Heidi Splete

The Food and Drug Administration has approved the oral medication fezolinetant (Veozah) for the treatment of moderate to severe hot flashes in menopausal women, according to an FDA statement. The approved dose is 45 mg once daily.

Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is the first drug of its kind to earn FDA approval for the vasomotor symptoms associated with menopause, according to the statement. The drug works by binding to the NK3 receptor, which plays a role in regulating body temperature, and blocking its activity. Fezolinetant is not a hormone, and can be taken by women for whom hormones are contraindicated, such as those with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease, the FDA stated.

The approval was based on data from the SKYLIGHT 2 trial, results of which were presented at the annual meeting of the Endocrine Society, reported by this news organization, and published in the Journal of Clinical Endocrinology and Metabolism.

In the two-phase trial, women were randomized to 30 mg or 45 mg of fezolinetant or a placebo. After 12 weeks, women in placebo groups were rerandomized to fezolinetant for a 40-week safety study.

The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe.

At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.

The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and a press release from the manufacturer Astellas.

The most common side effects associated with fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, according to the FDA statement. The FDA granted Astellas Pharma’s application a Priority Review designation. Astellas has priced the drug at $550 for a 30-day supply, significantly higher than the Institute for Clinical and Economic Review’s previously recommended range of $2,000 to $2,500 per year.

Full prescribing information is available here.

The Food and Drug Administration has approved the oral medication fezolinetant (Veozah) for the treatment of moderate to severe hot flashes in menopausal women, according to an FDA statement. The approved dose is 45 mg once daily.

Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is the first drug of its kind to earn FDA approval for the vasomotor symptoms associated with menopause, according to the statement. The drug works by binding to the NK3 receptor, which plays a role in regulating body temperature, and blocking its activity. Fezolinetant is not a hormone, and can be taken by women for whom hormones are contraindicated, such as those with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease, the FDA stated.

The approval was based on data from the SKYLIGHT 2 trial, results of which were presented at the annual meeting of the Endocrine Society, reported by this news organization, and published in the Journal of Clinical Endocrinology and Metabolism.

In the two-phase trial, women were randomized to 30 mg or 45 mg of fezolinetant or a placebo. After 12 weeks, women in placebo groups were rerandomized to fezolinetant for a 40-week safety study.

The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe.

At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.

The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and a press release from the manufacturer Astellas.

The most common side effects associated with fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, according to the FDA statement. The FDA granted Astellas Pharma’s application a Priority Review designation. Astellas has priced the drug at $550 for a 30-day supply, significantly higher than the Institute for Clinical and Economic Review’s previously recommended range of $2,000 to $2,500 per year.

Full prescribing information is available here.

The Food and Drug Administration has approved the oral medication fezolinetant (Veozah) for the treatment of moderate to severe hot flashes in menopausal women, according to an FDA statement. The approved dose is 45 mg once daily.

Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is the first drug of its kind to earn FDA approval for the vasomotor symptoms associated with menopause, according to the statement. The drug works by binding to the NK3 receptor, which plays a role in regulating body temperature, and blocking its activity. Fezolinetant is not a hormone, and can be taken by women for whom hormones are contraindicated, such as those with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease, the FDA stated.

The approval was based on data from the SKYLIGHT 2 trial, results of which were presented at the annual meeting of the Endocrine Society, reported by this news organization, and published in the Journal of Clinical Endocrinology and Metabolism.

In the two-phase trial, women were randomized to 30 mg or 45 mg of fezolinetant or a placebo. After 12 weeks, women in placebo groups were rerandomized to fezolinetant for a 40-week safety study.

The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe.

At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.

The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and a press release from the manufacturer Astellas.

The most common side effects associated with fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, according to the FDA statement. The FDA granted Astellas Pharma’s application a Priority Review designation. Astellas has priced the drug at $550 for a 30-day supply, significantly higher than the Institute for Clinical and Economic Review’s previously recommended range of $2,000 to $2,500 per year.

Full prescribing information is available here.

In postmenopausal women with hormone receptor–positive breast cancer, overweight and obesity were overall predictors of lower disease-free survival, but body mass index had no apparent association with the effect of extended endocrine therapy on disease-free survival, new data suggest.

Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.

Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.

The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.

Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²), or obese (30 kg/m² or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.

DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).

“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.

In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.

The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.

In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.

When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
 

Data draw attention to quality of life and lifestyle factors

The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.

Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.

Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.

“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.

The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.

In postmenopausal women with hormone receptor–positive breast cancer, overweight and obesity were overall predictors of lower disease-free survival, but body mass index had no apparent association with the effect of extended endocrine therapy on disease-free survival, new data suggest.

Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.

Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.

The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.

Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²), or obese (30 kg/m² or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.

DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).

“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.

In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.

The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.

In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.

When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
 

Data draw attention to quality of life and lifestyle factors

The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.

Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.

Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.

“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.

The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.

In postmenopausal women with hormone receptor–positive breast cancer, overweight and obesity were overall predictors of lower disease-free survival, but body mass index had no apparent association with the effect of extended endocrine therapy on disease-free survival, new data suggest.

Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.

Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.

The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.

Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²), or obese (30 kg/m² or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.

DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).

“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.

In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.

The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.

In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.

When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
 

Data draw attention to quality of life and lifestyle factors

The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.

Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.

Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.

“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.

The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

Adults with cutaneous vasculitis experience a significantly diminished quality of life across physical, symptom, and emotional domains, and its measurement with an organ-specific instrument may catch important disease outcomes better than a generic health-related quality of life index, according to survey responses from participants in the Vasculitis Patient-Powered Research Network (VPPRN).

Although cutaneous vasculitis often causes itching, pain, and ulceration, the impact of the disease on specific health-related quality of life (HRQOL) outcomes has not been systematically assessed, wrote Sarah Mann, MD, of the University of Pittsburgh, and colleagues.

In a study published in JAMA Dermatology, the researchers used the VPPRN to conduct an online survey of adults aged 18 years and older with cutaneous manifestations of vasculitis. The survey was conducted between January 2020 and August 2021.

The primary outcomes of HRQOL were determined using two validated measures. One measured skin-related HRQOL (the Effects of Skin Disease on Quality-of-Life Survey [Skindex-29]), and the other measured general health and well-being (36-Item Short Form Health Survey [SF-36]).

The final analysis included 190 survey responses. The mean age of the respondents was 50.5 years, 84.1% were female, and approximately two-thirds reported a duration of vasculitis of at least 5 years. Respondents’ vasculitides included cutaneous small-vessel vasculitis (14%), IgA vasculitis (6.5%), urticarial vasculitis (8.4%), granulomatosis with polyangiitis (17.6%), microscopic polyangiitis (10.3%), eosinophilic vasculitis (15%), polyarteritis nodosa (3.7%), and other vasculitis types (24.2%).

On the Skindex-29 domains, severely or very severely diminished HRQOL was reported by 77.6% of respondents for emotions, 78.5% for symptoms, 60.7% for functioning, and 75.7% for overall HRQOL.

On the SF-36, the HRQOL was below average on six of eight domains, and approximately half of the patients had summative physical component scores (56%) and mental component scores (52%) below 50.

The HRQOL outcomes of cutaneous vasculitis were worse on the Skindex-29 than the SF-36, the researchers noted. “This discordance may reflect the value of disease or organ-specific measures, which may be able to capture important outcomes of disease even when generic measures do not,” they said.

The study findings were limited by several factors, including the potential lack of generalizability to broader populations of vasculitis patients, the researchers noted. Other limitations included the underrepresentation of male patients and the lack of a disease-specific patient-reported outcome measure, they said.

In addition, “Because half of patients reported having disease which was in remission or mildly active, the study findings may underestimate the true role of active cutaneous vasculitis on HRQOL,” the researchers said.

More studies are needed to assess how HRQOL measures respond to disease treatment and control, the researchers wrote in their discussion. However, the results suggest that cutaneous vasculitis has a significant effect on patients’ perception of their health, as well as on their well-being and symptoms, they said.

The study was supported by the Patient-Centered Outcomes Research Institute and GlaxoSmithKline. Dr. Mann had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including GlaxoSmithKline.

Adults with cutaneous vasculitis experience a significantly diminished quality of life across physical, symptom, and emotional domains, and its measurement with an organ-specific instrument may catch important disease outcomes better than a generic health-related quality of life index, according to survey responses from participants in the Vasculitis Patient-Powered Research Network (VPPRN).

Although cutaneous vasculitis often causes itching, pain, and ulceration, the impact of the disease on specific health-related quality of life (HRQOL) outcomes has not been systematically assessed, wrote Sarah Mann, MD, of the University of Pittsburgh, and colleagues.

In a study published in JAMA Dermatology, the researchers used the VPPRN to conduct an online survey of adults aged 18 years and older with cutaneous manifestations of vasculitis. The survey was conducted between January 2020 and August 2021.

The primary outcomes of HRQOL were determined using two validated measures. One measured skin-related HRQOL (the Effects of Skin Disease on Quality-of-Life Survey [Skindex-29]), and the other measured general health and well-being (36-Item Short Form Health Survey [SF-36]).

The final analysis included 190 survey responses. The mean age of the respondents was 50.5 years, 84.1% were female, and approximately two-thirds reported a duration of vasculitis of at least 5 years. Respondents’ vasculitides included cutaneous small-vessel vasculitis (14%), IgA vasculitis (6.5%), urticarial vasculitis (8.4%), granulomatosis with polyangiitis (17.6%), microscopic polyangiitis (10.3%), eosinophilic vasculitis (15%), polyarteritis nodosa (3.7%), and other vasculitis types (24.2%).

On the Skindex-29 domains, severely or very severely diminished HRQOL was reported by 77.6% of respondents for emotions, 78.5% for symptoms, 60.7% for functioning, and 75.7% for overall HRQOL.

On the SF-36, the HRQOL was below average on six of eight domains, and approximately half of the patients had summative physical component scores (56%) and mental component scores (52%) below 50.

The HRQOL outcomes of cutaneous vasculitis were worse on the Skindex-29 than the SF-36, the researchers noted. “This discordance may reflect the value of disease or organ-specific measures, which may be able to capture important outcomes of disease even when generic measures do not,” they said.

The study findings were limited by several factors, including the potential lack of generalizability to broader populations of vasculitis patients, the researchers noted. Other limitations included the underrepresentation of male patients and the lack of a disease-specific patient-reported outcome measure, they said.

In addition, “Because half of patients reported having disease which was in remission or mildly active, the study findings may underestimate the true role of active cutaneous vasculitis on HRQOL,” the researchers said.

More studies are needed to assess how HRQOL measures respond to disease treatment and control, the researchers wrote in their discussion. However, the results suggest that cutaneous vasculitis has a significant effect on patients’ perception of their health, as well as on their well-being and symptoms, they said.

The study was supported by the Patient-Centered Outcomes Research Institute and GlaxoSmithKline. Dr. Mann had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including GlaxoSmithKline.

Adults with cutaneous vasculitis experience a significantly diminished quality of life across physical, symptom, and emotional domains, and its measurement with an organ-specific instrument may catch important disease outcomes better than a generic health-related quality of life index, according to survey responses from participants in the Vasculitis Patient-Powered Research Network (VPPRN).

Although cutaneous vasculitis often causes itching, pain, and ulceration, the impact of the disease on specific health-related quality of life (HRQOL) outcomes has not been systematically assessed, wrote Sarah Mann, MD, of the University of Pittsburgh, and colleagues.

In a study published in JAMA Dermatology, the researchers used the VPPRN to conduct an online survey of adults aged 18 years and older with cutaneous manifestations of vasculitis. The survey was conducted between January 2020 and August 2021.

The primary outcomes of HRQOL were determined using two validated measures. One measured skin-related HRQOL (the Effects of Skin Disease on Quality-of-Life Survey [Skindex-29]), and the other measured general health and well-being (36-Item Short Form Health Survey [SF-36]).

The final analysis included 190 survey responses. The mean age of the respondents was 50.5 years, 84.1% were female, and approximately two-thirds reported a duration of vasculitis of at least 5 years. Respondents’ vasculitides included cutaneous small-vessel vasculitis (14%), IgA vasculitis (6.5%), urticarial vasculitis (8.4%), granulomatosis with polyangiitis (17.6%), microscopic polyangiitis (10.3%), eosinophilic vasculitis (15%), polyarteritis nodosa (3.7%), and other vasculitis types (24.2%).

On the Skindex-29 domains, severely or very severely diminished HRQOL was reported by 77.6% of respondents for emotions, 78.5% for symptoms, 60.7% for functioning, and 75.7% for overall HRQOL.

On the SF-36, the HRQOL was below average on six of eight domains, and approximately half of the patients had summative physical component scores (56%) and mental component scores (52%) below 50.

The HRQOL outcomes of cutaneous vasculitis were worse on the Skindex-29 than the SF-36, the researchers noted. “This discordance may reflect the value of disease or organ-specific measures, which may be able to capture important outcomes of disease even when generic measures do not,” they said.

The study findings were limited by several factors, including the potential lack of generalizability to broader populations of vasculitis patients, the researchers noted. Other limitations included the underrepresentation of male patients and the lack of a disease-specific patient-reported outcome measure, they said.

In addition, “Because half of patients reported having disease which was in remission or mildly active, the study findings may underestimate the true role of active cutaneous vasculitis on HRQOL,” the researchers said.

More studies are needed to assess how HRQOL measures respond to disease treatment and control, the researchers wrote in their discussion. However, the results suggest that cutaneous vasculitis has a significant effect on patients’ perception of their health, as well as on their well-being and symptoms, they said.

The study was supported by the Patient-Centered Outcomes Research Institute and GlaxoSmithKline. Dr. Mann had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including GlaxoSmithKline.

Use of intravenous immunoglobulin (IVIG) had no apparent effect on the risk of venous thromboembolism (VTE) in adults with dermatomyositis (DM), based on data from more than 400 individuals.

DM has been associated with an increased risk of VTE in previous studies, wrote Elizabeth T. Rotrosen, of Boston University and Brigham and Women’s Hospital, Boston, and colleagues. Although IVIG is often effective for DM patients with recalcitrant disease, it carries a boxed warning for increased thrombosis risk; however, the association between IVIG use and VTE risk in DM has not been well examined, the researchers said.

In a study published in JAMA Dermatology, the researchers identified 458 adults with DM based on the European Alliance of Associations for Reumatology/American College of Rheumatology criteria. The mean age of the participants was 51.8 years, 76% were female, and 82% were White. Of these, 178 were treated with IVIG and 280 were not. The mean duration of IVIG treatment was 32.9 months. The researchers used the chi square test to test for independence between binary variables, the Pearson chi square test to test for independence between categorical variables, and the unpaired t test to compare continuous variables in their statistical analysis.

A total of 23 patients experienced DM-associated VTEs; 6 in the IVIG group and 17 in the non-IVIG group (3.4% vs. 5.7%, P = .20), a nonsignificant difference. The patients in the IVIG group who experienced a DM-associated VTE all underwent IVIG treatment within 4 weeks before the event.

bong hyunjung/iStock/Getty Images

The study findings were limited by several factors, including the retrospective design and small number of VTEs. Prospective studies are needed for better assessment of the VTE risk in patients with DM treated with IVIG, the researchers noted. However, the study is the largest known to explore the association between IVIG use and VTE risk in patients with DM, they said, and the results suggest that clinicians may continue IVIG use in these patients with considerations of risks and benefits on an individual basis.

The study received no outside funding. Ms. Rotrosen had no financial conflicts to disclose. Two coauthors reported financial relationships with Pfizer unrelated to this study.

Use of intravenous immunoglobulin (IVIG) had no apparent effect on the risk of venous thromboembolism (VTE) in adults with dermatomyositis (DM), based on data from more than 400 individuals.

DM has been associated with an increased risk of VTE in previous studies, wrote Elizabeth T. Rotrosen, of Boston University and Brigham and Women’s Hospital, Boston, and colleagues. Although IVIG is often effective for DM patients with recalcitrant disease, it carries a boxed warning for increased thrombosis risk; however, the association between IVIG use and VTE risk in DM has not been well examined, the researchers said.

In a study published in JAMA Dermatology, the researchers identified 458 adults with DM based on the European Alliance of Associations for Reumatology/American College of Rheumatology criteria. The mean age of the participants was 51.8 years, 76% were female, and 82% were White. Of these, 178 were treated with IVIG and 280 were not. The mean duration of IVIG treatment was 32.9 months. The researchers used the chi square test to test for independence between binary variables, the Pearson chi square test to test for independence between categorical variables, and the unpaired t test to compare continuous variables in their statistical analysis.

A total of 23 patients experienced DM-associated VTEs; 6 in the IVIG group and 17 in the non-IVIG group (3.4% vs. 5.7%, P = .20), a nonsignificant difference. The patients in the IVIG group who experienced a DM-associated VTE all underwent IVIG treatment within 4 weeks before the event.

bong hyunjung/iStock/Getty Images

The study findings were limited by several factors, including the retrospective design and small number of VTEs. Prospective studies are needed for better assessment of the VTE risk in patients with DM treated with IVIG, the researchers noted. However, the study is the largest known to explore the association between IVIG use and VTE risk in patients with DM, they said, and the results suggest that clinicians may continue IVIG use in these patients with considerations of risks and benefits on an individual basis.

The study received no outside funding. Ms. Rotrosen had no financial conflicts to disclose. Two coauthors reported financial relationships with Pfizer unrelated to this study.

Use of intravenous immunoglobulin (IVIG) had no apparent effect on the risk of venous thromboembolism (VTE) in adults with dermatomyositis (DM), based on data from more than 400 individuals.

DM has been associated with an increased risk of VTE in previous studies, wrote Elizabeth T. Rotrosen, of Boston University and Brigham and Women’s Hospital, Boston, and colleagues. Although IVIG is often effective for DM patients with recalcitrant disease, it carries a boxed warning for increased thrombosis risk; however, the association between IVIG use and VTE risk in DM has not been well examined, the researchers said.

In a study published in JAMA Dermatology, the researchers identified 458 adults with DM based on the European Alliance of Associations for Reumatology/American College of Rheumatology criteria. The mean age of the participants was 51.8 years, 76% were female, and 82% were White. Of these, 178 were treated with IVIG and 280 were not. The mean duration of IVIG treatment was 32.9 months. The researchers used the chi square test to test for independence between binary variables, the Pearson chi square test to test for independence between categorical variables, and the unpaired t test to compare continuous variables in their statistical analysis.

A total of 23 patients experienced DM-associated VTEs; 6 in the IVIG group and 17 in the non-IVIG group (3.4% vs. 5.7%, P = .20), a nonsignificant difference. The patients in the IVIG group who experienced a DM-associated VTE all underwent IVIG treatment within 4 weeks before the event.

bong hyunjung/iStock/Getty Images

The study findings were limited by several factors, including the retrospective design and small number of VTEs. Prospective studies are needed for better assessment of the VTE risk in patients with DM treated with IVIG, the researchers noted. However, the study is the largest known to explore the association between IVIG use and VTE risk in patients with DM, they said, and the results suggest that clinicians may continue IVIG use in these patients with considerations of risks and benefits on an individual basis.

The study received no outside funding. Ms. Rotrosen had no financial conflicts to disclose. Two coauthors reported financial relationships with Pfizer unrelated to this study.

WASHINGTON – A bundled intervention combining point-of-care testing, electronic medical record support, and provider education significantly improved lipid screening rates in children aged 9-11 years, according to data from approximately 100 monthly visits over a 3-year period.

Guidelines from the National Heart, Lung, and Blood Institute currently recommend universal lipid screening for children aged 9-11 years, but screening rates in clinical practice remain low, according to Ruth E. Gardner, MD, of Penn State University, Hershey, and colleagues.

In a poster presented at the Pediatric Academic Societies annual meeting, Dr. Gardner and colleagues shared results of the implementation of a bundled testing protocol designed to improve screening.

The researchers reviewed data on lipid testing within 30 days for all 9- to 11-year-old well child visits at a single center between May 2019 and February 2022. The bundled intervention was introduced in May 2021.

The bundled protocol included in-office capillary testing and provider education. In addition, electronic medical record templates were modified to include prompts for lipid screening at relevant ages, and EMR orders were adjusted to include lipid testing. The researchers also collected targeted provider feedback on individualized screening rates in February 2022.

Screening rates were plotted monthly. For the period from May 2019 through May 2021, the rates averaged 6.5%. However, after the introduction of the bundled intervention, the rate increased to 29.9%. Following targeted provider feedback in February 2022, the researchers found an additional shift to 52.1% through March and April 2022.

The findings were limited by the use of data from a single center, and the researchers used an extended study period to account for disruptions to well-child care in the spring of 2020 related to the COVID-19 pandemic.

However, the results support the effectiveness of a bundled intervention for improving lipid screening rates in children aged 9-11 years, the researchers said, and targeted provider feedback and education could yield additional improvements, they concluded.
 

Preteen years are an optimal time for screening

“The current study is important because atherosclerosis begins in childhood, and screening at ages 9-11 is an optimal time to begin lifestyle changes to improve overall health and reduce risks of heart disease,” said Margaret Thew, DNP, FNP-BC, of the Medical College of Wisconsin, Milwaukee, in an interview.

Ms. Thew, who was not involved in the study, said, “The number of recommended and required screening items needed in pediatrics is vast, so many providers have to select which items to focus on for their health screenings with these ages.”

Overall, “I was impressed with the improvements that were made in this quality improvement study,” said Ms. Thew.

Barriers to lipid screening in this population include the reduced number of health screenings and immunizations recommended for this age group; the consequence is that access is limited to discuss preventive care opportunities, said Ms. Thew in an interview. Steps to overcome these barriers could include the use of many of the screening tools introduced in the current study, such as point-of-care testing in the office, use of the EMR to remind providers of testing, which can be done during well visits or school physicals, and educating providers about the current guidelines, she noted.

Other strategies to increase screening include moving the immunization series to provide more frequent appointments to children aged 9-11 years to offer education and preventive care, Ms. Thew added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
 

WASHINGTON – A bundled intervention combining point-of-care testing, electronic medical record support, and provider education significantly improved lipid screening rates in children aged 9-11 years, according to data from approximately 100 monthly visits over a 3-year period.

Guidelines from the National Heart, Lung, and Blood Institute currently recommend universal lipid screening for children aged 9-11 years, but screening rates in clinical practice remain low, according to Ruth E. Gardner, MD, of Penn State University, Hershey, and colleagues.

In a poster presented at the Pediatric Academic Societies annual meeting, Dr. Gardner and colleagues shared results of the implementation of a bundled testing protocol designed to improve screening.

The researchers reviewed data on lipid testing within 30 days for all 9- to 11-year-old well child visits at a single center between May 2019 and February 2022. The bundled intervention was introduced in May 2021.

The bundled protocol included in-office capillary testing and provider education. In addition, electronic medical record templates were modified to include prompts for lipid screening at relevant ages, and EMR orders were adjusted to include lipid testing. The researchers also collected targeted provider feedback on individualized screening rates in February 2022.

Screening rates were plotted monthly. For the period from May 2019 through May 2021, the rates averaged 6.5%. However, after the introduction of the bundled intervention, the rate increased to 29.9%. Following targeted provider feedback in February 2022, the researchers found an additional shift to 52.1% through March and April 2022.

The findings were limited by the use of data from a single center, and the researchers used an extended study period to account for disruptions to well-child care in the spring of 2020 related to the COVID-19 pandemic.

However, the results support the effectiveness of a bundled intervention for improving lipid screening rates in children aged 9-11 years, the researchers said, and targeted provider feedback and education could yield additional improvements, they concluded.
 

Preteen years are an optimal time for screening

“The current study is important because atherosclerosis begins in childhood, and screening at ages 9-11 is an optimal time to begin lifestyle changes to improve overall health and reduce risks of heart disease,” said Margaret Thew, DNP, FNP-BC, of the Medical College of Wisconsin, Milwaukee, in an interview.

Ms. Thew, who was not involved in the study, said, “The number of recommended and required screening items needed in pediatrics is vast, so many providers have to select which items to focus on for their health screenings with these ages.”

Overall, “I was impressed with the improvements that were made in this quality improvement study,” said Ms. Thew.

Barriers to lipid screening in this population include the reduced number of health screenings and immunizations recommended for this age group; the consequence is that access is limited to discuss preventive care opportunities, said Ms. Thew in an interview. Steps to overcome these barriers could include the use of many of the screening tools introduced in the current study, such as point-of-care testing in the office, use of the EMR to remind providers of testing, which can be done during well visits or school physicals, and educating providers about the current guidelines, she noted.

Other strategies to increase screening include moving the immunization series to provide more frequent appointments to children aged 9-11 years to offer education and preventive care, Ms. Thew added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
 

WASHINGTON – A bundled intervention combining point-of-care testing, electronic medical record support, and provider education significantly improved lipid screening rates in children aged 9-11 years, according to data from approximately 100 monthly visits over a 3-year period.

Guidelines from the National Heart, Lung, and Blood Institute currently recommend universal lipid screening for children aged 9-11 years, but screening rates in clinical practice remain low, according to Ruth E. Gardner, MD, of Penn State University, Hershey, and colleagues.

In a poster presented at the Pediatric Academic Societies annual meeting, Dr. Gardner and colleagues shared results of the implementation of a bundled testing protocol designed to improve screening.

The researchers reviewed data on lipid testing within 30 days for all 9- to 11-year-old well child visits at a single center between May 2019 and February 2022. The bundled intervention was introduced in May 2021.

The bundled protocol included in-office capillary testing and provider education. In addition, electronic medical record templates were modified to include prompts for lipid screening at relevant ages, and EMR orders were adjusted to include lipid testing. The researchers also collected targeted provider feedback on individualized screening rates in February 2022.

Screening rates were plotted monthly. For the period from May 2019 through May 2021, the rates averaged 6.5%. However, after the introduction of the bundled intervention, the rate increased to 29.9%. Following targeted provider feedback in February 2022, the researchers found an additional shift to 52.1% through March and April 2022.

The findings were limited by the use of data from a single center, and the researchers used an extended study period to account for disruptions to well-child care in the spring of 2020 related to the COVID-19 pandemic.

However, the results support the effectiveness of a bundled intervention for improving lipid screening rates in children aged 9-11 years, the researchers said, and targeted provider feedback and education could yield additional improvements, they concluded.
 

Preteen years are an optimal time for screening

“The current study is important because atherosclerosis begins in childhood, and screening at ages 9-11 is an optimal time to begin lifestyle changes to improve overall health and reduce risks of heart disease,” said Margaret Thew, DNP, FNP-BC, of the Medical College of Wisconsin, Milwaukee, in an interview.

Ms. Thew, who was not involved in the study, said, “The number of recommended and required screening items needed in pediatrics is vast, so many providers have to select which items to focus on for their health screenings with these ages.”

Overall, “I was impressed with the improvements that were made in this quality improvement study,” said Ms. Thew.

Barriers to lipid screening in this population include the reduced number of health screenings and immunizations recommended for this age group; the consequence is that access is limited to discuss preventive care opportunities, said Ms. Thew in an interview. Steps to overcome these barriers could include the use of many of the screening tools introduced in the current study, such as point-of-care testing in the office, use of the EMR to remind providers of testing, which can be done during well visits or school physicals, and educating providers about the current guidelines, she noted.

Other strategies to increase screening include moving the immunization series to provide more frequent appointments to children aged 9-11 years to offer education and preventive care, Ms. Thew added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
 

WASHINGTON – A nonpharmacologic, interdisciplinary program significantly improved chronic pain in children and the quality of life for their families, based on data from 115 individuals.

Up to 40% of children experience chronic pain that affects their physical, psychosocial, and educational functioning, said Jessica Campanile, BA, a medical student at the University of Pennsylvania, Philadelphia, in a presentation at the Pediatric Academic Societies annual meeting.

Although interdisciplinary pediatric pain rehabilitation programs have shown positive outcomes, very few use only nonpharmacologic treatments, said Ms. Campanile. In addition, few studies have explored the effects of a hospital-based program on the patients and their families.

Ms. Campanile and colleagues conducted a retrospective cohort study of participants in an outpatient pain rehabilitation program at the Children’s Hospital of Philadelphia between April 2016 and December 2019. Patients were evaluated by a pediatric rheumatologist, psychologist, and physical and occupational therapists.

Patients engaged in 2-3 hours of physical therapy (PT) and 2-3 hours of occupational therapy (OT) in a 1:1 ratio at least 5 days a week. Physical activities included stepping into and out of a tub, carrying laundry, and desensitizing to allodynia as needed. Participants also received individual and group cognitive-behavior therapy interventions from psychologists, and psychological support during PT and OT sessions if needed. Parents/caregivers were invited to separate individual and group therapy sessions as part of the program. The median age at admission to the program was 15 years, and 79% of the participants were female. Patients participated the program for a median of 17 days, and 87% were outpatients who came to the hospital for the program.

Pain was assessed based on the 0-10 verbal pain intensity scale, energy was assessed on a scale of 0-100, and functional disability was assessed on a scale of 0-60, with higher scores indicating more pain, more energy, and more self-perceived disability, respectively.

Overall, scores on measures of pain, disability, allodynia, and energy improved significantly from baseline to discharge from the program. Verbal pain intensity scores decreased on average from 7 to 5, disability scores decreased from 26 to 9, the proportion of patients reporting allodynia decreased from 86% to 61%, and the energy level score increased from 70 to 77. The trend continued at the first follow-up visit, conducted 2-3 months after discharge from the program. Notably, pain intensity further decreased from a median of 5 at program completion to a median of 2 at the first follow-up, Ms. Campanile said. Improvements in allodynia also were sustained at the first follow-up.

Quality of life measures related to physical, emotional, social, and cognitive function also improved significantly from baseline to completion of the program.

In addition, scores on a quality of life family impact survey improved significantly; in particular, parent health-related quality of life scores (Parent HRQoL) improved from 60 at baseline to 71 at the end of the program on a scale of 0 to 100. The study findings were limited by several factors including the relatively short duration and use of a convenience sample from a retrospective cohort, with data limited to electronic health records, Ms. Campanile said. The study also was not powered to examine differential treatments based on psychiatric conditions, and any psychiatric conditions were based on self-reports.

However, the results support the value of a nonpharmacologic interdisciplinary program as “a robust treatment for youth with chronic idiopathic pain, for both patients and the family unit,” she said.

“This study also supports the need for and benefit of additional counseling for patients and their caregivers prior to and during enrollment in a pain rehabilitation program,” she concluded.
 

Study supports effectiveness of drug-free pain management

“The management of pain in any age group can be challenging, especially with current concerns for opioid dependence and abuse,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Chronic pain affects daily life for all populations, but for children, adolescents, and their families, it can have a long-lasting impact on growth and development, psychosocial and physical well-being,” Dr. Haut said. “Determining and testing nonpharmacologic alternative methods of pain control are extremely important.”

Given the debilitating effects of chronic pain, and the potential side effects and dependence that have been associated with use of pharmacologic modes of pain control, unique and creative solutions have begun to emerge and need further attention and study, she said.

However, “despite published research supporting the use of alternative and complementary approaches to pain control in children and adolescents, nonpharmacologic, collaborative, interprofessional approaches to pain control have not been widely shared in the literature,” she said.

“Barriers to this type of program include first and foremost a potential lack of financial and workforce-related resources,” Dr. Haut said. “Patient and family attendance at frequent health visits, daily or even every other day, may also hinder success, but opportunities for telehealth and family training to learn physical and occupational skills within this type of program may be beginning solutions.”

Additional research should be conducted at multiple children’s hospitals, with a larger number of children and adolescents at varying ages, with pain related to different diagnoses, and with the inclusion of collaborative methodology, said Dr. Haut. “The current study had some limitations, including the small sample size, predominantly female sex, and a short participation time frame utilizing retrospective review. Completing prospective research over a longer time frame can also yield generalizable results applicable to varied populations.”

The study received no outside funding. Ms. Campanile had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, and serves on the editorial advisory board of Pediatric News.

WASHINGTON – A nonpharmacologic, interdisciplinary program significantly improved chronic pain in children and the quality of life for their families, based on data from 115 individuals.

Up to 40% of children experience chronic pain that affects their physical, psychosocial, and educational functioning, said Jessica Campanile, BA, a medical student at the University of Pennsylvania, Philadelphia, in a presentation at the Pediatric Academic Societies annual meeting.

Although interdisciplinary pediatric pain rehabilitation programs have shown positive outcomes, very few use only nonpharmacologic treatments, said Ms. Campanile. In addition, few studies have explored the effects of a hospital-based program on the patients and their families.

Ms. Campanile and colleagues conducted a retrospective cohort study of participants in an outpatient pain rehabilitation program at the Children’s Hospital of Philadelphia between April 2016 and December 2019. Patients were evaluated by a pediatric rheumatologist, psychologist, and physical and occupational therapists.

Patients engaged in 2-3 hours of physical therapy (PT) and 2-3 hours of occupational therapy (OT) in a 1:1 ratio at least 5 days a week. Physical activities included stepping into and out of a tub, carrying laundry, and desensitizing to allodynia as needed. Participants also received individual and group cognitive-behavior therapy interventions from psychologists, and psychological support during PT and OT sessions if needed. Parents/caregivers were invited to separate individual and group therapy sessions as part of the program. The median age at admission to the program was 15 years, and 79% of the participants were female. Patients participated the program for a median of 17 days, and 87% were outpatients who came to the hospital for the program.

Pain was assessed based on the 0-10 verbal pain intensity scale, energy was assessed on a scale of 0-100, and functional disability was assessed on a scale of 0-60, with higher scores indicating more pain, more energy, and more self-perceived disability, respectively.

Overall, scores on measures of pain, disability, allodynia, and energy improved significantly from baseline to discharge from the program. Verbal pain intensity scores decreased on average from 7 to 5, disability scores decreased from 26 to 9, the proportion of patients reporting allodynia decreased from 86% to 61%, and the energy level score increased from 70 to 77. The trend continued at the first follow-up visit, conducted 2-3 months after discharge from the program. Notably, pain intensity further decreased from a median of 5 at program completion to a median of 2 at the first follow-up, Ms. Campanile said. Improvements in allodynia also were sustained at the first follow-up.

Quality of life measures related to physical, emotional, social, and cognitive function also improved significantly from baseline to completion of the program.

In addition, scores on a quality of life family impact survey improved significantly; in particular, parent health-related quality of life scores (Parent HRQoL) improved from 60 at baseline to 71 at the end of the program on a scale of 0 to 100. The study findings were limited by several factors including the relatively short duration and use of a convenience sample from a retrospective cohort, with data limited to electronic health records, Ms. Campanile said. The study also was not powered to examine differential treatments based on psychiatric conditions, and any psychiatric conditions were based on self-reports.

However, the results support the value of a nonpharmacologic interdisciplinary program as “a robust treatment for youth with chronic idiopathic pain, for both patients and the family unit,” she said.

“This study also supports the need for and benefit of additional counseling for patients and their caregivers prior to and during enrollment in a pain rehabilitation program,” she concluded.
 

Study supports effectiveness of drug-free pain management

“The management of pain in any age group can be challenging, especially with current concerns for opioid dependence and abuse,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Chronic pain affects daily life for all populations, but for children, adolescents, and their families, it can have a long-lasting impact on growth and development, psychosocial and physical well-being,” Dr. Haut said. “Determining and testing nonpharmacologic alternative methods of pain control are extremely important.”

Given the debilitating effects of chronic pain, and the potential side effects and dependence that have been associated with use of pharmacologic modes of pain control, unique and creative solutions have begun to emerge and need further attention and study, she said.

However, “despite published research supporting the use of alternative and complementary approaches to pain control in children and adolescents, nonpharmacologic, collaborative, interprofessional approaches to pain control have not been widely shared in the literature,” she said.

“Barriers to this type of program include first and foremost a potential lack of financial and workforce-related resources,” Dr. Haut said. “Patient and family attendance at frequent health visits, daily or even every other day, may also hinder success, but opportunities for telehealth and family training to learn physical and occupational skills within this type of program may be beginning solutions.”

Additional research should be conducted at multiple children’s hospitals, with a larger number of children and adolescents at varying ages, with pain related to different diagnoses, and with the inclusion of collaborative methodology, said Dr. Haut. “The current study had some limitations, including the small sample size, predominantly female sex, and a short participation time frame utilizing retrospective review. Completing prospective research over a longer time frame can also yield generalizable results applicable to varied populations.”

The study received no outside funding. Ms. Campanile had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, and serves on the editorial advisory board of Pediatric News.

WASHINGTON – A nonpharmacologic, interdisciplinary program significantly improved chronic pain in children and the quality of life for their families, based on data from 115 individuals.

Up to 40% of children experience chronic pain that affects their physical, psychosocial, and educational functioning, said Jessica Campanile, BA, a medical student at the University of Pennsylvania, Philadelphia, in a presentation at the Pediatric Academic Societies annual meeting.

Although interdisciplinary pediatric pain rehabilitation programs have shown positive outcomes, very few use only nonpharmacologic treatments, said Ms. Campanile. In addition, few studies have explored the effects of a hospital-based program on the patients and their families.

Ms. Campanile and colleagues conducted a retrospective cohort study of participants in an outpatient pain rehabilitation program at the Children’s Hospital of Philadelphia between April 2016 and December 2019. Patients were evaluated by a pediatric rheumatologist, psychologist, and physical and occupational therapists.

Patients engaged in 2-3 hours of physical therapy (PT) and 2-3 hours of occupational therapy (OT) in a 1:1 ratio at least 5 days a week. Physical activities included stepping into and out of a tub, carrying laundry, and desensitizing to allodynia as needed. Participants also received individual and group cognitive-behavior therapy interventions from psychologists, and psychological support during PT and OT sessions if needed. Parents/caregivers were invited to separate individual and group therapy sessions as part of the program. The median age at admission to the program was 15 years, and 79% of the participants were female. Patients participated the program for a median of 17 days, and 87% were outpatients who came to the hospital for the program.

Pain was assessed based on the 0-10 verbal pain intensity scale, energy was assessed on a scale of 0-100, and functional disability was assessed on a scale of 0-60, with higher scores indicating more pain, more energy, and more self-perceived disability, respectively.

Overall, scores on measures of pain, disability, allodynia, and energy improved significantly from baseline to discharge from the program. Verbal pain intensity scores decreased on average from 7 to 5, disability scores decreased from 26 to 9, the proportion of patients reporting allodynia decreased from 86% to 61%, and the energy level score increased from 70 to 77. The trend continued at the first follow-up visit, conducted 2-3 months after discharge from the program. Notably, pain intensity further decreased from a median of 5 at program completion to a median of 2 at the first follow-up, Ms. Campanile said. Improvements in allodynia also were sustained at the first follow-up.

Quality of life measures related to physical, emotional, social, and cognitive function also improved significantly from baseline to completion of the program.

In addition, scores on a quality of life family impact survey improved significantly; in particular, parent health-related quality of life scores (Parent HRQoL) improved from 60 at baseline to 71 at the end of the program on a scale of 0 to 100. The study findings were limited by several factors including the relatively short duration and use of a convenience sample from a retrospective cohort, with data limited to electronic health records, Ms. Campanile said. The study also was not powered to examine differential treatments based on psychiatric conditions, and any psychiatric conditions were based on self-reports.

However, the results support the value of a nonpharmacologic interdisciplinary program as “a robust treatment for youth with chronic idiopathic pain, for both patients and the family unit,” she said.

“This study also supports the need for and benefit of additional counseling for patients and their caregivers prior to and during enrollment in a pain rehabilitation program,” she concluded.
 

Study supports effectiveness of drug-free pain management

“The management of pain in any age group can be challenging, especially with current concerns for opioid dependence and abuse,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Chronic pain affects daily life for all populations, but for children, adolescents, and their families, it can have a long-lasting impact on growth and development, psychosocial and physical well-being,” Dr. Haut said. “Determining and testing nonpharmacologic alternative methods of pain control are extremely important.”

Given the debilitating effects of chronic pain, and the potential side effects and dependence that have been associated with use of pharmacologic modes of pain control, unique and creative solutions have begun to emerge and need further attention and study, she said.

However, “despite published research supporting the use of alternative and complementary approaches to pain control in children and adolescents, nonpharmacologic, collaborative, interprofessional approaches to pain control have not been widely shared in the literature,” she said.

“Barriers to this type of program include first and foremost a potential lack of financial and workforce-related resources,” Dr. Haut said. “Patient and family attendance at frequent health visits, daily or even every other day, may also hinder success, but opportunities for telehealth and family training to learn physical and occupational skills within this type of program may be beginning solutions.”

Additional research should be conducted at multiple children’s hospitals, with a larger number of children and adolescents at varying ages, with pain related to different diagnoses, and with the inclusion of collaborative methodology, said Dr. Haut. “The current study had some limitations, including the small sample size, predominantly female sex, and a short participation time frame utilizing retrospective review. Completing prospective research over a longer time frame can also yield generalizable results applicable to varied populations.”

The study received no outside funding. Ms. Campanile had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, and serves on the editorial advisory board of Pediatric News.

Dysphagia treatment may be a way to reduce risk for chronic obstructive pulmonary disease (COPD) exacerbations, according to Yoshitaka Oku, MD, of Hyogo Medical University, Nishinomiya, Japan.

Gastroesophageal regurgitation disease (GERD) is known to be associated with exacerbations in COPD, but previous studies have shown little impact of standard GERD therapy on COPD exacerbations. However, additional research indicates that delayed swallowing contributes to COPD exacerbations, as reported in a research review.

In an article published recently in Respiratory Physiology & Neurobiology, Dr. Oku hypothesized that swallowing abnormalities are a confounding factor in the association between GERD and COPD exacerbation, and that counteracting swallowing disorders may reduce COPD exacerbations.

Swallowing disorder (dysphagia) is a common comorbidity in patients with COPD and has been reported at a 17%-20% greater prevalence in those with COPD, compared with controls, the researchers said.

Patients with COPD have altered swallowing behavior because of several factors, including decreased maximal laryngeal elevation, Dr. Oku said. Individuals with COPD “are also prone to laryngeal penetration and aspiration when swallowing large volumes of liquid and tend to follow an inspiratory-swallow-expiratory (I-SW-E) pattern when swallowing large volumes,” he explained.

Dr. Oku conducted prospective studies to investigate the impact of breathing-swallowing discoordination on COPD exacerbation. He found that discoordination in swallowing patterns and the inability to produce airway protective mechanism (such as the I-SW-E pattern) may contribute to more frequent aspirations and more frequent exacerbations.

Dr. Oku also examined whether CPAP and bilevel positive airway pressure (BiPAP) might affect breathing-swallowing coordination in healthy controls and patients with COPD. They found a decrease in breathing-swallowing coordination with CPAP, but not BiPAP, in both controls and stable COPD patients. “During BiPAP, a brief negative flow associated with relaxation of the pharyngeal constrictor muscle triggers inspiratory support, which results in the SW-I pattern,” Dr. Oku noted.

Dr. Oku also wrote that interferential current stimulation (IFC) has been used to stimulate muscles. Studies of transcutaneous electrical sensory stimulation using IFC (IFC-TESS) as an intervention to improve swallowing have shown some success, and also may improve airway protection.

“However, its safety and efficacy in patients with COPD remains unknown,” he wrote. Dr. Oku conducted a study of stable COPD patients and found that repeated salivary swallow test (RSST) scores improved significantly after an IFC-TESS intervention.

Breathing-swallowing discoordination may be an early indicator of swallowing disorder in COPD, and interventions can improve these disorders, Dr. Oku added. However, more research is needed to explore whether interventions to improve dysphagia reduce the frequency of exacerbations in COPD patients, he concluded.

The study was supported by a grant from JSPS KAKENHI. Dr. Oku serves as a senior managing director at EuSense Medical Co.

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

Dysphagia treatment may be a way to reduce risk for chronic obstructive pulmonary disease (COPD) exacerbations, according to Yoshitaka Oku, MD, of Hyogo Medical University, Nishinomiya, Japan.

Gastroesophageal regurgitation disease (GERD) is known to be associated with exacerbations in COPD, but previous studies have shown little impact of standard GERD therapy on COPD exacerbations. However, additional research indicates that delayed swallowing contributes to COPD exacerbations, as reported in a research review.

In an article published recently in Respiratory Physiology & Neurobiology, Dr. Oku hypothesized that swallowing abnormalities are a confounding factor in the association between GERD and COPD exacerbation, and that counteracting swallowing disorders may reduce COPD exacerbations.

Swallowing disorder (dysphagia) is a common comorbidity in patients with COPD and has been reported at a 17%-20% greater prevalence in those with COPD, compared with controls, the researchers said.

Patients with COPD have altered swallowing behavior because of several factors, including decreased maximal laryngeal elevation, Dr. Oku said. Individuals with COPD “are also prone to laryngeal penetration and aspiration when swallowing large volumes of liquid and tend to follow an inspiratory-swallow-expiratory (I-SW-E) pattern when swallowing large volumes,” he explained.

Dr. Oku conducted prospective studies to investigate the impact of breathing-swallowing discoordination on COPD exacerbation. He found that discoordination in swallowing patterns and the inability to produce airway protective mechanism (such as the I-SW-E pattern) may contribute to more frequent aspirations and more frequent exacerbations.

Dr. Oku also examined whether CPAP and bilevel positive airway pressure (BiPAP) might affect breathing-swallowing coordination in healthy controls and patients with COPD. They found a decrease in breathing-swallowing coordination with CPAP, but not BiPAP, in both controls and stable COPD patients. “During BiPAP, a brief negative flow associated with relaxation of the pharyngeal constrictor muscle triggers inspiratory support, which results in the SW-I pattern,” Dr. Oku noted.

Dr. Oku also wrote that interferential current stimulation (IFC) has been used to stimulate muscles. Studies of transcutaneous electrical sensory stimulation using IFC (IFC-TESS) as an intervention to improve swallowing have shown some success, and also may improve airway protection.

“However, its safety and efficacy in patients with COPD remains unknown,” he wrote. Dr. Oku conducted a study of stable COPD patients and found that repeated salivary swallow test (RSST) scores improved significantly after an IFC-TESS intervention.

Breathing-swallowing discoordination may be an early indicator of swallowing disorder in COPD, and interventions can improve these disorders, Dr. Oku added. However, more research is needed to explore whether interventions to improve dysphagia reduce the frequency of exacerbations in COPD patients, he concluded.

The study was supported by a grant from JSPS KAKENHI. Dr. Oku serves as a senior managing director at EuSense Medical Co.

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

Dysphagia treatment may be a way to reduce risk for chronic obstructive pulmonary disease (COPD) exacerbations, according to Yoshitaka Oku, MD, of Hyogo Medical University, Nishinomiya, Japan.

Gastroesophageal regurgitation disease (GERD) is known to be associated with exacerbations in COPD, but previous studies have shown little impact of standard GERD therapy on COPD exacerbations. However, additional research indicates that delayed swallowing contributes to COPD exacerbations, as reported in a research review.

In an article published recently in Respiratory Physiology & Neurobiology, Dr. Oku hypothesized that swallowing abnormalities are a confounding factor in the association between GERD and COPD exacerbation, and that counteracting swallowing disorders may reduce COPD exacerbations.

Swallowing disorder (dysphagia) is a common comorbidity in patients with COPD and has been reported at a 17%-20% greater prevalence in those with COPD, compared with controls, the researchers said.

Patients with COPD have altered swallowing behavior because of several factors, including decreased maximal laryngeal elevation, Dr. Oku said. Individuals with COPD “are also prone to laryngeal penetration and aspiration when swallowing large volumes of liquid and tend to follow an inspiratory-swallow-expiratory (I-SW-E) pattern when swallowing large volumes,” he explained.

Dr. Oku conducted prospective studies to investigate the impact of breathing-swallowing discoordination on COPD exacerbation. He found that discoordination in swallowing patterns and the inability to produce airway protective mechanism (such as the I-SW-E pattern) may contribute to more frequent aspirations and more frequent exacerbations.

Dr. Oku also examined whether CPAP and bilevel positive airway pressure (BiPAP) might affect breathing-swallowing coordination in healthy controls and patients with COPD. They found a decrease in breathing-swallowing coordination with CPAP, but not BiPAP, in both controls and stable COPD patients. “During BiPAP, a brief negative flow associated with relaxation of the pharyngeal constrictor muscle triggers inspiratory support, which results in the SW-I pattern,” Dr. Oku noted.

Dr. Oku also wrote that interferential current stimulation (IFC) has been used to stimulate muscles. Studies of transcutaneous electrical sensory stimulation using IFC (IFC-TESS) as an intervention to improve swallowing have shown some success, and also may improve airway protection.

“However, its safety and efficacy in patients with COPD remains unknown,” he wrote. Dr. Oku conducted a study of stable COPD patients and found that repeated salivary swallow test (RSST) scores improved significantly after an IFC-TESS intervention.

Breathing-swallowing discoordination may be an early indicator of swallowing disorder in COPD, and interventions can improve these disorders, Dr. Oku added. However, more research is needed to explore whether interventions to improve dysphagia reduce the frequency of exacerbations in COPD patients, he concluded.

The study was supported by a grant from JSPS KAKENHI. Dr. Oku serves as a senior managing director at EuSense Medical Co.

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

WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting, researchers at Children’s Hospital of Philadelphia addressed initial ventilation and infant outcomes in the neonatal intensive care unit, prenatal brain immaturity and later cognitive development, and antibiotic use.

Initial ventilation mode shows little impact on NICU outcomes

In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.

The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.

Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO₂ (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
 

Prenatal brain immaturity associates with developmental delay

In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.

Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.

In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
 

Antibiotic use stays stable

In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.

They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).

The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
 

Studies show larger trends

“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.

The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”

The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.

“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.

Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.

“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.

The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.

WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting, researchers at Children’s Hospital of Philadelphia addressed initial ventilation and infant outcomes in the neonatal intensive care unit, prenatal brain immaturity and later cognitive development, and antibiotic use.

Initial ventilation mode shows little impact on NICU outcomes

In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.

The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.

Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO₂ (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
 

Prenatal brain immaturity associates with developmental delay

In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.

Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.

In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
 

Antibiotic use stays stable

In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.

They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).

The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
 

Studies show larger trends

“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.

The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”

The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.

“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.

Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.

“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.

The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.

WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting, researchers at Children’s Hospital of Philadelphia addressed initial ventilation and infant outcomes in the neonatal intensive care unit, prenatal brain immaturity and later cognitive development, and antibiotic use.

Initial ventilation mode shows little impact on NICU outcomes

In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.

The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.

Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO₂ (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
 

Prenatal brain immaturity associates with developmental delay

In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.

Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.

In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
 

Antibiotic use stays stable

In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.

They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).

The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
 

Studies show larger trends

“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.

The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”

The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.

“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.

Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.

“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.

The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

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

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

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

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

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