Kari Oakes

In back-to back advisory committee hearings, the Food and Drug Administration received recommendations for approval of two new combination medications to treat type 2 diabetes. The two medications each combine long-lasting insulin with a glucagon-like peptide–1 (GLP-1) receptor agonist in a once-daily injectable fixed-dose combination.

On May 24, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously to approve the fixed-dose combination of liraglutide and insulin degludec (individually marketed as Victoza and Tresiba, respectively, by Novo Nordisk). The new combination was referred to as IDegLira in the sponsor’s clinical trials.

The following day, the EMDAC recommended in a 12-2 vote to approve Sanofi-Aventis’ new fixed-dose combination of lixisenatide and insulin glargine (Lantus), also indicated as an add-on to lifestyle management for type 2 diabetes. The sponsor’s proposed name for this combination is iGlarLixi.

For both products, most committee members felt that the combo would most benefit patients who were already on either insulin or a GLP-1 agonist (though the second day’s panel noted that data were lacking on patients transitioning from a GLP-1 agonist to Sanofi-Aventis’ lixisenatide/glargine combo). “I tend to agree with many of the people who have gone before me that the population of patients this should be used in are those that are on one of these two injectable medications already and in particular I think the GLP-1 agonist,” said Dr. Marie Gelato, professor of medicine at Stony Brook (N.Y.) University, who voted in favor of the liraglutide/degludec combination medication.

A concern common to discussion on both days was that some patients with diabetes and a higher body mass might not be able to benefit from these medications, since each one caps insulin dosing.

Other themes common to both days’ deliberations among the largely overlapping panels included the need for fine-tuning the dosing apparatus, labeling, patient interface, and nomenclature for these novel devices. For Dr. Robert Smith, panel chair and professor of endocrinology at Brown University, Providence, R.I., his vote on the second day should be “considered contingent on accomplishing those things adequately.”

Most of the endocrinologists on the committees noted that they personally felt more comfortable beginning a single agent, and probably tended to tinker with patients’ regimens fairly frequently at least during the initial period of diabetes management. However, the committees on both days felt that having the fixed-dose combination agent available might be a particularly useful tool for family practice physicians and those practicing general internal medicine.

Since the proposed lixisenatide/glargine combination would be dispensed as one of two pens, each with a different dose range of lixisenatide, the second day’s panel spent more time in discussion of the potential for confusion or misdosing with two choices.

“It’s incumbent upon the sponsor to make it easier for the doctor. I have confidence that they will work out the delivery system,” said Dr. Peter Wilson, explaining his rationale for voting for approval of the lixisenatide/glargine combo despite some reservations about the device and delivery system, “I think this will be a boon for the patients,” added Dr. Wilson, professor of medicine and public health at Emory University, Atlanta.

Lixisenatide, marketed as Lyxumia in Europe and elsewhere by Sanofi-Aventis, is pending FDA approval, so it received some additional attention during the committee hearing for lixisenatide/glargine. Though it would be the sixth GLP-1 agonist on the U.S. market, committee members did not voice concerns that it would be a “me too” drug; rather, said Dr. Wilson, “It provides yet another choice. ... Choice is very important for physicians and for patients.”

During Sanofi-Aventis’ and the FDA’s presentations, safety data, especially as interpreted by the FDA, seemed to indicate a slightly elevated risk of significant allergic reactions with lixisenatide compared with placebo. However, conceded the FDA’s clinical reviewer Dr. Suchitra Balakrishnan, the postmarketing surveillance program for lixisenatide was “a larger program, which may have contributed to more events occurring.”

Earlier concerns about lixisenatide’s cardiovascular safety have been largely assuaged after publication late last year of results from the ELIXA trial (N Engl J Med. 2015; 373:2247-57) that showed no increased risk – but no benefit – for those with type 2 diabetes taking lixisenatide.

The FDA usually follows the advice of its advisory committees.

[email protected]

On Twitter @karioakes

In back-to back advisory committee hearings, the Food and Drug Administration received recommendations for approval of two new combination medications to treat type 2 diabetes. The two medications each combine long-lasting insulin with a glucagon-like peptide–1 (GLP-1) receptor agonist in a once-daily injectable fixed-dose combination.

On May 24, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously to approve the fixed-dose combination of liraglutide and insulin degludec (individually marketed as Victoza and Tresiba, respectively, by Novo Nordisk). The new combination was referred to as IDegLira in the sponsor’s clinical trials.

The following day, the EMDAC recommended in a 12-2 vote to approve Sanofi-Aventis’ new fixed-dose combination of lixisenatide and insulin glargine (Lantus), also indicated as an add-on to lifestyle management for type 2 diabetes. The sponsor’s proposed name for this combination is iGlarLixi.

For both products, most committee members felt that the combo would most benefit patients who were already on either insulin or a GLP-1 agonist (though the second day’s panel noted that data were lacking on patients transitioning from a GLP-1 agonist to Sanofi-Aventis’ lixisenatide/glargine combo). “I tend to agree with many of the people who have gone before me that the population of patients this should be used in are those that are on one of these two injectable medications already and in particular I think the GLP-1 agonist,” said Dr. Marie Gelato, professor of medicine at Stony Brook (N.Y.) University, who voted in favor of the liraglutide/degludec combination medication.

A concern common to discussion on both days was that some patients with diabetes and a higher body mass might not be able to benefit from these medications, since each one caps insulin dosing.

Other themes common to both days’ deliberations among the largely overlapping panels included the need for fine-tuning the dosing apparatus, labeling, patient interface, and nomenclature for these novel devices. For Dr. Robert Smith, panel chair and professor of endocrinology at Brown University, Providence, R.I., his vote on the second day should be “considered contingent on accomplishing those things adequately.”

Most of the endocrinologists on the committees noted that they personally felt more comfortable beginning a single agent, and probably tended to tinker with patients’ regimens fairly frequently at least during the initial period of diabetes management. However, the committees on both days felt that having the fixed-dose combination agent available might be a particularly useful tool for family practice physicians and those practicing general internal medicine.

Since the proposed lixisenatide/glargine combination would be dispensed as one of two pens, each with a different dose range of lixisenatide, the second day’s panel spent more time in discussion of the potential for confusion or misdosing with two choices.

“It’s incumbent upon the sponsor to make it easier for the doctor. I have confidence that they will work out the delivery system,” said Dr. Peter Wilson, explaining his rationale for voting for approval of the lixisenatide/glargine combo despite some reservations about the device and delivery system, “I think this will be a boon for the patients,” added Dr. Wilson, professor of medicine and public health at Emory University, Atlanta.

Lixisenatide, marketed as Lyxumia in Europe and elsewhere by Sanofi-Aventis, is pending FDA approval, so it received some additional attention during the committee hearing for lixisenatide/glargine. Though it would be the sixth GLP-1 agonist on the U.S. market, committee members did not voice concerns that it would be a “me too” drug; rather, said Dr. Wilson, “It provides yet another choice. ... Choice is very important for physicians and for patients.”

During Sanofi-Aventis’ and the FDA’s presentations, safety data, especially as interpreted by the FDA, seemed to indicate a slightly elevated risk of significant allergic reactions with lixisenatide compared with placebo. However, conceded the FDA’s clinical reviewer Dr. Suchitra Balakrishnan, the postmarketing surveillance program for lixisenatide was “a larger program, which may have contributed to more events occurring.”

Earlier concerns about lixisenatide’s cardiovascular safety have been largely assuaged after publication late last year of results from the ELIXA trial (N Engl J Med. 2015; 373:2247-57) that showed no increased risk – but no benefit – for those with type 2 diabetes taking lixisenatide.

The FDA usually follows the advice of its advisory committees.

[email protected]

On Twitter @karioakes

In back-to back advisory committee hearings, the Food and Drug Administration received recommendations for approval of two new combination medications to treat type 2 diabetes. The two medications each combine long-lasting insulin with a glucagon-like peptide–1 (GLP-1) receptor agonist in a once-daily injectable fixed-dose combination.

On May 24, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously to approve the fixed-dose combination of liraglutide and insulin degludec (individually marketed as Victoza and Tresiba, respectively, by Novo Nordisk). The new combination was referred to as IDegLira in the sponsor’s clinical trials.

The following day, the EMDAC recommended in a 12-2 vote to approve Sanofi-Aventis’ new fixed-dose combination of lixisenatide and insulin glargine (Lantus), also indicated as an add-on to lifestyle management for type 2 diabetes. The sponsor’s proposed name for this combination is iGlarLixi.

For both products, most committee members felt that the combo would most benefit patients who were already on either insulin or a GLP-1 agonist (though the second day’s panel noted that data were lacking on patients transitioning from a GLP-1 agonist to Sanofi-Aventis’ lixisenatide/glargine combo). “I tend to agree with many of the people who have gone before me that the population of patients this should be used in are those that are on one of these two injectable medications already and in particular I think the GLP-1 agonist,” said Dr. Marie Gelato, professor of medicine at Stony Brook (N.Y.) University, who voted in favor of the liraglutide/degludec combination medication.

A concern common to discussion on both days was that some patients with diabetes and a higher body mass might not be able to benefit from these medications, since each one caps insulin dosing.

Other themes common to both days’ deliberations among the largely overlapping panels included the need for fine-tuning the dosing apparatus, labeling, patient interface, and nomenclature for these novel devices. For Dr. Robert Smith, panel chair and professor of endocrinology at Brown University, Providence, R.I., his vote on the second day should be “considered contingent on accomplishing those things adequately.”

Most of the endocrinologists on the committees noted that they personally felt more comfortable beginning a single agent, and probably tended to tinker with patients’ regimens fairly frequently at least during the initial period of diabetes management. However, the committees on both days felt that having the fixed-dose combination agent available might be a particularly useful tool for family practice physicians and those practicing general internal medicine.

Since the proposed lixisenatide/glargine combination would be dispensed as one of two pens, each with a different dose range of lixisenatide, the second day’s panel spent more time in discussion of the potential for confusion or misdosing with two choices.

“It’s incumbent upon the sponsor to make it easier for the doctor. I have confidence that they will work out the delivery system,” said Dr. Peter Wilson, explaining his rationale for voting for approval of the lixisenatide/glargine combo despite some reservations about the device and delivery system, “I think this will be a boon for the patients,” added Dr. Wilson, professor of medicine and public health at Emory University, Atlanta.

Lixisenatide, marketed as Lyxumia in Europe and elsewhere by Sanofi-Aventis, is pending FDA approval, so it received some additional attention during the committee hearing for lixisenatide/glargine. Though it would be the sixth GLP-1 agonist on the U.S. market, committee members did not voice concerns that it would be a “me too” drug; rather, said Dr. Wilson, “It provides yet another choice. ... Choice is very important for physicians and for patients.”

During Sanofi-Aventis’ and the FDA’s presentations, safety data, especially as interpreted by the FDA, seemed to indicate a slightly elevated risk of significant allergic reactions with lixisenatide compared with placebo. However, conceded the FDA’s clinical reviewer Dr. Suchitra Balakrishnan, the postmarketing surveillance program for lixisenatide was “a larger program, which may have contributed to more events occurring.”

Earlier concerns about lixisenatide’s cardiovascular safety have been largely assuaged after publication late last year of results from the ELIXA trial (N Engl J Med. 2015; 373:2247-57) that showed no increased risk – but no benefit – for those with type 2 diabetes taking lixisenatide.

The FDA usually follows the advice of its advisory committees.

[email protected]

On Twitter @karioakes

BALTIMORE – Persistent attention-deficit/hyperactivity disorder (ADHD) through young childhood is associated with both poorer academic outcomes and an increased risk of other mental health problems, according to a longitudinal study of younger children with ADHD.

An Australian study presented at the annual meeting of the Pediatric Academic Societies found that 67% of children who had ADHD at age 7 years still met the diagnostic criteria 3 years later, when they were 10 years old. Boys were more likely than girls to have retained the diagnosis (74% vs. 50%; odds ratio, 3.4; P = .01).

On average, children with ADHD had lower scores on math and reading tests than their matched peers without ADHD, even after adjustment for socioeconomic variables and comorbidities (mean difference, –7.6 for math and –8.7 for reading, P less than .001 for both).

When Emma Sciberras, Ph.D., and her colleagues examined the longitudinal data, they found that children who had a persistent ADHD diagnosis were more likely to have an externalizing disorder, such as a conduct disorder (57% vs. 33%; OR, 2.8; P = .008). They also were more likely to have a mood disorder (8% vs. 0%; P = .04).

No sex differences were seen, aside from the increased likelihood of a persistent diagnosis.

“Childhood ADHD confers risk for future mental health difficulties,” said Dr. Sciberras, a psychologist at Deakin University, Melbourne. Dr. Sciberras presented preliminary findings from the Children’s Attention Project, a 3-year study of 179 young children with ADHD and 212 children without the diagnosis.

The goal of the Children’s Attention Project, a community-based longitudinal study, was to document the natural history of ADHD. Aspects of the study included assessing the impact of ADHD on the mental health of both children and parents, as well as examining social, academic, and family functioning, and overall quality of life. The study also seeks to tease out both risks and protective factors that can tip outcomes toward the better – or worse – end of the spectrum, said Dr. Sciberras.

The Children’s Attention Project enrolled first graders from 43 primary schools in Melbourne, to compare 3-year outcomes of a sample of children with ADHD with a control group of children who did not have ADHD. In addition to assessing diagnostic stability (the persistence of an ADHD diagnosis), Dr. Sciberras and her collaborators also looked at functional outcomes. Sex differences in outcomes, as well as the effect of ADHD persistence, also were assessed for the community-based sample of children.

Children were enrolled after families and teachers of the first graders completed the Conners 3 ADHD Index. Families of children with positive screens and matched controls were offered enrollment in the study, with intake involving confirmation of the ADHD diagnosis, as well as detailed academic and behavioral assessments and a family survey. Children in the study were assessed at baseline, and then again at 18 and 36 months after enrollment. Longitudinal data were available for 72% of those initially enrolled.

Children in the study averaged 7.3 years old. Of the ADHD group, 124/179 (69%) were male, as were 135/212 (64%) of the control group. For children in the ADHD group, 31 (17%) had previously been diagnosed with ADHD, and 23 children (13%) were on ADHD medication at enrollment; none of the control group had a prior ADHD diagnosis or was taking medication. For 63 (38%) of the children in the ADHD group, their primary caregiver had not completed high school, compared with 39 (19%) in the control group.

“This is really more of a community-based approach to researching ADHD,” Dr. Sciberras said in an interview. Previous longitudinal studies, she said, had a near-exclusive focus on clinical samples, which can “overrepresent boys and children with more severe symptoms,” she said. Age ranges were broad, and follow-up was often infrequent. Most importantly, positive factors that lead to good outcomes for children with ADHD had been understudied, she said, and she and her colleagues are continuing to look for factors, such as resilience, that contribute to better social and emotional functioning.

It’s important to study children with ADHD in a real world manner because “childhood ADHD is associated with poorer academic outcomes, and the risk is evident from the second year of school,” said Dr. Sciberras. “We need to identify which factors lead to improved outcomes over time. The ultimate aim is to map functional impairment and key predictors from age 7 to later adolescence and adulthood.”

The study was funded by Australia’s National Health and Medical Research Council and by the Collier Foundation. Dr. Sciberras and her collaborators had no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Persistent attention-deficit/hyperactivity disorder (ADHD) through young childhood is associated with both poorer academic outcomes and an increased risk of other mental health problems, according to a longitudinal study of younger children with ADHD.

An Australian study presented at the annual meeting of the Pediatric Academic Societies found that 67% of children who had ADHD at age 7 years still met the diagnostic criteria 3 years later, when they were 10 years old. Boys were more likely than girls to have retained the diagnosis (74% vs. 50%; odds ratio, 3.4; P = .01).

On average, children with ADHD had lower scores on math and reading tests than their matched peers without ADHD, even after adjustment for socioeconomic variables and comorbidities (mean difference, –7.6 for math and –8.7 for reading, P less than .001 for both).

When Emma Sciberras, Ph.D., and her colleagues examined the longitudinal data, they found that children who had a persistent ADHD diagnosis were more likely to have an externalizing disorder, such as a conduct disorder (57% vs. 33%; OR, 2.8; P = .008). They also were more likely to have a mood disorder (8% vs. 0%; P = .04).

No sex differences were seen, aside from the increased likelihood of a persistent diagnosis.

“Childhood ADHD confers risk for future mental health difficulties,” said Dr. Sciberras, a psychologist at Deakin University, Melbourne. Dr. Sciberras presented preliminary findings from the Children’s Attention Project, a 3-year study of 179 young children with ADHD and 212 children without the diagnosis.

The goal of the Children’s Attention Project, a community-based longitudinal study, was to document the natural history of ADHD. Aspects of the study included assessing the impact of ADHD on the mental health of both children and parents, as well as examining social, academic, and family functioning, and overall quality of life. The study also seeks to tease out both risks and protective factors that can tip outcomes toward the better – or worse – end of the spectrum, said Dr. Sciberras.

The Children’s Attention Project enrolled first graders from 43 primary schools in Melbourne, to compare 3-year outcomes of a sample of children with ADHD with a control group of children who did not have ADHD. In addition to assessing diagnostic stability (the persistence of an ADHD diagnosis), Dr. Sciberras and her collaborators also looked at functional outcomes. Sex differences in outcomes, as well as the effect of ADHD persistence, also were assessed for the community-based sample of children.

Children were enrolled after families and teachers of the first graders completed the Conners 3 ADHD Index. Families of children with positive screens and matched controls were offered enrollment in the study, with intake involving confirmation of the ADHD diagnosis, as well as detailed academic and behavioral assessments and a family survey. Children in the study were assessed at baseline, and then again at 18 and 36 months after enrollment. Longitudinal data were available for 72% of those initially enrolled.

Children in the study averaged 7.3 years old. Of the ADHD group, 124/179 (69%) were male, as were 135/212 (64%) of the control group. For children in the ADHD group, 31 (17%) had previously been diagnosed with ADHD, and 23 children (13%) were on ADHD medication at enrollment; none of the control group had a prior ADHD diagnosis or was taking medication. For 63 (38%) of the children in the ADHD group, their primary caregiver had not completed high school, compared with 39 (19%) in the control group.

“This is really more of a community-based approach to researching ADHD,” Dr. Sciberras said in an interview. Previous longitudinal studies, she said, had a near-exclusive focus on clinical samples, which can “overrepresent boys and children with more severe symptoms,” she said. Age ranges were broad, and follow-up was often infrequent. Most importantly, positive factors that lead to good outcomes for children with ADHD had been understudied, she said, and she and her colleagues are continuing to look for factors, such as resilience, that contribute to better social and emotional functioning.

It’s important to study children with ADHD in a real world manner because “childhood ADHD is associated with poorer academic outcomes, and the risk is evident from the second year of school,” said Dr. Sciberras. “We need to identify which factors lead to improved outcomes over time. The ultimate aim is to map functional impairment and key predictors from age 7 to later adolescence and adulthood.”

The study was funded by Australia’s National Health and Medical Research Council and by the Collier Foundation. Dr. Sciberras and her collaborators had no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Persistent attention-deficit/hyperactivity disorder (ADHD) through young childhood is associated with both poorer academic outcomes and an increased risk of other mental health problems, according to a longitudinal study of younger children with ADHD.

An Australian study presented at the annual meeting of the Pediatric Academic Societies found that 67% of children who had ADHD at age 7 years still met the diagnostic criteria 3 years later, when they were 10 years old. Boys were more likely than girls to have retained the diagnosis (74% vs. 50%; odds ratio, 3.4; P = .01).

On average, children with ADHD had lower scores on math and reading tests than their matched peers without ADHD, even after adjustment for socioeconomic variables and comorbidities (mean difference, –7.6 for math and –8.7 for reading, P less than .001 for both).

When Emma Sciberras, Ph.D., and her colleagues examined the longitudinal data, they found that children who had a persistent ADHD diagnosis were more likely to have an externalizing disorder, such as a conduct disorder (57% vs. 33%; OR, 2.8; P = .008). They also were more likely to have a mood disorder (8% vs. 0%; P = .04).

No sex differences were seen, aside from the increased likelihood of a persistent diagnosis.

“Childhood ADHD confers risk for future mental health difficulties,” said Dr. Sciberras, a psychologist at Deakin University, Melbourne. Dr. Sciberras presented preliminary findings from the Children’s Attention Project, a 3-year study of 179 young children with ADHD and 212 children without the diagnosis.

The goal of the Children’s Attention Project, a community-based longitudinal study, was to document the natural history of ADHD. Aspects of the study included assessing the impact of ADHD on the mental health of both children and parents, as well as examining social, academic, and family functioning, and overall quality of life. The study also seeks to tease out both risks and protective factors that can tip outcomes toward the better – or worse – end of the spectrum, said Dr. Sciberras.

The Children’s Attention Project enrolled first graders from 43 primary schools in Melbourne, to compare 3-year outcomes of a sample of children with ADHD with a control group of children who did not have ADHD. In addition to assessing diagnostic stability (the persistence of an ADHD diagnosis), Dr. Sciberras and her collaborators also looked at functional outcomes. Sex differences in outcomes, as well as the effect of ADHD persistence, also were assessed for the community-based sample of children.

Children were enrolled after families and teachers of the first graders completed the Conners 3 ADHD Index. Families of children with positive screens and matched controls were offered enrollment in the study, with intake involving confirmation of the ADHD diagnosis, as well as detailed academic and behavioral assessments and a family survey. Children in the study were assessed at baseline, and then again at 18 and 36 months after enrollment. Longitudinal data were available for 72% of those initially enrolled.

Children in the study averaged 7.3 years old. Of the ADHD group, 124/179 (69%) were male, as were 135/212 (64%) of the control group. For children in the ADHD group, 31 (17%) had previously been diagnosed with ADHD, and 23 children (13%) were on ADHD medication at enrollment; none of the control group had a prior ADHD diagnosis or was taking medication. For 63 (38%) of the children in the ADHD group, their primary caregiver had not completed high school, compared with 39 (19%) in the control group.

“This is really more of a community-based approach to researching ADHD,” Dr. Sciberras said in an interview. Previous longitudinal studies, she said, had a near-exclusive focus on clinical samples, which can “overrepresent boys and children with more severe symptoms,” she said. Age ranges were broad, and follow-up was often infrequent. Most importantly, positive factors that lead to good outcomes for children with ADHD had been understudied, she said, and she and her colleagues are continuing to look for factors, such as resilience, that contribute to better social and emotional functioning.

It’s important to study children with ADHD in a real world manner because “childhood ADHD is associated with poorer academic outcomes, and the risk is evident from the second year of school,” said Dr. Sciberras. “We need to identify which factors lead to improved outcomes over time. The ultimate aim is to map functional impairment and key predictors from age 7 to later adolescence and adulthood.”

The study was funded by Australia’s National Health and Medical Research Council and by the Collier Foundation. Dr. Sciberras and her collaborators had no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Almost all teenagers with attention-deficit/hyperactivity disorder (ADHD) stopped their medication at some point during their teen years, a study showed.

The stoppages happened for a variety of reasons, many of which stemmed from the normal curiosity and independence of adolescence, especially as teens got older.

Further, almost three-quarters of adolescents with ADHD did not restart medication after stopping, a concerning statistic given the often poor outcomes for youth with untreated ADHD, said Dr. William Brinkman, professor of pediatrics at the University of Cincinnati.

A better understanding of the reasons why adolescents come off and on ADHD medication may help physicians and families craft smart approaches to keep youth on track during the experimental teenage years, according to Dr. Brinkman, who presented his findings at the annual meeting of the Pediatric Academic Societies.

Using data from the National Institute of Mental Health–supported Multimodal Treatment of Attention-Deficit/Hyperactivity Disorder (MTA) trial, Dr. Brinkman and his collaborators collated and analyzed the responses of 394 participants who had ever taken medication for ADHD.

The MTA study was a 14-month randomized clinical trial with a community control group, a behavior therapy group, a medication management group, and a combined treatment group. Naturalistic longitudinal follow-up extended for 12 years. At the end of study follow-up, participants were a mean 21.0 years old; 78% were male, and most (67%) were white.

Using a self-report measure developed in the MTA study, participants reported the age when they last had stopped taking ADHD medication and/or had restarted it. They also used a 6-point Likert scale to endorse how “true” a variety of reasons were for them to have stopped, or restarted, their ADHD medication. Scale responses ranged from 1, “really true,” to 6, “not at all true.”

Dr. Brinkman and his colleagues dichotomized the responses so that responses from 1 to 3 were characterized as “true,” while responses from 4 to 6 were characterized as “not true” when descriptive statistics were used.

Nearly all teenagers – 95% (376/394) – reported stopping their medication at some point. Commonly reported reasons for stopping included “I felt I could manage without it” (81%), “I wanted to find out if I could manage without it,” (68%), and “I was doing so well I no longer needed it” (68%). Dr. Brinkman noted that these stoppage reasons all fell into the broad category of feeling the medicine was not helping, or being curious about what would happen when they stopped taking the medicine.

Another common reason was very simple, but not easily categorized: 69% of respondents who had stopped medication endorsed the statement, “I was tired of taking it.” Almost half (46%) of respondents reported that physical side effects were a contributor to stopping the medication, while others said they stopped for the summer (30%), or that their parents had made the decision to stop the medication (26%).

Only 28% of youth in the MTA study who had stopped their medication restarted it. Of those who did, most reported they did so because the medication helped them: More than 80% of respondents felt that it helped with concentration and focus at school or work, or that it made school or work easier. Some participants felt that ADHD medication helped them organize their thoughts (68%), while 36% felt it helped decrease impulsivity.

The age at which respondents reported they had stopped or restarted their medication was broken down into childhood, aged 5-12; adolescence, aged 13-17; and emerging adulthood, aged 18-22 years. This was done so that trends in the reasons for stopping and restarting could be tracked by age.

“Parent/doctor influence decreases, while teencentric reasons increase” through adolescence, said Dr. Brinkman. The effect of parental or physician decision making about stopping or restarting medication declined significantly over the course of adolescence. The steepest declines were seen in endorsements of the statements, “My parents decided to stop it” and “My parents decided to restart it” (P for both less than .0001). The reason with the steepest increase as adolescents became adults was “I was allowed to decide when to take it” (P less than .0001).

A safer way to get teens through the experimentation and drive for autonomy that are natural parts of growing up may be physician-supervised trials on/off medicine to help curious teens more objectively assess the continued need for medicine.

Study data were drawn from the National Institutes of Mental Health–funded MTA study. Dr. Brinkman reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Almost all teenagers with attention-deficit/hyperactivity disorder (ADHD) stopped their medication at some point during their teen years, a study showed.

The stoppages happened for a variety of reasons, many of which stemmed from the normal curiosity and independence of adolescence, especially as teens got older.

Further, almost three-quarters of adolescents with ADHD did not restart medication after stopping, a concerning statistic given the often poor outcomes for youth with untreated ADHD, said Dr. William Brinkman, professor of pediatrics at the University of Cincinnati.

A better understanding of the reasons why adolescents come off and on ADHD medication may help physicians and families craft smart approaches to keep youth on track during the experimental teenage years, according to Dr. Brinkman, who presented his findings at the annual meeting of the Pediatric Academic Societies.

Using data from the National Institute of Mental Health–supported Multimodal Treatment of Attention-Deficit/Hyperactivity Disorder (MTA) trial, Dr. Brinkman and his collaborators collated and analyzed the responses of 394 participants who had ever taken medication for ADHD.

The MTA study was a 14-month randomized clinical trial with a community control group, a behavior therapy group, a medication management group, and a combined treatment group. Naturalistic longitudinal follow-up extended for 12 years. At the end of study follow-up, participants were a mean 21.0 years old; 78% were male, and most (67%) were white.

Using a self-report measure developed in the MTA study, participants reported the age when they last had stopped taking ADHD medication and/or had restarted it. They also used a 6-point Likert scale to endorse how “true” a variety of reasons were for them to have stopped, or restarted, their ADHD medication. Scale responses ranged from 1, “really true,” to 6, “not at all true.”

Dr. Brinkman and his colleagues dichotomized the responses so that responses from 1 to 3 were characterized as “true,” while responses from 4 to 6 were characterized as “not true” when descriptive statistics were used.

Nearly all teenagers – 95% (376/394) – reported stopping their medication at some point. Commonly reported reasons for stopping included “I felt I could manage without it” (81%), “I wanted to find out if I could manage without it,” (68%), and “I was doing so well I no longer needed it” (68%). Dr. Brinkman noted that these stoppage reasons all fell into the broad category of feeling the medicine was not helping, or being curious about what would happen when they stopped taking the medicine.

Another common reason was very simple, but not easily categorized: 69% of respondents who had stopped medication endorsed the statement, “I was tired of taking it.” Almost half (46%) of respondents reported that physical side effects were a contributor to stopping the medication, while others said they stopped for the summer (30%), or that their parents had made the decision to stop the medication (26%).

Only 28% of youth in the MTA study who had stopped their medication restarted it. Of those who did, most reported they did so because the medication helped them: More than 80% of respondents felt that it helped with concentration and focus at school or work, or that it made school or work easier. Some participants felt that ADHD medication helped them organize their thoughts (68%), while 36% felt it helped decrease impulsivity.

The age at which respondents reported they had stopped or restarted their medication was broken down into childhood, aged 5-12; adolescence, aged 13-17; and emerging adulthood, aged 18-22 years. This was done so that trends in the reasons for stopping and restarting could be tracked by age.

“Parent/doctor influence decreases, while teencentric reasons increase” through adolescence, said Dr. Brinkman. The effect of parental or physician decision making about stopping or restarting medication declined significantly over the course of adolescence. The steepest declines were seen in endorsements of the statements, “My parents decided to stop it” and “My parents decided to restart it” (P for both less than .0001). The reason with the steepest increase as adolescents became adults was “I was allowed to decide when to take it” (P less than .0001).

A safer way to get teens through the experimentation and drive for autonomy that are natural parts of growing up may be physician-supervised trials on/off medicine to help curious teens more objectively assess the continued need for medicine.

Study data were drawn from the National Institutes of Mental Health–funded MTA study. Dr. Brinkman reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Almost all teenagers with attention-deficit/hyperactivity disorder (ADHD) stopped their medication at some point during their teen years, a study showed.

The stoppages happened for a variety of reasons, many of which stemmed from the normal curiosity and independence of adolescence, especially as teens got older.

Further, almost three-quarters of adolescents with ADHD did not restart medication after stopping, a concerning statistic given the often poor outcomes for youth with untreated ADHD, said Dr. William Brinkman, professor of pediatrics at the University of Cincinnati.

A better understanding of the reasons why adolescents come off and on ADHD medication may help physicians and families craft smart approaches to keep youth on track during the experimental teenage years, according to Dr. Brinkman, who presented his findings at the annual meeting of the Pediatric Academic Societies.

Using data from the National Institute of Mental Health–supported Multimodal Treatment of Attention-Deficit/Hyperactivity Disorder (MTA) trial, Dr. Brinkman and his collaborators collated and analyzed the responses of 394 participants who had ever taken medication for ADHD.

The MTA study was a 14-month randomized clinical trial with a community control group, a behavior therapy group, a medication management group, and a combined treatment group. Naturalistic longitudinal follow-up extended for 12 years. At the end of study follow-up, participants were a mean 21.0 years old; 78% were male, and most (67%) were white.

Using a self-report measure developed in the MTA study, participants reported the age when they last had stopped taking ADHD medication and/or had restarted it. They also used a 6-point Likert scale to endorse how “true” a variety of reasons were for them to have stopped, or restarted, their ADHD medication. Scale responses ranged from 1, “really true,” to 6, “not at all true.”

Dr. Brinkman and his colleagues dichotomized the responses so that responses from 1 to 3 were characterized as “true,” while responses from 4 to 6 were characterized as “not true” when descriptive statistics were used.

Nearly all teenagers – 95% (376/394) – reported stopping their medication at some point. Commonly reported reasons for stopping included “I felt I could manage without it” (81%), “I wanted to find out if I could manage without it,” (68%), and “I was doing so well I no longer needed it” (68%). Dr. Brinkman noted that these stoppage reasons all fell into the broad category of feeling the medicine was not helping, or being curious about what would happen when they stopped taking the medicine.

Another common reason was very simple, but not easily categorized: 69% of respondents who had stopped medication endorsed the statement, “I was tired of taking it.” Almost half (46%) of respondents reported that physical side effects were a contributor to stopping the medication, while others said they stopped for the summer (30%), or that their parents had made the decision to stop the medication (26%).

Only 28% of youth in the MTA study who had stopped their medication restarted it. Of those who did, most reported they did so because the medication helped them: More than 80% of respondents felt that it helped with concentration and focus at school or work, or that it made school or work easier. Some participants felt that ADHD medication helped them organize their thoughts (68%), while 36% felt it helped decrease impulsivity.

The age at which respondents reported they had stopped or restarted their medication was broken down into childhood, aged 5-12; adolescence, aged 13-17; and emerging adulthood, aged 18-22 years. This was done so that trends in the reasons for stopping and restarting could be tracked by age.

“Parent/doctor influence decreases, while teencentric reasons increase” through adolescence, said Dr. Brinkman. The effect of parental or physician decision making about stopping or restarting medication declined significantly over the course of adolescence. The steepest declines were seen in endorsements of the statements, “My parents decided to stop it” and “My parents decided to restart it” (P for both less than .0001). The reason with the steepest increase as adolescents became adults was “I was allowed to decide when to take it” (P less than .0001).

A safer way to get teens through the experimentation and drive for autonomy that are natural parts of growing up may be physician-supervised trials on/off medicine to help curious teens more objectively assess the continued need for medicine.

Study data were drawn from the National Institutes of Mental Health–funded MTA study. Dr. Brinkman reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BALTIMORE – A pilot program that trained pediatric primary care providers to insert long-acting reversible contraceptives (LARCs) delivered etonogestrel contraceptive implants to 135 adolescent and young women, with insertions provided by 16 providers within the first 16 months of the project.

“Pediatric offices offer a unique opportunity to provide contraceptive education and offer LARCs, reducing the need for referrals and potential delay in LARC provision that could lead to an unintended pregnancy,” wrote Dr. Kristine Schmitz, director of medical services for the Healthy Generations Program at Children’s National Health System, and her collaborators.

In a poster session of the annual meeting of the Pediatric Academic Societies, Dr. Schmitz reported that 20 general pediatricians and 2 pediatric nurse practitioners participated in LARC insertion training, and 16 providers, some of whom had previously received training, went on to begin LARC education and insertion as part of their primary care practice. Merck, the company that manufactures the etonogestrel implant marketed as Nexplanon, requires training and a certification for providers who implant the devices, which provide contraception for 3 years but can be removed at any time.

Intrauterine devices constitute the other form of LARC; taken together, they are the most effective form of contraception, but have historically been underutilized in the teen population.

In structuring the pilot program, Dr. Schmitz and her coinvestigators sought to assess not just the willingness of pediatricians to insert LARCs, but also to see how willing teenage girls were to receive the implants in their pediatricians’ offices; those data were not analyzed for this poster presentation. The study also polled clinicians to see what barriers existed to providing LARCs in a primary care setting.

In the pilot program, pediatricians at six general pediatric offices received etonogestrel implant insertion certification. Over the 16 months of the pilot study, a total of 135 teenage girls received implants. The number of insertions performed per provider during the study period ranged from 1 to 31.

Patient age for those receiving implants ranged from 12 to 22 years, with a median age of 18.

An electronic survey tracking clinician attitudes about LARC counseling and implantation was conducted 10 months into the study. The voluntary, non-anonymous survey was given to all providers at the pilot clinics, whether or not they were trained to insert LARCs. When providers were questioned about barriers to offering LARCs in the pediatric medical home, the primary barrier was simply the lack of availability of insertion trainings, cited by 48% of respondents as a “moderate” or “significant” barrier. Patient no-show rate was the second most common barrier, falling into the “moderate” or “significant” category for 29% of providers.

When surveyed, most pediatric primary care providers in the participating practices felt “comfortable” or “very comfortable” counseling teens on all birth control options (24/30 providers). Most (20/30) also felt “comfortable” or “very comfortable” providing anticipatory guidance about side effects of etonogestrel implants. Fewer clinicians (14/30) had the same degree of assurance that they could provide follow-up care for patients who experienced negative side effects from the implants, prompting Dr. Schmitz and her colleagues to comment that “Clinicians need additional training on side effect management.”

In an interview, Dr. Schmitz commented that pediatric primary care providers have relationships with patients and their family members, and can build on that trust to provide optimal contraceptive counseling.

Still, Dr. Schmitz and her colleagues quoted a survey response that observed, “The biggest difficulty in inserting and removing Nexplanon is time constraints – fitting patients into the schedule... and patients not showing up for scheduled procedures.”

Some providers also called for more case management support, she said.

Overall, she thinks the project shows great promise, saying, “It’s exciting to see how passionate our pediatric providers are about preventing unintended teen pregnancies, and how receptive our teen patients have been to receiving their chosen birth control method from their pediatrician.”

The study was funded by the Naomi and Nehemiah Cohen Foundation and the Children’s Health Board. Dr. Schmitz had no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – A pilot program that trained pediatric primary care providers to insert long-acting reversible contraceptives (LARCs) delivered etonogestrel contraceptive implants to 135 adolescent and young women, with insertions provided by 16 providers within the first 16 months of the project.

“Pediatric offices offer a unique opportunity to provide contraceptive education and offer LARCs, reducing the need for referrals and potential delay in LARC provision that could lead to an unintended pregnancy,” wrote Dr. Kristine Schmitz, director of medical services for the Healthy Generations Program at Children’s National Health System, and her collaborators.

In a poster session of the annual meeting of the Pediatric Academic Societies, Dr. Schmitz reported that 20 general pediatricians and 2 pediatric nurse practitioners participated in LARC insertion training, and 16 providers, some of whom had previously received training, went on to begin LARC education and insertion as part of their primary care practice. Merck, the company that manufactures the etonogestrel implant marketed as Nexplanon, requires training and a certification for providers who implant the devices, which provide contraception for 3 years but can be removed at any time.

Intrauterine devices constitute the other form of LARC; taken together, they are the most effective form of contraception, but have historically been underutilized in the teen population.

In structuring the pilot program, Dr. Schmitz and her coinvestigators sought to assess not just the willingness of pediatricians to insert LARCs, but also to see how willing teenage girls were to receive the implants in their pediatricians’ offices; those data were not analyzed for this poster presentation. The study also polled clinicians to see what barriers existed to providing LARCs in a primary care setting.

In the pilot program, pediatricians at six general pediatric offices received etonogestrel implant insertion certification. Over the 16 months of the pilot study, a total of 135 teenage girls received implants. The number of insertions performed per provider during the study period ranged from 1 to 31.

Patient age for those receiving implants ranged from 12 to 22 years, with a median age of 18.

An electronic survey tracking clinician attitudes about LARC counseling and implantation was conducted 10 months into the study. The voluntary, non-anonymous survey was given to all providers at the pilot clinics, whether or not they were trained to insert LARCs. When providers were questioned about barriers to offering LARCs in the pediatric medical home, the primary barrier was simply the lack of availability of insertion trainings, cited by 48% of respondents as a “moderate” or “significant” barrier. Patient no-show rate was the second most common barrier, falling into the “moderate” or “significant” category for 29% of providers.

When surveyed, most pediatric primary care providers in the participating practices felt “comfortable” or “very comfortable” counseling teens on all birth control options (24/30 providers). Most (20/30) also felt “comfortable” or “very comfortable” providing anticipatory guidance about side effects of etonogestrel implants. Fewer clinicians (14/30) had the same degree of assurance that they could provide follow-up care for patients who experienced negative side effects from the implants, prompting Dr. Schmitz and her colleagues to comment that “Clinicians need additional training on side effect management.”

In an interview, Dr. Schmitz commented that pediatric primary care providers have relationships with patients and their family members, and can build on that trust to provide optimal contraceptive counseling.

Still, Dr. Schmitz and her colleagues quoted a survey response that observed, “The biggest difficulty in inserting and removing Nexplanon is time constraints – fitting patients into the schedule... and patients not showing up for scheduled procedures.”

Some providers also called for more case management support, she said.

Overall, she thinks the project shows great promise, saying, “It’s exciting to see how passionate our pediatric providers are about preventing unintended teen pregnancies, and how receptive our teen patients have been to receiving their chosen birth control method from their pediatrician.”

The study was funded by the Naomi and Nehemiah Cohen Foundation and the Children’s Health Board. Dr. Schmitz had no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – A pilot program that trained pediatric primary care providers to insert long-acting reversible contraceptives (LARCs) delivered etonogestrel contraceptive implants to 135 adolescent and young women, with insertions provided by 16 providers within the first 16 months of the project.

“Pediatric offices offer a unique opportunity to provide contraceptive education and offer LARCs, reducing the need for referrals and potential delay in LARC provision that could lead to an unintended pregnancy,” wrote Dr. Kristine Schmitz, director of medical services for the Healthy Generations Program at Children’s National Health System, and her collaborators.

In a poster session of the annual meeting of the Pediatric Academic Societies, Dr. Schmitz reported that 20 general pediatricians and 2 pediatric nurse practitioners participated in LARC insertion training, and 16 providers, some of whom had previously received training, went on to begin LARC education and insertion as part of their primary care practice. Merck, the company that manufactures the etonogestrel implant marketed as Nexplanon, requires training and a certification for providers who implant the devices, which provide contraception for 3 years but can be removed at any time.

Intrauterine devices constitute the other form of LARC; taken together, they are the most effective form of contraception, but have historically been underutilized in the teen population.

In structuring the pilot program, Dr. Schmitz and her coinvestigators sought to assess not just the willingness of pediatricians to insert LARCs, but also to see how willing teenage girls were to receive the implants in their pediatricians’ offices; those data were not analyzed for this poster presentation. The study also polled clinicians to see what barriers existed to providing LARCs in a primary care setting.

In the pilot program, pediatricians at six general pediatric offices received etonogestrel implant insertion certification. Over the 16 months of the pilot study, a total of 135 teenage girls received implants. The number of insertions performed per provider during the study period ranged from 1 to 31.

Patient age for those receiving implants ranged from 12 to 22 years, with a median age of 18.

An electronic survey tracking clinician attitudes about LARC counseling and implantation was conducted 10 months into the study. The voluntary, non-anonymous survey was given to all providers at the pilot clinics, whether or not they were trained to insert LARCs. When providers were questioned about barriers to offering LARCs in the pediatric medical home, the primary barrier was simply the lack of availability of insertion trainings, cited by 48% of respondents as a “moderate” or “significant” barrier. Patient no-show rate was the second most common barrier, falling into the “moderate” or “significant” category for 29% of providers.

When surveyed, most pediatric primary care providers in the participating practices felt “comfortable” or “very comfortable” counseling teens on all birth control options (24/30 providers). Most (20/30) also felt “comfortable” or “very comfortable” providing anticipatory guidance about side effects of etonogestrel implants. Fewer clinicians (14/30) had the same degree of assurance that they could provide follow-up care for patients who experienced negative side effects from the implants, prompting Dr. Schmitz and her colleagues to comment that “Clinicians need additional training on side effect management.”

In an interview, Dr. Schmitz commented that pediatric primary care providers have relationships with patients and their family members, and can build on that trust to provide optimal contraceptive counseling.

Still, Dr. Schmitz and her colleagues quoted a survey response that observed, “The biggest difficulty in inserting and removing Nexplanon is time constraints – fitting patients into the schedule... and patients not showing up for scheduled procedures.”

Some providers also called for more case management support, she said.

Overall, she thinks the project shows great promise, saying, “It’s exciting to see how passionate our pediatric providers are about preventing unintended teen pregnancies, and how receptive our teen patients have been to receiving their chosen birth control method from their pediatrician.”

The study was funded by the Naomi and Nehemiah Cohen Foundation and the Children’s Health Board. Dr. Schmitz had no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Most families’ kindergarteners met the full vaccination requirements of their state in a 2013 national survey, although 17% of parents were notified that their children still needed vaccines to comply with state requirements.

Of those 17% of families, however, 7.5% claimed exemptions from their states’ vaccination requirements at school entry, according to a study conducted by Philip Smith, Ph.D., and his associates at the Centers for Disease Control and Prevention.

©dina2001/Thinkstock

Using data from the 1,465 parents who participated in the 2013 National Immunization Survey–Kindergarten (NIS-K,), Dr. Smith and his colleagues found that among the required vaccines, full coverage (five or more doses) was lowest for the DTaP vaccine, at 88.5% of 5- to 7-year-olds. Next was the varicella vaccine, with 89.4% of children having received at least two doses. For the inactivated polio vaccine, 90.9% of children had received at least four doses. The highest rate of full coverage – 91.8% – was for the MMR vaccine.

Whether children attended public or private school didn’t make a difference in vaccination rates. However, for children who had not entered kindergarten, “vaccination coverage was significantly lower than coverage for children who had entered kindergarten,” at least in part because those children were younger than those who had entered kindergarten, said Dr. Smith.

Health insurance status did not make a difference in the likelihood that a family would receive notification that their kindergartener needed vaccinations, implying that the differences “may not be attributable to access to primary care,” wrote Dr. Smith, presenting his work at a poster session of the annual meeting of the Pediatric Academic Societies.

The number of parents overall who claimed an exemption was “really, really small,” said Dr. Smith, just 1.9% of all families surveyed. He noted that his work shows that most of the children who have not met their state’s full immunization requirements for school entry do not come from families who seek exemption from the requirements.

Limitations of the survey, said Dr. Smith and his colleagues, included the inability to determine vaccination rates at the precise time of kindergarten entry. “As a consequence, our estimates of differences in vaccination coverage that is associated with notification as of the date of school entry may underestimate the true differences,” they wrote. Also, the small sample size made it difficult to ascertain the proportion of parents who took exemptions from vaccination of their child for medical, religious, or philosophical reasons.

“While our findings show that national vaccination coverage at school entry was high and exemption levels were low, some children remained undervaccinated after the start of the school year despite efforts of school vaccination programs to notify parents about needed vaccines,” wrote Dr. Smith and his coauthors.

The NIS-K is conducted by the Centers for Disease Control and Prevention, where Dr. Smith is employed. Dr. Smith reported no relevant financial disclosures.

BALTIMORE – Most families’ kindergarteners met the full vaccination requirements of their state in a 2013 national survey, although 17% of parents were notified that their children still needed vaccines to comply with state requirements.

Of those 17% of families, however, 7.5% claimed exemptions from their states’ vaccination requirements at school entry, according to a study conducted by Philip Smith, Ph.D., and his associates at the Centers for Disease Control and Prevention.

©dina2001/Thinkstock

Using data from the 1,465 parents who participated in the 2013 National Immunization Survey–Kindergarten (NIS-K,), Dr. Smith and his colleagues found that among the required vaccines, full coverage (five or more doses) was lowest for the DTaP vaccine, at 88.5% of 5- to 7-year-olds. Next was the varicella vaccine, with 89.4% of children having received at least two doses. For the inactivated polio vaccine, 90.9% of children had received at least four doses. The highest rate of full coverage – 91.8% – was for the MMR vaccine.

Whether children attended public or private school didn’t make a difference in vaccination rates. However, for children who had not entered kindergarten, “vaccination coverage was significantly lower than coverage for children who had entered kindergarten,” at least in part because those children were younger than those who had entered kindergarten, said Dr. Smith.

Health insurance status did not make a difference in the likelihood that a family would receive notification that their kindergartener needed vaccinations, implying that the differences “may not be attributable to access to primary care,” wrote Dr. Smith, presenting his work at a poster session of the annual meeting of the Pediatric Academic Societies.

The number of parents overall who claimed an exemption was “really, really small,” said Dr. Smith, just 1.9% of all families surveyed. He noted that his work shows that most of the children who have not met their state’s full immunization requirements for school entry do not come from families who seek exemption from the requirements.

Limitations of the survey, said Dr. Smith and his colleagues, included the inability to determine vaccination rates at the precise time of kindergarten entry. “As a consequence, our estimates of differences in vaccination coverage that is associated with notification as of the date of school entry may underestimate the true differences,” they wrote. Also, the small sample size made it difficult to ascertain the proportion of parents who took exemptions from vaccination of their child for medical, religious, or philosophical reasons.

“While our findings show that national vaccination coverage at school entry was high and exemption levels were low, some children remained undervaccinated after the start of the school year despite efforts of school vaccination programs to notify parents about needed vaccines,” wrote Dr. Smith and his coauthors.

The NIS-K is conducted by the Centers for Disease Control and Prevention, where Dr. Smith is employed. Dr. Smith reported no relevant financial disclosures.

BALTIMORE – Most families’ kindergarteners met the full vaccination requirements of their state in a 2013 national survey, although 17% of parents were notified that their children still needed vaccines to comply with state requirements.

Of those 17% of families, however, 7.5% claimed exemptions from their states’ vaccination requirements at school entry, according to a study conducted by Philip Smith, Ph.D., and his associates at the Centers for Disease Control and Prevention.

©dina2001/Thinkstock

Using data from the 1,465 parents who participated in the 2013 National Immunization Survey–Kindergarten (NIS-K,), Dr. Smith and his colleagues found that among the required vaccines, full coverage (five or more doses) was lowest for the DTaP vaccine, at 88.5% of 5- to 7-year-olds. Next was the varicella vaccine, with 89.4% of children having received at least two doses. For the inactivated polio vaccine, 90.9% of children had received at least four doses. The highest rate of full coverage – 91.8% – was for the MMR vaccine.

Whether children attended public or private school didn’t make a difference in vaccination rates. However, for children who had not entered kindergarten, “vaccination coverage was significantly lower than coverage for children who had entered kindergarten,” at least in part because those children were younger than those who had entered kindergarten, said Dr. Smith.

Health insurance status did not make a difference in the likelihood that a family would receive notification that their kindergartener needed vaccinations, implying that the differences “may not be attributable to access to primary care,” wrote Dr. Smith, presenting his work at a poster session of the annual meeting of the Pediatric Academic Societies.

The number of parents overall who claimed an exemption was “really, really small,” said Dr. Smith, just 1.9% of all families surveyed. He noted that his work shows that most of the children who have not met their state’s full immunization requirements for school entry do not come from families who seek exemption from the requirements.

Limitations of the survey, said Dr. Smith and his colleagues, included the inability to determine vaccination rates at the precise time of kindergarten entry. “As a consequence, our estimates of differences in vaccination coverage that is associated with notification as of the date of school entry may underestimate the true differences,” they wrote. Also, the small sample size made it difficult to ascertain the proportion of parents who took exemptions from vaccination of their child for medical, religious, or philosophical reasons.

“While our findings show that national vaccination coverage at school entry was high and exemption levels were low, some children remained undervaccinated after the start of the school year despite efforts of school vaccination programs to notify parents about needed vaccines,” wrote Dr. Smith and his coauthors.

The NIS-K is conducted by the Centers for Disease Control and Prevention, where Dr. Smith is employed. Dr. Smith reported no relevant financial disclosures.

BALTIMORE – Most families’ kindergarteners met the full vaccination requirements of their state in a 2013 national survey, although 17% of parents were notified that their children still needed vaccines to comply with state requirements.

Of those 17% of families, however, 7.5% claimed exemptions from their states’ vaccination requirements at school entry, according to a study conducted by Philip Smith, Ph.D., and his associates at the Centers for Disease Control and Prevention.

©dina2001/Thinkstock

Using data from the 1,465 parents who participated in the 2013 National Immunization Survey–Kindergarten (NIS-K,), Dr. Smith and his colleagues found that among the required vaccines, full coverage (five or more doses) was lowest for the DTaP vaccine, at 88.5% of 5- to 7-year-olds. Next was the varicella vaccine, with 89.4% of children having received at least two doses. For the inactivated polio vaccine, 90.9% of children had received at least four doses. The highest rate of full coverage – 91.8% – was for the MMR vaccine.

Whether children attended public or private school didn’t make a difference in vaccination rates. However, for children who had not entered kindergarten, “vaccination coverage was significantly lower than coverage for children who had entered kindergarten,” at least in part because those children were younger than those who had entered kindergarten, said Dr. Smith.

Health insurance status did not make a difference in the likelihood that a family would receive notification that their kindergartener needed vaccinations, implying that the differences “may not be attributable to access to primary care,” wrote Dr. Smith, presenting his work at a poster session of the annual meeting of the Pediatric Academic Societies.

The number of parents overall who claimed an exemption was “really, really small,” said Dr. Smith, just 1.9% of all families surveyed. He noted that his work shows that most of the children who have not met their state’s full immunization requirements for school entry do not come from families who seek exemption from the requirements.

Limitations of the survey, said Dr. Smith and his colleagues, included the inability to determine vaccination rates at the precise time of kindergarten entry. “As a consequence, our estimates of differences in vaccination coverage that is associated with notification as of the date of school entry may underestimate the true differences,” they wrote. Also, the small sample size made it difficult to ascertain the proportion of parents who took exemptions from vaccination of their child for medical, religious, or philosophical reasons.

“While our findings show that national vaccination coverage at school entry was high and exemption levels were low, some children remained undervaccinated after the start of the school year despite efforts of school vaccination programs to notify parents about needed vaccines,” wrote Dr. Smith and his coauthors.

The NIS-K is conducted by the Centers for Disease Control and Prevention, where Dr. Smith is employed. Dr. Smith reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Most families’ kindergarteners met the full vaccination requirements of their state in a 2013 national survey, although 17% of parents were notified that their children still needed vaccines to comply with state requirements.

Of those 17% of families, however, 7.5% claimed exemptions from their states’ vaccination requirements at school entry, according to a study conducted by Philip Smith, Ph.D., and his associates at the Centers for Disease Control and Prevention.

©dina2001/Thinkstock

Using data from the 1,465 parents who participated in the 2013 National Immunization Survey–Kindergarten (NIS-K,), Dr. Smith and his colleagues found that among the required vaccines, full coverage (five or more doses) was lowest for the DTaP vaccine, at 88.5% of 5- to 7-year-olds. Next was the varicella vaccine, with 89.4% of children having received at least two doses. For the inactivated polio vaccine, 90.9% of children had received at least four doses. The highest rate of full coverage – 91.8% – was for the MMR vaccine.

Whether children attended public or private school didn’t make a difference in vaccination rates. However, for children who had not entered kindergarten, “vaccination coverage was significantly lower than coverage for children who had entered kindergarten,” at least in part because those children were younger than those who had entered kindergarten, said Dr. Smith.

Health insurance status did not make a difference in the likelihood that a family would receive notification that their kindergartener needed vaccinations, implying that the differences “may not be attributable to access to primary care,” wrote Dr. Smith, presenting his work at a poster session of the annual meeting of the Pediatric Academic Societies.

The number of parents overall who claimed an exemption was “really, really small,” said Dr. Smith, just 1.9% of all families surveyed. He noted that his work shows that most of the children who have not met their state’s full immunization requirements for school entry do not come from families who seek exemption from the requirements.

Limitations of the survey, said Dr. Smith and his colleagues, included the inability to determine vaccination rates at the precise time of kindergarten entry. “As a consequence, our estimates of differences in vaccination coverage that is associated with notification as of the date of school entry may underestimate the true differences,” they wrote. Also, the small sample size made it difficult to ascertain the proportion of parents who took exemptions from vaccination of their child for medical, religious, or philosophical reasons.

“While our findings show that national vaccination coverage at school entry was high and exemption levels were low, some children remained undervaccinated after the start of the school year despite efforts of school vaccination programs to notify parents about needed vaccines,” wrote Dr. Smith and his coauthors.

The NIS-K is conducted by the Centers for Disease Control and Prevention, where Dr. Smith is employed. Dr. Smith reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

BALTIMORE – Most families’ kindergarteners met the full vaccination requirements of their state in a 2013 national survey, although 17% of parents were notified that their children still needed vaccines to comply with state requirements.

Of those 17% of families, however, 7.5% claimed exemptions from their states’ vaccination requirements at school entry, according to a study conducted by Philip Smith, Ph.D., and his associates at the Centers for Disease Control and Prevention.

©dina2001/Thinkstock

Using data from the 1,465 parents who participated in the 2013 National Immunization Survey–Kindergarten (NIS-K,), Dr. Smith and his colleagues found that among the required vaccines, full coverage (five or more doses) was lowest for the DTaP vaccine, at 88.5% of 5- to 7-year-olds. Next was the varicella vaccine, with 89.4% of children having received at least two doses. For the inactivated polio vaccine, 90.9% of children had received at least four doses. The highest rate of full coverage – 91.8% – was for the MMR vaccine.

Whether children attended public or private school didn’t make a difference in vaccination rates. However, for children who had not entered kindergarten, “vaccination coverage was significantly lower than coverage for children who had entered kindergarten,” at least in part because those children were younger than those who had entered kindergarten, said Dr. Smith.

Health insurance status did not make a difference in the likelihood that a family would receive notification that their kindergartener needed vaccinations, implying that the differences “may not be attributable to access to primary care,” wrote Dr. Smith, presenting his work at a poster session of the annual meeting of the Pediatric Academic Societies.

The number of parents overall who claimed an exemption was “really, really small,” said Dr. Smith, just 1.9% of all families surveyed. He noted that his work shows that most of the children who have not met their state’s full immunization requirements for school entry do not come from families who seek exemption from the requirements.

Limitations of the survey, said Dr. Smith and his colleagues, included the inability to determine vaccination rates at the precise time of kindergarten entry. “As a consequence, our estimates of differences in vaccination coverage that is associated with notification as of the date of school entry may underestimate the true differences,” they wrote. Also, the small sample size made it difficult to ascertain the proportion of parents who took exemptions from vaccination of their child for medical, religious, or philosophical reasons.

“While our findings show that national vaccination coverage at school entry was high and exemption levels were low, some children remained undervaccinated after the start of the school year despite efforts of school vaccination programs to notify parents about needed vaccines,” wrote Dr. Smith and his coauthors.

The NIS-K is conducted by the Centers for Disease Control and Prevention, where Dr. Smith is employed. Dr. Smith reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes