly 400 individuals.

Fractures in the elderly remain a major health concern, and readmissions are common; however, “The predictive factors for hospital readmission of elderly people with fractures are multifactorial and complex,” Lara Cristina da Cunha Guimarães, MSN, of State School of Public Health Candido Santiago, State Department of Health of Goiás (Brazil), and colleagues wrote.

Previous research suggests that readmissions risk may be greater in patients with preadmission conditions including pulmonary and cardiac disease, history of stroke and other neurological conditions, and other factors associated with aging in general, they said.

In a study published in the journal Injury , the researchers reviewed data from 376 adults aged 60 years and older in a trauma referral hospital in Brazil who had suffered fractures and were hospitalized between Sept. 1, 2016, and Feb. 28, 2017. The primary outcome was readmission up to one year after discharge from the initial hospitalization for fracture.

Approximately half of the patients experienced femur fractures (53.2%), and the most frequent cause was falling from standing height (72.9%). The overall incidence of readmission was 20.7%. A total of 30.5% of readmissions were related to the fracture, and surgical-site infections were the most common cause of fracture-related complications.

More than half (58.3%) of the readmissions were related to clinical complications.

In a multivariate analysis, several clinical factors not related to fractures were independently associated with readmission, including a previous diagnosis of COPD, age between 60 and 69 years, a fracture of the femur, and delirium at the time of the first hospitalization for fracture.

Pneumonia was the most frequent cause of clinical complications, reflecting data from other recent studies, the researchers noted. “Elderly people with COPD are more susceptible to infections, such as pneumonia, which was a cause of frequent readmissions in the population studied. The presence of COPD can contribute to imbalance in the pulmonary microbiome, mucus production and persistent inflammation of the airways, and structural damage, which increases exposure of the pulmonary mucosa to pathogens.” COPD also can be associated with cardiovascular, mental, and musculoskeletal diseases that can further complicate and delay recovery from fractures.

The study findings were limited by the potential for incomplete information in medical records. However, the results indicate a range of causes and conditions associated with hospital readmission after fractures in older adults, they said. Recognizing these factors can guide plans for transitions from hospital to home care to reduce complications and readmissions.

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

Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.

“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.

Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.

In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.

The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.

Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.

Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).

Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).

The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.

The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.

“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.

“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”

Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.

A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
 

Education is essential

Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.

“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.” 

On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.

“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.

The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.

“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.

Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.

In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.

The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.

Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.

Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).

Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).

The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.

The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.

“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.

“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”

Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.

A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
 

Education is essential

Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.

“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.” 

On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.

“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.

The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.

“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.

Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.

In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.

The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.

Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.

Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).

Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).

The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.

The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.

“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.

“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”

Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.

A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
 

Education is essential

Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.

“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.” 

On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.

“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.

The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

Compulsivity is a significant contributor to disability and poor quality of life for individuals with trichotillomania (TTM) and skin-picking disorder (SPD), based on data from 91 adults.

Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.

In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.

Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.

“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.

The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.

However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.

The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.

Compulsivity is a significant contributor to disability and poor quality of life for individuals with trichotillomania (TTM) and skin-picking disorder (SPD), based on data from 91 adults.

Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.

In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.

Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.

“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.

The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.

However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.

The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.

Compulsivity is a significant contributor to disability and poor quality of life for individuals with trichotillomania (TTM) and skin-picking disorder (SPD), based on data from 91 adults.

Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.

In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.

Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.

“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.

The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.

However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.

The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.

Use of mepolizumab significantly reduced the need for maintenance oral corticosteroids in adults with severe asthma, based on data from more than 800 individuals.

Many patients with severe asthma require bursts of systemic corticosteroids (SCS) or maintenance oral corticosteroids (mOCS) for disease control, but these strategies are associated with side effects that can increase the disease burden, wrote Charles Pilette, MD, of Cliniques Universitaires Saint-Luc, Brussels, and colleagues.

Previous studies have shown that the humanized, monoclonal anti-interleukin (IL)–5 antibody mepolizumab, which is approved for the treatment of severe asthma, reduced use of SCS and has shown effectiveness in less homogeneous populations, but robust, real-world data on the occurrence and magnitude of these effects are lacking, the researchers said.

In a study known as REALITI-A, the researchers enrolled 822 adults with asthma diagnoses from 82 centers in Europe, Canada, and the United States who initiated mepolizumab at a subcutaneous dose of 100 mg. The study endpoints included daily use of oral corticosteroids at baseline and 1 year, percentage reduction in oral corticosteroid use from baseline, patients discontinuing oral corticosteroids; the primary outcome was the rate of clinically significant exacerbations (CSEs). CSEs were defined as the need for OCS for at least 3 days/parenteral administration, and/or an emergency department or hospital admission before and after treatment. The mean age of the participants was 54 years, 63% were women, and 60% were never-smokers. The mean asthma duration was 19.7 years.

A total of 319 patients (39%), used mOCS at baseline, and dose information was available for 298.

Real-world outcomes

At 1 year, the median mOCS dose in the study population was reduced by 75%, and 64% reduced their mOCS dose by at least 50% from baseline.

In addition, the proportion of patients who discontinued daily mOCS increased from 29% during week 25-28 to 43% during week 53-56.

Overall, 80% of patients remained on mepolizumab at 1 year. Lack of efficacy and patient decision were the top two reasons for discontinuation (6% and 4%, respectively).

The primary outcome of rate of CSE decreased by a clinically significant rate ratio of 0.29 (P < .001).

“The requirement for SCS bursts was also reduced, as observed by a decreased rate of CSEs,” the researchers wrote in their discussion. The results were consistent for patients receiving lower (less than 10 mg/day) or higher (10 mg/day or more) mOCS doses at baseline, they said. No unexpected safety signals were noted during the study period.

“Furthermore, mepolizumab was associated with significant decreases in the rate of exacerbations requiring hospitalizations, or those requiring hospitalization or an ER visit, improved symptom control, and lower work productivity and activity impairment,” they added.

The study findings were limited by several factors including the observational design, lack of mepolizumab comparator, and open-label data capture, the researchers noted. However, the results were consistent with similar studies, and support the use of mepolizumab as part of the standard of care for clinically effective disease control in severe asthma patients, they concluded.

The study was funded by GlaxoSmithKline. Lead author Dr. Pilette disclosed fees for advisory boards, speaker meetings, and 42 research grants from GSK, AstraZeneca, Chiesi, Novartis, Teva, and ALK-Abello.

Use of mepolizumab significantly reduced the need for maintenance oral corticosteroids in adults with severe asthma, based on data from more than 800 individuals.

Many patients with severe asthma require bursts of systemic corticosteroids (SCS) or maintenance oral corticosteroids (mOCS) for disease control, but these strategies are associated with side effects that can increase the disease burden, wrote Charles Pilette, MD, of Cliniques Universitaires Saint-Luc, Brussels, and colleagues.

Previous studies have shown that the humanized, monoclonal anti-interleukin (IL)–5 antibody mepolizumab, which is approved for the treatment of severe asthma, reduced use of SCS and has shown effectiveness in less homogeneous populations, but robust, real-world data on the occurrence and magnitude of these effects are lacking, the researchers said.

In a study known as REALITI-A, the researchers enrolled 822 adults with asthma diagnoses from 82 centers in Europe, Canada, and the United States who initiated mepolizumab at a subcutaneous dose of 100 mg. The study endpoints included daily use of oral corticosteroids at baseline and 1 year, percentage reduction in oral corticosteroid use from baseline, patients discontinuing oral corticosteroids; the primary outcome was the rate of clinically significant exacerbations (CSEs). CSEs were defined as the need for OCS for at least 3 days/parenteral administration, and/or an emergency department or hospital admission before and after treatment. The mean age of the participants was 54 years, 63% were women, and 60% were never-smokers. The mean asthma duration was 19.7 years.

A total of 319 patients (39%), used mOCS at baseline, and dose information was available for 298.

Real-world outcomes

At 1 year, the median mOCS dose in the study population was reduced by 75%, and 64% reduced their mOCS dose by at least 50% from baseline.

In addition, the proportion of patients who discontinued daily mOCS increased from 29% during week 25-28 to 43% during week 53-56.

Overall, 80% of patients remained on mepolizumab at 1 year. Lack of efficacy and patient decision were the top two reasons for discontinuation (6% and 4%, respectively).

The primary outcome of rate of CSE decreased by a clinically significant rate ratio of 0.29 (P < .001).

“The requirement for SCS bursts was also reduced, as observed by a decreased rate of CSEs,” the researchers wrote in their discussion. The results were consistent for patients receiving lower (less than 10 mg/day) or higher (10 mg/day or more) mOCS doses at baseline, they said. No unexpected safety signals were noted during the study period.

“Furthermore, mepolizumab was associated with significant decreases in the rate of exacerbations requiring hospitalizations, or those requiring hospitalization or an ER visit, improved symptom control, and lower work productivity and activity impairment,” they added.

The study findings were limited by several factors including the observational design, lack of mepolizumab comparator, and open-label data capture, the researchers noted. However, the results were consistent with similar studies, and support the use of mepolizumab as part of the standard of care for clinically effective disease control in severe asthma patients, they concluded.

The study was funded by GlaxoSmithKline. Lead author Dr. Pilette disclosed fees for advisory boards, speaker meetings, and 42 research grants from GSK, AstraZeneca, Chiesi, Novartis, Teva, and ALK-Abello.

Use of mepolizumab significantly reduced the need for maintenance oral corticosteroids in adults with severe asthma, based on data from more than 800 individuals.

Many patients with severe asthma require bursts of systemic corticosteroids (SCS) or maintenance oral corticosteroids (mOCS) for disease control, but these strategies are associated with side effects that can increase the disease burden, wrote Charles Pilette, MD, of Cliniques Universitaires Saint-Luc, Brussels, and colleagues.

Previous studies have shown that the humanized, monoclonal anti-interleukin (IL)–5 antibody mepolizumab, which is approved for the treatment of severe asthma, reduced use of SCS and has shown effectiveness in less homogeneous populations, but robust, real-world data on the occurrence and magnitude of these effects are lacking, the researchers said.

In a study known as REALITI-A, the researchers enrolled 822 adults with asthma diagnoses from 82 centers in Europe, Canada, and the United States who initiated mepolizumab at a subcutaneous dose of 100 mg. The study endpoints included daily use of oral corticosteroids at baseline and 1 year, percentage reduction in oral corticosteroid use from baseline, patients discontinuing oral corticosteroids; the primary outcome was the rate of clinically significant exacerbations (CSEs). CSEs were defined as the need for OCS for at least 3 days/parenteral administration, and/or an emergency department or hospital admission before and after treatment. The mean age of the participants was 54 years, 63% were women, and 60% were never-smokers. The mean asthma duration was 19.7 years.

A total of 319 patients (39%), used mOCS at baseline, and dose information was available for 298.

Real-world outcomes

At 1 year, the median mOCS dose in the study population was reduced by 75%, and 64% reduced their mOCS dose by at least 50% from baseline.

In addition, the proportion of patients who discontinued daily mOCS increased from 29% during week 25-28 to 43% during week 53-56.

Overall, 80% of patients remained on mepolizumab at 1 year. Lack of efficacy and patient decision were the top two reasons for discontinuation (6% and 4%, respectively).

The primary outcome of rate of CSE decreased by a clinically significant rate ratio of 0.29 (P < .001).

“The requirement for SCS bursts was also reduced, as observed by a decreased rate of CSEs,” the researchers wrote in their discussion. The results were consistent for patients receiving lower (less than 10 mg/day) or higher (10 mg/day or more) mOCS doses at baseline, they said. No unexpected safety signals were noted during the study period.

“Furthermore, mepolizumab was associated with significant decreases in the rate of exacerbations requiring hospitalizations, or those requiring hospitalization or an ER visit, improved symptom control, and lower work productivity and activity impairment,” they added.

The study findings were limited by several factors including the observational design, lack of mepolizumab comparator, and open-label data capture, the researchers noted. However, the results were consistent with similar studies, and support the use of mepolizumab as part of the standard of care for clinically effective disease control in severe asthma patients, they concluded.

The study was funded by GlaxoSmithKline. Lead author Dr. Pilette disclosed fees for advisory boards, speaker meetings, and 42 research grants from GSK, AstraZeneca, Chiesi, Novartis, Teva, and ALK-Abello.

Air pollution levels mediated the impact of temperature on oxygen saturation in adults with chronic obstructive pulmonary disease (COPD) based on data from 117 individuals.

COPD is attributed to environmental factors including air pollution, and air pollution has been linked to increased risk of hospitalization and mortality because of acute COPD exacerbation, wrote Huan Minh Tran, PhD, of Taipei (Taiwan) Medical University and colleagues. However, the effects of air pollution on climate-associated health outcomes in COPD have not been explored, they said.

In a study published in Science of The Total Environment the researchers identified 117 adult COPD patients at a single center in Taiwan. They measured lung function, 6-minute walking distance, oxygen desaturation, white blood cell count, and percent emphysema (defined as low attenuation area [LAA]) and linked them to 0- to 1-year, 0- to 3-year, and 0- to 5-year lags in exposures to relative humidity (RH), temperature, and air pollution. The mean age of the participants was 72.9 years; 93% were men.

Pollution was defined in terms of fine particulate matter (PM2.5).

Overall, an increase in RH by 1% was associated with increases in forced expiratory volume in 1 second (FEV₁), eosinophils, and lymphocytes.

A 1% increase in RH also was associated with a decrease in the total-lobe LAA.

As for temperature, an increase of 1° C was associated with decreased oxygen desaturation and with decreases in right-, left-, and upper-lobe LAA values.

When the researchers examined the impact of pollution, they found that a 1 mcg/m³ increase in PM2.5 was associated with a decrease in the FEV₁ as well as with an increase in oxygen desaturation. A 1 mcg/m³ increase in PM10 and PM2.5 was associated with increases in the total-, right-, left, and upper-lobe LAA; increases in lower-lobe LAA were associated with an increase in PM2.5 only.

“This is reasonable because PM2.5 can travel and deposit in distal parts of the lung, while PM10 is preferably deposited in the larger airways of the upper lung regions,” the researchers wrote in their discussion.

A one part per billion increase in nitrogen dioxide (NO₂) was associated with decreased FEV₁ and increased upper-lobe LAA.

“We observed that NO₂ fully mediated the association between RH and FEV₁, while PM2.5 fully mediated associations of temperature with oxygen saturation and emphysema severity in COPD patients,” the researchers added.

The study findings were limited by several factors including the relatively small and homogeneous male, Taiwanese population, which may limit generalizability, the researchers noted. Other limitations included the lack of control for factors such as body mass index, occupational exposure, comorbidities, medication use, and indoor air pollution, they said.

However, the results suggest that air pollution could have an effect on the established associations between climate and adverse health outcomes in COPD, and more research is needed. Climate change–related air pollution is an important public health issue, especially with regards to respiratory disease,” they concluded.

The study was supported by the Ministry of Science and Technology of Taiwan. The researchers had no financial conflicts to disclose.

Air pollution levels mediated the impact of temperature on oxygen saturation in adults with chronic obstructive pulmonary disease (COPD) based on data from 117 individuals.

COPD is attributed to environmental factors including air pollution, and air pollution has been linked to increased risk of hospitalization and mortality because of acute COPD exacerbation, wrote Huan Minh Tran, PhD, of Taipei (Taiwan) Medical University and colleagues. However, the effects of air pollution on climate-associated health outcomes in COPD have not been explored, they said.

In a study published in Science of The Total Environment the researchers identified 117 adult COPD patients at a single center in Taiwan. They measured lung function, 6-minute walking distance, oxygen desaturation, white blood cell count, and percent emphysema (defined as low attenuation area [LAA]) and linked them to 0- to 1-year, 0- to 3-year, and 0- to 5-year lags in exposures to relative humidity (RH), temperature, and air pollution. The mean age of the participants was 72.9 years; 93% were men.

Pollution was defined in terms of fine particulate matter (PM2.5).

Overall, an increase in RH by 1% was associated with increases in forced expiratory volume in 1 second (FEV₁), eosinophils, and lymphocytes.

A 1% increase in RH also was associated with a decrease in the total-lobe LAA.

As for temperature, an increase of 1° C was associated with decreased oxygen desaturation and with decreases in right-, left-, and upper-lobe LAA values.

When the researchers examined the impact of pollution, they found that a 1 mcg/m³ increase in PM2.5 was associated with a decrease in the FEV₁ as well as with an increase in oxygen desaturation. A 1 mcg/m³ increase in PM10 and PM2.5 was associated with increases in the total-, right-, left, and upper-lobe LAA; increases in lower-lobe LAA were associated with an increase in PM2.5 only.

“This is reasonable because PM2.5 can travel and deposit in distal parts of the lung, while PM10 is preferably deposited in the larger airways of the upper lung regions,” the researchers wrote in their discussion.

A one part per billion increase in nitrogen dioxide (NO₂) was associated with decreased FEV₁ and increased upper-lobe LAA.

“We observed that NO₂ fully mediated the association between RH and FEV₁, while PM2.5 fully mediated associations of temperature with oxygen saturation and emphysema severity in COPD patients,” the researchers added.

The study findings were limited by several factors including the relatively small and homogeneous male, Taiwanese population, which may limit generalizability, the researchers noted. Other limitations included the lack of control for factors such as body mass index, occupational exposure, comorbidities, medication use, and indoor air pollution, they said.

However, the results suggest that air pollution could have an effect on the established associations between climate and adverse health outcomes in COPD, and more research is needed. Climate change–related air pollution is an important public health issue, especially with regards to respiratory disease,” they concluded.

The study was supported by the Ministry of Science and Technology of Taiwan. The researchers had no financial conflicts to disclose.

Air pollution levels mediated the impact of temperature on oxygen saturation in adults with chronic obstructive pulmonary disease (COPD) based on data from 117 individuals.

COPD is attributed to environmental factors including air pollution, and air pollution has been linked to increased risk of hospitalization and mortality because of acute COPD exacerbation, wrote Huan Minh Tran, PhD, of Taipei (Taiwan) Medical University and colleagues. However, the effects of air pollution on climate-associated health outcomes in COPD have not been explored, they said.

In a study published in Science of The Total Environment the researchers identified 117 adult COPD patients at a single center in Taiwan. They measured lung function, 6-minute walking distance, oxygen desaturation, white blood cell count, and percent emphysema (defined as low attenuation area [LAA]) and linked them to 0- to 1-year, 0- to 3-year, and 0- to 5-year lags in exposures to relative humidity (RH), temperature, and air pollution. The mean age of the participants was 72.9 years; 93% were men.

Pollution was defined in terms of fine particulate matter (PM2.5).

Overall, an increase in RH by 1% was associated with increases in forced expiratory volume in 1 second (FEV₁), eosinophils, and lymphocytes.

A 1% increase in RH also was associated with a decrease in the total-lobe LAA.

As for temperature, an increase of 1° C was associated with decreased oxygen desaturation and with decreases in right-, left-, and upper-lobe LAA values.

When the researchers examined the impact of pollution, they found that a 1 mcg/m³ increase in PM2.5 was associated with a decrease in the FEV₁ as well as with an increase in oxygen desaturation. A 1 mcg/m³ increase in PM10 and PM2.5 was associated with increases in the total-, right-, left, and upper-lobe LAA; increases in lower-lobe LAA were associated with an increase in PM2.5 only.

“This is reasonable because PM2.5 can travel and deposit in distal parts of the lung, while PM10 is preferably deposited in the larger airways of the upper lung regions,” the researchers wrote in their discussion.

A one part per billion increase in nitrogen dioxide (NO₂) was associated with decreased FEV₁ and increased upper-lobe LAA.

“We observed that NO₂ fully mediated the association between RH and FEV₁, while PM2.5 fully mediated associations of temperature with oxygen saturation and emphysema severity in COPD patients,” the researchers added.

The study findings were limited by several factors including the relatively small and homogeneous male, Taiwanese population, which may limit generalizability, the researchers noted. Other limitations included the lack of control for factors such as body mass index, occupational exposure, comorbidities, medication use, and indoor air pollution, they said.

However, the results suggest that air pollution could have an effect on the established associations between climate and adverse health outcomes in COPD, and more research is needed. Climate change–related air pollution is an important public health issue, especially with regards to respiratory disease,” they concluded.

The study was supported by the Ministry of Science and Technology of Taiwan. The researchers had no financial conflicts to disclose.

Women with type 1 diabetes may need additional glucose after exercise during the luteal phase of the menstrual cycle, compared with other times, according to a study in nine women.

“We know that exercise is very beneficial for people with type 1 diabetes; we also know that fear of hypoglycemia is a major barrier to exercise in this population,” said Jane E. Yardley, PhD, in a presentation at the annual scientific sessions of the American Diabetes Association, New Orleans. Women with type 1 diabetes (T1D) perceive more barriers, compared with men, she added.

The menstrual cycle could be an additional barrier to exercise for women with T1D because it increases glucose fluctuations that have not been well documented in the literature to date, said Dr. Yardley, of the University of Alberta, Augustana.

The follicular phase of the menstrual cycle lasts from menses to the midcycle, about 14 days later. This is followed by the luteal phase, which lasts until approximately day 28, Dr. Yardley explained. Data on insulin sensitivity have shown that the late luteal phase is associated with “a little less insulin sensitivity” in women with T1D, she noted.

To assess the relationship between menstrual cycle, glucose control, and exercise, Dr. Yardley and colleagues compared the effects of a moderate aerobic exercise on glycemic responses between the early follicular and late luteal phases of the menstrual cycle in nine female participants with T1D.

The exercise involved 45 minutes of aerobic cycling at 50% of predetermined peak oxygen uptake (VO2peak) for 45 min. The mean age of the participants was 30.2 years, the mean hemoglobin A1C was 7.4%, and the mean VO2peak was 32.5 mL/kg per min. The women reported regular menstrual cycles, and none were using oral contraceptives.

Blood samples were collected before and immediately after exercise and after an hour of recovery. Participants wore continuous glucose monitors for at least 1 hour before and after exercise.

Menstrual cycle was confirmed via estrogen, estradiol, and progesterone.

Insulin levels varied greatly among the study participants, but the differences were not significant, Dr. Yardley said. Glucose levels consistently decreased during exercise and increased after exercise, she noted.

No significant difference in glucose was observed between the follicular and luteal phases.

However, “this needs to be interpreted in the context of the safety profiles that are in place in our lab,” which include carbohydrate supplements for individuals whose blood glucose levels drop below 4.5 mmol/L, she said.

In the current study, 6 of 9 participants required additional carbohydrates during the luteal phase, but only 1 participant needed additional carbohydrates during the follicular phase, she noted. For this reason, no differences were noted. “We actually prevented changes,” she said.

No significant differences were noted in mean glucose levels or number of hypoglycemic episodes at any of the time points between the two phases.

“One place where we did see a difference was in hyperglycemia 24 hours after exercise,” Dr. Yardley said. Level 1 hyperglycemia 24 hours after exercise was significantly more frequent in the follicular phase, compared with the luteal phase (P = .028).

The study findings were limited by the small sample size and homogenous population, and more research is needed to interpret the data, said Dr. Yardley.

However, the need for more glucose supplementation to prevent hypoglycemia during the luteal phase suggests a higher hypoglycemic risk associated with aerobic exercise during this time, she said.

In addition, the results suggest that the menstrual cycle should be taken into consideration when female participants are involved in exercise studies, she noted.

Study supports personalized exercise plans

“It is important to evaluate effects of exercise in people with type 1 diabetes and evaluate whether there is a difference those effects in men and women,” said Helena W. Rodbard, MD, an endocrinologist in private practice in Rockville, Md., in an interview. “There is also a need to evaluate to what extent the changes in blood glucose patterns in women in response to exercise differ depending on the phase of the ovarian cycle,” said Dr. Rodbard, who was not involved in the study.

In the current study, “the researchers observed a decline in glucose during a 45-minute period of moderate aerobic exercise, cycling at 50% VO2peak followed by an increase during a 60-minute recovery period. There was a suggestive finding, in the nine subjects, that more carbohydrate supplementation was needed during the late luteal phase of the menstrual cycle than during the follicular phase,” Dr. Rodbard noted. “In contrast, the authors reported a significantly increased degree of hyperglycemia during the recovery phase for subjects during the follicular phase. These findings are consistent with and extend several recent studies from Dr. Yardley and coworkers, who have been focused on this area of research,” she said.

“This study provides provocative evidence that glucose responses to aerobic exercise in women may depend on the timing in relationship to their ovarian cycle,” said Dr. Rodbard. “These findings are based on a small group of subjects and were present in some but not all subjects. Clinicians should encourage women to evaluate and record their experiences during and after exercise in terms of need for carbohydrate supplementation for documented or symptomatic hypoglycemia and in terms of glucose changes as recorded using continuous glucose monitoring (CGM), both in relation to type of exercise and in relation to time in the menstrual cycle,” she said.

The findings also highlight the importance of individualized therapy that is “based on subjective inputs combined with analysis of CGM data during and following exercise,” said Dr. Rodbard. “It is likely that use of Automated Insulin Delivery (AID) will be helpful in achieving this level of individualization in view of the wide range of types, intensity, and duration of physical activity and exercise in which people with T1D engage and the myriad factors that can influence the glycemic response,” she said.

Looking ahead, “the authors and others should expand the present series of subjects using aerobic exercise and examine other types of exercise as well,” Dr. Rodbard noted. “It will be important to evaluate the consistency of these changes in glucose patterns within individuals on multiple occasions, and it would be helpful to repeat the studies in women using oral contraceptives.”

Dr. Yardley disclosed research support from Abbott, Dexcom, and LifeScan and disclosed serving on the speaker’s bureau for Abbott Diabetes. Dr. Rodbard had no financial conflicts to disclose. She serves on the Editorial Advisory Board of Clinical Endocrinology News.

Women with type 1 diabetes may need additional glucose after exercise during the luteal phase of the menstrual cycle, compared with other times, according to a study in nine women.

“We know that exercise is very beneficial for people with type 1 diabetes; we also know that fear of hypoglycemia is a major barrier to exercise in this population,” said Jane E. Yardley, PhD, in a presentation at the annual scientific sessions of the American Diabetes Association, New Orleans. Women with type 1 diabetes (T1D) perceive more barriers, compared with men, she added.

The menstrual cycle could be an additional barrier to exercise for women with T1D because it increases glucose fluctuations that have not been well documented in the literature to date, said Dr. Yardley, of the University of Alberta, Augustana.

The follicular phase of the menstrual cycle lasts from menses to the midcycle, about 14 days later. This is followed by the luteal phase, which lasts until approximately day 28, Dr. Yardley explained. Data on insulin sensitivity have shown that the late luteal phase is associated with “a little less insulin sensitivity” in women with T1D, she noted.

To assess the relationship between menstrual cycle, glucose control, and exercise, Dr. Yardley and colleagues compared the effects of a moderate aerobic exercise on glycemic responses between the early follicular and late luteal phases of the menstrual cycle in nine female participants with T1D.

The exercise involved 45 minutes of aerobic cycling at 50% of predetermined peak oxygen uptake (VO2peak) for 45 min. The mean age of the participants was 30.2 years, the mean hemoglobin A1C was 7.4%, and the mean VO2peak was 32.5 mL/kg per min. The women reported regular menstrual cycles, and none were using oral contraceptives.

Blood samples were collected before and immediately after exercise and after an hour of recovery. Participants wore continuous glucose monitors for at least 1 hour before and after exercise.

Menstrual cycle was confirmed via estrogen, estradiol, and progesterone.

Insulin levels varied greatly among the study participants, but the differences were not significant, Dr. Yardley said. Glucose levels consistently decreased during exercise and increased after exercise, she noted.

No significant difference in glucose was observed between the follicular and luteal phases.

However, “this needs to be interpreted in the context of the safety profiles that are in place in our lab,” which include carbohydrate supplements for individuals whose blood glucose levels drop below 4.5 mmol/L, she said.

In the current study, 6 of 9 participants required additional carbohydrates during the luteal phase, but only 1 participant needed additional carbohydrates during the follicular phase, she noted. For this reason, no differences were noted. “We actually prevented changes,” she said.

No significant differences were noted in mean glucose levels or number of hypoglycemic episodes at any of the time points between the two phases.

“One place where we did see a difference was in hyperglycemia 24 hours after exercise,” Dr. Yardley said. Level 1 hyperglycemia 24 hours after exercise was significantly more frequent in the follicular phase, compared with the luteal phase (P = .028).

The study findings were limited by the small sample size and homogenous population, and more research is needed to interpret the data, said Dr. Yardley.

However, the need for more glucose supplementation to prevent hypoglycemia during the luteal phase suggests a higher hypoglycemic risk associated with aerobic exercise during this time, she said.

In addition, the results suggest that the menstrual cycle should be taken into consideration when female participants are involved in exercise studies, she noted.

Study supports personalized exercise plans

“It is important to evaluate effects of exercise in people with type 1 diabetes and evaluate whether there is a difference those effects in men and women,” said Helena W. Rodbard, MD, an endocrinologist in private practice in Rockville, Md., in an interview. “There is also a need to evaluate to what extent the changes in blood glucose patterns in women in response to exercise differ depending on the phase of the ovarian cycle,” said Dr. Rodbard, who was not involved in the study.

In the current study, “the researchers observed a decline in glucose during a 45-minute period of moderate aerobic exercise, cycling at 50% VO2peak followed by an increase during a 60-minute recovery period. There was a suggestive finding, in the nine subjects, that more carbohydrate supplementation was needed during the late luteal phase of the menstrual cycle than during the follicular phase,” Dr. Rodbard noted. “In contrast, the authors reported a significantly increased degree of hyperglycemia during the recovery phase for subjects during the follicular phase. These findings are consistent with and extend several recent studies from Dr. Yardley and coworkers, who have been focused on this area of research,” she said.

“This study provides provocative evidence that glucose responses to aerobic exercise in women may depend on the timing in relationship to their ovarian cycle,” said Dr. Rodbard. “These findings are based on a small group of subjects and were present in some but not all subjects. Clinicians should encourage women to evaluate and record their experiences during and after exercise in terms of need for carbohydrate supplementation for documented or symptomatic hypoglycemia and in terms of glucose changes as recorded using continuous glucose monitoring (CGM), both in relation to type of exercise and in relation to time in the menstrual cycle,” she said.

The findings also highlight the importance of individualized therapy that is “based on subjective inputs combined with analysis of CGM data during and following exercise,” said Dr. Rodbard. “It is likely that use of Automated Insulin Delivery (AID) will be helpful in achieving this level of individualization in view of the wide range of types, intensity, and duration of physical activity and exercise in which people with T1D engage and the myriad factors that can influence the glycemic response,” she said.

Looking ahead, “the authors and others should expand the present series of subjects using aerobic exercise and examine other types of exercise as well,” Dr. Rodbard noted. “It will be important to evaluate the consistency of these changes in glucose patterns within individuals on multiple occasions, and it would be helpful to repeat the studies in women using oral contraceptives.”

Dr. Yardley disclosed research support from Abbott, Dexcom, and LifeScan and disclosed serving on the speaker’s bureau for Abbott Diabetes. Dr. Rodbard had no financial conflicts to disclose. She serves on the Editorial Advisory Board of Clinical Endocrinology News.

Women with type 1 diabetes may need additional glucose after exercise during the luteal phase of the menstrual cycle, compared with other times, according to a study in nine women.

“We know that exercise is very beneficial for people with type 1 diabetes; we also know that fear of hypoglycemia is a major barrier to exercise in this population,” said Jane E. Yardley, PhD, in a presentation at the annual scientific sessions of the American Diabetes Association, New Orleans. Women with type 1 diabetes (T1D) perceive more barriers, compared with men, she added.

The menstrual cycle could be an additional barrier to exercise for women with T1D because it increases glucose fluctuations that have not been well documented in the literature to date, said Dr. Yardley, of the University of Alberta, Augustana.

The follicular phase of the menstrual cycle lasts from menses to the midcycle, about 14 days later. This is followed by the luteal phase, which lasts until approximately day 28, Dr. Yardley explained. Data on insulin sensitivity have shown that the late luteal phase is associated with “a little less insulin sensitivity” in women with T1D, she noted.

To assess the relationship between menstrual cycle, glucose control, and exercise, Dr. Yardley and colleagues compared the effects of a moderate aerobic exercise on glycemic responses between the early follicular and late luteal phases of the menstrual cycle in nine female participants with T1D.

The exercise involved 45 minutes of aerobic cycling at 50% of predetermined peak oxygen uptake (VO2peak) for 45 min. The mean age of the participants was 30.2 years, the mean hemoglobin A1C was 7.4%, and the mean VO2peak was 32.5 mL/kg per min. The women reported regular menstrual cycles, and none were using oral contraceptives.

Blood samples were collected before and immediately after exercise and after an hour of recovery. Participants wore continuous glucose monitors for at least 1 hour before and after exercise.

Menstrual cycle was confirmed via estrogen, estradiol, and progesterone.

Insulin levels varied greatly among the study participants, but the differences were not significant, Dr. Yardley said. Glucose levels consistently decreased during exercise and increased after exercise, she noted.

No significant difference in glucose was observed between the follicular and luteal phases.

However, “this needs to be interpreted in the context of the safety profiles that are in place in our lab,” which include carbohydrate supplements for individuals whose blood glucose levels drop below 4.5 mmol/L, she said.

In the current study, 6 of 9 participants required additional carbohydrates during the luteal phase, but only 1 participant needed additional carbohydrates during the follicular phase, she noted. For this reason, no differences were noted. “We actually prevented changes,” she said.

No significant differences were noted in mean glucose levels or number of hypoglycemic episodes at any of the time points between the two phases.

“One place where we did see a difference was in hyperglycemia 24 hours after exercise,” Dr. Yardley said. Level 1 hyperglycemia 24 hours after exercise was significantly more frequent in the follicular phase, compared with the luteal phase (P = .028).

The study findings were limited by the small sample size and homogenous population, and more research is needed to interpret the data, said Dr. Yardley.

However, the need for more glucose supplementation to prevent hypoglycemia during the luteal phase suggests a higher hypoglycemic risk associated with aerobic exercise during this time, she said.

In addition, the results suggest that the menstrual cycle should be taken into consideration when female participants are involved in exercise studies, she noted.

Study supports personalized exercise plans

“It is important to evaluate effects of exercise in people with type 1 diabetes and evaluate whether there is a difference those effects in men and women,” said Helena W. Rodbard, MD, an endocrinologist in private practice in Rockville, Md., in an interview. “There is also a need to evaluate to what extent the changes in blood glucose patterns in women in response to exercise differ depending on the phase of the ovarian cycle,” said Dr. Rodbard, who was not involved in the study.

In the current study, “the researchers observed a decline in glucose during a 45-minute period of moderate aerobic exercise, cycling at 50% VO2peak followed by an increase during a 60-minute recovery period. There was a suggestive finding, in the nine subjects, that more carbohydrate supplementation was needed during the late luteal phase of the menstrual cycle than during the follicular phase,” Dr. Rodbard noted. “In contrast, the authors reported a significantly increased degree of hyperglycemia during the recovery phase for subjects during the follicular phase. These findings are consistent with and extend several recent studies from Dr. Yardley and coworkers, who have been focused on this area of research,” she said.

“This study provides provocative evidence that glucose responses to aerobic exercise in women may depend on the timing in relationship to their ovarian cycle,” said Dr. Rodbard. “These findings are based on a small group of subjects and were present in some but not all subjects. Clinicians should encourage women to evaluate and record their experiences during and after exercise in terms of need for carbohydrate supplementation for documented or symptomatic hypoglycemia and in terms of glucose changes as recorded using continuous glucose monitoring (CGM), both in relation to type of exercise and in relation to time in the menstrual cycle,” she said.

The findings also highlight the importance of individualized therapy that is “based on subjective inputs combined with analysis of CGM data during and following exercise,” said Dr. Rodbard. “It is likely that use of Automated Insulin Delivery (AID) will be helpful in achieving this level of individualization in view of the wide range of types, intensity, and duration of physical activity and exercise in which people with T1D engage and the myriad factors that can influence the glycemic response,” she said.

Looking ahead, “the authors and others should expand the present series of subjects using aerobic exercise and examine other types of exercise as well,” Dr. Rodbard noted. “It will be important to evaluate the consistency of these changes in glucose patterns within individuals on multiple occasions, and it would be helpful to repeat the studies in women using oral contraceptives.”

Dr. Yardley disclosed research support from Abbott, Dexcom, and LifeScan and disclosed serving on the speaker’s bureau for Abbott Diabetes. Dr. Rodbard had no financial conflicts to disclose. She serves on the Editorial Advisory Board of Clinical Endocrinology News.

Cannabis users had a 22% increased risk of an emergency department (ED) visit or hospitalization compared to nonusers, as determined from data from more than 30,000 individuals.

Although cannabis contains compounds similar to tobacco, “data published on the association between cannabis smoking and airways health have been contradictory,” and whether smoking cannabis increases a user’s risk of developing acute respiratory illness remains unclear, wrote Nicholas T. Vozoris, MD, of the University of Toronto, and colleagues.

Smithore/Getty Images

In a study published in BMJ Open Respiratory Research, the investigators reviewed national health records data from 35,114 individuals aged 12-65 years for the period January 2009 to December 2015. Of these persons, 4,807 of the 6,425 who reported cannabis use in the past year were matched with 10,395 never-users who served as controls. The mean age of the study population at the index date was 35 years, and 42% were women; demographics were similar between users and control persons.

Overall, the odds of respiratory-related emergency department visits or hospitalizations were not significantly different between the cannabis users and the control persons (3.6% vs. 3.9%; odds ratio, 0.91). However, cannabis users had significantly greater odds of all-cause ED visits or hospitalizations (30.0% vs. 26.0%; OR, 1.22). All-cause mortality was 0.2% for both groups.

Respiratory problems were the second-highest reason for all-cause visits, the researchers noted. The lack of a difference in respiratory-related visits between cannabis users and nonusers conflicts somewhat with previous studies on this topic, which were limited, the researchers noted in their discussion.

The negative results also might stem from factors for which the researchers could not adjust, including insufficient cannabis smoke exposure among users in the study population, noninhalational cannabis use, which is less likely to have a respiratory effect, and possible secondhand exposure among control persons.

“It is also possible that our analysis might have been insufficiently powered to detect a significant signal with respect to the primary outcome,” they noted.

However, after the researchers controlled for multiple variables, the risk of an equally important morbidity outcome, all-cause ED visits or hospitalizations, was significantly greater among cannabis users than among control individuals, and respiratory reasons were the second most common cause for ED visits and hospitalizations in the all-cause outcome, they emphasized.

The study findings were limited by several factors, including the retrospective and observational design and the inability to control for all confounding variables, the researchers noted. Other limitations include the use of self-reports and potential for bias, the inability to perform dose-response analysis, and the high number of infrequent cannabis users in the study population.

However, the results suggest that cannabis use is associated with an increased risk of serious health events and should be discouraged, although more research is needed to confirm the current study findings, they concluded.
 

Consider range of causes for cannabis emergency visits

“With growing numbers of states legalizing recreational use of cannabis, it’s important to understand whether cannabis use is associated with increased emergency department visits,” Robert D. Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, told this news organization.

Previous studies have shown an association between increased ED visits and cannabis use in states, especially with edibles, where cannabis is legal, and “the current study reinforces the elevated risk of ED visits along with hospitalizations,” he said.

“While the researchers found no increased risk of respiratory-related complaints among users compared to the general population, there was an associated increase in ED visits and hospitalizations, which is important to understand,” said Dr. Glatter, who was not involved in the study.

“While this observational study found that the incidence of respiratory complaints was not significantly different among frequent users of cannabis, the increased odds that cannabis users would require evaluation in the emergency room or even hospitalization was still apparent even after the investigators controlled for such factors as use of alcohol, tobacco, illicit drug use, or other mental health–related disorders,” Dr. Glatter noted.

“That said, it’s a bit surprising that with the continued popularity of vaping, especially among teens, there was still not any appreciable or significant increase in respiratory complaints observed. Beyond this finding, I was not surprised by the overall conclusions of the current study, as we continue to see an elevated number of patients presenting to the ED with adverse events related to cannabis use.”

Dr. Glatter noted that “the majority of patients we see in the ED are associated with use of edibles, since it takes longer for the person to feel the effects, leading the user to consume more of the product up front, with delayed effects lasting up to 12 hours. This is what gets people into trouble and leads to toxicity of cannabis, or ‘overdoses,’ “ he explained.

When consuming edible cannabis products, “[p]eople need to begin at low dosages and not take additional gummies up front, since it can take up to 2 or even 3 hours in some cases to feel the initial effects. With the drug’s effects lasting up to 12 hours, it’s especially important to avoid operating any motor vehicles, bicycles, or scooters, since reaction time is impaired, as well as overall judgment, balance, and fine motor skills,” Dr. Glatter said.

Cannabis can land users in the ED for a range of reasons, said Dr. Glatter. “According to the study, 15% of the emergency room visits and hospitalizations were due to acute trauma, 14% due to respiratory issues, and 13% to gastrointestinal illnesses. These effects were seen in first-time users but not those with chronic use, according to the study inclusion criteria.”

Cannabis use could result in physical injuries through “impaired judgment, coordination, combined with an altered state of consciousness or generalized drowsiness, that could contribute to an increase in motor vehicle collisions, along with an increased risk for falls leading to lacerations, fractures, contusions, or bruising,” said Dr. Glatter. “Cannabis may also lead to an altered sense of perception related to interactions with others, resulting in feelings of anxiety or restlessness culminating in physical altercations and other injuries.”

The current study indicates the need for understanding the potential physical and psychological effects of cannabis use, he said.

“Additional research is needed to better understand the relative percentage cases related to edibles vs. inhalation presenting to the ED,” he noted. “There is no question that edibles continue to present significant dangers for those who don’t read labels or remain poorly informed regarding their dosing as a result of delayed onset and longer duration,” he said. To help reduce risk of toxicity, the concept of a “high lasting 12-15 hours, as with edibles, as opposed to 3-4 hours from inhalation must be clearly stated on packaging and better communicated with users, as the toxicity with edibles is more often from lack of prior knowledge about onset of effects related to dosing.”

In addition, the “potential for psychosis to develop with more chronic cannabis use, along with cannabinoid hyperemesis syndrome should be on every clinician’s radar,” Dr. Glatter emphasized.

“The bottom line is that as more states legalize the use of cannabis, it’s vital to also implement comprehensive public education efforts to provide users with the reported risks associated with not only inhalation (vaping or flower) but also edibles, which account for an increasingly greater percentage of ED visits and associated adverse effects,” he said.

The study was supported by the Lung Association–Ontario, as well as by grants from the Ontario Ministry of Health and the Ministry of Long-Term Care. The researchers and Dr. Glatter have disclosed no relevant financial relationships.

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

Cannabis users had a 22% increased risk of an emergency department (ED) visit or hospitalization compared to nonusers, as determined from data from more than 30,000 individuals.

Although cannabis contains compounds similar to tobacco, “data published on the association between cannabis smoking and airways health have been contradictory,” and whether smoking cannabis increases a user’s risk of developing acute respiratory illness remains unclear, wrote Nicholas T. Vozoris, MD, of the University of Toronto, and colleagues.

Smithore/Getty Images

In a study published in BMJ Open Respiratory Research, the investigators reviewed national health records data from 35,114 individuals aged 12-65 years for the period January 2009 to December 2015. Of these persons, 4,807 of the 6,425 who reported cannabis use in the past year were matched with 10,395 never-users who served as controls. The mean age of the study population at the index date was 35 years, and 42% were women; demographics were similar between users and control persons.

Overall, the odds of respiratory-related emergency department visits or hospitalizations were not significantly different between the cannabis users and the control persons (3.6% vs. 3.9%; odds ratio, 0.91). However, cannabis users had significantly greater odds of all-cause ED visits or hospitalizations (30.0% vs. 26.0%; OR, 1.22). All-cause mortality was 0.2% for both groups.

Respiratory problems were the second-highest reason for all-cause visits, the researchers noted. The lack of a difference in respiratory-related visits between cannabis users and nonusers conflicts somewhat with previous studies on this topic, which were limited, the researchers noted in their discussion.

The negative results also might stem from factors for which the researchers could not adjust, including insufficient cannabis smoke exposure among users in the study population, noninhalational cannabis use, which is less likely to have a respiratory effect, and possible secondhand exposure among control persons.

“It is also possible that our analysis might have been insufficiently powered to detect a significant signal with respect to the primary outcome,” they noted.

However, after the researchers controlled for multiple variables, the risk of an equally important morbidity outcome, all-cause ED visits or hospitalizations, was significantly greater among cannabis users than among control individuals, and respiratory reasons were the second most common cause for ED visits and hospitalizations in the all-cause outcome, they emphasized.

The study findings were limited by several factors, including the retrospective and observational design and the inability to control for all confounding variables, the researchers noted. Other limitations include the use of self-reports and potential for bias, the inability to perform dose-response analysis, and the high number of infrequent cannabis users in the study population.

However, the results suggest that cannabis use is associated with an increased risk of serious health events and should be discouraged, although more research is needed to confirm the current study findings, they concluded.
 

Consider range of causes for cannabis emergency visits

“With growing numbers of states legalizing recreational use of cannabis, it’s important to understand whether cannabis use is associated with increased emergency department visits,” Robert D. Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, told this news organization.

Previous studies have shown an association between increased ED visits and cannabis use in states, especially with edibles, where cannabis is legal, and “the current study reinforces the elevated risk of ED visits along with hospitalizations,” he said.

“While the researchers found no increased risk of respiratory-related complaints among users compared to the general population, there was an associated increase in ED visits and hospitalizations, which is important to understand,” said Dr. Glatter, who was not involved in the study.

“While this observational study found that the incidence of respiratory complaints was not significantly different among frequent users of cannabis, the increased odds that cannabis users would require evaluation in the emergency room or even hospitalization was still apparent even after the investigators controlled for such factors as use of alcohol, tobacco, illicit drug use, or other mental health–related disorders,” Dr. Glatter noted.

“That said, it’s a bit surprising that with the continued popularity of vaping, especially among teens, there was still not any appreciable or significant increase in respiratory complaints observed. Beyond this finding, I was not surprised by the overall conclusions of the current study, as we continue to see an elevated number of patients presenting to the ED with adverse events related to cannabis use.”

Dr. Glatter noted that “the majority of patients we see in the ED are associated with use of edibles, since it takes longer for the person to feel the effects, leading the user to consume more of the product up front, with delayed effects lasting up to 12 hours. This is what gets people into trouble and leads to toxicity of cannabis, or ‘overdoses,’ “ he explained.

When consuming edible cannabis products, “[p]eople need to begin at low dosages and not take additional gummies up front, since it can take up to 2 or even 3 hours in some cases to feel the initial effects. With the drug’s effects lasting up to 12 hours, it’s especially important to avoid operating any motor vehicles, bicycles, or scooters, since reaction time is impaired, as well as overall judgment, balance, and fine motor skills,” Dr. Glatter said.

Cannabis can land users in the ED for a range of reasons, said Dr. Glatter. “According to the study, 15% of the emergency room visits and hospitalizations were due to acute trauma, 14% due to respiratory issues, and 13% to gastrointestinal illnesses. These effects were seen in first-time users but not those with chronic use, according to the study inclusion criteria.”

Cannabis use could result in physical injuries through “impaired judgment, coordination, combined with an altered state of consciousness or generalized drowsiness, that could contribute to an increase in motor vehicle collisions, along with an increased risk for falls leading to lacerations, fractures, contusions, or bruising,” said Dr. Glatter. “Cannabis may also lead to an altered sense of perception related to interactions with others, resulting in feelings of anxiety or restlessness culminating in physical altercations and other injuries.”

The current study indicates the need for understanding the potential physical and psychological effects of cannabis use, he said.

“Additional research is needed to better understand the relative percentage cases related to edibles vs. inhalation presenting to the ED,” he noted. “There is no question that edibles continue to present significant dangers for those who don’t read labels or remain poorly informed regarding their dosing as a result of delayed onset and longer duration,” he said. To help reduce risk of toxicity, the concept of a “high lasting 12-15 hours, as with edibles, as opposed to 3-4 hours from inhalation must be clearly stated on packaging and better communicated with users, as the toxicity with edibles is more often from lack of prior knowledge about onset of effects related to dosing.”

In addition, the “potential for psychosis to develop with more chronic cannabis use, along with cannabinoid hyperemesis syndrome should be on every clinician’s radar,” Dr. Glatter emphasized.

“The bottom line is that as more states legalize the use of cannabis, it’s vital to also implement comprehensive public education efforts to provide users with the reported risks associated with not only inhalation (vaping or flower) but also edibles, which account for an increasingly greater percentage of ED visits and associated adverse effects,” he said.

The study was supported by the Lung Association–Ontario, as well as by grants from the Ontario Ministry of Health and the Ministry of Long-Term Care. The researchers and Dr. Glatter have disclosed no relevant financial relationships.

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

Cannabis users had a 22% increased risk of an emergency department (ED) visit or hospitalization compared to nonusers, as determined from data from more than 30,000 individuals.

Although cannabis contains compounds similar to tobacco, “data published on the association between cannabis smoking and airways health have been contradictory,” and whether smoking cannabis increases a user’s risk of developing acute respiratory illness remains unclear, wrote Nicholas T. Vozoris, MD, of the University of Toronto, and colleagues.

Smithore/Getty Images

In a study published in BMJ Open Respiratory Research, the investigators reviewed national health records data from 35,114 individuals aged 12-65 years for the period January 2009 to December 2015. Of these persons, 4,807 of the 6,425 who reported cannabis use in the past year were matched with 10,395 never-users who served as controls. The mean age of the study population at the index date was 35 years, and 42% were women; demographics were similar between users and control persons.

Overall, the odds of respiratory-related emergency department visits or hospitalizations were not significantly different between the cannabis users and the control persons (3.6% vs. 3.9%; odds ratio, 0.91). However, cannabis users had significantly greater odds of all-cause ED visits or hospitalizations (30.0% vs. 26.0%; OR, 1.22). All-cause mortality was 0.2% for both groups.

Respiratory problems were the second-highest reason for all-cause visits, the researchers noted. The lack of a difference in respiratory-related visits between cannabis users and nonusers conflicts somewhat with previous studies on this topic, which were limited, the researchers noted in their discussion.

The negative results also might stem from factors for which the researchers could not adjust, including insufficient cannabis smoke exposure among users in the study population, noninhalational cannabis use, which is less likely to have a respiratory effect, and possible secondhand exposure among control persons.

“It is also possible that our analysis might have been insufficiently powered to detect a significant signal with respect to the primary outcome,” they noted.

However, after the researchers controlled for multiple variables, the risk of an equally important morbidity outcome, all-cause ED visits or hospitalizations, was significantly greater among cannabis users than among control individuals, and respiratory reasons were the second most common cause for ED visits and hospitalizations in the all-cause outcome, they emphasized.

The study findings were limited by several factors, including the retrospective and observational design and the inability to control for all confounding variables, the researchers noted. Other limitations include the use of self-reports and potential for bias, the inability to perform dose-response analysis, and the high number of infrequent cannabis users in the study population.

However, the results suggest that cannabis use is associated with an increased risk of serious health events and should be discouraged, although more research is needed to confirm the current study findings, they concluded.
 

Consider range of causes for cannabis emergency visits

“With growing numbers of states legalizing recreational use of cannabis, it’s important to understand whether cannabis use is associated with increased emergency department visits,” Robert D. Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, told this news organization.

Previous studies have shown an association between increased ED visits and cannabis use in states, especially with edibles, where cannabis is legal, and “the current study reinforces the elevated risk of ED visits along with hospitalizations,” he said.

“While the researchers found no increased risk of respiratory-related complaints among users compared to the general population, there was an associated increase in ED visits and hospitalizations, which is important to understand,” said Dr. Glatter, who was not involved in the study.

“While this observational study found that the incidence of respiratory complaints was not significantly different among frequent users of cannabis, the increased odds that cannabis users would require evaluation in the emergency room or even hospitalization was still apparent even after the investigators controlled for such factors as use of alcohol, tobacco, illicit drug use, or other mental health–related disorders,” Dr. Glatter noted.

“That said, it’s a bit surprising that with the continued popularity of vaping, especially among teens, there was still not any appreciable or significant increase in respiratory complaints observed. Beyond this finding, I was not surprised by the overall conclusions of the current study, as we continue to see an elevated number of patients presenting to the ED with adverse events related to cannabis use.”

Dr. Glatter noted that “the majority of patients we see in the ED are associated with use of edibles, since it takes longer for the person to feel the effects, leading the user to consume more of the product up front, with delayed effects lasting up to 12 hours. This is what gets people into trouble and leads to toxicity of cannabis, or ‘overdoses,’ “ he explained.

When consuming edible cannabis products, “[p]eople need to begin at low dosages and not take additional gummies up front, since it can take up to 2 or even 3 hours in some cases to feel the initial effects. With the drug’s effects lasting up to 12 hours, it’s especially important to avoid operating any motor vehicles, bicycles, or scooters, since reaction time is impaired, as well as overall judgment, balance, and fine motor skills,” Dr. Glatter said.

Cannabis can land users in the ED for a range of reasons, said Dr. Glatter. “According to the study, 15% of the emergency room visits and hospitalizations were due to acute trauma, 14% due to respiratory issues, and 13% to gastrointestinal illnesses. These effects were seen in first-time users but not those with chronic use, according to the study inclusion criteria.”

Cannabis use could result in physical injuries through “impaired judgment, coordination, combined with an altered state of consciousness or generalized drowsiness, that could contribute to an increase in motor vehicle collisions, along with an increased risk for falls leading to lacerations, fractures, contusions, or bruising,” said Dr. Glatter. “Cannabis may also lead to an altered sense of perception related to interactions with others, resulting in feelings of anxiety or restlessness culminating in physical altercations and other injuries.”

The current study indicates the need for understanding the potential physical and psychological effects of cannabis use, he said.

“Additional research is needed to better understand the relative percentage cases related to edibles vs. inhalation presenting to the ED,” he noted. “There is no question that edibles continue to present significant dangers for those who don’t read labels or remain poorly informed regarding their dosing as a result of delayed onset and longer duration,” he said. To help reduce risk of toxicity, the concept of a “high lasting 12-15 hours, as with edibles, as opposed to 3-4 hours from inhalation must be clearly stated on packaging and better communicated with users, as the toxicity with edibles is more often from lack of prior knowledge about onset of effects related to dosing.”

In addition, the “potential for psychosis to develop with more chronic cannabis use, along with cannabinoid hyperemesis syndrome should be on every clinician’s radar,” Dr. Glatter emphasized.

“The bottom line is that as more states legalize the use of cannabis, it’s vital to also implement comprehensive public education efforts to provide users with the reported risks associated with not only inhalation (vaping or flower) but also edibles, which account for an increasingly greater percentage of ED visits and associated adverse effects,” he said.

The study was supported by the Lung Association–Ontario, as well as by grants from the Ontario Ministry of Health and the Ministry of Long-Term Care. The researchers and Dr. Glatter have disclosed no relevant financial relationships.

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