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Brief stress management training helps teens with mental health complaints
TORONTO – A brief stress management intervention left a lasting effect on adolescents referred for mental health–related complaints, significantly reducing perceived distress, and heart rate variability. The majority of recipients expressed interest in additional training at follow-up.
Elizabeth B. Mason, MD, and her colleagues from Rainbow Babies and Children’s Hospital in Cleveland, reported in a poster presentation at the Pediatric Academic Societies annual meeting.
The vast majority of participants (96.5%) were African American, mean age was 16 years, and 36% were male. Cutoff criteria for generalized anxiety on the SCARED was met by 35 (41%) participants, and 23 (27%) participants scored positive for depression on the PHQ-A.
Following completion of preintervention questionnaires, 50 of 86 (58%) participants received psychoeducation from an adolescent medicine fellow or a pediatric psychologist on the effect stress has on the body, training in diaphragmatic breathing and progressive muscle relaxation, and no-cost/low-cost exercise options. Study participants also engaged in a peripheral biofeedback program called Unyte that has been shown to improve heart rate variability. The remaining 36 participants received no training and served as controls.
Those in the intervention group had significantly lower SUDS scores postintervention than did the control group. Heart rate variability coherence rates also decreased significantly postintervention in those who received the intervention, compared with controls.
When reached by phone 1 week after the session, 92% of participants said they found the intervention helpful and felt more relaxed, and 44% expressed interest in additional relaxation training.
The investigators concluded that “the results of this study suggest that a brief stress management intervention in an urban adolescent medicine clinic is effective at decreasing subjective distress and improving heart rate variability coherence rates. Future studies should include a control group and longer-term follow-up.”
TORONTO – A brief stress management intervention left a lasting effect on adolescents referred for mental health–related complaints, significantly reducing perceived distress, and heart rate variability. The majority of recipients expressed interest in additional training at follow-up.
Elizabeth B. Mason, MD, and her colleagues from Rainbow Babies and Children’s Hospital in Cleveland, reported in a poster presentation at the Pediatric Academic Societies annual meeting.
The vast majority of participants (96.5%) were African American, mean age was 16 years, and 36% were male. Cutoff criteria for generalized anxiety on the SCARED was met by 35 (41%) participants, and 23 (27%) participants scored positive for depression on the PHQ-A.
Following completion of preintervention questionnaires, 50 of 86 (58%) participants received psychoeducation from an adolescent medicine fellow or a pediatric psychologist on the effect stress has on the body, training in diaphragmatic breathing and progressive muscle relaxation, and no-cost/low-cost exercise options. Study participants also engaged in a peripheral biofeedback program called Unyte that has been shown to improve heart rate variability. The remaining 36 participants received no training and served as controls.
Those in the intervention group had significantly lower SUDS scores postintervention than did the control group. Heart rate variability coherence rates also decreased significantly postintervention in those who received the intervention, compared with controls.
When reached by phone 1 week after the session, 92% of participants said they found the intervention helpful and felt more relaxed, and 44% expressed interest in additional relaxation training.
The investigators concluded that “the results of this study suggest that a brief stress management intervention in an urban adolescent medicine clinic is effective at decreasing subjective distress and improving heart rate variability coherence rates. Future studies should include a control group and longer-term follow-up.”
TORONTO – A brief stress management intervention left a lasting effect on adolescents referred for mental health–related complaints, significantly reducing perceived distress, and heart rate variability. The majority of recipients expressed interest in additional training at follow-up.
Elizabeth B. Mason, MD, and her colleagues from Rainbow Babies and Children’s Hospital in Cleveland, reported in a poster presentation at the Pediatric Academic Societies annual meeting.
The vast majority of participants (96.5%) were African American, mean age was 16 years, and 36% were male. Cutoff criteria for generalized anxiety on the SCARED was met by 35 (41%) participants, and 23 (27%) participants scored positive for depression on the PHQ-A.
Following completion of preintervention questionnaires, 50 of 86 (58%) participants received psychoeducation from an adolescent medicine fellow or a pediatric psychologist on the effect stress has on the body, training in diaphragmatic breathing and progressive muscle relaxation, and no-cost/low-cost exercise options. Study participants also engaged in a peripheral biofeedback program called Unyte that has been shown to improve heart rate variability. The remaining 36 participants received no training and served as controls.
Those in the intervention group had significantly lower SUDS scores postintervention than did the control group. Heart rate variability coherence rates also decreased significantly postintervention in those who received the intervention, compared with controls.
When reached by phone 1 week after the session, 92% of participants said they found the intervention helpful and felt more relaxed, and 44% expressed interest in additional relaxation training.
The investigators concluded that “the results of this study suggest that a brief stress management intervention in an urban adolescent medicine clinic is effective at decreasing subjective distress and improving heart rate variability coherence rates. Future studies should include a control group and longer-term follow-up.”
REPORTING FROM PAS 2018
Key clinical point: A brief stress management intervention had a lasting effect on adolescents referred for mental health–related complaints.
Major finding: Nearly all participants found the intervention helpful and felt more relaxed and 44% were interested in additional training.
Study details: A randomized trial including 86 adolescents (mean age, 16 years) referred for anxiety, somatic complaints, or difficulty managing mood.
Disclosures: The investigators reported no conflict of interest.
Patient adjustments needed for closed-loop insulin delivery
TORONTO – Closed-loop insulin delivery is expected to become the standard of care in type 1 diabetes mellitus (T1DM), but there are multiple barriers that patients need to overcome.
“Many people who are potentially going to be using closed-loop systems are enthusiastic but have unrealistic expectations of how the systems are going to perform, and there are many barriers to uptake and optimal use that we still haven’t quite figured out,” said Korey K. Hood, PhD, a professor in the departments of pediatrics and psychiatry & behavioral sciences at Stanford (Calif.) University.
In a session dedicated to all aspects of closed-loop automated insulin delivery at the Pediatric Academic Societies annual meeting, Dr. Hood offered comments on patient and family factors important to the uptake and use of closed-loop technologies. His research at Stanford is focused on understanding the psychosocial aspects of diabetes management and how these factors contribute to disease outcomes.
Closed-loop insulin delivery refers to technologies that combine automated glucose monitoring (AGM) with an algorithm to determine insulin needs and an insulin delivery device. Sometimes called an “artificial pancreas” or “bionic pancreas,” closed-loop insulin delivery is considered a significant advance in the management of T1DM, relegating daily finger sticks and nighttime hypoglycemia to things of the past.
In a recent meta-analysis of randomized clinical trials, use of any automated device added nearly 2.5 hours of time in near normoglycemia over 24 hours in patients with TIDM, compared with any other type of insulin-based treatment (BMJ. 2018. doi: 10.1136/bmj.k1310). The benefit was primarily based on better glucose control in the overnight period.
In September 2016, the Food and Drug Administration approved the MiniMed 670G Insulin Pump System (Medtronic), the first hybrid automated insulin delivery device for T1DM and the only one approved in the United States. The system is intended for subcutaneous continuous glucose monitoring (CGM) and continuous delivery of basal insulin and administration of insulin for the management of T1DM in persons 14 years of age and older.
Barriers from different perspectives
Barriers to uptake and use are common for the devices that are components of closed-loop systems. In a survey of 1,503 adults with TIDM, Dr. Hood’s group found a wide range of barriers to adoption of CGM or insulin pumps that could potentially also impact use of closed-loop systems (Diabetes Care. 2017;40:181-7). Some were nonmodifiable, like costs, but most were modifiable.
“Many people talk about the hassle of wearing devices. They don’t like having multiple devices on their bodies. They don’t always like the way that they look, and so these are things that we can have some kind of impact on and need to be paying attention to,” he said.
“The younger participants indicated a lot more barriers to using devices, and as they got older, they indicated fewer barriers. But what was also interesting is that the younger participants also indicated a lot more diabetes distress. As time went on, that was less of a factor in whether or not people were using diabetes devices,” reported Dr. Hood.
Not surprisingly, he added, was that younger participants had more favorable views of technology in general. “But they had less favorable views of diabetes technology [than older participants], so they’re really not crazy about using these devices.”
Dr. Hood’s group has also studied whether patient-reported barriers to CGM use align with what clinicians perceive to be patient-related barriers (Diabetes Sci Technol. 2017;11[3]484-92). Similar to the patients, clinicians most frequently endorsed the perception that patients dislike having the device on their body. However, other things they felt their patients worried about were the alarms on the device and the difficulty in understanding its features, neither of which patients considered a primary barrier to CGM or insulin pump adoption.
“So, we need to be cautious and mindful as we move forward that there are mismatches between the patient-reported and clinician-reported barriers,” said Dr. Hood. “Our response, often, is to teach and to provide some kind of education, when that’s not necessarily what the patient is asking for.”
Would you use it?
In 2017, a group of investigators conducted a qualitative study of 284 participants, ranging in age from 8 to 86 years, with T1DM. The researchers used structured interviews or focus groups to explore expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems (Diabetes Care. 2017;40[11]:1453-61).
“We were interested in children, adolescents, and adults with type 1, and then also the partners of the adults and the parents of the youth,” he explained.
“The findings revealed three themes identified as pressing for the uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption.
“For children, the areas of most concern revolved around specific social situations. Adolescents, on the other hand, were more concerned about the physical features of the device, the wearability, the discreetness of using it, and the comfort,” said Dr. Hood.
Adults and parents were much more interested in device accuracy, safety, adaptability, and algorithm quality. “For the kids and teens, not surprisingly, this wasn’t high on their list,” he added.
A clear indication of the unrealistic expectations surrounding this technology came from a 2018 study of almost 200 family members, which found that “reducing the constant concerns about diabetes, relieving family stress, and improving overall family relationships” were the three major areas the participants hoped would be helped with automated insulin delivery (Diabetes Technol Ther. 2018;20[3]:222-8).
“If we come up with a device that does this, then I think we will have fixed everything!” Dr. Hood said, adding that it really highlights the “very high hopes and expectations” of what closed-loop systems should deliver.
Device readiness is another area researchers have studied in the run-up to closed-loop systems. “The idea that everybody’s going to be ready to start in the same way, I think, is going to set us up for some failures,” he noted, adding that, in general, parents are much more enthusiastic about this than pediatric patients.
“Individuals who had been using diabetes devices – and some had already been in closed-loop studies – They had more realistic expectations of what these systems are going to be, because they knew that it wasn’t going to be a complete fix. Whereas others with more limited experience with component devices and these systems had much higher expectations and reported a fair amount of dissatisfaction at the end of the study because it didn’t do everything that they wanted it to do.”
Waves of uptake
“Ultimately, a closed-loop system is going to be judged by whether it can increase time on target and reduce cognitive burden,” said Dr. Hood. He finished his talk with some projections about the future of closed-loop systems. “I think we’re going to probably to have different waves, or types, of closed-loop users.”
The first wave will be the group that’s already “sold” on the idea, which might encompass about 15% of patients. The second wave, which might represent about 30% of the relevant patient population, will be those who are sold on the idea and will likely use it but will have high expectations of the system’s ease of use and effectiveness and thus are highly likely to discontinue its use if those expectations are not met.
“The third wave will be those who might use a closed-loop system but might be unaware of them currently and will need a fair amount of education.” And, finally, the fourth group are unlikely to ever use closed-loop insulin delivery. “They are a group that feels burned by previous generations of systems, and I think that they may not perceive benefit,” Dr. Hood suggested.
“But all of this is to say that I do think that a tailored experience, and one that is focused on different profiles, can optimize both the uptake and the use of these systems.”
Dr. Hood reported receiving grant/research support from Dexcom and being a consultant for Lilly Innovation Center, J&J Diabetes Institute, and Bigfoot Biomedical.
TORONTO – Closed-loop insulin delivery is expected to become the standard of care in type 1 diabetes mellitus (T1DM), but there are multiple barriers that patients need to overcome.
“Many people who are potentially going to be using closed-loop systems are enthusiastic but have unrealistic expectations of how the systems are going to perform, and there are many barriers to uptake and optimal use that we still haven’t quite figured out,” said Korey K. Hood, PhD, a professor in the departments of pediatrics and psychiatry & behavioral sciences at Stanford (Calif.) University.
In a session dedicated to all aspects of closed-loop automated insulin delivery at the Pediatric Academic Societies annual meeting, Dr. Hood offered comments on patient and family factors important to the uptake and use of closed-loop technologies. His research at Stanford is focused on understanding the psychosocial aspects of diabetes management and how these factors contribute to disease outcomes.
Closed-loop insulin delivery refers to technologies that combine automated glucose monitoring (AGM) with an algorithm to determine insulin needs and an insulin delivery device. Sometimes called an “artificial pancreas” or “bionic pancreas,” closed-loop insulin delivery is considered a significant advance in the management of T1DM, relegating daily finger sticks and nighttime hypoglycemia to things of the past.
In a recent meta-analysis of randomized clinical trials, use of any automated device added nearly 2.5 hours of time in near normoglycemia over 24 hours in patients with TIDM, compared with any other type of insulin-based treatment (BMJ. 2018. doi: 10.1136/bmj.k1310). The benefit was primarily based on better glucose control in the overnight period.
In September 2016, the Food and Drug Administration approved the MiniMed 670G Insulin Pump System (Medtronic), the first hybrid automated insulin delivery device for T1DM and the only one approved in the United States. The system is intended for subcutaneous continuous glucose monitoring (CGM) and continuous delivery of basal insulin and administration of insulin for the management of T1DM in persons 14 years of age and older.
Barriers from different perspectives
Barriers to uptake and use are common for the devices that are components of closed-loop systems. In a survey of 1,503 adults with TIDM, Dr. Hood’s group found a wide range of barriers to adoption of CGM or insulin pumps that could potentially also impact use of closed-loop systems (Diabetes Care. 2017;40:181-7). Some were nonmodifiable, like costs, but most were modifiable.
“Many people talk about the hassle of wearing devices. They don’t like having multiple devices on their bodies. They don’t always like the way that they look, and so these are things that we can have some kind of impact on and need to be paying attention to,” he said.
“The younger participants indicated a lot more barriers to using devices, and as they got older, they indicated fewer barriers. But what was also interesting is that the younger participants also indicated a lot more diabetes distress. As time went on, that was less of a factor in whether or not people were using diabetes devices,” reported Dr. Hood.
Not surprisingly, he added, was that younger participants had more favorable views of technology in general. “But they had less favorable views of diabetes technology [than older participants], so they’re really not crazy about using these devices.”
Dr. Hood’s group has also studied whether patient-reported barriers to CGM use align with what clinicians perceive to be patient-related barriers (Diabetes Sci Technol. 2017;11[3]484-92). Similar to the patients, clinicians most frequently endorsed the perception that patients dislike having the device on their body. However, other things they felt their patients worried about were the alarms on the device and the difficulty in understanding its features, neither of which patients considered a primary barrier to CGM or insulin pump adoption.
“So, we need to be cautious and mindful as we move forward that there are mismatches between the patient-reported and clinician-reported barriers,” said Dr. Hood. “Our response, often, is to teach and to provide some kind of education, when that’s not necessarily what the patient is asking for.”
Would you use it?
In 2017, a group of investigators conducted a qualitative study of 284 participants, ranging in age from 8 to 86 years, with T1DM. The researchers used structured interviews or focus groups to explore expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems (Diabetes Care. 2017;40[11]:1453-61).
“We were interested in children, adolescents, and adults with type 1, and then also the partners of the adults and the parents of the youth,” he explained.
“The findings revealed three themes identified as pressing for the uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption.
“For children, the areas of most concern revolved around specific social situations. Adolescents, on the other hand, were more concerned about the physical features of the device, the wearability, the discreetness of using it, and the comfort,” said Dr. Hood.
Adults and parents were much more interested in device accuracy, safety, adaptability, and algorithm quality. “For the kids and teens, not surprisingly, this wasn’t high on their list,” he added.
A clear indication of the unrealistic expectations surrounding this technology came from a 2018 study of almost 200 family members, which found that “reducing the constant concerns about diabetes, relieving family stress, and improving overall family relationships” were the three major areas the participants hoped would be helped with automated insulin delivery (Diabetes Technol Ther. 2018;20[3]:222-8).
“If we come up with a device that does this, then I think we will have fixed everything!” Dr. Hood said, adding that it really highlights the “very high hopes and expectations” of what closed-loop systems should deliver.
Device readiness is another area researchers have studied in the run-up to closed-loop systems. “The idea that everybody’s going to be ready to start in the same way, I think, is going to set us up for some failures,” he noted, adding that, in general, parents are much more enthusiastic about this than pediatric patients.
“Individuals who had been using diabetes devices – and some had already been in closed-loop studies – They had more realistic expectations of what these systems are going to be, because they knew that it wasn’t going to be a complete fix. Whereas others with more limited experience with component devices and these systems had much higher expectations and reported a fair amount of dissatisfaction at the end of the study because it didn’t do everything that they wanted it to do.”
Waves of uptake
“Ultimately, a closed-loop system is going to be judged by whether it can increase time on target and reduce cognitive burden,” said Dr. Hood. He finished his talk with some projections about the future of closed-loop systems. “I think we’re going to probably to have different waves, or types, of closed-loop users.”
The first wave will be the group that’s already “sold” on the idea, which might encompass about 15% of patients. The second wave, which might represent about 30% of the relevant patient population, will be those who are sold on the idea and will likely use it but will have high expectations of the system’s ease of use and effectiveness and thus are highly likely to discontinue its use if those expectations are not met.
“The third wave will be those who might use a closed-loop system but might be unaware of them currently and will need a fair amount of education.” And, finally, the fourth group are unlikely to ever use closed-loop insulin delivery. “They are a group that feels burned by previous generations of systems, and I think that they may not perceive benefit,” Dr. Hood suggested.
“But all of this is to say that I do think that a tailored experience, and one that is focused on different profiles, can optimize both the uptake and the use of these systems.”
Dr. Hood reported receiving grant/research support from Dexcom and being a consultant for Lilly Innovation Center, J&J Diabetes Institute, and Bigfoot Biomedical.
TORONTO – Closed-loop insulin delivery is expected to become the standard of care in type 1 diabetes mellitus (T1DM), but there are multiple barriers that patients need to overcome.
“Many people who are potentially going to be using closed-loop systems are enthusiastic but have unrealistic expectations of how the systems are going to perform, and there are many barriers to uptake and optimal use that we still haven’t quite figured out,” said Korey K. Hood, PhD, a professor in the departments of pediatrics and psychiatry & behavioral sciences at Stanford (Calif.) University.
In a session dedicated to all aspects of closed-loop automated insulin delivery at the Pediatric Academic Societies annual meeting, Dr. Hood offered comments on patient and family factors important to the uptake and use of closed-loop technologies. His research at Stanford is focused on understanding the psychosocial aspects of diabetes management and how these factors contribute to disease outcomes.
Closed-loop insulin delivery refers to technologies that combine automated glucose monitoring (AGM) with an algorithm to determine insulin needs and an insulin delivery device. Sometimes called an “artificial pancreas” or “bionic pancreas,” closed-loop insulin delivery is considered a significant advance in the management of T1DM, relegating daily finger sticks and nighttime hypoglycemia to things of the past.
In a recent meta-analysis of randomized clinical trials, use of any automated device added nearly 2.5 hours of time in near normoglycemia over 24 hours in patients with TIDM, compared with any other type of insulin-based treatment (BMJ. 2018. doi: 10.1136/bmj.k1310). The benefit was primarily based on better glucose control in the overnight period.
In September 2016, the Food and Drug Administration approved the MiniMed 670G Insulin Pump System (Medtronic), the first hybrid automated insulin delivery device for T1DM and the only one approved in the United States. The system is intended for subcutaneous continuous glucose monitoring (CGM) and continuous delivery of basal insulin and administration of insulin for the management of T1DM in persons 14 years of age and older.
Barriers from different perspectives
Barriers to uptake and use are common for the devices that are components of closed-loop systems. In a survey of 1,503 adults with TIDM, Dr. Hood’s group found a wide range of barriers to adoption of CGM or insulin pumps that could potentially also impact use of closed-loop systems (Diabetes Care. 2017;40:181-7). Some were nonmodifiable, like costs, but most were modifiable.
“Many people talk about the hassle of wearing devices. They don’t like having multiple devices on their bodies. They don’t always like the way that they look, and so these are things that we can have some kind of impact on and need to be paying attention to,” he said.
“The younger participants indicated a lot more barriers to using devices, and as they got older, they indicated fewer barriers. But what was also interesting is that the younger participants also indicated a lot more diabetes distress. As time went on, that was less of a factor in whether or not people were using diabetes devices,” reported Dr. Hood.
Not surprisingly, he added, was that younger participants had more favorable views of technology in general. “But they had less favorable views of diabetes technology [than older participants], so they’re really not crazy about using these devices.”
Dr. Hood’s group has also studied whether patient-reported barriers to CGM use align with what clinicians perceive to be patient-related barriers (Diabetes Sci Technol. 2017;11[3]484-92). Similar to the patients, clinicians most frequently endorsed the perception that patients dislike having the device on their body. However, other things they felt their patients worried about were the alarms on the device and the difficulty in understanding its features, neither of which patients considered a primary barrier to CGM or insulin pump adoption.
“So, we need to be cautious and mindful as we move forward that there are mismatches between the patient-reported and clinician-reported barriers,” said Dr. Hood. “Our response, often, is to teach and to provide some kind of education, when that’s not necessarily what the patient is asking for.”
Would you use it?
In 2017, a group of investigators conducted a qualitative study of 284 participants, ranging in age from 8 to 86 years, with T1DM. The researchers used structured interviews or focus groups to explore expectations, desired features, potential benefits, and perceived burdens of automated insulin delivery systems (Diabetes Care. 2017;40[11]:1453-61).
“We were interested in children, adolescents, and adults with type 1, and then also the partners of the adults and the parents of the youth,” he explained.
“The findings revealed three themes identified as pressing for the uptake of automated insulin delivery: considerations of trust and control, system features, and concerns and barriers to adoption.
“For children, the areas of most concern revolved around specific social situations. Adolescents, on the other hand, were more concerned about the physical features of the device, the wearability, the discreetness of using it, and the comfort,” said Dr. Hood.
Adults and parents were much more interested in device accuracy, safety, adaptability, and algorithm quality. “For the kids and teens, not surprisingly, this wasn’t high on their list,” he added.
A clear indication of the unrealistic expectations surrounding this technology came from a 2018 study of almost 200 family members, which found that “reducing the constant concerns about diabetes, relieving family stress, and improving overall family relationships” were the three major areas the participants hoped would be helped with automated insulin delivery (Diabetes Technol Ther. 2018;20[3]:222-8).
“If we come up with a device that does this, then I think we will have fixed everything!” Dr. Hood said, adding that it really highlights the “very high hopes and expectations” of what closed-loop systems should deliver.
Device readiness is another area researchers have studied in the run-up to closed-loop systems. “The idea that everybody’s going to be ready to start in the same way, I think, is going to set us up for some failures,” he noted, adding that, in general, parents are much more enthusiastic about this than pediatric patients.
“Individuals who had been using diabetes devices – and some had already been in closed-loop studies – They had more realistic expectations of what these systems are going to be, because they knew that it wasn’t going to be a complete fix. Whereas others with more limited experience with component devices and these systems had much higher expectations and reported a fair amount of dissatisfaction at the end of the study because it didn’t do everything that they wanted it to do.”
Waves of uptake
“Ultimately, a closed-loop system is going to be judged by whether it can increase time on target and reduce cognitive burden,” said Dr. Hood. He finished his talk with some projections about the future of closed-loop systems. “I think we’re going to probably to have different waves, or types, of closed-loop users.”
The first wave will be the group that’s already “sold” on the idea, which might encompass about 15% of patients. The second wave, which might represent about 30% of the relevant patient population, will be those who are sold on the idea and will likely use it but will have high expectations of the system’s ease of use and effectiveness and thus are highly likely to discontinue its use if those expectations are not met.
“The third wave will be those who might use a closed-loop system but might be unaware of them currently and will need a fair amount of education.” And, finally, the fourth group are unlikely to ever use closed-loop insulin delivery. “They are a group that feels burned by previous generations of systems, and I think that they may not perceive benefit,” Dr. Hood suggested.
“But all of this is to say that I do think that a tailored experience, and one that is focused on different profiles, can optimize both the uptake and the use of these systems.”
Dr. Hood reported receiving grant/research support from Dexcom and being a consultant for Lilly Innovation Center, J&J Diabetes Institute, and Bigfoot Biomedical.
EXPERT ANALYSIS FROM PAS 2018
Babies exposed to SSRIs in utero have decreased LV size
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
AT PAS 2018
Key clinical point: Babies exposed to SSRIs in utero have smaller hearts compared with babies not exposed to SSRIs.
Major finding: Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular diameter in diastole (P = .02) and a 22% reduction in left ventricular volume in systole (P = .02).
Study details: A study of 20 babies exposed to SSRIs in utero and 21 not exposed.
Disclosures: This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
Texas pharmacies restrict access to morning-after pill
TORONTO – Despite federal legislation making emergency contraception available without age limits or a prescription, Texas adolescents may be denied or hindered in their attempts to obtain it, according to a study presented at the Pediatric Academic Societies.
When researchers queried 768 Texas pharmacy employees (97% of whom were pharmacists or pharmacy techs) about the availability of levonorgestrel at their stores, the drug was available in only 76% of pharmacies. However, contrary to federal law, 6% of stores required a prescription to obtain it.
Almost half (47%) of the pharmacies who stocked the drug reported an age requirement for purchase; this rose to 81% in the panhandle of the state, which is considered a more socially conservative region. The researchers divided the pharmacies into six geographic regions and 25% of pharmacies in each region were randomly selected for inclusion.
“Typically, the age limit these pharmacies picked was 17, which is what the most recent federal law said too, but in 2013, that was changed such that there is not supposed to be an age limit,” said Mr. Goff. “But it really varied – some told us 18, some said 21, and some said, ‘I don’t know the age limit, but I would give it out without checking their ID.’ ”
As well, 52% required some degree of interaction or consultation with pharmacy staff to obtain the drug – either it was behind the counter or on the shelf, but maybe in a locked cabinet.
Turns out, pharmacy staff also aren’t well versed in the use of levonorgestrel. Only 10% of those surveyed recognized that there may be a weight limitation with use of levonorgestrel and only 2% knew that the medication could be used up to 120 hours after unprotected intercourse.
“Texas has the fifth highest rate of teen pregnancy and the highest rate of repeat teen pregnancy in the United States, and we think these barriers are a big contributor to this,” Mr. Goff said in an interview.
Senior author, Maria C. Monge, MD, of the university, added in a press release that comprehensive sex education and contraception services also are not readily available to all adolescents across the state, which likely increases the use of emergency contraception.
In the United States, levonorgestrel 1.5 mg oral tablet has been available over the counter for more than 10 years and without an age limit since 2013.
TORONTO – Despite federal legislation making emergency contraception available without age limits or a prescription, Texas adolescents may be denied or hindered in their attempts to obtain it, according to a study presented at the Pediatric Academic Societies.
When researchers queried 768 Texas pharmacy employees (97% of whom were pharmacists or pharmacy techs) about the availability of levonorgestrel at their stores, the drug was available in only 76% of pharmacies. However, contrary to federal law, 6% of stores required a prescription to obtain it.
Almost half (47%) of the pharmacies who stocked the drug reported an age requirement for purchase; this rose to 81% in the panhandle of the state, which is considered a more socially conservative region. The researchers divided the pharmacies into six geographic regions and 25% of pharmacies in each region were randomly selected for inclusion.
“Typically, the age limit these pharmacies picked was 17, which is what the most recent federal law said too, but in 2013, that was changed such that there is not supposed to be an age limit,” said Mr. Goff. “But it really varied – some told us 18, some said 21, and some said, ‘I don’t know the age limit, but I would give it out without checking their ID.’ ”
As well, 52% required some degree of interaction or consultation with pharmacy staff to obtain the drug – either it was behind the counter or on the shelf, but maybe in a locked cabinet.
Turns out, pharmacy staff also aren’t well versed in the use of levonorgestrel. Only 10% of those surveyed recognized that there may be a weight limitation with use of levonorgestrel and only 2% knew that the medication could be used up to 120 hours after unprotected intercourse.
“Texas has the fifth highest rate of teen pregnancy and the highest rate of repeat teen pregnancy in the United States, and we think these barriers are a big contributor to this,” Mr. Goff said in an interview.
Senior author, Maria C. Monge, MD, of the university, added in a press release that comprehensive sex education and contraception services also are not readily available to all adolescents across the state, which likely increases the use of emergency contraception.
In the United States, levonorgestrel 1.5 mg oral tablet has been available over the counter for more than 10 years and without an age limit since 2013.
TORONTO – Despite federal legislation making emergency contraception available without age limits or a prescription, Texas adolescents may be denied or hindered in their attempts to obtain it, according to a study presented at the Pediatric Academic Societies.
When researchers queried 768 Texas pharmacy employees (97% of whom were pharmacists or pharmacy techs) about the availability of levonorgestrel at their stores, the drug was available in only 76% of pharmacies. However, contrary to federal law, 6% of stores required a prescription to obtain it.
Almost half (47%) of the pharmacies who stocked the drug reported an age requirement for purchase; this rose to 81% in the panhandle of the state, which is considered a more socially conservative region. The researchers divided the pharmacies into six geographic regions and 25% of pharmacies in each region were randomly selected for inclusion.
“Typically, the age limit these pharmacies picked was 17, which is what the most recent federal law said too, but in 2013, that was changed such that there is not supposed to be an age limit,” said Mr. Goff. “But it really varied – some told us 18, some said 21, and some said, ‘I don’t know the age limit, but I would give it out without checking their ID.’ ”
As well, 52% required some degree of interaction or consultation with pharmacy staff to obtain the drug – either it was behind the counter or on the shelf, but maybe in a locked cabinet.
Turns out, pharmacy staff also aren’t well versed in the use of levonorgestrel. Only 10% of those surveyed recognized that there may be a weight limitation with use of levonorgestrel and only 2% knew that the medication could be used up to 120 hours after unprotected intercourse.
“Texas has the fifth highest rate of teen pregnancy and the highest rate of repeat teen pregnancy in the United States, and we think these barriers are a big contributor to this,” Mr. Goff said in an interview.
Senior author, Maria C. Monge, MD, of the university, added in a press release that comprehensive sex education and contraception services also are not readily available to all adolescents across the state, which likely increases the use of emergency contraception.
In the United States, levonorgestrel 1.5 mg oral tablet has been available over the counter for more than 10 years and without an age limit since 2013.
AT PAS 2018
Key clinical point:
Major finding: 76% of pharmacies carried levonorgestrel, but 6% required a prescription, and 47% set an age requirement on its purchase.
Study details: A survey of 768 Texas pharmacy employees from randomly sampled pharmacies, 97% pharmacists or pharmacy technicians.
Disclosures: The author reported no financial conflict of interest.
Most moms with PPD identified by pediatricians don’t receive mental health care
TORONTO – according to results of a retrospective study that used linked data from children’s EHRs and maternal Medicaid claims.
“My big takeaway from all of this is, if as pediatricians we’re committed to screening for postpartum depression, which we are – it’s in our Bright Futures guidelines – then we also need to focus on that next step and make sure that the mothers we find actually get services,” Stacey Kallem, MD, a pediatrician at Children’s Hospital of Philadelphia, reported at the Pediatric Academic Societies meeting.
“Most moms are still bringing their children to see us, the pediatricians, so we’re really a touch-point to the health care system for a lot of mothers, which is why over the last decade or so there has been a big shift within pediatrics to screen mothers for postpartum depression,” said Dr. Kallem.
Because of the growing prevalence of PPD – one in seven women will suffer from it – and mindful of its negative effects on infant health, safety, and development, the American Academy of Pediatrics recommends that pediatricians screen mothers when they bring children for visits. However, what is unknown is the effectiveness of this screening and if the affected mothers ultimately are getting mental health services.
Dr. Kallem and her colleagues designed a retrospective cohort study that would include mothers attending their infants’ 2-month well child visits at one of five academic urban primary care practices between 2011 and 2014. The obtained data came from linking the child’s EHRs and birth certificate records to maternal Medicaid claims.
The primary outcome was mental health care utilization within 6 months of screening positive for PPD on the Edinburgh Postnatal Depression Scale. A total of 3,052 mothers met study criteria, of whom 1,986 (65.1%) completed the PPD screen, and 263 (13.2%) screened positive for PPD. Only 9.9% of women had one Medicaid claim for depression in the 6 months after screening positive and 4.2% had two or more visits.
“Moms with postpartum depression are less likely to breastfeed and less likely to adhere to infant safety practices like using car seats, but the good news is that if you screen and treat mothers with postpartum depression, many of these negative effects on the child can be mitigated,” said Dr. Kallem, a National Clinical Scholar at the University of Pennsylvania, Philadelphia.
She noted a few limitations of the study, including that she was unable to collect any qualitative data regarding the interaction between the provider and the mother at the time of screening. Also, mothers may have received care that was not reimbursed by Medicaid.
Dr. Kallem reported having no financial conflicts of interest. The Eisenberg Fund and the National Clinician Scholars Program at the University of Pennsylvania, Philadelphia, supported the study.
TORONTO – according to results of a retrospective study that used linked data from children’s EHRs and maternal Medicaid claims.
“My big takeaway from all of this is, if as pediatricians we’re committed to screening for postpartum depression, which we are – it’s in our Bright Futures guidelines – then we also need to focus on that next step and make sure that the mothers we find actually get services,” Stacey Kallem, MD, a pediatrician at Children’s Hospital of Philadelphia, reported at the Pediatric Academic Societies meeting.
“Most moms are still bringing their children to see us, the pediatricians, so we’re really a touch-point to the health care system for a lot of mothers, which is why over the last decade or so there has been a big shift within pediatrics to screen mothers for postpartum depression,” said Dr. Kallem.
Because of the growing prevalence of PPD – one in seven women will suffer from it – and mindful of its negative effects on infant health, safety, and development, the American Academy of Pediatrics recommends that pediatricians screen mothers when they bring children for visits. However, what is unknown is the effectiveness of this screening and if the affected mothers ultimately are getting mental health services.
Dr. Kallem and her colleagues designed a retrospective cohort study that would include mothers attending their infants’ 2-month well child visits at one of five academic urban primary care practices between 2011 and 2014. The obtained data came from linking the child’s EHRs and birth certificate records to maternal Medicaid claims.
The primary outcome was mental health care utilization within 6 months of screening positive for PPD on the Edinburgh Postnatal Depression Scale. A total of 3,052 mothers met study criteria, of whom 1,986 (65.1%) completed the PPD screen, and 263 (13.2%) screened positive for PPD. Only 9.9% of women had one Medicaid claim for depression in the 6 months after screening positive and 4.2% had two or more visits.
“Moms with postpartum depression are less likely to breastfeed and less likely to adhere to infant safety practices like using car seats, but the good news is that if you screen and treat mothers with postpartum depression, many of these negative effects on the child can be mitigated,” said Dr. Kallem, a National Clinical Scholar at the University of Pennsylvania, Philadelphia.
She noted a few limitations of the study, including that she was unable to collect any qualitative data regarding the interaction between the provider and the mother at the time of screening. Also, mothers may have received care that was not reimbursed by Medicaid.
Dr. Kallem reported having no financial conflicts of interest. The Eisenberg Fund and the National Clinician Scholars Program at the University of Pennsylvania, Philadelphia, supported the study.
TORONTO – according to results of a retrospective study that used linked data from children’s EHRs and maternal Medicaid claims.
“My big takeaway from all of this is, if as pediatricians we’re committed to screening for postpartum depression, which we are – it’s in our Bright Futures guidelines – then we also need to focus on that next step and make sure that the mothers we find actually get services,” Stacey Kallem, MD, a pediatrician at Children’s Hospital of Philadelphia, reported at the Pediatric Academic Societies meeting.
“Most moms are still bringing their children to see us, the pediatricians, so we’re really a touch-point to the health care system for a lot of mothers, which is why over the last decade or so there has been a big shift within pediatrics to screen mothers for postpartum depression,” said Dr. Kallem.
Because of the growing prevalence of PPD – one in seven women will suffer from it – and mindful of its negative effects on infant health, safety, and development, the American Academy of Pediatrics recommends that pediatricians screen mothers when they bring children for visits. However, what is unknown is the effectiveness of this screening and if the affected mothers ultimately are getting mental health services.
Dr. Kallem and her colleagues designed a retrospective cohort study that would include mothers attending their infants’ 2-month well child visits at one of five academic urban primary care practices between 2011 and 2014. The obtained data came from linking the child’s EHRs and birth certificate records to maternal Medicaid claims.
The primary outcome was mental health care utilization within 6 months of screening positive for PPD on the Edinburgh Postnatal Depression Scale. A total of 3,052 mothers met study criteria, of whom 1,986 (65.1%) completed the PPD screen, and 263 (13.2%) screened positive for PPD. Only 9.9% of women had one Medicaid claim for depression in the 6 months after screening positive and 4.2% had two or more visits.
“Moms with postpartum depression are less likely to breastfeed and less likely to adhere to infant safety practices like using car seats, but the good news is that if you screen and treat mothers with postpartum depression, many of these negative effects on the child can be mitigated,” said Dr. Kallem, a National Clinical Scholar at the University of Pennsylvania, Philadelphia.
She noted a few limitations of the study, including that she was unable to collect any qualitative data regarding the interaction between the provider and the mother at the time of screening. Also, mothers may have received care that was not reimbursed by Medicaid.
Dr. Kallem reported having no financial conflicts of interest. The Eisenberg Fund and the National Clinician Scholars Program at the University of Pennsylvania, Philadelphia, supported the study.
AT PAS 18
Key clinical point: Mothers who screen positive for PPD in a pediatric setting may need more help accessing mental health services.
Major finding: Among women who screened positive for PPD, 9.9% had one Medicaid claim for depression in the 6 months post partum and 4.2% had two or more visits.
Study details: A retrospective study that used linked data from children’s EHRs and maternal Medicaid claims.
Disclosures: Dr. Kallem reported having no financial conflicts of interest. The Eisenberg Fund and the National Clinician Scholars Program at the University of Pennsylvania, Philadelphia, supported the study.
Responsive parenting intervention slows weight gain in infancy
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
REPORTING FROM PAS 2018
Key clinical point:
Major finding: For the primary outcome of body mass index z score at 3 years, a significant difference favoring the responsive parenting intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04).
Study details: A randomized clinical trial including 279 mother-newborn dyads.
Disclosures: Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
About sex, adults aren’t talking or kids aren’t listening
TORONTO – Almost half of adolescents (45%) reported that their primary care providers (PCPs) do not routinely ask them about sex, and only 13% report they’ve been offered screening for sexually transmitted infections (STIs), according to a survey study presented at the Pediatric Academic Societies meeting.
And it appears the teenagers aren’t even listening to much of what their parents are saying on the subject: The survey also found that 90% of parents reported that they talk to their adolescents about sex, but only 39% of adolescents reported the same.
Regarding the discrepancy between the parents’ and adolescents’ responses, “Our best guess is that parents may have mentioned sex with their adolescents at some point, but the conversation was not meaningful enough to register on the adolescents’ radars! That type of discussion is probably best had more than once and in more than one way,”she said in an interview.
The adolescents, aged 13-17 years, and parents of adolescents attending the 2017 Minnesota State Fair were invited to complete an 18-question anonymous survey. The teens were queried whether they had seen a PCP in the last year and asked about their discussions about sexual activity and STIs with their physicians and parents. Parents were asked about their knowledge of discussions the teens had with their PCPs and their own discussions with their children. A total of 582 adolescents and 516 parents completed the survey.
One-quarter of parents who completed the survey felt that PCPs should not discuss sex with their teens.
“I think that primary care physicians have a lot to cover when doing preventive health visits with adolescents, and talking about sex is not necessarily an easy or comfortable thing to do and so may be something that falls to a lower priority. And it certainly doesn’t help if parents are not supportive of the concept of confidential adolescent care,” Dr. Schneider related.
“We were very surprised to see that 25% of parents did not feel that PCPs should be discussing sex with their child. I think that we need to next work on getting the parents on board and building an expectation that adolescents, when visiting their PCP, will have confidential discussions about sexual health,” she said.
TORONTO – Almost half of adolescents (45%) reported that their primary care providers (PCPs) do not routinely ask them about sex, and only 13% report they’ve been offered screening for sexually transmitted infections (STIs), according to a survey study presented at the Pediatric Academic Societies meeting.
And it appears the teenagers aren’t even listening to much of what their parents are saying on the subject: The survey also found that 90% of parents reported that they talk to their adolescents about sex, but only 39% of adolescents reported the same.
Regarding the discrepancy between the parents’ and adolescents’ responses, “Our best guess is that parents may have mentioned sex with their adolescents at some point, but the conversation was not meaningful enough to register on the adolescents’ radars! That type of discussion is probably best had more than once and in more than one way,”she said in an interview.
The adolescents, aged 13-17 years, and parents of adolescents attending the 2017 Minnesota State Fair were invited to complete an 18-question anonymous survey. The teens were queried whether they had seen a PCP in the last year and asked about their discussions about sexual activity and STIs with their physicians and parents. Parents were asked about their knowledge of discussions the teens had with their PCPs and their own discussions with their children. A total of 582 adolescents and 516 parents completed the survey.
One-quarter of parents who completed the survey felt that PCPs should not discuss sex with their teens.
“I think that primary care physicians have a lot to cover when doing preventive health visits with adolescents, and talking about sex is not necessarily an easy or comfortable thing to do and so may be something that falls to a lower priority. And it certainly doesn’t help if parents are not supportive of the concept of confidential adolescent care,” Dr. Schneider related.
“We were very surprised to see that 25% of parents did not feel that PCPs should be discussing sex with their child. I think that we need to next work on getting the parents on board and building an expectation that adolescents, when visiting their PCP, will have confidential discussions about sexual health,” she said.
TORONTO – Almost half of adolescents (45%) reported that their primary care providers (PCPs) do not routinely ask them about sex, and only 13% report they’ve been offered screening for sexually transmitted infections (STIs), according to a survey study presented at the Pediatric Academic Societies meeting.
And it appears the teenagers aren’t even listening to much of what their parents are saying on the subject: The survey also found that 90% of parents reported that they talk to their adolescents about sex, but only 39% of adolescents reported the same.
Regarding the discrepancy between the parents’ and adolescents’ responses, “Our best guess is that parents may have mentioned sex with their adolescents at some point, but the conversation was not meaningful enough to register on the adolescents’ radars! That type of discussion is probably best had more than once and in more than one way,”she said in an interview.
The adolescents, aged 13-17 years, and parents of adolescents attending the 2017 Minnesota State Fair were invited to complete an 18-question anonymous survey. The teens were queried whether they had seen a PCP in the last year and asked about their discussions about sexual activity and STIs with their physicians and parents. Parents were asked about their knowledge of discussions the teens had with their PCPs and their own discussions with their children. A total of 582 adolescents and 516 parents completed the survey.
One-quarter of parents who completed the survey felt that PCPs should not discuss sex with their teens.
“I think that primary care physicians have a lot to cover when doing preventive health visits with adolescents, and talking about sex is not necessarily an easy or comfortable thing to do and so may be something that falls to a lower priority. And it certainly doesn’t help if parents are not supportive of the concept of confidential adolescent care,” Dr. Schneider related.
“We were very surprised to see that 25% of parents did not feel that PCPs should be discussing sex with their child. I think that we need to next work on getting the parents on board and building an expectation that adolescents, when visiting their PCP, will have confidential discussions about sexual health,” she said.
Key clinical point:
Major finding: Of the adolescents who responded to the survey, 45% said their PCPs don’t routinely discuss sex with them, and only 13% reported being offered screening for STIs.
Study details: Survey study including 582 adolescents aged 13-17 years and 516 parents of adolescents.
Disclosures: Dr. Schneider reported no financial conflicts of interest.
Reduce referrals: Skip eye chart with automated vision checker for kids
TORONTO – Using an automated photorefractor-based vision screening in preschool-age children reduced referrals to ophthalmologists and optometrists by one-third, compared with standard chart-based screening, according to a nonrandomized trial conducted in Boston. The handheld device that was used requires minimal cooperation from the child and also checks ocular alignment.
“This device requires almost zero cooperation from the child. The nurse or assistant holds the device and the child has to look at it for about two seconds, as opposed to several minutes to do a chart-based test,” reported Louis Vernacchio, MD, at the 2018 Pediatric Academic Societies meeting.
They found a 33.7% decline in initial ophthalmology and optometry visits after practices switched from chart-based vision screening to the hand-held screening device.
“Optometry and ophthalmology is the No. 1 specialist to whom our patients of all ages are referred to in our pediatric network, and the No. 1 diagnosis was normal vision, so in most cases, there’s nothing wrong, and they’re clogging up the system.”
Instrument-based vision screening has been shown to have high sensitivity and specificity, compared with ophthalmic vision screening, and has much better testability in young children than traditional eye chart–based screening.
In previously reported data, Dr. Vernacchio’s group showed that, with instrument-based vision screening, completed screening rates among children aged 3-5 years improved. The most marked improvement was in the 3-year-olds, among whom completed screening rates increased from 39% with chart-based screening to 87% with instrument screening. (Modest JR et al. Pediatrics. 2017 Jul;140[1]. pii: e20163745.) Family satisfaction is also improved with the automated method.
The automated vision screening device used in the study was the Spot Vision Screener produced by Welch Allyn.
“Our nurses are in heaven with these devices, so besides the billing that you can do, you can save staff time and easily justify the cost of the device. My office now has 4 or 5 of these devices because it just saves so much time to have them readily available.”
Professional societies endorse automated vision screening
Amblyopia is seen in 2 or 3 children per 100 in the United States, reported Dr. Vernacchio. Chart-based vision screening is notoriously difficult to accomplish in young children and there is both a risk of missing amblyopia in those who do not cooperate and a risk of overreferral because of poor performance on the test.
Recently, the American Academy of Pediatrics, the U.S. Preventive Services Task Force, and others have endorsed the use of instrument-based vision screening in place of chart-based screening for children aged 3-5 years based on evidence of improved testability and acceptable sensitivity and specificity.
The Spot Vision Screener has a retail cost between $6000 and $7000, according to Dr. Vernacchio. “Many” insurance companies will pay a separate fee for vision screening using an instrument, but others bundle the screening into a well visit, he noted.
“So, you can actually calculate the time to recover the cost of the device based on your payer practices,” he said. Another option is a smart phone app that uses a subscription model, in which the test results are interpreted by the company within a few minutes with a per test charge of about .99 cents.
“The Holy Grail is whether this process will reduce the incidence of amblyopia,” said Dr. Vernacchio. That study is next on his to-do list, he said, but “it’s going to take longer to answer that question.”
The authors reported no conflicts of interest. There was no external funding.
TORONTO – Using an automated photorefractor-based vision screening in preschool-age children reduced referrals to ophthalmologists and optometrists by one-third, compared with standard chart-based screening, according to a nonrandomized trial conducted in Boston. The handheld device that was used requires minimal cooperation from the child and also checks ocular alignment.
“This device requires almost zero cooperation from the child. The nurse or assistant holds the device and the child has to look at it for about two seconds, as opposed to several minutes to do a chart-based test,” reported Louis Vernacchio, MD, at the 2018 Pediatric Academic Societies meeting.
They found a 33.7% decline in initial ophthalmology and optometry visits after practices switched from chart-based vision screening to the hand-held screening device.
“Optometry and ophthalmology is the No. 1 specialist to whom our patients of all ages are referred to in our pediatric network, and the No. 1 diagnosis was normal vision, so in most cases, there’s nothing wrong, and they’re clogging up the system.”
Instrument-based vision screening has been shown to have high sensitivity and specificity, compared with ophthalmic vision screening, and has much better testability in young children than traditional eye chart–based screening.
In previously reported data, Dr. Vernacchio’s group showed that, with instrument-based vision screening, completed screening rates among children aged 3-5 years improved. The most marked improvement was in the 3-year-olds, among whom completed screening rates increased from 39% with chart-based screening to 87% with instrument screening. (Modest JR et al. Pediatrics. 2017 Jul;140[1]. pii: e20163745.) Family satisfaction is also improved with the automated method.
The automated vision screening device used in the study was the Spot Vision Screener produced by Welch Allyn.
“Our nurses are in heaven with these devices, so besides the billing that you can do, you can save staff time and easily justify the cost of the device. My office now has 4 or 5 of these devices because it just saves so much time to have them readily available.”
Professional societies endorse automated vision screening
Amblyopia is seen in 2 or 3 children per 100 in the United States, reported Dr. Vernacchio. Chart-based vision screening is notoriously difficult to accomplish in young children and there is both a risk of missing amblyopia in those who do not cooperate and a risk of overreferral because of poor performance on the test.
Recently, the American Academy of Pediatrics, the U.S. Preventive Services Task Force, and others have endorsed the use of instrument-based vision screening in place of chart-based screening for children aged 3-5 years based on evidence of improved testability and acceptable sensitivity and specificity.
The Spot Vision Screener has a retail cost between $6000 and $7000, according to Dr. Vernacchio. “Many” insurance companies will pay a separate fee for vision screening using an instrument, but others bundle the screening into a well visit, he noted.
“So, you can actually calculate the time to recover the cost of the device based on your payer practices,” he said. Another option is a smart phone app that uses a subscription model, in which the test results are interpreted by the company within a few minutes with a per test charge of about .99 cents.
“The Holy Grail is whether this process will reduce the incidence of amblyopia,” said Dr. Vernacchio. That study is next on his to-do list, he said, but “it’s going to take longer to answer that question.”
The authors reported no conflicts of interest. There was no external funding.
TORONTO – Using an automated photorefractor-based vision screening in preschool-age children reduced referrals to ophthalmologists and optometrists by one-third, compared with standard chart-based screening, according to a nonrandomized trial conducted in Boston. The handheld device that was used requires minimal cooperation from the child and also checks ocular alignment.
“This device requires almost zero cooperation from the child. The nurse or assistant holds the device and the child has to look at it for about two seconds, as opposed to several minutes to do a chart-based test,” reported Louis Vernacchio, MD, at the 2018 Pediatric Academic Societies meeting.
They found a 33.7% decline in initial ophthalmology and optometry visits after practices switched from chart-based vision screening to the hand-held screening device.
“Optometry and ophthalmology is the No. 1 specialist to whom our patients of all ages are referred to in our pediatric network, and the No. 1 diagnosis was normal vision, so in most cases, there’s nothing wrong, and they’re clogging up the system.”
Instrument-based vision screening has been shown to have high sensitivity and specificity, compared with ophthalmic vision screening, and has much better testability in young children than traditional eye chart–based screening.
In previously reported data, Dr. Vernacchio’s group showed that, with instrument-based vision screening, completed screening rates among children aged 3-5 years improved. The most marked improvement was in the 3-year-olds, among whom completed screening rates increased from 39% with chart-based screening to 87% with instrument screening. (Modest JR et al. Pediatrics. 2017 Jul;140[1]. pii: e20163745.) Family satisfaction is also improved with the automated method.
The automated vision screening device used in the study was the Spot Vision Screener produced by Welch Allyn.
“Our nurses are in heaven with these devices, so besides the billing that you can do, you can save staff time and easily justify the cost of the device. My office now has 4 or 5 of these devices because it just saves so much time to have them readily available.”
Professional societies endorse automated vision screening
Amblyopia is seen in 2 or 3 children per 100 in the United States, reported Dr. Vernacchio. Chart-based vision screening is notoriously difficult to accomplish in young children and there is both a risk of missing amblyopia in those who do not cooperate and a risk of overreferral because of poor performance on the test.
Recently, the American Academy of Pediatrics, the U.S. Preventive Services Task Force, and others have endorsed the use of instrument-based vision screening in place of chart-based screening for children aged 3-5 years based on evidence of improved testability and acceptable sensitivity and specificity.
The Spot Vision Screener has a retail cost between $6000 and $7000, according to Dr. Vernacchio. “Many” insurance companies will pay a separate fee for vision screening using an instrument, but others bundle the screening into a well visit, he noted.
“So, you can actually calculate the time to recover the cost of the device based on your payer practices,” he said. Another option is a smart phone app that uses a subscription model, in which the test results are interpreted by the company within a few minutes with a per test charge of about .99 cents.
“The Holy Grail is whether this process will reduce the incidence of amblyopia,” said Dr. Vernacchio. That study is next on his to-do list, he said, but “it’s going to take longer to answer that question.”
The authors reported no conflicts of interest. There was no external funding.
Key clinical point: Switching from a chart-based to an instrument-based vision screening reduced unnecessary pediatric eye care referrals.
Major finding: Use of an automated vision screening system reduced referrals for pediatric eye care by 33.7%.
Study details: A nonrandomized analysis of referral patterns from January 2015 to June 2015 from 12 pediatric primary care practices, with findings compared with a prior time period before the vision screening device was used.
Disclosures: The authors reported no conflicts of interest. There was no external funding
FDA’s standards for approving generics are questioned
TORONTO – The Food and Drug Administration’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products, which allow for single batch comparisons of approved and generic candidate products, need to be revised to address batch to batch variability, suggested a presenter at the CHEST annual meeting.
Marketing approval of a new generic drug in the United States, including orally inhaled products, generally requires a demonstration of pharmacokinetic bioequivalence to a reference listed product. The standard criterion for statistical bioequivalence applied by the FDA requires the pharmacokinetics of the generic to be within about 10% of the branded product.
In early pharmacokinetic bioequivalence studies, Elise Burmeister Getz, PhD, and her colleagues compared single batches of their generic candidate OT329 Solis 100/50 to single batches of Advair Diskus 100/50 in five individual studies and single batches of Advair Diskus 100/50 to single batches of the same drug. They also found Advair Diskus 100/50 batches that were more than 30% different from each other. 
“When patients differ from one another, we put many patients in the trial. And when batches differ from one another, we should be putting many batches in the trial,” Dr. Burmeister Getz, director of clinical pharmacology at Oriel Therapeutics, said at the CHEST meeting. “If we want a robust assessment of bioequivalence and not just a check the box exercise, we really need to have product sampling that’s aligned with product variability.”
When the researchers combined the data in a meta-analysis, bioequivalence was demonstrated, but the pooled analysis could not be used for FDA registration because of its retrospective nature.
They later conducted a prospective study with multiple batches of both the generic and branded drugs. This multiple-batch bioequivalence study involved 96 healthy subjects using 16 batches each of Advair Diskus and Oriel’s OT329 Solis 100/50. A single inhalation was administered to healthy adult subjects in a randomized crossover design and blood samples were collected pre dose and up to 48 hours after inhalation.
With the FDA’s definition of bioequivalence, the generic candidate fell within the bioequivalence goalposts, Dr. Burmeister Getz noted.
The issue of pharmacokinetic variance is not unique to Advair Diskus, but she and her colleagues don’t understand why different batches show such wide variability, Dr. Burmeister Getz noted.
“The advantage of this multibatch approach is that the results of the bioequivalence assessment aren’t dependent on the single batch that happened to be chosen for the study. They are generalizable to the product because the product has been robustly represented in the study,” Dr. Burmeister Getz told attendees.
Oriel makes OT329 Solis 100/50, a fully substitutable generic to Advair Diskus 100/50, which is indicated for treating asthma. Both are multidose dry powder oral inhalation products containing fluticasone propionate, to reduce inflammation in the lungs, and salmeterol, to relax muscles in the airways, for the maintenance treatment of asthma. Advair Diskus at higher doses is indicated for asthma and COPD.
An FDA response?
Asked what the FDA makes of the batch-to-batch variability data, Dr. Burmeister Getz answered simply, “We don’t know.” Before she and her colleagues ran the 16 batch per product study, they submitted their protocol to the FDA for review, but 1 year later, they still hadn’t heard any response.
“Sponsors are apparently allowed to simply pick their batch in a careful and, dare I say manipulative way, to gain the result they want. With a single batch study the selection of batch will absolutely determine the outcome of the study.”
In vitro bioequivalence studies are already required to use multiple batches, she noted.
This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG.
TORONTO – The Food and Drug Administration’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products, which allow for single batch comparisons of approved and generic candidate products, need to be revised to address batch to batch variability, suggested a presenter at the CHEST annual meeting.
Marketing approval of a new generic drug in the United States, including orally inhaled products, generally requires a demonstration of pharmacokinetic bioequivalence to a reference listed product. The standard criterion for statistical bioequivalence applied by the FDA requires the pharmacokinetics of the generic to be within about 10% of the branded product.
In early pharmacokinetic bioequivalence studies, Elise Burmeister Getz, PhD, and her colleagues compared single batches of their generic candidate OT329 Solis 100/50 to single batches of Advair Diskus 100/50 in five individual studies and single batches of Advair Diskus 100/50 to single batches of the same drug. They also found Advair Diskus 100/50 batches that were more than 30% different from each other.
“When patients differ from one another, we put many patients in the trial. And when batches differ from one another, we should be putting many batches in the trial,” Dr. Burmeister Getz, director of clinical pharmacology at Oriel Therapeutics, said at the CHEST meeting. “If we want a robust assessment of bioequivalence and not just a check the box exercise, we really need to have product sampling that’s aligned with product variability.”
When the researchers combined the data in a meta-analysis, bioequivalence was demonstrated, but the pooled analysis could not be used for FDA registration because of its retrospective nature.
They later conducted a prospective study with multiple batches of both the generic and branded drugs. This multiple-batch bioequivalence study involved 96 healthy subjects using 16 batches each of Advair Diskus and Oriel’s OT329 Solis 100/50. A single inhalation was administered to healthy adult subjects in a randomized crossover design and blood samples were collected pre dose and up to 48 hours after inhalation.
With the FDA’s definition of bioequivalence, the generic candidate fell within the bioequivalence goalposts, Dr. Burmeister Getz noted.
The issue of pharmacokinetic variance is not unique to Advair Diskus, but she and her colleagues don’t understand why different batches show such wide variability, Dr. Burmeister Getz noted.
“The advantage of this multibatch approach is that the results of the bioequivalence assessment aren’t dependent on the single batch that happened to be chosen for the study. They are generalizable to the product because the product has been robustly represented in the study,” Dr. Burmeister Getz told attendees.
Oriel makes OT329 Solis 100/50, a fully substitutable generic to Advair Diskus 100/50, which is indicated for treating asthma. Both are multidose dry powder oral inhalation products containing fluticasone propionate, to reduce inflammation in the lungs, and salmeterol, to relax muscles in the airways, for the maintenance treatment of asthma. Advair Diskus at higher doses is indicated for asthma and COPD.
An FDA response?
Asked what the FDA makes of the batch-to-batch variability data, Dr. Burmeister Getz answered simply, “We don’t know.” Before she and her colleagues ran the 16 batch per product study, they submitted their protocol to the FDA for review, but 1 year later, they still hadn’t heard any response.
“Sponsors are apparently allowed to simply pick their batch in a careful and, dare I say manipulative way, to gain the result they want. With a single batch study the selection of batch will absolutely determine the outcome of the study.”
In vitro bioequivalence studies are already required to use multiple batches, she noted.
This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG.
TORONTO – The Food and Drug Administration’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products, which allow for single batch comparisons of approved and generic candidate products, need to be revised to address batch to batch variability, suggested a presenter at the CHEST annual meeting.
Marketing approval of a new generic drug in the United States, including orally inhaled products, generally requires a demonstration of pharmacokinetic bioequivalence to a reference listed product. The standard criterion for statistical bioequivalence applied by the FDA requires the pharmacokinetics of the generic to be within about 10% of the branded product.
In early pharmacokinetic bioequivalence studies, Elise Burmeister Getz, PhD, and her colleagues compared single batches of their generic candidate OT329 Solis 100/50 to single batches of Advair Diskus 100/50 in five individual studies and single batches of Advair Diskus 100/50 to single batches of the same drug. They also found Advair Diskus 100/50 batches that were more than 30% different from each other.
“When patients differ from one another, we put many patients in the trial. And when batches differ from one another, we should be putting many batches in the trial,” Dr. Burmeister Getz, director of clinical pharmacology at Oriel Therapeutics, said at the CHEST meeting. “If we want a robust assessment of bioequivalence and not just a check the box exercise, we really need to have product sampling that’s aligned with product variability.”
When the researchers combined the data in a meta-analysis, bioequivalence was demonstrated, but the pooled analysis could not be used for FDA registration because of its retrospective nature.
They later conducted a prospective study with multiple batches of both the generic and branded drugs. This multiple-batch bioequivalence study involved 96 healthy subjects using 16 batches each of Advair Diskus and Oriel’s OT329 Solis 100/50. A single inhalation was administered to healthy adult subjects in a randomized crossover design and blood samples were collected pre dose and up to 48 hours after inhalation.
With the FDA’s definition of bioequivalence, the generic candidate fell within the bioequivalence goalposts, Dr. Burmeister Getz noted.
The issue of pharmacokinetic variance is not unique to Advair Diskus, but she and her colleagues don’t understand why different batches show such wide variability, Dr. Burmeister Getz noted.
“The advantage of this multibatch approach is that the results of the bioequivalence assessment aren’t dependent on the single batch that happened to be chosen for the study. They are generalizable to the product because the product has been robustly represented in the study,” Dr. Burmeister Getz told attendees.
Oriel makes OT329 Solis 100/50, a fully substitutable generic to Advair Diskus 100/50, which is indicated for treating asthma. Both are multidose dry powder oral inhalation products containing fluticasone propionate, to reduce inflammation in the lungs, and salmeterol, to relax muscles in the airways, for the maintenance treatment of asthma. Advair Diskus at higher doses is indicated for asthma and COPD.
An FDA response?
Asked what the FDA makes of the batch-to-batch variability data, Dr. Burmeister Getz answered simply, “We don’t know.” Before she and her colleagues ran the 16 batch per product study, they submitted their protocol to the FDA for review, but 1 year later, they still hadn’t heard any response.
“Sponsors are apparently allowed to simply pick their batch in a careful and, dare I say manipulative way, to gain the result they want. With a single batch study the selection of batch will absolutely determine the outcome of the study.”
In vitro bioequivalence studies are already required to use multiple batches, she noted.
This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG.
AT CHEST 2017
Key clinical point: The FDA’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products need to be revised to address batch to batch variability.
Major finding: Investigators found Advair Diskus 100/50 batches that were more than 30% different from each other.
Data source: Pharmacokinetic bioequivalence studies comparing batches of Advair Diskus 100/50 to each other, and to batches of the generic candidate OT329 Solis 100/50.
Disclosures: This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG. Dr. Burmeister Getz is director of clinical pharmacology at Oriel Therapeutics.
ARDS incidence is declining. Is it a preventable syndrome?
TORONTO – The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.
“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”
To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.
The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.
“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.
While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.
The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
TORONTO – The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.
“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”
To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.
The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.
“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.
While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.
The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
TORONTO – The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.
“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”
To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.
The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.
“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.
While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.
The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
AT CHEST 2017
Key clinical point: The incidence of acute respiratory distress syndrome is declining, an indication that it may be preventable, according to researchers.
Major finding: The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Data source: Retrospective, population-based cohort study of all (505) patients admitted to the ICU for ARDS at a single center.
Disclosures: The authors reported having no relevant disclosures.