Earlier diagnosis, treatment needed to curb dramatic rise in neonatal HSV

Diagnostic conundrum persists despite new data
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A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.

Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.

A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.

Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).

HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.

Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).

Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.

ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.

The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.

That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.

“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.

The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.

SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.

Body

The rise in herpes simplex virus cases among neonates reported by Mahant et al. is significant, but there are other possible explanations that warrant additional research, James Gaensbauer, MD, and Joseph A. Grubenhoff, MD, wrote in an accompanying editorial.

Among those explanations, Dr. Gaensbauer and Dr. Grubenhoff cite recommendations made nationally in 2013 to screen asymptomatic infants who had been exposed to HSV at the time of delivery as one possible factor elevating the number of cases being reported. More widespread use of polymerase chain reaction (PCR)–based diagnostic testing, which is reported to be more sensitive, also could play a role in increasing the number of cases being identified.

As part of a larger diagnostic “conundrum” challenging clinicians, the editorialists noted that, at present, there is no uniform consensus for performing HSV testing and providing empirical treatment. “Current recommendations from the American Academy of Pediatrics identify and emphasize the importance of recognition of the factors associated with increased likelihood of HSV infection but do not specify a more comprehensive (e.g., all febrile infants) strategy.” Stakeholders should build flexibility into their recommended treatment approaches for the benefit of practitioners operating on the front lines, they advised.

Ultimately, if the increase in incidence of neonatal HSV cases proves largely attributable to the changing behaviors of young women, who have been engaging more frequently in oral sex, as Dr. Mahant and his colleagues suggest, further research will be warranted, cautioned Dr. Gaensbauer and Dr. Grubenhoff.

“With their work, the authors contribute further nuance to a complicated and ongoing question: How do we correctly identify all infants with neonatal HSV in a timely manner while avoiding subjecting large numbers of children to unnecessary tests and empirical treatments?” This debate “is likely to be transformed by increasing availability of rapid PCR testing for HSV,” they said.

The “pathway to better clarity will depend on researchers and clinicians such as Mahant et al., who continue to provide important data and ask critical questions,” Dr. Gaensbauer and Dr. Grubenhoff concluded.

Dr. Gaensbauer and Dr. Grubenhoff are affiliated with the Denver Health Medical Center; the Children’s Hospital Colorado, Aurora; and the department of pediatrics at University of Colorado at Denver, Aurora. This is a summarization of their editorial, which accompanied the article by Mahant et al. (Pediatrics. 2019 Mar. doi: 10.1542/peds.2019-0159). They received no external funding and had no relevant financial disclosures.

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The rise in herpes simplex virus cases among neonates reported by Mahant et al. is significant, but there are other possible explanations that warrant additional research, James Gaensbauer, MD, and Joseph A. Grubenhoff, MD, wrote in an accompanying editorial.

Among those explanations, Dr. Gaensbauer and Dr. Grubenhoff cite recommendations made nationally in 2013 to screen asymptomatic infants who had been exposed to HSV at the time of delivery as one possible factor elevating the number of cases being reported. More widespread use of polymerase chain reaction (PCR)–based diagnostic testing, which is reported to be more sensitive, also could play a role in increasing the number of cases being identified.

As part of a larger diagnostic “conundrum” challenging clinicians, the editorialists noted that, at present, there is no uniform consensus for performing HSV testing and providing empirical treatment. “Current recommendations from the American Academy of Pediatrics identify and emphasize the importance of recognition of the factors associated with increased likelihood of HSV infection but do not specify a more comprehensive (e.g., all febrile infants) strategy.” Stakeholders should build flexibility into their recommended treatment approaches for the benefit of practitioners operating on the front lines, they advised.

Ultimately, if the increase in incidence of neonatal HSV cases proves largely attributable to the changing behaviors of young women, who have been engaging more frequently in oral sex, as Dr. Mahant and his colleagues suggest, further research will be warranted, cautioned Dr. Gaensbauer and Dr. Grubenhoff.

“With their work, the authors contribute further nuance to a complicated and ongoing question: How do we correctly identify all infants with neonatal HSV in a timely manner while avoiding subjecting large numbers of children to unnecessary tests and empirical treatments?” This debate “is likely to be transformed by increasing availability of rapid PCR testing for HSV,” they said.

The “pathway to better clarity will depend on researchers and clinicians such as Mahant et al., who continue to provide important data and ask critical questions,” Dr. Gaensbauer and Dr. Grubenhoff concluded.

Dr. Gaensbauer and Dr. Grubenhoff are affiliated with the Denver Health Medical Center; the Children’s Hospital Colorado, Aurora; and the department of pediatrics at University of Colorado at Denver, Aurora. This is a summarization of their editorial, which accompanied the article by Mahant et al. (Pediatrics. 2019 Mar. doi: 10.1542/peds.2019-0159). They received no external funding and had no relevant financial disclosures.

Body

The rise in herpes simplex virus cases among neonates reported by Mahant et al. is significant, but there are other possible explanations that warrant additional research, James Gaensbauer, MD, and Joseph A. Grubenhoff, MD, wrote in an accompanying editorial.

Among those explanations, Dr. Gaensbauer and Dr. Grubenhoff cite recommendations made nationally in 2013 to screen asymptomatic infants who had been exposed to HSV at the time of delivery as one possible factor elevating the number of cases being reported. More widespread use of polymerase chain reaction (PCR)–based diagnostic testing, which is reported to be more sensitive, also could play a role in increasing the number of cases being identified.

As part of a larger diagnostic “conundrum” challenging clinicians, the editorialists noted that, at present, there is no uniform consensus for performing HSV testing and providing empirical treatment. “Current recommendations from the American Academy of Pediatrics identify and emphasize the importance of recognition of the factors associated with increased likelihood of HSV infection but do not specify a more comprehensive (e.g., all febrile infants) strategy.” Stakeholders should build flexibility into their recommended treatment approaches for the benefit of practitioners operating on the front lines, they advised.

Ultimately, if the increase in incidence of neonatal HSV cases proves largely attributable to the changing behaviors of young women, who have been engaging more frequently in oral sex, as Dr. Mahant and his colleagues suggest, further research will be warranted, cautioned Dr. Gaensbauer and Dr. Grubenhoff.

“With their work, the authors contribute further nuance to a complicated and ongoing question: How do we correctly identify all infants with neonatal HSV in a timely manner while avoiding subjecting large numbers of children to unnecessary tests and empirical treatments?” This debate “is likely to be transformed by increasing availability of rapid PCR testing for HSV,” they said.

The “pathway to better clarity will depend on researchers and clinicians such as Mahant et al., who continue to provide important data and ask critical questions,” Dr. Gaensbauer and Dr. Grubenhoff concluded.

Dr. Gaensbauer and Dr. Grubenhoff are affiliated with the Denver Health Medical Center; the Children’s Hospital Colorado, Aurora; and the department of pediatrics at University of Colorado at Denver, Aurora. This is a summarization of their editorial, which accompanied the article by Mahant et al. (Pediatrics. 2019 Mar. doi: 10.1542/peds.2019-0159). They received no external funding and had no relevant financial disclosures.

Title
Diagnostic conundrum persists despite new data
Diagnostic conundrum persists despite new data

A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.

Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.

A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.

Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).

HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.

Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).

Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.

ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.

The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.

That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.

“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.

The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.

SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.

A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.

Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.

A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.

Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).

HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.

Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).

Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.

ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.

The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.

That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.

“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.

The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.

SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.

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Breast cancer survivors offer realistic strategies for easing cost burden

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A qualitative study representing the patient perspective provides insight on reducing economic burden after breast cancer, including specific recommendations for changes to insurance, supportive services, financial assistance, and protective policies.

As part of a 6-month observational study conducted in 2015, Lorraine T. Dean, ScD, of Johns Hopkins Schools of Public Health and Medicine, Baltimore, and her associates, interviewed 40 women diagnosed with invasive stage I-III breast cancer who had completed active cancer treatment. All patients, who reported having more than one lymph node removed resided in Pennsylvania or New Jersey. The mean age of the women was 64 years.

Of those interviewed, 53% were white; 42.5% were black. More than half of participants (53%) were college graduates or had received a graduate degree. Annual income for 58% of the patients ranged from $30,000 to $70,000; 11% earned under $30,000. All participants included in the study were insured, including 82.5% who had private insurance. The patients had been diagnosed a mean of 12 years prior. Breast cancer–related lymphedema was reported in 60% of patients, Dr. Dean and her associates reported in a report published in Cancer.

Among the 40 participants, 27 made recommendations for easing economic burden, including nine key recommendations across four significant areas: insurance, supportive services and care, financial assistance, and protective policies. These findings are consistent with previous studies that examined patient recommendations, but they address additional areas where cost-saving services and policies could be offered or improved upon, the investigators noted.

Insurance-related recommendations included offering more complementary and integrative treatments as well as helping patients understand what insurance plans cover and how to adjust to changes under new insurance plans. Providing high-quality plans with low copays, premiums, and deductibles that cover required as well as elective cancer-related services, and covering lymphedema-related materials and treatments also were flagged as important.

Supportive service recommendations included addressing psychosocial costs through expansion of support groups and buddy services, offering extended home health services following cancer treatment, and providing domestic assistance with household chores, child care, and transportation.

Financial assistance that broadens financial aid and social services eligibility to those not classified as being in poverty was considered important.

Protective policy recommendations focused on expanding employment and medical leave policies concerning the amount of time offered off from work.

Patient recommendations offer just one viewpoint concerning potential challenges to the overall system, but “their thoughts on how it can be improved add value to decision-making processes,” noted Dr. Dean and her associates.

They were careful to acknowledge the benefits of the Patient Protection and Affordable Care Act, but they noted that it does not include provisions to address the adverse treatment effects of conditions such as cancer. While some states already have successfully passed legislation requiring private insurance carriers to cover lymphedema treatment, similar legislation should be adopted at a national level through joint efforts of Congress and the Department of Labor, they advised.

Any such efforts to make sweeping changes within the insurance industry would take considerable effort on the part of patients, providers, insurers, and state and federal policy makers, as well as the pharmaceutical industry. Yet, such “top-down and bottom-up strategies that involve all parties are warranted,” they urged.

Several important limitations of the study are worth noting. All participants were from the East Coast, had insurance coverage, and reported an overall low level of economic burden. Responses may have differed had the study been conducted in other regions of the country. The study was voluntary, so it is important to consider that patients with greater financial challenges may not have had time to enroll and participate, which suggests that the level of economic burden affecting this population actually could be understated.

SOURCE: Dean LT et al. Cancer 2019 Mar 6. doi: 10.1002/cncr.32012.

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A qualitative study representing the patient perspective provides insight on reducing economic burden after breast cancer, including specific recommendations for changes to insurance, supportive services, financial assistance, and protective policies.

As part of a 6-month observational study conducted in 2015, Lorraine T. Dean, ScD, of Johns Hopkins Schools of Public Health and Medicine, Baltimore, and her associates, interviewed 40 women diagnosed with invasive stage I-III breast cancer who had completed active cancer treatment. All patients, who reported having more than one lymph node removed resided in Pennsylvania or New Jersey. The mean age of the women was 64 years.

Of those interviewed, 53% were white; 42.5% were black. More than half of participants (53%) were college graduates or had received a graduate degree. Annual income for 58% of the patients ranged from $30,000 to $70,000; 11% earned under $30,000. All participants included in the study were insured, including 82.5% who had private insurance. The patients had been diagnosed a mean of 12 years prior. Breast cancer–related lymphedema was reported in 60% of patients, Dr. Dean and her associates reported in a report published in Cancer.

Among the 40 participants, 27 made recommendations for easing economic burden, including nine key recommendations across four significant areas: insurance, supportive services and care, financial assistance, and protective policies. These findings are consistent with previous studies that examined patient recommendations, but they address additional areas where cost-saving services and policies could be offered or improved upon, the investigators noted.

Insurance-related recommendations included offering more complementary and integrative treatments as well as helping patients understand what insurance plans cover and how to adjust to changes under new insurance plans. Providing high-quality plans with low copays, premiums, and deductibles that cover required as well as elective cancer-related services, and covering lymphedema-related materials and treatments also were flagged as important.

Supportive service recommendations included addressing psychosocial costs through expansion of support groups and buddy services, offering extended home health services following cancer treatment, and providing domestic assistance with household chores, child care, and transportation.

Financial assistance that broadens financial aid and social services eligibility to those not classified as being in poverty was considered important.

Protective policy recommendations focused on expanding employment and medical leave policies concerning the amount of time offered off from work.

Patient recommendations offer just one viewpoint concerning potential challenges to the overall system, but “their thoughts on how it can be improved add value to decision-making processes,” noted Dr. Dean and her associates.

They were careful to acknowledge the benefits of the Patient Protection and Affordable Care Act, but they noted that it does not include provisions to address the adverse treatment effects of conditions such as cancer. While some states already have successfully passed legislation requiring private insurance carriers to cover lymphedema treatment, similar legislation should be adopted at a national level through joint efforts of Congress and the Department of Labor, they advised.

Any such efforts to make sweeping changes within the insurance industry would take considerable effort on the part of patients, providers, insurers, and state and federal policy makers, as well as the pharmaceutical industry. Yet, such “top-down and bottom-up strategies that involve all parties are warranted,” they urged.

Several important limitations of the study are worth noting. All participants were from the East Coast, had insurance coverage, and reported an overall low level of economic burden. Responses may have differed had the study been conducted in other regions of the country. The study was voluntary, so it is important to consider that patients with greater financial challenges may not have had time to enroll and participate, which suggests that the level of economic burden affecting this population actually could be understated.

SOURCE: Dean LT et al. Cancer 2019 Mar 6. doi: 10.1002/cncr.32012.

A qualitative study representing the patient perspective provides insight on reducing economic burden after breast cancer, including specific recommendations for changes to insurance, supportive services, financial assistance, and protective policies.

As part of a 6-month observational study conducted in 2015, Lorraine T. Dean, ScD, of Johns Hopkins Schools of Public Health and Medicine, Baltimore, and her associates, interviewed 40 women diagnosed with invasive stage I-III breast cancer who had completed active cancer treatment. All patients, who reported having more than one lymph node removed resided in Pennsylvania or New Jersey. The mean age of the women was 64 years.

Of those interviewed, 53% were white; 42.5% were black. More than half of participants (53%) were college graduates or had received a graduate degree. Annual income for 58% of the patients ranged from $30,000 to $70,000; 11% earned under $30,000. All participants included in the study were insured, including 82.5% who had private insurance. The patients had been diagnosed a mean of 12 years prior. Breast cancer–related lymphedema was reported in 60% of patients, Dr. Dean and her associates reported in a report published in Cancer.

Among the 40 participants, 27 made recommendations for easing economic burden, including nine key recommendations across four significant areas: insurance, supportive services and care, financial assistance, and protective policies. These findings are consistent with previous studies that examined patient recommendations, but they address additional areas where cost-saving services and policies could be offered or improved upon, the investigators noted.

Insurance-related recommendations included offering more complementary and integrative treatments as well as helping patients understand what insurance plans cover and how to adjust to changes under new insurance plans. Providing high-quality plans with low copays, premiums, and deductibles that cover required as well as elective cancer-related services, and covering lymphedema-related materials and treatments also were flagged as important.

Supportive service recommendations included addressing psychosocial costs through expansion of support groups and buddy services, offering extended home health services following cancer treatment, and providing domestic assistance with household chores, child care, and transportation.

Financial assistance that broadens financial aid and social services eligibility to those not classified as being in poverty was considered important.

Protective policy recommendations focused on expanding employment and medical leave policies concerning the amount of time offered off from work.

Patient recommendations offer just one viewpoint concerning potential challenges to the overall system, but “their thoughts on how it can be improved add value to decision-making processes,” noted Dr. Dean and her associates.

They were careful to acknowledge the benefits of the Patient Protection and Affordable Care Act, but they noted that it does not include provisions to address the adverse treatment effects of conditions such as cancer. While some states already have successfully passed legislation requiring private insurance carriers to cover lymphedema treatment, similar legislation should be adopted at a national level through joint efforts of Congress and the Department of Labor, they advised.

Any such efforts to make sweeping changes within the insurance industry would take considerable effort on the part of patients, providers, insurers, and state and federal policy makers, as well as the pharmaceutical industry. Yet, such “top-down and bottom-up strategies that involve all parties are warranted,” they urged.

Several important limitations of the study are worth noting. All participants were from the East Coast, had insurance coverage, and reported an overall low level of economic burden. Responses may have differed had the study been conducted in other regions of the country. The study was voluntary, so it is important to consider that patients with greater financial challenges may not have had time to enroll and participate, which suggests that the level of economic burden affecting this population actually could be understated.

SOURCE: Dean LT et al. Cancer 2019 Mar 6. doi: 10.1002/cncr.32012.

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Consider individualized testosterone protocol for transgender acne

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Tue, 03/19/2019 - 16:36

 

Testosterone therapy can be personalized for transgender men who begin to develop acne during masculinizing hormone treatment, but patient compatibility will depend upon several factors, advised Jason A. Park and his associates in a research letter to the editor of the Journal of the American Academy of Dermatology.

In a multivariate logistic regression analysis, Mr. Park and his colleagues at Boston University sought to determine the timing of onset of acne in female-to-male transgender patients.

A total of 55 patients undergoing hormone therapy at the Center for Transgender Medicine and Surgery at Boston Medical Center between January 1, 2010, and December 31, 2017 were selected following a systematic chart review. Patients were excluded who were under the age of 18 years, who had been receiving testosterone therapy for less than 2 years, who presented with acne before start of treatment, or whose medical records were incomplete.

Given evidence in prior studies reporting on an association between elevated androgen levels and increased incidence of acne in this patient group, a median serum testosterone level of 630 ng/dL “was used to differentiate between higher and lower levels.”

Acne was found to develop in 9% of transgender men after 3 months and in 18% after 6 months; 38% of the subjects were found to have developed acne at some point during the study after 24 months of treatment. The authors found that acne was “significantly associated with serum testosterone levels higher than 630 ng/dL.” Increased body mass index (BMI), especially in those with positive smoking status, also was associated with an increased incidence of acne, the authors said.

According to several existing studies, transgender men undergoing testosterone therapy tend to develop increased sebum production and acne. Because the systemic and dermatologic virilization effects of testosterone are unpredictable once treatment has started, and because individual goals also are varied (from maximum virilization to only suppressing feminine secondary sex characteristics), Mr. Park and his colleagues suggested that customization may be ideal, provided they do not clash with individual patient transition goals, priorities, risk factors, and other comorbidities that may be present.

The study was funded by the Medical Student Summer Research Program at Boston University. The authors had no conflicts of interest to report.

SOURCE: Park JA et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2018.12.040.

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Testosterone therapy can be personalized for transgender men who begin to develop acne during masculinizing hormone treatment, but patient compatibility will depend upon several factors, advised Jason A. Park and his associates in a research letter to the editor of the Journal of the American Academy of Dermatology.

In a multivariate logistic regression analysis, Mr. Park and his colleagues at Boston University sought to determine the timing of onset of acne in female-to-male transgender patients.

A total of 55 patients undergoing hormone therapy at the Center for Transgender Medicine and Surgery at Boston Medical Center between January 1, 2010, and December 31, 2017 were selected following a systematic chart review. Patients were excluded who were under the age of 18 years, who had been receiving testosterone therapy for less than 2 years, who presented with acne before start of treatment, or whose medical records were incomplete.

Given evidence in prior studies reporting on an association between elevated androgen levels and increased incidence of acne in this patient group, a median serum testosterone level of 630 ng/dL “was used to differentiate between higher and lower levels.”

Acne was found to develop in 9% of transgender men after 3 months and in 18% after 6 months; 38% of the subjects were found to have developed acne at some point during the study after 24 months of treatment. The authors found that acne was “significantly associated with serum testosterone levels higher than 630 ng/dL.” Increased body mass index (BMI), especially in those with positive smoking status, also was associated with an increased incidence of acne, the authors said.

According to several existing studies, transgender men undergoing testosterone therapy tend to develop increased sebum production and acne. Because the systemic and dermatologic virilization effects of testosterone are unpredictable once treatment has started, and because individual goals also are varied (from maximum virilization to only suppressing feminine secondary sex characteristics), Mr. Park and his colleagues suggested that customization may be ideal, provided they do not clash with individual patient transition goals, priorities, risk factors, and other comorbidities that may be present.

The study was funded by the Medical Student Summer Research Program at Boston University. The authors had no conflicts of interest to report.

SOURCE: Park JA et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2018.12.040.

 

Testosterone therapy can be personalized for transgender men who begin to develop acne during masculinizing hormone treatment, but patient compatibility will depend upon several factors, advised Jason A. Park and his associates in a research letter to the editor of the Journal of the American Academy of Dermatology.

In a multivariate logistic regression analysis, Mr. Park and his colleagues at Boston University sought to determine the timing of onset of acne in female-to-male transgender patients.

A total of 55 patients undergoing hormone therapy at the Center for Transgender Medicine and Surgery at Boston Medical Center between January 1, 2010, and December 31, 2017 were selected following a systematic chart review. Patients were excluded who were under the age of 18 years, who had been receiving testosterone therapy for less than 2 years, who presented with acne before start of treatment, or whose medical records were incomplete.

Given evidence in prior studies reporting on an association between elevated androgen levels and increased incidence of acne in this patient group, a median serum testosterone level of 630 ng/dL “was used to differentiate between higher and lower levels.”

Acne was found to develop in 9% of transgender men after 3 months and in 18% after 6 months; 38% of the subjects were found to have developed acne at some point during the study after 24 months of treatment. The authors found that acne was “significantly associated with serum testosterone levels higher than 630 ng/dL.” Increased body mass index (BMI), especially in those with positive smoking status, also was associated with an increased incidence of acne, the authors said.

According to several existing studies, transgender men undergoing testosterone therapy tend to develop increased sebum production and acne. Because the systemic and dermatologic virilization effects of testosterone are unpredictable once treatment has started, and because individual goals also are varied (from maximum virilization to only suppressing feminine secondary sex characteristics), Mr. Park and his colleagues suggested that customization may be ideal, provided they do not clash with individual patient transition goals, priorities, risk factors, and other comorbidities that may be present.

The study was funded by the Medical Student Summer Research Program at Boston University. The authors had no conflicts of interest to report.

SOURCE: Park JA et al. J Am Acad Dermatol. 2019. doi: 10.1016/j.jaad.2018.12.040.

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Teens likely to mimic parents’ opioid use

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The correlation between parental nonmedical prescription opioid use and offspring use should be considered in targeted efforts to reduce adolescent use, reported Pamela C. Griesler, PhD, of Columbia University, New York, and her associates.

Bottles of pills
BackyardProduction/Thinkstock

Given the significant link between parental and adolescent smoking and adolescent nonmedical prescription opioid (NMPO) use, smoking also should be included in targeted interventions, they wrote in Pediatrics.

Dr. Griesler and her colleagues noted that there actually are three classes of factors influencing the association between parent and adolescent NMPO use: phenotypic heritability, parental role modeling, and parental socialization and other environmental influences.

In the first known study to explore the relationship of parent-adolescent NMPO use within a nationally representative sampling of parent-child dyads taken from the National Surveys on Drug Use and Health, Dr. Griesler and her colleagues examined the intergenerational association of lifetime NMPO use among 35,000 parent-adolescent dyads (21,200 mothers, 13,800 fathers). Of the 35,000 children aged 12-17 years included in the sample, 90% were biological, 8% were stepchildren, and 2% were adopted.

Given the absence of previous studies exploring the relationship between parent-adolescent NMPO use, Dr. Griesler and her associates used established findings for smoking and substance use to hypothesize that there would be stronger associations for mothers than fathers, daughters than sons, and for whites than African Americans.

The investigators posed three questions that formed the basis of their research: 1) What is the association between lifetime parental and child NMPO use? 2) What is the unique association between parental and child NMPO use, controlling for other factors? 3) Do parental/adolescent NMPO use associations differ by parent/child gender and race and/or ethnicity?

About 14% of parents reported ever using an NMPO; fathers (14%) had slightly higher rates of usage than mothers (13%), and white parents had higher rates of use (16%) than African American (10%) or Hispanic (9%) parents. Among adolescents, 9% reported ever having used an NMPO; this included similar rates for boys (9%) and girls (9%), as well as whites (9%), Hispanics (9%), and African Americans (8%). Use increased with age over time, from 4% among 12-year-olds to 15% among 17-year-olds.

 

 


Dr. Griesler and her colleagues did find “a significant positive association between NMPO use by parents and adolescents.” Adolescents were more likely to use an NMPO in their lifetime (14%) if a parent had a history of any use than adolescents whose parents did not have a history (8%). This association persisted even when controlling for other factors (adjusted odds ratio, 1.3).

Adolescent reporting identified low levels of parental support and monitoring, as well as parent approval of drug use, as the primary factors contributing to perceptions of subpar parent-child relationship quality and subsequent NMPO use. Additional adolescent behaviors contributing to increased risk of drug use included delinquency, depression, anxiety, reduced academic and religious involvement, and perceptions around peer drug use and approval of drug use, as well as being older.

Consistent with their original hypothesis, “only maternal NMPO use was significantly associated with adolescent NMPO use,” the investigators wrote (aOR, 1.62), which was not correlated either way concerning the gender of the child. The authors did note, however, “a marginally significant negative association among sons, [aOR, 0.71],” even though no overall paternal-child NMPO correlation was found (aOR, 0.98). They speculated that this negative association might be explained “by the father’s use of other drugs, particularly marijuana.”

Parental factors independently associated with adolescent NMPO use included smoking, alcohol and/or marijuana use, as well as other illicit drug use. When controlling for their use of different drugs and other covariates, only smoking remained associated with adolescent NMPO use (aOR, 1.24). Importantly, higher NMPO usage was observed in cases of poor parenting quality, especially for low levels of monitoring and high incidence of conflict between parents and adolescents. Adolescent NMPO usage were conversely lower in cases where parents self-reported their belief that drug use was risky.

Adolescent behaviors that predicted lifetime NMPO use included starting to smoke cigarettes or marijuana before using NMPO, being depressed or delinquent, having the perception that most peers use drugs, and being older in age. Dr. Griesler and her associates also observed that adolescents who began using alcohol before NMPO were likely to experiment first with smoking cigarettes and marijuana before NMPO.

The lack of differences observed with regard to child gender, race, or ethnicity warrants further investigation, but the authors speculated that “such differences might be detected with measures of current or heavy use.”

One limitation of the study was the focus on lifetime use, Dr. Griesler and her colleagues wrote. Observing patterns of current or heavy use, as well as disorder and “genetically informative samples,” might shed light on the role that familial environmental and genetic influences could play. Additionally, limiting households to one parent and one adolescent discounts the possible combined influence of mother and father NMPO usage on adolescent usage. The research also did not explore the role that adolescent NMPO use could play in influencing “parent-child interactions.”

The authors reported no financial relationships or potential conflicts of interest. The study was supported by grants from the National Institute on Drug Abuse and the New York State Psychiatric Institute; it was funded by the National Institutes of Health.

SOURCE: Griesler PC et al. Pediatrics. 2019;143(3):e20182354.

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The correlation between parental nonmedical prescription opioid use and offspring use should be considered in targeted efforts to reduce adolescent use, reported Pamela C. Griesler, PhD, of Columbia University, New York, and her associates.

Bottles of pills
BackyardProduction/Thinkstock

Given the significant link between parental and adolescent smoking and adolescent nonmedical prescription opioid (NMPO) use, smoking also should be included in targeted interventions, they wrote in Pediatrics.

Dr. Griesler and her colleagues noted that there actually are three classes of factors influencing the association between parent and adolescent NMPO use: phenotypic heritability, parental role modeling, and parental socialization and other environmental influences.

In the first known study to explore the relationship of parent-adolescent NMPO use within a nationally representative sampling of parent-child dyads taken from the National Surveys on Drug Use and Health, Dr. Griesler and her colleagues examined the intergenerational association of lifetime NMPO use among 35,000 parent-adolescent dyads (21,200 mothers, 13,800 fathers). Of the 35,000 children aged 12-17 years included in the sample, 90% were biological, 8% were stepchildren, and 2% were adopted.

Given the absence of previous studies exploring the relationship between parent-adolescent NMPO use, Dr. Griesler and her associates used established findings for smoking and substance use to hypothesize that there would be stronger associations for mothers than fathers, daughters than sons, and for whites than African Americans.

The investigators posed three questions that formed the basis of their research: 1) What is the association between lifetime parental and child NMPO use? 2) What is the unique association between parental and child NMPO use, controlling for other factors? 3) Do parental/adolescent NMPO use associations differ by parent/child gender and race and/or ethnicity?

About 14% of parents reported ever using an NMPO; fathers (14%) had slightly higher rates of usage than mothers (13%), and white parents had higher rates of use (16%) than African American (10%) or Hispanic (9%) parents. Among adolescents, 9% reported ever having used an NMPO; this included similar rates for boys (9%) and girls (9%), as well as whites (9%), Hispanics (9%), and African Americans (8%). Use increased with age over time, from 4% among 12-year-olds to 15% among 17-year-olds.

 

 


Dr. Griesler and her colleagues did find “a significant positive association between NMPO use by parents and adolescents.” Adolescents were more likely to use an NMPO in their lifetime (14%) if a parent had a history of any use than adolescents whose parents did not have a history (8%). This association persisted even when controlling for other factors (adjusted odds ratio, 1.3).

Adolescent reporting identified low levels of parental support and monitoring, as well as parent approval of drug use, as the primary factors contributing to perceptions of subpar parent-child relationship quality and subsequent NMPO use. Additional adolescent behaviors contributing to increased risk of drug use included delinquency, depression, anxiety, reduced academic and religious involvement, and perceptions around peer drug use and approval of drug use, as well as being older.

Consistent with their original hypothesis, “only maternal NMPO use was significantly associated with adolescent NMPO use,” the investigators wrote (aOR, 1.62), which was not correlated either way concerning the gender of the child. The authors did note, however, “a marginally significant negative association among sons, [aOR, 0.71],” even though no overall paternal-child NMPO correlation was found (aOR, 0.98). They speculated that this negative association might be explained “by the father’s use of other drugs, particularly marijuana.”

Parental factors independently associated with adolescent NMPO use included smoking, alcohol and/or marijuana use, as well as other illicit drug use. When controlling for their use of different drugs and other covariates, only smoking remained associated with adolescent NMPO use (aOR, 1.24). Importantly, higher NMPO usage was observed in cases of poor parenting quality, especially for low levels of monitoring and high incidence of conflict between parents and adolescents. Adolescent NMPO usage were conversely lower in cases where parents self-reported their belief that drug use was risky.

Adolescent behaviors that predicted lifetime NMPO use included starting to smoke cigarettes or marijuana before using NMPO, being depressed or delinquent, having the perception that most peers use drugs, and being older in age. Dr. Griesler and her associates also observed that adolescents who began using alcohol before NMPO were likely to experiment first with smoking cigarettes and marijuana before NMPO.

The lack of differences observed with regard to child gender, race, or ethnicity warrants further investigation, but the authors speculated that “such differences might be detected with measures of current or heavy use.”

One limitation of the study was the focus on lifetime use, Dr. Griesler and her colleagues wrote. Observing patterns of current or heavy use, as well as disorder and “genetically informative samples,” might shed light on the role that familial environmental and genetic influences could play. Additionally, limiting households to one parent and one adolescent discounts the possible combined influence of mother and father NMPO usage on adolescent usage. The research also did not explore the role that adolescent NMPO use could play in influencing “parent-child interactions.”

The authors reported no financial relationships or potential conflicts of interest. The study was supported by grants from the National Institute on Drug Abuse and the New York State Psychiatric Institute; it was funded by the National Institutes of Health.

SOURCE: Griesler PC et al. Pediatrics. 2019;143(3):e20182354.

 

The correlation between parental nonmedical prescription opioid use and offspring use should be considered in targeted efforts to reduce adolescent use, reported Pamela C. Griesler, PhD, of Columbia University, New York, and her associates.

Bottles of pills
BackyardProduction/Thinkstock

Given the significant link between parental and adolescent smoking and adolescent nonmedical prescription opioid (NMPO) use, smoking also should be included in targeted interventions, they wrote in Pediatrics.

Dr. Griesler and her colleagues noted that there actually are three classes of factors influencing the association between parent and adolescent NMPO use: phenotypic heritability, parental role modeling, and parental socialization and other environmental influences.

In the first known study to explore the relationship of parent-adolescent NMPO use within a nationally representative sampling of parent-child dyads taken from the National Surveys on Drug Use and Health, Dr. Griesler and her colleagues examined the intergenerational association of lifetime NMPO use among 35,000 parent-adolescent dyads (21,200 mothers, 13,800 fathers). Of the 35,000 children aged 12-17 years included in the sample, 90% were biological, 8% were stepchildren, and 2% were adopted.

Given the absence of previous studies exploring the relationship between parent-adolescent NMPO use, Dr. Griesler and her associates used established findings for smoking and substance use to hypothesize that there would be stronger associations for mothers than fathers, daughters than sons, and for whites than African Americans.

The investigators posed three questions that formed the basis of their research: 1) What is the association between lifetime parental and child NMPO use? 2) What is the unique association between parental and child NMPO use, controlling for other factors? 3) Do parental/adolescent NMPO use associations differ by parent/child gender and race and/or ethnicity?

About 14% of parents reported ever using an NMPO; fathers (14%) had slightly higher rates of usage than mothers (13%), and white parents had higher rates of use (16%) than African American (10%) or Hispanic (9%) parents. Among adolescents, 9% reported ever having used an NMPO; this included similar rates for boys (9%) and girls (9%), as well as whites (9%), Hispanics (9%), and African Americans (8%). Use increased with age over time, from 4% among 12-year-olds to 15% among 17-year-olds.

 

 


Dr. Griesler and her colleagues did find “a significant positive association between NMPO use by parents and adolescents.” Adolescents were more likely to use an NMPO in their lifetime (14%) if a parent had a history of any use than adolescents whose parents did not have a history (8%). This association persisted even when controlling for other factors (adjusted odds ratio, 1.3).

Adolescent reporting identified low levels of parental support and monitoring, as well as parent approval of drug use, as the primary factors contributing to perceptions of subpar parent-child relationship quality and subsequent NMPO use. Additional adolescent behaviors contributing to increased risk of drug use included delinquency, depression, anxiety, reduced academic and religious involvement, and perceptions around peer drug use and approval of drug use, as well as being older.

Consistent with their original hypothesis, “only maternal NMPO use was significantly associated with adolescent NMPO use,” the investigators wrote (aOR, 1.62), which was not correlated either way concerning the gender of the child. The authors did note, however, “a marginally significant negative association among sons, [aOR, 0.71],” even though no overall paternal-child NMPO correlation was found (aOR, 0.98). They speculated that this negative association might be explained “by the father’s use of other drugs, particularly marijuana.”

Parental factors independently associated with adolescent NMPO use included smoking, alcohol and/or marijuana use, as well as other illicit drug use. When controlling for their use of different drugs and other covariates, only smoking remained associated with adolescent NMPO use (aOR, 1.24). Importantly, higher NMPO usage was observed in cases of poor parenting quality, especially for low levels of monitoring and high incidence of conflict between parents and adolescents. Adolescent NMPO usage were conversely lower in cases where parents self-reported their belief that drug use was risky.

Adolescent behaviors that predicted lifetime NMPO use included starting to smoke cigarettes or marijuana before using NMPO, being depressed or delinquent, having the perception that most peers use drugs, and being older in age. Dr. Griesler and her associates also observed that adolescents who began using alcohol before NMPO were likely to experiment first with smoking cigarettes and marijuana before NMPO.

The lack of differences observed with regard to child gender, race, or ethnicity warrants further investigation, but the authors speculated that “such differences might be detected with measures of current or heavy use.”

One limitation of the study was the focus on lifetime use, Dr. Griesler and her colleagues wrote. Observing patterns of current or heavy use, as well as disorder and “genetically informative samples,” might shed light on the role that familial environmental and genetic influences could play. Additionally, limiting households to one parent and one adolescent discounts the possible combined influence of mother and father NMPO usage on adolescent usage. The research also did not explore the role that adolescent NMPO use could play in influencing “parent-child interactions.”

The authors reported no financial relationships or potential conflicts of interest. The study was supported by grants from the National Institute on Drug Abuse and the New York State Psychiatric Institute; it was funded by the National Institutes of Health.

SOURCE: Griesler PC et al. Pediatrics. 2019;143(3):e20182354.

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Adolescents’ screen time tied to more depression, less sleep

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Screen-based activities and sleep behaviors could be “intervention targets” for adolescents with depressive symptoms, results of a study of almost 3,000 U.S. adolescents suggest.

A teenager in bed looks at her mobile phone.
maewjpho/Thinkstock

“Overall, our results indicated that [social messaging, Web surfing, TV/movie watching, and video gaming] ... were associated with greater depressive symptoms and poorer sleep characteristics,” Xian Li, PhD, and her associates reported in Sleep Medicine.

Numerous studies previously have demonstrated a positive link between adolescent depression and exposure to electronic devices, although little is known about the precise mechanism(s) of action involved and to what extent sleep plays a role. To address those gaps, Dr. Li, of the State University of New York at Stony Brook, and her associates examined four types of screen activities to determine whether symptoms of adolescent depression, sleep duration, and symptoms of insomnia – including problems falling asleep and staying asleep – are influenced in any way by those activities.

Using data from the Fragile Families and Child Wellbeing Study, a longitudinal urban birth cohort study that included an “oversampling of nonmarital births,” Dr. Li and her associates evaluated a total of 2,865 adolescents (mean 15.53 years of age; 48.2% female) self-identifying as African American (47.4%), Hispanic/Latino (23.7%), white (16.8%), or other/multiracial (12.1%). In participant interviews conducted with adolescents and caregivers during 2014-2016, 17.5% of caregivers reported having less than a high school education; 31.1% of teens lived in households below 100% of poverty; 32.8% came from single-mother families; and just 26.9% lived with both biological parents. The investigators assessed depressive symptoms at age 15 years by using five items from Center for Epidemiologic Studies Depression Scale.

Overall, Dr. Li and her associates found greater depressive symptoms associated with all four of the screen-based activities (P less than .01). In addition, more problems were observed with falling and staying asleep as well as shortened duration of sleep during the week for each of the activities monitored.

Social messaging, Web surfing, and time spent watching TV and movies appeared to be directly correlated with sleep characteristics, but the same could not be said for gaming, which showed only partial correlation with sleep characteristics. In that case, the authors speculated that the association between gaming and depression could be at least partly explained by individual characteristics such as trait neuroticism and self-control or a self-selection behavior in which those exhibiting greater signs of depression turn to gaming as an escape. “Thus, interventions among heavy gamers to reduce depression may need to consider other mechanisms,” Dr. Li and her associates wrote. The authors also noted a significant link between depressive symptoms at age 9 years and gaming behavior at age 15 years.

Several study limitations were noted. Causality and temporality could not be teased apart given that screen activities, sleep, and depressive symptoms all were measured concurrently at age 15 years. Screen activities also were noted to have captured only duration and not content or interactivity of the activities. Self-reports of screen time also might have been inaccurate because of general error in recall or even overlap in cases where participants were using more than one device simultaneously.

It is important to consider that while the relationships in the models might have statistical significance, “the effect size in the study as a whole are small.”

Nevertheless, they wrote, their findings “suggest that screen-based activities have negative implications for both sleep quality and sleep quantity, which further relates to depressive symptoms.”

Future studies should examine the “temporal sequencing” of those three limitations as well as adding more informants, including parent and teacher reports, and methods for objectively measuring screen activities and sleep, the authors cautioned.

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, and several private foundations. Dr. Buxton received two subcontract grants to Pennsylvania State University from Mobile Sleep Technologies. Dr. Hale received an honorarium from the National Sleep Foundation for her role as editor in chief of the journal Sleep Health.

SOURCE: Li X et al. Sleep Med. 2019 Feb 2. doi: 10.1016/j.sleep.2019.01.029.

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Screen-based activities and sleep behaviors could be “intervention targets” for adolescents with depressive symptoms, results of a study of almost 3,000 U.S. adolescents suggest.

A teenager in bed looks at her mobile phone.
maewjpho/Thinkstock

“Overall, our results indicated that [social messaging, Web surfing, TV/movie watching, and video gaming] ... were associated with greater depressive symptoms and poorer sleep characteristics,” Xian Li, PhD, and her associates reported in Sleep Medicine.

Numerous studies previously have demonstrated a positive link between adolescent depression and exposure to electronic devices, although little is known about the precise mechanism(s) of action involved and to what extent sleep plays a role. To address those gaps, Dr. Li, of the State University of New York at Stony Brook, and her associates examined four types of screen activities to determine whether symptoms of adolescent depression, sleep duration, and symptoms of insomnia – including problems falling asleep and staying asleep – are influenced in any way by those activities.

Using data from the Fragile Families and Child Wellbeing Study, a longitudinal urban birth cohort study that included an “oversampling of nonmarital births,” Dr. Li and her associates evaluated a total of 2,865 adolescents (mean 15.53 years of age; 48.2% female) self-identifying as African American (47.4%), Hispanic/Latino (23.7%), white (16.8%), or other/multiracial (12.1%). In participant interviews conducted with adolescents and caregivers during 2014-2016, 17.5% of caregivers reported having less than a high school education; 31.1% of teens lived in households below 100% of poverty; 32.8% came from single-mother families; and just 26.9% lived with both biological parents. The investigators assessed depressive symptoms at age 15 years by using five items from Center for Epidemiologic Studies Depression Scale.

Overall, Dr. Li and her associates found greater depressive symptoms associated with all four of the screen-based activities (P less than .01). In addition, more problems were observed with falling and staying asleep as well as shortened duration of sleep during the week for each of the activities monitored.

Social messaging, Web surfing, and time spent watching TV and movies appeared to be directly correlated with sleep characteristics, but the same could not be said for gaming, which showed only partial correlation with sleep characteristics. In that case, the authors speculated that the association between gaming and depression could be at least partly explained by individual characteristics such as trait neuroticism and self-control or a self-selection behavior in which those exhibiting greater signs of depression turn to gaming as an escape. “Thus, interventions among heavy gamers to reduce depression may need to consider other mechanisms,” Dr. Li and her associates wrote. The authors also noted a significant link between depressive symptoms at age 9 years and gaming behavior at age 15 years.

Several study limitations were noted. Causality and temporality could not be teased apart given that screen activities, sleep, and depressive symptoms all were measured concurrently at age 15 years. Screen activities also were noted to have captured only duration and not content or interactivity of the activities. Self-reports of screen time also might have been inaccurate because of general error in recall or even overlap in cases where participants were using more than one device simultaneously.

It is important to consider that while the relationships in the models might have statistical significance, “the effect size in the study as a whole are small.”

Nevertheless, they wrote, their findings “suggest that screen-based activities have negative implications for both sleep quality and sleep quantity, which further relates to depressive symptoms.”

Future studies should examine the “temporal sequencing” of those three limitations as well as adding more informants, including parent and teacher reports, and methods for objectively measuring screen activities and sleep, the authors cautioned.

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, and several private foundations. Dr. Buxton received two subcontract grants to Pennsylvania State University from Mobile Sleep Technologies. Dr. Hale received an honorarium from the National Sleep Foundation for her role as editor in chief of the journal Sleep Health.

SOURCE: Li X et al. Sleep Med. 2019 Feb 2. doi: 10.1016/j.sleep.2019.01.029.

Screen-based activities and sleep behaviors could be “intervention targets” for adolescents with depressive symptoms, results of a study of almost 3,000 U.S. adolescents suggest.

A teenager in bed looks at her mobile phone.
maewjpho/Thinkstock

“Overall, our results indicated that [social messaging, Web surfing, TV/movie watching, and video gaming] ... were associated with greater depressive symptoms and poorer sleep characteristics,” Xian Li, PhD, and her associates reported in Sleep Medicine.

Numerous studies previously have demonstrated a positive link between adolescent depression and exposure to electronic devices, although little is known about the precise mechanism(s) of action involved and to what extent sleep plays a role. To address those gaps, Dr. Li, of the State University of New York at Stony Brook, and her associates examined four types of screen activities to determine whether symptoms of adolescent depression, sleep duration, and symptoms of insomnia – including problems falling asleep and staying asleep – are influenced in any way by those activities.

Using data from the Fragile Families and Child Wellbeing Study, a longitudinal urban birth cohort study that included an “oversampling of nonmarital births,” Dr. Li and her associates evaluated a total of 2,865 adolescents (mean 15.53 years of age; 48.2% female) self-identifying as African American (47.4%), Hispanic/Latino (23.7%), white (16.8%), or other/multiracial (12.1%). In participant interviews conducted with adolescents and caregivers during 2014-2016, 17.5% of caregivers reported having less than a high school education; 31.1% of teens lived in households below 100% of poverty; 32.8% came from single-mother families; and just 26.9% lived with both biological parents. The investigators assessed depressive symptoms at age 15 years by using five items from Center for Epidemiologic Studies Depression Scale.

Overall, Dr. Li and her associates found greater depressive symptoms associated with all four of the screen-based activities (P less than .01). In addition, more problems were observed with falling and staying asleep as well as shortened duration of sleep during the week for each of the activities monitored.

Social messaging, Web surfing, and time spent watching TV and movies appeared to be directly correlated with sleep characteristics, but the same could not be said for gaming, which showed only partial correlation with sleep characteristics. In that case, the authors speculated that the association between gaming and depression could be at least partly explained by individual characteristics such as trait neuroticism and self-control or a self-selection behavior in which those exhibiting greater signs of depression turn to gaming as an escape. “Thus, interventions among heavy gamers to reduce depression may need to consider other mechanisms,” Dr. Li and her associates wrote. The authors also noted a significant link between depressive symptoms at age 9 years and gaming behavior at age 15 years.

Several study limitations were noted. Causality and temporality could not be teased apart given that screen activities, sleep, and depressive symptoms all were measured concurrently at age 15 years. Screen activities also were noted to have captured only duration and not content or interactivity of the activities. Self-reports of screen time also might have been inaccurate because of general error in recall or even overlap in cases where participants were using more than one device simultaneously.

It is important to consider that while the relationships in the models might have statistical significance, “the effect size in the study as a whole are small.”

Nevertheless, they wrote, their findings “suggest that screen-based activities have negative implications for both sleep quality and sleep quantity, which further relates to depressive symptoms.”

Future studies should examine the “temporal sequencing” of those three limitations as well as adding more informants, including parent and teacher reports, and methods for objectively measuring screen activities and sleep, the authors cautioned.

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, and several private foundations. Dr. Buxton received two subcontract grants to Pennsylvania State University from Mobile Sleep Technologies. Dr. Hale received an honorarium from the National Sleep Foundation for her role as editor in chief of the journal Sleep Health.

SOURCE: Li X et al. Sleep Med. 2019 Feb 2. doi: 10.1016/j.sleep.2019.01.029.

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Key clinical point: “Screen-based activities have negative implications for both sleep quality and sleep quantity, which further relates to depressive symptoms.”

Major finding: Greater depressive symptoms were associated with all four of the screen-based activities (P less than .01).

Study details: Analysis of surveys from 2,865 U.S. adolescents who were asked about sleep duration and quality, typical daily screen time, and depressive symptoms.

Disclosures: The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, and several private foundations. Dr. Buxton received two subcontract grants to Pennsylvania State University from Mobile Sleep Technologies. Dr. Hale received an honorarium from the National Sleep Foundation for her role as editor-in-chief of the journal Sleep Health.

Source: Li X et al. Sleep Med. 2019 Feb. 2. doi: 10.1016/j.sleep.2019.01.029.

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Buprenorphine for NAS shows promise in reducing length of stay

Is NAS risk of readmission worth pushing for shorter treatment and stay?
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Thu, 01/24/2019 - 10:56

In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.

A mom holding her baby with neonatal abstinence syndrome skin-to-skin
Courtesy UNC Children's Hospital

It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.

In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.

Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies

Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.

Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.

Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.

In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.

In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.

Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”

Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”

Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.

Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.

Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.

One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.

SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.

Body

Most of the 50%-80% of newborns treated for NAS are treated pharmacologically in newborn ICUs at significant cost ($93,400 for mean stay of 23 days). To date, the wide variations in care, including pharmacologic options for treating NAS, leave clinicians with no consensus regarding which medication is best. The further absence of high-quality studies that depict effective management strategies for NAS offers “little guidance to inform best practice recommendations,” Elisha M. Wachman, MD, and Martha M. Werler, DSc, wrote in an editorial published with the study.

The network analysis approach followed by Disher et al. requires some assumptions, namely “minimal bias and homogeneity of methods,” the authors observed. Yet, some of the randomized, clinical trials included in their evaluation were “not blinded and thus carry high risk of bias.” In addition, given the varied methods employed across the studies cited, “the primary findings of this meta-analysis warrant further discussion.”

Disher et al. concede that the benefits afforded with buprenorphine treatment could be more pronounced because of the dosing and weaning methods rather than from the effect of the medicine alone. Given that some studies cited did experience a shorter absolute median length of treatment with morphine, it is possible that the shortened lengths of treatment and stay concerning buprenorphine treatment “may be overestimates,” suggested Dr. Wachman and Dr. Werler.

Because of the extent of variability across studies cited, “results of the network meta-analysis by Disher et al. should be interpreted with caution.” It is worth noting that most of the studies evaluated did not “examine long-term outcomes beyond the initial birth hospitalization.” The question is: Does shorter length of treatment lead to improved long-term outcomes, or “does it put the infant at risk for readmission and altered neurobehavior and development?”

Although the researchers provide evidence of buprenorphine’s effectiveness in significantly shortening length of treatment, compared with morphine, “results should be interpreted with caution given the small number of RCTs, small sample sizes, heterogeneous methods and study populations, and lack of long-term outcome data.”
 

Dr. Wachman is affiliated with the department of pediatrics, Boston Medical Center. Dr. Werler is chair of the department of epidemiology, Boston University School of Public Health. The authors were supported by a grant from the National Institute of Child Health and Human Development. Dr. Werler also is supported by a grant from the Centers for Disease Control and Prevention/Massachusetts Department of Public Health. This editorial accompanied the article by Disher et al. (JAMA Pediatrics. 2019. doi: 10. 1001/jamapediatric.2018.5029).

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Most of the 50%-80% of newborns treated for NAS are treated pharmacologically in newborn ICUs at significant cost ($93,400 for mean stay of 23 days). To date, the wide variations in care, including pharmacologic options for treating NAS, leave clinicians with no consensus regarding which medication is best. The further absence of high-quality studies that depict effective management strategies for NAS offers “little guidance to inform best practice recommendations,” Elisha M. Wachman, MD, and Martha M. Werler, DSc, wrote in an editorial published with the study.

The network analysis approach followed by Disher et al. requires some assumptions, namely “minimal bias and homogeneity of methods,” the authors observed. Yet, some of the randomized, clinical trials included in their evaluation were “not blinded and thus carry high risk of bias.” In addition, given the varied methods employed across the studies cited, “the primary findings of this meta-analysis warrant further discussion.”

Disher et al. concede that the benefits afforded with buprenorphine treatment could be more pronounced because of the dosing and weaning methods rather than from the effect of the medicine alone. Given that some studies cited did experience a shorter absolute median length of treatment with morphine, it is possible that the shortened lengths of treatment and stay concerning buprenorphine treatment “may be overestimates,” suggested Dr. Wachman and Dr. Werler.

Because of the extent of variability across studies cited, “results of the network meta-analysis by Disher et al. should be interpreted with caution.” It is worth noting that most of the studies evaluated did not “examine long-term outcomes beyond the initial birth hospitalization.” The question is: Does shorter length of treatment lead to improved long-term outcomes, or “does it put the infant at risk for readmission and altered neurobehavior and development?”

Although the researchers provide evidence of buprenorphine’s effectiveness in significantly shortening length of treatment, compared with morphine, “results should be interpreted with caution given the small number of RCTs, small sample sizes, heterogeneous methods and study populations, and lack of long-term outcome data.”
 

Dr. Wachman is affiliated with the department of pediatrics, Boston Medical Center. Dr. Werler is chair of the department of epidemiology, Boston University School of Public Health. The authors were supported by a grant from the National Institute of Child Health and Human Development. Dr. Werler also is supported by a grant from the Centers for Disease Control and Prevention/Massachusetts Department of Public Health. This editorial accompanied the article by Disher et al. (JAMA Pediatrics. 2019. doi: 10. 1001/jamapediatric.2018.5029).

Body

Most of the 50%-80% of newborns treated for NAS are treated pharmacologically in newborn ICUs at significant cost ($93,400 for mean stay of 23 days). To date, the wide variations in care, including pharmacologic options for treating NAS, leave clinicians with no consensus regarding which medication is best. The further absence of high-quality studies that depict effective management strategies for NAS offers “little guidance to inform best practice recommendations,” Elisha M. Wachman, MD, and Martha M. Werler, DSc, wrote in an editorial published with the study.

The network analysis approach followed by Disher et al. requires some assumptions, namely “minimal bias and homogeneity of methods,” the authors observed. Yet, some of the randomized, clinical trials included in their evaluation were “not blinded and thus carry high risk of bias.” In addition, given the varied methods employed across the studies cited, “the primary findings of this meta-analysis warrant further discussion.”

Disher et al. concede that the benefits afforded with buprenorphine treatment could be more pronounced because of the dosing and weaning methods rather than from the effect of the medicine alone. Given that some studies cited did experience a shorter absolute median length of treatment with morphine, it is possible that the shortened lengths of treatment and stay concerning buprenorphine treatment “may be overestimates,” suggested Dr. Wachman and Dr. Werler.

Because of the extent of variability across studies cited, “results of the network meta-analysis by Disher et al. should be interpreted with caution.” It is worth noting that most of the studies evaluated did not “examine long-term outcomes beyond the initial birth hospitalization.” The question is: Does shorter length of treatment lead to improved long-term outcomes, or “does it put the infant at risk for readmission and altered neurobehavior and development?”

Although the researchers provide evidence of buprenorphine’s effectiveness in significantly shortening length of treatment, compared with morphine, “results should be interpreted with caution given the small number of RCTs, small sample sizes, heterogeneous methods and study populations, and lack of long-term outcome data.”
 

Dr. Wachman is affiliated with the department of pediatrics, Boston Medical Center. Dr. Werler is chair of the department of epidemiology, Boston University School of Public Health. The authors were supported by a grant from the National Institute of Child Health and Human Development. Dr. Werler also is supported by a grant from the Centers for Disease Control and Prevention/Massachusetts Department of Public Health. This editorial accompanied the article by Disher et al. (JAMA Pediatrics. 2019. doi: 10. 1001/jamapediatric.2018.5029).

Title
Is NAS risk of readmission worth pushing for shorter treatment and stay?
Is NAS risk of readmission worth pushing for shorter treatment and stay?

In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.

A mom holding her baby with neonatal abstinence syndrome skin-to-skin
Courtesy UNC Children's Hospital

It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.

In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.

Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies

Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.

Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.

Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.

In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.

In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.

Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”

Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”

Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.

Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.

Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.

One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.

SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.

In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.

A mom holding her baby with neonatal abstinence syndrome skin-to-skin
Courtesy UNC Children's Hospital

It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.

In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.

Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies

Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.

Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.

Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.

In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.

In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.

Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”

Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”

Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.

Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.

Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.

One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.

SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.

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Key clinical point: A larger study comparing buprenorphine and morphine is needed to confirm study findings.

Major finding: Although morphine and phenobarbital are prescribed most frequently in the United States, they were found to be the least effective treatments available.

Study details: Systematic review and network meta-analysis.

Disclosures: The authors had no financial relationships relevant to this article to disclose.

Source: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.

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Confidential, parent-free discussion should occur by age 13

Change the office culture to ensure confidential dialogue with teens
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Discussing confidentiality is essential to the appropriate health care of adolescents, especially prior to discussing sensitive subjects, reported John S. Santelli, MD, MPH, of Mailman School of Public Health, Columbia University, New York, N.Y., and his associates.

Doctor talking with teen girl.
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“Previous research has shown that when adolescents and young adults (AYAs) are not assured of confidentiality, they are less willing to discuss sensitive topics with their providers,” they wrote. The report is in Pediatrics.

According to national guidelines, although discussions concerning confidentiality can begin with parents in early adolescence, over time, the goal should be to allow fully for alone time for the AYA with you without parents present in the room.

You have a unique opportunity to help parents understand confidentiality and aid them in transitioning over time, with full respect and support for the developing adolescent-provider relationship, so that it can be fully realized by the time the adolescent reaches 13 years of age.

Using a nationally representative age-, race/ethnicity-, and income-matched sample of AYAs, the authors surveyed youth aged 13-26 years concerning preventive services received and discussions held with health care providers. Of the 1,918 individuals who completed the survey, the authors’ analysis was limited to the 1,509 (79%) youth who had seen their providers in the past 2 years.

The study focused on 11 youth-provider discussion topics. For 10 of the 11 topics, less than half of the young people said they had a discussion on the topic with a health care provider on their last visit. The most commonly discussed topics overall included mental health/emotional issues (55%), drug or alcohol use (46%), tobacco use (44%), and school performance (43%); the least common were gun safety (14%), sexual orientation (20%), and sexual or physical abuse (21%). There were more discussions concerning birth control among young women (from 26% at ages 13-14 to 54% by ages 23-26) compared with young men (13% at ages 13-14 to 12% by ages 23-26).

On average, young women reported discussing just 3.7 of the 11 topics during their last preventive care visit; young men similarly reported an average of 3.6 topics. Overall, the mean number of youth-provider discussions declined over time from 4.1 at ages 13-14 and 4.4 at ages 15-18 to 2.6 by ages 23-26.

Compared with white youth, who reported 3.3 topics at their last visit, Hispanic and African American youth reported discussing 4.2 topics. Similar differences were seen when comparing rural (2.7 topics) and urban or suburban youth (3.8 topics) or incomes greater than $75,000 (3.6 topics) compared with incomes of $25,000 or less (4.2 topics).

Youth who previously discussed confidentiality also reported discussing more topics (4.4), compared with those who had not talked about confidentiality (2.9).

Before the implementation of the Patient Protection and Affordable Care Act (ACA), which requires the provision of prevention services without cost sharing, less than half of adolescents visited a medical provider for annual preventive care visits, other studies have shown.

Although professional guidelines for adolescent preventive care recommend youth access to confidential services, “young people report that health care encounters often do not include an explanation of confidentiality by their health care provider.” Without the assurance of confidentiality, adolescents are more likely to not seek care or to opt not to disclose risky behaviors.

Current systems tend to rely on parent reporting regarding uses of services, and there is no mechanism in place for collection of data on discussion of sensitive health topics. The authors also noted a lack of time available for dialogue during visits as well as an absence of screening questionnaires prior to visits that might invite opportunities to disclose information on sensitive topics.

“Young people who reported ever having talked about confidentiality with their regular provider were more likely to engage in health discussions with providers,” emphasized Dr. Santelli and his associates. “The use of a health checklist and/or questionnaire and having spent more time with their provider during the visit were consistently associated with more of these discussions.”

You can build rapport with AYAs during preventive care visits that include screening and counseling. Immunizations, screening, and treatment of sexually transmitted infections, and dispensing of reproductive and sexual health services, including contraception, offer good opportunities for these discussions. Other sensitive topics are tobacco, alcohol, and drug use; depression and mental health; and obesity and physical activity.

Dr. Santelli and his associates consider the results of their research to serve as a “valuable addition to the literature.” They did, however, note several limitations. Because the data are cross-sectional, they cannot demonstrate causality. The use of self-report data may have contributed to underreporting of risk behaviors because adolescents were interviewed directly following parents on the same computer. Survey questions did account for the existence of youth-provider discussions, but the researchers were not able to measure the impact or quality of the resulting conversations.

It is important to note that because providers were not interviewed, the time pressures and other expected barriers were not fully accounted for in this research, Dr. Santelli and his colleagues cautioned. “Future research should ask specifically about provider-level barriers to providing preventive care to better understand their impact,” they advised.

Ultimately, the clinicians who are providing care to youth and their families will need support in implementing such changes, especially where education in the importance of discussion confidentiality and private time are concerned, they added.

The authors had no relevant financial disclosures. The study was funded by an unrestricted research grant from the Merck Foundation.

SOURCE: Santelli J et. al. Pediatrics. 2019. doi: 10.1542/peds.2018-1403.

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Passage of the Affordable Care Act “provides a rich opportunity to improve the delivery of adolescent preventive services,” by lowering the financial barriers that had impeded preventive care, Jeanne Van Cleave, MD, wrote in an editorial published with the study. The findings in Santelli et al. “provide important direction for efforts to improve the delivery of adolescent preventive care.”

Specifically, changing office culture to ensure consistent screening, private time with providers, and policies that ensure discussion of confidentiality, can be accomplished by incorporating new roles for office staff, establishing team-based care, and requiring performance measurement. “By involving the whole practice, the burden of ensuring the elements of adolescent preventive care that facilitate discussion of potentially sensitive topics is lifted from individual providers,” advised Dr. Van Cleave.

Essential to the success of such a revised model of care is the practice-wide implementation and understanding of confidentiality. Dr. Van Cleave envisions a partnership between front-desk staff, medical assistants, and providers for administering screening tools and explaining to families the role of private time as well as confidentiality policies. Also essential is routine measurement of performance; the success of such a system would depend upon identifying where the gaps in care exist and what the options are for improving those gaps, she explained.

The use of alternative providers, such as nurses, social workers, or even properly trained parents, is a concept that has been tested previously. They afford greater flexibility, both during and outside of regular office hours, and they have been shown to raise the level of comfort among some youth who might otherwise be reluctant to discuss sensitive topics with their regular providers. These providers can be contacted by families outside of office visits when there are questions, giving advice and counseling by phone and electronic communication.

Dr. Van Cleave points out that while adolescents have many resources at their disposal for researching sensitive topics, including parents, social media, and even school health programs, such sources have been known to provide less accurate or incomplete information, compared with the specific, individually-tailored advice that only the primary care provider can give.

The important take-away message from the Santelli et al. report is that regular discussion of potentially sensitive topics in pediatric primary care leads to “positive patterns for seeking help later in adulthood,” Dr. Van Cleave observed. Their research offers important evidence concerning what needs to change in the practice care environment to facilitate these improvements.

What comes next, namely development and testing of appropriate interventions, will determine whether we can effectively change the role health care has to play in mitigating health risks for this population, she concluded.
 

Dr. Van Cleave is affiliated with Children’s Hospital Colorado and adult and child consortium for health outcomes research and delivery science, University of Colorado, Aurora. These comments are excerpted from an editorial by Dr. Van Cleave on the study by Santelli et al. (Pediatrics. 2019. doi: 10.1542/peds.2018-3618). She had no relevant financial disclosures and received no external funding.

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Passage of the Affordable Care Act “provides a rich opportunity to improve the delivery of adolescent preventive services,” by lowering the financial barriers that had impeded preventive care, Jeanne Van Cleave, MD, wrote in an editorial published with the study. The findings in Santelli et al. “provide important direction for efforts to improve the delivery of adolescent preventive care.”

Specifically, changing office culture to ensure consistent screening, private time with providers, and policies that ensure discussion of confidentiality, can be accomplished by incorporating new roles for office staff, establishing team-based care, and requiring performance measurement. “By involving the whole practice, the burden of ensuring the elements of adolescent preventive care that facilitate discussion of potentially sensitive topics is lifted from individual providers,” advised Dr. Van Cleave.

Essential to the success of such a revised model of care is the practice-wide implementation and understanding of confidentiality. Dr. Van Cleave envisions a partnership between front-desk staff, medical assistants, and providers for administering screening tools and explaining to families the role of private time as well as confidentiality policies. Also essential is routine measurement of performance; the success of such a system would depend upon identifying where the gaps in care exist and what the options are for improving those gaps, she explained.

The use of alternative providers, such as nurses, social workers, or even properly trained parents, is a concept that has been tested previously. They afford greater flexibility, both during and outside of regular office hours, and they have been shown to raise the level of comfort among some youth who might otherwise be reluctant to discuss sensitive topics with their regular providers. These providers can be contacted by families outside of office visits when there are questions, giving advice and counseling by phone and electronic communication.

Dr. Van Cleave points out that while adolescents have many resources at their disposal for researching sensitive topics, including parents, social media, and even school health programs, such sources have been known to provide less accurate or incomplete information, compared with the specific, individually-tailored advice that only the primary care provider can give.

The important take-away message from the Santelli et al. report is that regular discussion of potentially sensitive topics in pediatric primary care leads to “positive patterns for seeking help later in adulthood,” Dr. Van Cleave observed. Their research offers important evidence concerning what needs to change in the practice care environment to facilitate these improvements.

What comes next, namely development and testing of appropriate interventions, will determine whether we can effectively change the role health care has to play in mitigating health risks for this population, she concluded.
 

Dr. Van Cleave is affiliated with Children’s Hospital Colorado and adult and child consortium for health outcomes research and delivery science, University of Colorado, Aurora. These comments are excerpted from an editorial by Dr. Van Cleave on the study by Santelli et al. (Pediatrics. 2019. doi: 10.1542/peds.2018-3618). She had no relevant financial disclosures and received no external funding.

Body

 

Passage of the Affordable Care Act “provides a rich opportunity to improve the delivery of adolescent preventive services,” by lowering the financial barriers that had impeded preventive care, Jeanne Van Cleave, MD, wrote in an editorial published with the study. The findings in Santelli et al. “provide important direction for efforts to improve the delivery of adolescent preventive care.”

Specifically, changing office culture to ensure consistent screening, private time with providers, and policies that ensure discussion of confidentiality, can be accomplished by incorporating new roles for office staff, establishing team-based care, and requiring performance measurement. “By involving the whole practice, the burden of ensuring the elements of adolescent preventive care that facilitate discussion of potentially sensitive topics is lifted from individual providers,” advised Dr. Van Cleave.

Essential to the success of such a revised model of care is the practice-wide implementation and understanding of confidentiality. Dr. Van Cleave envisions a partnership between front-desk staff, medical assistants, and providers for administering screening tools and explaining to families the role of private time as well as confidentiality policies. Also essential is routine measurement of performance; the success of such a system would depend upon identifying where the gaps in care exist and what the options are for improving those gaps, she explained.

The use of alternative providers, such as nurses, social workers, or even properly trained parents, is a concept that has been tested previously. They afford greater flexibility, both during and outside of regular office hours, and they have been shown to raise the level of comfort among some youth who might otherwise be reluctant to discuss sensitive topics with their regular providers. These providers can be contacted by families outside of office visits when there are questions, giving advice and counseling by phone and electronic communication.

Dr. Van Cleave points out that while adolescents have many resources at their disposal for researching sensitive topics, including parents, social media, and even school health programs, such sources have been known to provide less accurate or incomplete information, compared with the specific, individually-tailored advice that only the primary care provider can give.

The important take-away message from the Santelli et al. report is that regular discussion of potentially sensitive topics in pediatric primary care leads to “positive patterns for seeking help later in adulthood,” Dr. Van Cleave observed. Their research offers important evidence concerning what needs to change in the practice care environment to facilitate these improvements.

What comes next, namely development and testing of appropriate interventions, will determine whether we can effectively change the role health care has to play in mitigating health risks for this population, she concluded.
 

Dr. Van Cleave is affiliated with Children’s Hospital Colorado and adult and child consortium for health outcomes research and delivery science, University of Colorado, Aurora. These comments are excerpted from an editorial by Dr. Van Cleave on the study by Santelli et al. (Pediatrics. 2019. doi: 10.1542/peds.2018-3618). She had no relevant financial disclosures and received no external funding.

Title
Change the office culture to ensure confidential dialogue with teens
Change the office culture to ensure confidential dialogue with teens

 

Discussing confidentiality is essential to the appropriate health care of adolescents, especially prior to discussing sensitive subjects, reported John S. Santelli, MD, MPH, of Mailman School of Public Health, Columbia University, New York, N.Y., and his associates.

Doctor talking with teen girl.
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“Previous research has shown that when adolescents and young adults (AYAs) are not assured of confidentiality, they are less willing to discuss sensitive topics with their providers,” they wrote. The report is in Pediatrics.

According to national guidelines, although discussions concerning confidentiality can begin with parents in early adolescence, over time, the goal should be to allow fully for alone time for the AYA with you without parents present in the room.

You have a unique opportunity to help parents understand confidentiality and aid them in transitioning over time, with full respect and support for the developing adolescent-provider relationship, so that it can be fully realized by the time the adolescent reaches 13 years of age.

Using a nationally representative age-, race/ethnicity-, and income-matched sample of AYAs, the authors surveyed youth aged 13-26 years concerning preventive services received and discussions held with health care providers. Of the 1,918 individuals who completed the survey, the authors’ analysis was limited to the 1,509 (79%) youth who had seen their providers in the past 2 years.

The study focused on 11 youth-provider discussion topics. For 10 of the 11 topics, less than half of the young people said they had a discussion on the topic with a health care provider on their last visit. The most commonly discussed topics overall included mental health/emotional issues (55%), drug or alcohol use (46%), tobacco use (44%), and school performance (43%); the least common were gun safety (14%), sexual orientation (20%), and sexual or physical abuse (21%). There were more discussions concerning birth control among young women (from 26% at ages 13-14 to 54% by ages 23-26) compared with young men (13% at ages 13-14 to 12% by ages 23-26).

On average, young women reported discussing just 3.7 of the 11 topics during their last preventive care visit; young men similarly reported an average of 3.6 topics. Overall, the mean number of youth-provider discussions declined over time from 4.1 at ages 13-14 and 4.4 at ages 15-18 to 2.6 by ages 23-26.

Compared with white youth, who reported 3.3 topics at their last visit, Hispanic and African American youth reported discussing 4.2 topics. Similar differences were seen when comparing rural (2.7 topics) and urban or suburban youth (3.8 topics) or incomes greater than $75,000 (3.6 topics) compared with incomes of $25,000 or less (4.2 topics).

Youth who previously discussed confidentiality also reported discussing more topics (4.4), compared with those who had not talked about confidentiality (2.9).

Before the implementation of the Patient Protection and Affordable Care Act (ACA), which requires the provision of prevention services without cost sharing, less than half of adolescents visited a medical provider for annual preventive care visits, other studies have shown.

Although professional guidelines for adolescent preventive care recommend youth access to confidential services, “young people report that health care encounters often do not include an explanation of confidentiality by their health care provider.” Without the assurance of confidentiality, adolescents are more likely to not seek care or to opt not to disclose risky behaviors.

Current systems tend to rely on parent reporting regarding uses of services, and there is no mechanism in place for collection of data on discussion of sensitive health topics. The authors also noted a lack of time available for dialogue during visits as well as an absence of screening questionnaires prior to visits that might invite opportunities to disclose information on sensitive topics.

“Young people who reported ever having talked about confidentiality with their regular provider were more likely to engage in health discussions with providers,” emphasized Dr. Santelli and his associates. “The use of a health checklist and/or questionnaire and having spent more time with their provider during the visit were consistently associated with more of these discussions.”

You can build rapport with AYAs during preventive care visits that include screening and counseling. Immunizations, screening, and treatment of sexually transmitted infections, and dispensing of reproductive and sexual health services, including contraception, offer good opportunities for these discussions. Other sensitive topics are tobacco, alcohol, and drug use; depression and mental health; and obesity and physical activity.

Dr. Santelli and his associates consider the results of their research to serve as a “valuable addition to the literature.” They did, however, note several limitations. Because the data are cross-sectional, they cannot demonstrate causality. The use of self-report data may have contributed to underreporting of risk behaviors because adolescents were interviewed directly following parents on the same computer. Survey questions did account for the existence of youth-provider discussions, but the researchers were not able to measure the impact or quality of the resulting conversations.

It is important to note that because providers were not interviewed, the time pressures and other expected barriers were not fully accounted for in this research, Dr. Santelli and his colleagues cautioned. “Future research should ask specifically about provider-level barriers to providing preventive care to better understand their impact,” they advised.

Ultimately, the clinicians who are providing care to youth and their families will need support in implementing such changes, especially where education in the importance of discussion confidentiality and private time are concerned, they added.

The authors had no relevant financial disclosures. The study was funded by an unrestricted research grant from the Merck Foundation.

SOURCE: Santelli J et. al. Pediatrics. 2019. doi: 10.1542/peds.2018-1403.

 

Discussing confidentiality is essential to the appropriate health care of adolescents, especially prior to discussing sensitive subjects, reported John S. Santelli, MD, MPH, of Mailman School of Public Health, Columbia University, New York, N.Y., and his associates.

Doctor talking with teen girl.
Rawpixel/Thinkstock

“Previous research has shown that when adolescents and young adults (AYAs) are not assured of confidentiality, they are less willing to discuss sensitive topics with their providers,” they wrote. The report is in Pediatrics.

According to national guidelines, although discussions concerning confidentiality can begin with parents in early adolescence, over time, the goal should be to allow fully for alone time for the AYA with you without parents present in the room.

You have a unique opportunity to help parents understand confidentiality and aid them in transitioning over time, with full respect and support for the developing adolescent-provider relationship, so that it can be fully realized by the time the adolescent reaches 13 years of age.

Using a nationally representative age-, race/ethnicity-, and income-matched sample of AYAs, the authors surveyed youth aged 13-26 years concerning preventive services received and discussions held with health care providers. Of the 1,918 individuals who completed the survey, the authors’ analysis was limited to the 1,509 (79%) youth who had seen their providers in the past 2 years.

The study focused on 11 youth-provider discussion topics. For 10 of the 11 topics, less than half of the young people said they had a discussion on the topic with a health care provider on their last visit. The most commonly discussed topics overall included mental health/emotional issues (55%), drug or alcohol use (46%), tobacco use (44%), and school performance (43%); the least common were gun safety (14%), sexual orientation (20%), and sexual or physical abuse (21%). There were more discussions concerning birth control among young women (from 26% at ages 13-14 to 54% by ages 23-26) compared with young men (13% at ages 13-14 to 12% by ages 23-26).

On average, young women reported discussing just 3.7 of the 11 topics during their last preventive care visit; young men similarly reported an average of 3.6 topics. Overall, the mean number of youth-provider discussions declined over time from 4.1 at ages 13-14 and 4.4 at ages 15-18 to 2.6 by ages 23-26.

Compared with white youth, who reported 3.3 topics at their last visit, Hispanic and African American youth reported discussing 4.2 topics. Similar differences were seen when comparing rural (2.7 topics) and urban or suburban youth (3.8 topics) or incomes greater than $75,000 (3.6 topics) compared with incomes of $25,000 or less (4.2 topics).

Youth who previously discussed confidentiality also reported discussing more topics (4.4), compared with those who had not talked about confidentiality (2.9).

Before the implementation of the Patient Protection and Affordable Care Act (ACA), which requires the provision of prevention services without cost sharing, less than half of adolescents visited a medical provider for annual preventive care visits, other studies have shown.

Although professional guidelines for adolescent preventive care recommend youth access to confidential services, “young people report that health care encounters often do not include an explanation of confidentiality by their health care provider.” Without the assurance of confidentiality, adolescents are more likely to not seek care or to opt not to disclose risky behaviors.

Current systems tend to rely on parent reporting regarding uses of services, and there is no mechanism in place for collection of data on discussion of sensitive health topics. The authors also noted a lack of time available for dialogue during visits as well as an absence of screening questionnaires prior to visits that might invite opportunities to disclose information on sensitive topics.

“Young people who reported ever having talked about confidentiality with their regular provider were more likely to engage in health discussions with providers,” emphasized Dr. Santelli and his associates. “The use of a health checklist and/or questionnaire and having spent more time with their provider during the visit were consistently associated with more of these discussions.”

You can build rapport with AYAs during preventive care visits that include screening and counseling. Immunizations, screening, and treatment of sexually transmitted infections, and dispensing of reproductive and sexual health services, including contraception, offer good opportunities for these discussions. Other sensitive topics are tobacco, alcohol, and drug use; depression and mental health; and obesity and physical activity.

Dr. Santelli and his associates consider the results of their research to serve as a “valuable addition to the literature.” They did, however, note several limitations. Because the data are cross-sectional, they cannot demonstrate causality. The use of self-report data may have contributed to underreporting of risk behaviors because adolescents were interviewed directly following parents on the same computer. Survey questions did account for the existence of youth-provider discussions, but the researchers were not able to measure the impact or quality of the resulting conversations.

It is important to note that because providers were not interviewed, the time pressures and other expected barriers were not fully accounted for in this research, Dr. Santelli and his colleagues cautioned. “Future research should ask specifically about provider-level barriers to providing preventive care to better understand their impact,” they advised.

Ultimately, the clinicians who are providing care to youth and their families will need support in implementing such changes, especially where education in the importance of discussion confidentiality and private time are concerned, they added.

The authors had no relevant financial disclosures. The study was funded by an unrestricted research grant from the Merck Foundation.

SOURCE: Santelli J et. al. Pediatrics. 2019. doi: 10.1542/peds.2018-1403.

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Key clinical point: Confidential, parent-free discussions that honor the adolescent-provider relationship should be in practice when the adolescent is 13 years old.

Major finding: The most commonly discussed topics overall included mental health/emotional issues (55%), drug or alcohol use (46%), tobacco use (44%), and school performance (43%); the least common were gun safety (14%), sexual orientation (20%), and sexual or physical abuse (21%).

Study details: Self-report survey.

Disclosures: The authors had no financial relationships relevant to this article to disclose. The study was funded by an unrestricted research grant from the Merck Foundation.

Source: Santelli J. et. al. Pediatrics. 2019;143(2):e20181403.

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AAP infantile hemangioma guideline should empower primary care clinicians

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The American Academy of Pediatrics has issued its first clinical practice guideline on infantile hemangiomas (IHs), given the dramatic increase in information available over the past decade.

Summary of the clinical practice guideline's key action statements

The aim in providing an evidence-based approach to evaluating, triaging, and managing IH cases is to arm primary care providers with the confidence needed to successfully treat high-risk cases, reported Daniel P. Krowchuk, MD, of the department of pediatrics and dermatology, Wake Forest University, Winston-Salem, N.C., and his associates who are members of the AAP subcommittee on the management of IHs.

With an occurrence rate of 4%-5%, IHs are the most common benign tumor presenting in childhood, especially occurring in girls, twins, preterm or low-birth-weight infants, and white neonates.

The AAP’s guideline “provides a framework for clinical decision-making” – it should not be considered a sole source of guidance. It also should not be used to replace clinical judgment or as a protocol for managing all patients with IHs, explained Dr. Krowchuk and his associates.

Clinicians, especially, are encouraged to consult promptly with a hemangioma specialist if they are not experienced in managing IHs.

According to one study cited by the authors, the mean age of examination by a dermatologist is 5 months, when most growth has already been completed. Lesions are first noticed, on average, at 2 weeks; 4 weeks has been recommended as the ideal time for professional consultation. It is important for clinicians to recognize the difficulty families are likely to face in obtaining an appointment, which makes caregiver and clinician advocacy on behalf of infants affected critical, urged Dr. Krowchuk and his colleagues. In cases or locations where hemangioma specialists are in short supply, telemedicine triage or photographic consultation is especially helpful.

Dr. Krowchuk and his associates noted several possible challenges in implementing this clinical practice guideline (CPG) published in Pediatrics. The growth of individual IHs is difficult to predict, especially in young infants, and there are no markers or imaging studies to correct this challenge. For this reason, they advised: “Prompt evaluation, either in-person or via photographs, is warranted for any infant reported by parents to have a changing birthmark during the first 2 months of life.”

Wide heterogeneity in terms of size, location, patterns, of distribution, and depth, when coupled with unpredictable growth, makes management of IHs unpredictable. Thus, there can be no one-size-fits-all treatment approach.

Further complicating implementation of the CPG is the long-held myth that IHs are benign and resolve spontaneously. While this may accurately describe the vast majority of outcomes, “ample evidence” demonstrates what can happen when family and/or caregivers yield to such “false reassurance.” According to Dr. Krowchuk and his associates, hemangioma specialists have seen their share of “examples of lost opportunities to intervene and prevent poor outcomes because of lack of or delayed referral.”

The paucity of data on high-risk cases in primary care and referral care settings should be the subject of future research, the authors noted. Scorings systems, such as the Hemangioma Severity Score, are growing in popularity as a triage tool, but more research is needed to demonstrate that primary care physicians are accurately interpreting findings and that high-risk cases are accurately identified to avoid over-referral to specialists.

Dr. Krowchuk and his colleagues did call attention to important evidence gaps that may be answered by research currently underway, or that may require further research in the future by asking the following questions: How safe is treatment with topical timolol in early infancy, and what proportion of patients can be observed without referral? For healthy infants 5 weeks or older, to what extent, if any, is cardiovascular monitoring for propranolol necessary? How should pediatricians be involved in beta-blocker management of infants and when should specialty reevaluation be made? What is the accuracy of primary care identification of high-risk IH cases using many of the parameters offered within this CPG? Are pediatric trainees being sufficiently trained in stratifying and managing IH risk?

One noteworthy barrier to improved management and outcomes noted by the authors is the “imprecision of current diagnostic codes.” At present, the existing coding in the International Classification of Diseases, 10th Revision does not include specific reference to IH but rather describes “hemangioma of the skin and subcutaneous tissues” and can include congenital as well as verrucous hemangioma. The codes also do not address the details characteristic of IHs or the higher risk aspects of IH, such as location or multifocality. Advocacy, in this instance, would be appropriate, advised Dr. Krowchuk and his associates.

In an interview, Dr. Krowchuk provided additional insight into what sets the AAP’s CPG apart from consensus statements published previously by European and Australasian expert groups. Although these might appear to be similar documents with analogous content at first glance, there are important differences, he said.

The consensus statements were based on expert opinion, while “the academy’s CPG was founded on an extensive review of the medical literature (1982-2017) regarding the potential benefits and harms of diagnostic modalities and pharmacologic and surgical treatments,” Dr. Krowchuk explained. The information that came out of this extensive review is what members of the subcommittee used to develop key action statements that pediatricians can use to evaluate and manage infants with IHs.

“The scope of the consensus statements was more limited, focusing primarily on the treatment of IH with propranolol. While the benefits of propranolol, its use and dosing, and potential adverse effects were addressed in depth in the academy’s CPG, the document went well beyond this,” he clarified.

The AAP also previously published a clinical report that provides a comprehensive evaluation of the pathogenesis, clinical features, and treatment of IH (Pediatrics. 2015 Oct. doi: 10.1542/peds.2015-2485).

There was no external funding for the CPG, and the authors said there were no potential conflicts of interest. Ilona J. Frieden, MD, is a member of the data monitoring safety board for Pfizer and the scientific advisory board for Venthera/Bridge Bio; Anthony J. Mancini, MD, said he has advisory board relationships with Verrica, Valeant, and Pfizer.

SOURCE: Krowchuk, DP et al. Pediatrics 2019;143(1):e20183475.

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The American Academy of Pediatrics has issued its first clinical practice guideline on infantile hemangiomas (IHs), given the dramatic increase in information available over the past decade.

Summary of the clinical practice guideline's key action statements

The aim in providing an evidence-based approach to evaluating, triaging, and managing IH cases is to arm primary care providers with the confidence needed to successfully treat high-risk cases, reported Daniel P. Krowchuk, MD, of the department of pediatrics and dermatology, Wake Forest University, Winston-Salem, N.C., and his associates who are members of the AAP subcommittee on the management of IHs.

With an occurrence rate of 4%-5%, IHs are the most common benign tumor presenting in childhood, especially occurring in girls, twins, preterm or low-birth-weight infants, and white neonates.

The AAP’s guideline “provides a framework for clinical decision-making” – it should not be considered a sole source of guidance. It also should not be used to replace clinical judgment or as a protocol for managing all patients with IHs, explained Dr. Krowchuk and his associates.

Clinicians, especially, are encouraged to consult promptly with a hemangioma specialist if they are not experienced in managing IHs.

According to one study cited by the authors, the mean age of examination by a dermatologist is 5 months, when most growth has already been completed. Lesions are first noticed, on average, at 2 weeks; 4 weeks has been recommended as the ideal time for professional consultation. It is important for clinicians to recognize the difficulty families are likely to face in obtaining an appointment, which makes caregiver and clinician advocacy on behalf of infants affected critical, urged Dr. Krowchuk and his colleagues. In cases or locations where hemangioma specialists are in short supply, telemedicine triage or photographic consultation is especially helpful.

Dr. Krowchuk and his associates noted several possible challenges in implementing this clinical practice guideline (CPG) published in Pediatrics. The growth of individual IHs is difficult to predict, especially in young infants, and there are no markers or imaging studies to correct this challenge. For this reason, they advised: “Prompt evaluation, either in-person or via photographs, is warranted for any infant reported by parents to have a changing birthmark during the first 2 months of life.”

Wide heterogeneity in terms of size, location, patterns, of distribution, and depth, when coupled with unpredictable growth, makes management of IHs unpredictable. Thus, there can be no one-size-fits-all treatment approach.

Further complicating implementation of the CPG is the long-held myth that IHs are benign and resolve spontaneously. While this may accurately describe the vast majority of outcomes, “ample evidence” demonstrates what can happen when family and/or caregivers yield to such “false reassurance.” According to Dr. Krowchuk and his associates, hemangioma specialists have seen their share of “examples of lost opportunities to intervene and prevent poor outcomes because of lack of or delayed referral.”

The paucity of data on high-risk cases in primary care and referral care settings should be the subject of future research, the authors noted. Scorings systems, such as the Hemangioma Severity Score, are growing in popularity as a triage tool, but more research is needed to demonstrate that primary care physicians are accurately interpreting findings and that high-risk cases are accurately identified to avoid over-referral to specialists.

Dr. Krowchuk and his colleagues did call attention to important evidence gaps that may be answered by research currently underway, or that may require further research in the future by asking the following questions: How safe is treatment with topical timolol in early infancy, and what proportion of patients can be observed without referral? For healthy infants 5 weeks or older, to what extent, if any, is cardiovascular monitoring for propranolol necessary? How should pediatricians be involved in beta-blocker management of infants and when should specialty reevaluation be made? What is the accuracy of primary care identification of high-risk IH cases using many of the parameters offered within this CPG? Are pediatric trainees being sufficiently trained in stratifying and managing IH risk?

One noteworthy barrier to improved management and outcomes noted by the authors is the “imprecision of current diagnostic codes.” At present, the existing coding in the International Classification of Diseases, 10th Revision does not include specific reference to IH but rather describes “hemangioma of the skin and subcutaneous tissues” and can include congenital as well as verrucous hemangioma. The codes also do not address the details characteristic of IHs or the higher risk aspects of IH, such as location or multifocality. Advocacy, in this instance, would be appropriate, advised Dr. Krowchuk and his associates.

In an interview, Dr. Krowchuk provided additional insight into what sets the AAP’s CPG apart from consensus statements published previously by European and Australasian expert groups. Although these might appear to be similar documents with analogous content at first glance, there are important differences, he said.

The consensus statements were based on expert opinion, while “the academy’s CPG was founded on an extensive review of the medical literature (1982-2017) regarding the potential benefits and harms of diagnostic modalities and pharmacologic and surgical treatments,” Dr. Krowchuk explained. The information that came out of this extensive review is what members of the subcommittee used to develop key action statements that pediatricians can use to evaluate and manage infants with IHs.

“The scope of the consensus statements was more limited, focusing primarily on the treatment of IH with propranolol. While the benefits of propranolol, its use and dosing, and potential adverse effects were addressed in depth in the academy’s CPG, the document went well beyond this,” he clarified.

The AAP also previously published a clinical report that provides a comprehensive evaluation of the pathogenesis, clinical features, and treatment of IH (Pediatrics. 2015 Oct. doi: 10.1542/peds.2015-2485).

There was no external funding for the CPG, and the authors said there were no potential conflicts of interest. Ilona J. Frieden, MD, is a member of the data monitoring safety board for Pfizer and the scientific advisory board for Venthera/Bridge Bio; Anthony J. Mancini, MD, said he has advisory board relationships with Verrica, Valeant, and Pfizer.

SOURCE: Krowchuk, DP et al. Pediatrics 2019;143(1):e20183475.

 

The American Academy of Pediatrics has issued its first clinical practice guideline on infantile hemangiomas (IHs), given the dramatic increase in information available over the past decade.

Summary of the clinical practice guideline's key action statements

The aim in providing an evidence-based approach to evaluating, triaging, and managing IH cases is to arm primary care providers with the confidence needed to successfully treat high-risk cases, reported Daniel P. Krowchuk, MD, of the department of pediatrics and dermatology, Wake Forest University, Winston-Salem, N.C., and his associates who are members of the AAP subcommittee on the management of IHs.

With an occurrence rate of 4%-5%, IHs are the most common benign tumor presenting in childhood, especially occurring in girls, twins, preterm or low-birth-weight infants, and white neonates.

The AAP’s guideline “provides a framework for clinical decision-making” – it should not be considered a sole source of guidance. It also should not be used to replace clinical judgment or as a protocol for managing all patients with IHs, explained Dr. Krowchuk and his associates.

Clinicians, especially, are encouraged to consult promptly with a hemangioma specialist if they are not experienced in managing IHs.

According to one study cited by the authors, the mean age of examination by a dermatologist is 5 months, when most growth has already been completed. Lesions are first noticed, on average, at 2 weeks; 4 weeks has been recommended as the ideal time for professional consultation. It is important for clinicians to recognize the difficulty families are likely to face in obtaining an appointment, which makes caregiver and clinician advocacy on behalf of infants affected critical, urged Dr. Krowchuk and his colleagues. In cases or locations where hemangioma specialists are in short supply, telemedicine triage or photographic consultation is especially helpful.

Dr. Krowchuk and his associates noted several possible challenges in implementing this clinical practice guideline (CPG) published in Pediatrics. The growth of individual IHs is difficult to predict, especially in young infants, and there are no markers or imaging studies to correct this challenge. For this reason, they advised: “Prompt evaluation, either in-person or via photographs, is warranted for any infant reported by parents to have a changing birthmark during the first 2 months of life.”

Wide heterogeneity in terms of size, location, patterns, of distribution, and depth, when coupled with unpredictable growth, makes management of IHs unpredictable. Thus, there can be no one-size-fits-all treatment approach.

Further complicating implementation of the CPG is the long-held myth that IHs are benign and resolve spontaneously. While this may accurately describe the vast majority of outcomes, “ample evidence” demonstrates what can happen when family and/or caregivers yield to such “false reassurance.” According to Dr. Krowchuk and his associates, hemangioma specialists have seen their share of “examples of lost opportunities to intervene and prevent poor outcomes because of lack of or delayed referral.”

The paucity of data on high-risk cases in primary care and referral care settings should be the subject of future research, the authors noted. Scorings systems, such as the Hemangioma Severity Score, are growing in popularity as a triage tool, but more research is needed to demonstrate that primary care physicians are accurately interpreting findings and that high-risk cases are accurately identified to avoid over-referral to specialists.

Dr. Krowchuk and his colleagues did call attention to important evidence gaps that may be answered by research currently underway, or that may require further research in the future by asking the following questions: How safe is treatment with topical timolol in early infancy, and what proportion of patients can be observed without referral? For healthy infants 5 weeks or older, to what extent, if any, is cardiovascular monitoring for propranolol necessary? How should pediatricians be involved in beta-blocker management of infants and when should specialty reevaluation be made? What is the accuracy of primary care identification of high-risk IH cases using many of the parameters offered within this CPG? Are pediatric trainees being sufficiently trained in stratifying and managing IH risk?

One noteworthy barrier to improved management and outcomes noted by the authors is the “imprecision of current diagnostic codes.” At present, the existing coding in the International Classification of Diseases, 10th Revision does not include specific reference to IH but rather describes “hemangioma of the skin and subcutaneous tissues” and can include congenital as well as verrucous hemangioma. The codes also do not address the details characteristic of IHs or the higher risk aspects of IH, such as location or multifocality. Advocacy, in this instance, would be appropriate, advised Dr. Krowchuk and his associates.

In an interview, Dr. Krowchuk provided additional insight into what sets the AAP’s CPG apart from consensus statements published previously by European and Australasian expert groups. Although these might appear to be similar documents with analogous content at first glance, there are important differences, he said.

The consensus statements were based on expert opinion, while “the academy’s CPG was founded on an extensive review of the medical literature (1982-2017) regarding the potential benefits and harms of diagnostic modalities and pharmacologic and surgical treatments,” Dr. Krowchuk explained. The information that came out of this extensive review is what members of the subcommittee used to develop key action statements that pediatricians can use to evaluate and manage infants with IHs.

“The scope of the consensus statements was more limited, focusing primarily on the treatment of IH with propranolol. While the benefits of propranolol, its use and dosing, and potential adverse effects were addressed in depth in the academy’s CPG, the document went well beyond this,” he clarified.

The AAP also previously published a clinical report that provides a comprehensive evaluation of the pathogenesis, clinical features, and treatment of IH (Pediatrics. 2015 Oct. doi: 10.1542/peds.2015-2485).

There was no external funding for the CPG, and the authors said there were no potential conflicts of interest. Ilona J. Frieden, MD, is a member of the data monitoring safety board for Pfizer and the scientific advisory board for Venthera/Bridge Bio; Anthony J. Mancini, MD, said he has advisory board relationships with Verrica, Valeant, and Pfizer.

SOURCE: Krowchuk, DP et al. Pediatrics 2019;143(1):e20183475.

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Chronic opioid use during pregnancy linked with reduced head circumference in NAS newborns

Add optimizing outcomes to NAS focus
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Fri, 01/18/2019 - 18:12

 

Newborns who develop neonatal abstinence syndrome (NAS) caused by chronic maternal opioid use during pregnancy are at risk of significantly smaller head circumference (HC), reported Craig V. Towers, MD, and his associates at the University of Tennessee Medical Center in Knoxville in Pediatrics.

In the first large prospective cohort study to compare HC in newborns being treated for NAS, a total of 858 neonates, including 429 with NAS and 429 controls, were enrolled and assessed at the University of Tennessee Medical Center, Knoxville, from April 1, 2014, to Dec. 31, 2016.

A mom holding her baby with neonatal abstinence syndrome skin-to-skin


Dr. Towers and his associates found that mean HC in those neonates with NAS was significantly smaller, by 9.5 mm, than it was in controls. Of the 429 newborns with NAS, 62% had a normal HC, 30% had an HC less than the 10th percentile, and 8% had an HC less than or equal to the third percentile. Of the controls, 12% had an HC less than the 10th percentile.

The authors identified a significant 3% reduction in mean HC as well as a 2% reduction in mean birth weight. “Because newborn HC is an indirect measure of brain volume, further research is necessary to determine if this finding increases the risk for long-term neurodevelopmental delay,” they said.

Even though the newborns with NAS were found to experience greater coexposure to benzodiazepines, stimulants, marijuana, gabapentin, tobacco, and SSRIs, compared with controls, none of these coexposures was determined to be a significant risk factor for smaller head circumference at birth when individual drug exposure relationships within the newborn population alone were assessed, the researchers observed.

Dr. Towers and his associates did consider it noteworthy, however, that the majority of NAS cases included in the study were born to mothers receiving opioid agonist medication–assisted treatment (MAT), which is the recommended treatment in cases where opioid use disorder is addressed during pregnancy. Among the 429 NAS cases, the mothers of 372 (87%) were on opioid agonist MAT (320 buprenorphine and 52 methadone); the remaining 13% were born to mothers who were prescribed other opioid drugs.

There is limited data available to determine whether detoxification during pregnancy for patients with opioid use disorder (OUD) has any effect on lessening the risk of lower HC. In fact, the authors caution that detoxification during pregnancy is not recommended for managing OUD. To date, there are only a few locations in the United States and other countries offering such treatment. If the practice becomes more widespread, they cautioned, further research examining new born HC and long-term outcomes “is of paramount importance.”

Further prospective studies evaluating the effects of opioid exposure in newborns who do not develop NAS also are needed. Such data could provide clues concerning whether there is a crucial period of exposure that leads to reduced HC or whether the effects of opioid exposure are in fact cumulative. In cases where newborns are exposed as a result of maintenance MAT, through illicit use, or as a result of maternal detoxification, such studies also could assist with determining whether it is necessary to reconsider current practices for managing OUD in pregnancy.

The study was partially funded through the Blue Cross Blue Shield Research Foundation. The authors reported no relevant financial disclosures.

 

SOURCE: Towers CV et al. Pediatrics. 2019;143(1):e20180541.

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At a time when more people in the United States are dying from opioid overdose than from automobile trauma, the number of newborns with NAS has virtually exploded, rising fivefold since 2000. In some states, more than 30 infants per 1,000 live births develop NAS “effectively transforming some NICUs into NAS wards,” Mark L. Hudak, MD, and Kartikeya Makker, MD, wrote in an accompanying editorial.

Among the strengths of the current study, they cited “universal dating of pregnancies by early ultrasound, multiple antenatal maternal urine drug tests for exposures in both cases and controls, and the use of a fairly robust statistical methodology to account for confounding exposures.”

Among the findings of the study were that, “compared with well-matched controls, newborns with NAS demonstrated a highly significant (nearly 1 cm) decrease in the mean head circumference. Another finding was that newborns with NAS showed proportionately greater decreases in head circumference than in birth weight,” the editorialists said.

Dr. Hadak and Dr. Makker noted that, while NAS can be challenging to manage, the acute effects of withdrawal are transient. The more important questions, they propose are: “What are the best methods to prevent NAS?” and “What, if any, are the long-term effects of fetal and neonatal opioid exposure on the developing child?”

Dr. Hudak and Dr. Makker question the practicality of closely following maternal opioid usage during pregnancy, but they do foresee value in the anticipated findings of a current study in which Dr. Towers and his associates are observing newborns with reduced fetal exposure to opioids who have not developed NAS.

“Additional evidence revealing that the reduction of maternal opioid use can protect normal fetal head and brain growth should energize discussion about refining the management of the opioid-maintained maternal-fetal dyad, with the goal not solely to prevent NAS but more importantly to optimize the outcome of the child,” they said.

Dr. Hudak and Dr. Makker are affiliated with the department of pediatrics at the University of Florida, Jacksonville. These comments are summarized from an editorial commenting on the study by Towers et al. (Pediatrics. 2019;143[1]:e20183376). Dr. Hudak and Dr. Makker said they had no relevant financial disclosures.

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At a time when more people in the United States are dying from opioid overdose than from automobile trauma, the number of newborns with NAS has virtually exploded, rising fivefold since 2000. In some states, more than 30 infants per 1,000 live births develop NAS “effectively transforming some NICUs into NAS wards,” Mark L. Hudak, MD, and Kartikeya Makker, MD, wrote in an accompanying editorial.

Among the strengths of the current study, they cited “universal dating of pregnancies by early ultrasound, multiple antenatal maternal urine drug tests for exposures in both cases and controls, and the use of a fairly robust statistical methodology to account for confounding exposures.”

Among the findings of the study were that, “compared with well-matched controls, newborns with NAS demonstrated a highly significant (nearly 1 cm) decrease in the mean head circumference. Another finding was that newborns with NAS showed proportionately greater decreases in head circumference than in birth weight,” the editorialists said.

Dr. Hadak and Dr. Makker noted that, while NAS can be challenging to manage, the acute effects of withdrawal are transient. The more important questions, they propose are: “What are the best methods to prevent NAS?” and “What, if any, are the long-term effects of fetal and neonatal opioid exposure on the developing child?”

Dr. Hudak and Dr. Makker question the practicality of closely following maternal opioid usage during pregnancy, but they do foresee value in the anticipated findings of a current study in which Dr. Towers and his associates are observing newborns with reduced fetal exposure to opioids who have not developed NAS.

“Additional evidence revealing that the reduction of maternal opioid use can protect normal fetal head and brain growth should energize discussion about refining the management of the opioid-maintained maternal-fetal dyad, with the goal not solely to prevent NAS but more importantly to optimize the outcome of the child,” they said.

Dr. Hudak and Dr. Makker are affiliated with the department of pediatrics at the University of Florida, Jacksonville. These comments are summarized from an editorial commenting on the study by Towers et al. (Pediatrics. 2019;143[1]:e20183376). Dr. Hudak and Dr. Makker said they had no relevant financial disclosures.

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At a time when more people in the United States are dying from opioid overdose than from automobile trauma, the number of newborns with NAS has virtually exploded, rising fivefold since 2000. In some states, more than 30 infants per 1,000 live births develop NAS “effectively transforming some NICUs into NAS wards,” Mark L. Hudak, MD, and Kartikeya Makker, MD, wrote in an accompanying editorial.

Among the strengths of the current study, they cited “universal dating of pregnancies by early ultrasound, multiple antenatal maternal urine drug tests for exposures in both cases and controls, and the use of a fairly robust statistical methodology to account for confounding exposures.”

Among the findings of the study were that, “compared with well-matched controls, newborns with NAS demonstrated a highly significant (nearly 1 cm) decrease in the mean head circumference. Another finding was that newborns with NAS showed proportionately greater decreases in head circumference than in birth weight,” the editorialists said.

Dr. Hadak and Dr. Makker noted that, while NAS can be challenging to manage, the acute effects of withdrawal are transient. The more important questions, they propose are: “What are the best methods to prevent NAS?” and “What, if any, are the long-term effects of fetal and neonatal opioid exposure on the developing child?”

Dr. Hudak and Dr. Makker question the practicality of closely following maternal opioid usage during pregnancy, but they do foresee value in the anticipated findings of a current study in which Dr. Towers and his associates are observing newborns with reduced fetal exposure to opioids who have not developed NAS.

“Additional evidence revealing that the reduction of maternal opioid use can protect normal fetal head and brain growth should energize discussion about refining the management of the opioid-maintained maternal-fetal dyad, with the goal not solely to prevent NAS but more importantly to optimize the outcome of the child,” they said.

Dr. Hudak and Dr. Makker are affiliated with the department of pediatrics at the University of Florida, Jacksonville. These comments are summarized from an editorial commenting on the study by Towers et al. (Pediatrics. 2019;143[1]:e20183376). Dr. Hudak and Dr. Makker said they had no relevant financial disclosures.

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Add optimizing outcomes to NAS focus

 

Newborns who develop neonatal abstinence syndrome (NAS) caused by chronic maternal opioid use during pregnancy are at risk of significantly smaller head circumference (HC), reported Craig V. Towers, MD, and his associates at the University of Tennessee Medical Center in Knoxville in Pediatrics.

In the first large prospective cohort study to compare HC in newborns being treated for NAS, a total of 858 neonates, including 429 with NAS and 429 controls, were enrolled and assessed at the University of Tennessee Medical Center, Knoxville, from April 1, 2014, to Dec. 31, 2016.

A mom holding her baby with neonatal abstinence syndrome skin-to-skin


Dr. Towers and his associates found that mean HC in those neonates with NAS was significantly smaller, by 9.5 mm, than it was in controls. Of the 429 newborns with NAS, 62% had a normal HC, 30% had an HC less than the 10th percentile, and 8% had an HC less than or equal to the third percentile. Of the controls, 12% had an HC less than the 10th percentile.

The authors identified a significant 3% reduction in mean HC as well as a 2% reduction in mean birth weight. “Because newborn HC is an indirect measure of brain volume, further research is necessary to determine if this finding increases the risk for long-term neurodevelopmental delay,” they said.

Even though the newborns with NAS were found to experience greater coexposure to benzodiazepines, stimulants, marijuana, gabapentin, tobacco, and SSRIs, compared with controls, none of these coexposures was determined to be a significant risk factor for smaller head circumference at birth when individual drug exposure relationships within the newborn population alone were assessed, the researchers observed.

Dr. Towers and his associates did consider it noteworthy, however, that the majority of NAS cases included in the study were born to mothers receiving opioid agonist medication–assisted treatment (MAT), which is the recommended treatment in cases where opioid use disorder is addressed during pregnancy. Among the 429 NAS cases, the mothers of 372 (87%) were on opioid agonist MAT (320 buprenorphine and 52 methadone); the remaining 13% were born to mothers who were prescribed other opioid drugs.

There is limited data available to determine whether detoxification during pregnancy for patients with opioid use disorder (OUD) has any effect on lessening the risk of lower HC. In fact, the authors caution that detoxification during pregnancy is not recommended for managing OUD. To date, there are only a few locations in the United States and other countries offering such treatment. If the practice becomes more widespread, they cautioned, further research examining new born HC and long-term outcomes “is of paramount importance.”

Further prospective studies evaluating the effects of opioid exposure in newborns who do not develop NAS also are needed. Such data could provide clues concerning whether there is a crucial period of exposure that leads to reduced HC or whether the effects of opioid exposure are in fact cumulative. In cases where newborns are exposed as a result of maintenance MAT, through illicit use, or as a result of maternal detoxification, such studies also could assist with determining whether it is necessary to reconsider current practices for managing OUD in pregnancy.

The study was partially funded through the Blue Cross Blue Shield Research Foundation. The authors reported no relevant financial disclosures.

 

SOURCE: Towers CV et al. Pediatrics. 2019;143(1):e20180541.

 

Newborns who develop neonatal abstinence syndrome (NAS) caused by chronic maternal opioid use during pregnancy are at risk of significantly smaller head circumference (HC), reported Craig V. Towers, MD, and his associates at the University of Tennessee Medical Center in Knoxville in Pediatrics.

In the first large prospective cohort study to compare HC in newborns being treated for NAS, a total of 858 neonates, including 429 with NAS and 429 controls, were enrolled and assessed at the University of Tennessee Medical Center, Knoxville, from April 1, 2014, to Dec. 31, 2016.

A mom holding her baby with neonatal abstinence syndrome skin-to-skin


Dr. Towers and his associates found that mean HC in those neonates with NAS was significantly smaller, by 9.5 mm, than it was in controls. Of the 429 newborns with NAS, 62% had a normal HC, 30% had an HC less than the 10th percentile, and 8% had an HC less than or equal to the third percentile. Of the controls, 12% had an HC less than the 10th percentile.

The authors identified a significant 3% reduction in mean HC as well as a 2% reduction in mean birth weight. “Because newborn HC is an indirect measure of brain volume, further research is necessary to determine if this finding increases the risk for long-term neurodevelopmental delay,” they said.

Even though the newborns with NAS were found to experience greater coexposure to benzodiazepines, stimulants, marijuana, gabapentin, tobacco, and SSRIs, compared with controls, none of these coexposures was determined to be a significant risk factor for smaller head circumference at birth when individual drug exposure relationships within the newborn population alone were assessed, the researchers observed.

Dr. Towers and his associates did consider it noteworthy, however, that the majority of NAS cases included in the study were born to mothers receiving opioid agonist medication–assisted treatment (MAT), which is the recommended treatment in cases where opioid use disorder is addressed during pregnancy. Among the 429 NAS cases, the mothers of 372 (87%) were on opioid agonist MAT (320 buprenorphine and 52 methadone); the remaining 13% were born to mothers who were prescribed other opioid drugs.

There is limited data available to determine whether detoxification during pregnancy for patients with opioid use disorder (OUD) has any effect on lessening the risk of lower HC. In fact, the authors caution that detoxification during pregnancy is not recommended for managing OUD. To date, there are only a few locations in the United States and other countries offering such treatment. If the practice becomes more widespread, they cautioned, further research examining new born HC and long-term outcomes “is of paramount importance.”

Further prospective studies evaluating the effects of opioid exposure in newborns who do not develop NAS also are needed. Such data could provide clues concerning whether there is a crucial period of exposure that leads to reduced HC or whether the effects of opioid exposure are in fact cumulative. In cases where newborns are exposed as a result of maintenance MAT, through illicit use, or as a result of maternal detoxification, such studies also could assist with determining whether it is necessary to reconsider current practices for managing OUD in pregnancy.

The study was partially funded through the Blue Cross Blue Shield Research Foundation. The authors reported no relevant financial disclosures.

 

SOURCE: Towers CV et al. Pediatrics. 2019;143(1):e20180541.

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Key clinical point: Detoxification during pregnancy may be ill advised for patients with opioid use disorder.

Major finding: Head circumference was smaller by a mean 9.5 mm.

Study details: Prospective cohort study of 429 NAS neonates and 429 controls.

Disclosures: The study was partially funded through the Blue Cross Blue Shield Research Foundation. The authors reported no relevant financial disclosures.

Source: Towers CV et al. Pediatrics. 2019;143(1):e20180541.

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Comorbid TBI & PTSD raise the risk for sleep disturbances, pain

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Veterans living with comorbid traumatic brain injury (TBI) and posttraumatic stress disorder were at increased risk for worse pain and sleep disturbances, reported Nadir M. Balba and colleagues at the VA Portland (Ore.) Health Care System.

Difficulty sleeping
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The authors conducted a retrospective review of medical records at the VA Portland Health Care System (VAPORHCS) that evaluated 639 veterans who were referred to the VAPORHCS Sleep Disorders Clinic between May 2015 and November 2016. They wrote, “The purpose of this study was to determine whether Veterans with comorbid TBI and PTSD exhibit a higher prevalence of sleep disturbances (determined via self-report and objective polysomnography) and pain compared to Veterans with only TBI or PTSD.”

Patients were recruited to participate in the cross-sectional study, which included participation in an overnight sleep clinic as well as patient self-reported sleep quality, pain, and TBI and PTSD symptom severity. Sleep disturbances included insomnia, nightmares, sleep fragmentation, obstructive sleep apnea, and parasomnias. The survey tools used in the study included the Rivermead Post Concussion Questionnaire (RPCQ), the PTSD Checklist DSM-5 (PSTD-5), the Insomnia Severity Index (ISI), and the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Sleep studies were recorded using Polysmith version 9.0 and sleep staging was performed by a certified sleep technician and verified by a board-certified sleep medicine physician.

Patients were grouped into one of four trauma exposure classifications based on their prior history of trauma, including neither (n = 383), TBI (n = 67), PTSD (n = 126), and TBI+PTSD (n = 63).

Self-reported sleep disturbance, which was the worst among those with PTSD and those with comorbid TBI and PTSD, indicated that PTSD plays a more significant role in the occurrence of disturbed sleep than TBI, the researchers noted. “Participants in the TBI+PTSD and PTSD groups had significantly worse ISI scores (i.e., higher scores) compared to both the TBI and neither groups (P less than .001). Furthermore, participants in the TBI+PTSD and PTSD groups had significantly worse FOSQ-10 scores (ie, lower scores) compared to both the TBI and neither groups (P less than .001),” they wrote.

In terms of pain, patients with comorbid TBI and PTSD reported the greatest severity of pain, including more frequent headaches and worse photo and phono sensitivities. The TBI and PTSD groups, however, both scored significantly higher in their pain reports than those in the neither group, which suggests “that each of these conditions independently contributes to increased pain,” the authors observed. Ultimately, they cited multiple linear regression models, which attributed sleep disturbances and TBI symptom severity as the primary contributors to pain presentation.

“It is well established that sleep disturbances and pain are inextricably linked,” they said. The results of this study serve to validate that connection “but also suggest this link may be even stronger in those with comorbid TBI and PTSD,” they added.

The researchers cited self-report data as a possible study limitation. They also conceded that comorbid depression and substance use disorder could both play a role in further exacerbating sleep disturbance and pain.

Future research should evaluate how TBI and PTSD, along with other unidentified comorbid conditions, may work together in exacerbating symptoms so that more effective treatment interventions can be developed to address sleep and pain disturbance following multiple traumas.

The authors had no relevant financial disclosures to report.

SOURCE: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.

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Veterans living with comorbid traumatic brain injury (TBI) and posttraumatic stress disorder were at increased risk for worse pain and sleep disturbances, reported Nadir M. Balba and colleagues at the VA Portland (Ore.) Health Care System.

Difficulty sleeping
Tab1962/iStockphoto.com

The authors conducted a retrospective review of medical records at the VA Portland Health Care System (VAPORHCS) that evaluated 639 veterans who were referred to the VAPORHCS Sleep Disorders Clinic between May 2015 and November 2016. They wrote, “The purpose of this study was to determine whether Veterans with comorbid TBI and PTSD exhibit a higher prevalence of sleep disturbances (determined via self-report and objective polysomnography) and pain compared to Veterans with only TBI or PTSD.”

Patients were recruited to participate in the cross-sectional study, which included participation in an overnight sleep clinic as well as patient self-reported sleep quality, pain, and TBI and PTSD symptom severity. Sleep disturbances included insomnia, nightmares, sleep fragmentation, obstructive sleep apnea, and parasomnias. The survey tools used in the study included the Rivermead Post Concussion Questionnaire (RPCQ), the PTSD Checklist DSM-5 (PSTD-5), the Insomnia Severity Index (ISI), and the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Sleep studies were recorded using Polysmith version 9.0 and sleep staging was performed by a certified sleep technician and verified by a board-certified sleep medicine physician.

Patients were grouped into one of four trauma exposure classifications based on their prior history of trauma, including neither (n = 383), TBI (n = 67), PTSD (n = 126), and TBI+PTSD (n = 63).

Self-reported sleep disturbance, which was the worst among those with PTSD and those with comorbid TBI and PTSD, indicated that PTSD plays a more significant role in the occurrence of disturbed sleep than TBI, the researchers noted. “Participants in the TBI+PTSD and PTSD groups had significantly worse ISI scores (i.e., higher scores) compared to both the TBI and neither groups (P less than .001). Furthermore, participants in the TBI+PTSD and PTSD groups had significantly worse FOSQ-10 scores (ie, lower scores) compared to both the TBI and neither groups (P less than .001),” they wrote.

In terms of pain, patients with comorbid TBI and PTSD reported the greatest severity of pain, including more frequent headaches and worse photo and phono sensitivities. The TBI and PTSD groups, however, both scored significantly higher in their pain reports than those in the neither group, which suggests “that each of these conditions independently contributes to increased pain,” the authors observed. Ultimately, they cited multiple linear regression models, which attributed sleep disturbances and TBI symptom severity as the primary contributors to pain presentation.

“It is well established that sleep disturbances and pain are inextricably linked,” they said. The results of this study serve to validate that connection “but also suggest this link may be even stronger in those with comorbid TBI and PTSD,” they added.

The researchers cited self-report data as a possible study limitation. They also conceded that comorbid depression and substance use disorder could both play a role in further exacerbating sleep disturbance and pain.

Future research should evaluate how TBI and PTSD, along with other unidentified comorbid conditions, may work together in exacerbating symptoms so that more effective treatment interventions can be developed to address sleep and pain disturbance following multiple traumas.

The authors had no relevant financial disclosures to report.

SOURCE: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.

Veterans living with comorbid traumatic brain injury (TBI) and posttraumatic stress disorder were at increased risk for worse pain and sleep disturbances, reported Nadir M. Balba and colleagues at the VA Portland (Ore.) Health Care System.

Difficulty sleeping
Tab1962/iStockphoto.com

The authors conducted a retrospective review of medical records at the VA Portland Health Care System (VAPORHCS) that evaluated 639 veterans who were referred to the VAPORHCS Sleep Disorders Clinic between May 2015 and November 2016. They wrote, “The purpose of this study was to determine whether Veterans with comorbid TBI and PTSD exhibit a higher prevalence of sleep disturbances (determined via self-report and objective polysomnography) and pain compared to Veterans with only TBI or PTSD.”

Patients were recruited to participate in the cross-sectional study, which included participation in an overnight sleep clinic as well as patient self-reported sleep quality, pain, and TBI and PTSD symptom severity. Sleep disturbances included insomnia, nightmares, sleep fragmentation, obstructive sleep apnea, and parasomnias. The survey tools used in the study included the Rivermead Post Concussion Questionnaire (RPCQ), the PTSD Checklist DSM-5 (PSTD-5), the Insomnia Severity Index (ISI), and the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Sleep studies were recorded using Polysmith version 9.0 and sleep staging was performed by a certified sleep technician and verified by a board-certified sleep medicine physician.

Patients were grouped into one of four trauma exposure classifications based on their prior history of trauma, including neither (n = 383), TBI (n = 67), PTSD (n = 126), and TBI+PTSD (n = 63).

Self-reported sleep disturbance, which was the worst among those with PTSD and those with comorbid TBI and PTSD, indicated that PTSD plays a more significant role in the occurrence of disturbed sleep than TBI, the researchers noted. “Participants in the TBI+PTSD and PTSD groups had significantly worse ISI scores (i.e., higher scores) compared to both the TBI and neither groups (P less than .001). Furthermore, participants in the TBI+PTSD and PTSD groups had significantly worse FOSQ-10 scores (ie, lower scores) compared to both the TBI and neither groups (P less than .001),” they wrote.

In terms of pain, patients with comorbid TBI and PTSD reported the greatest severity of pain, including more frequent headaches and worse photo and phono sensitivities. The TBI and PTSD groups, however, both scored significantly higher in their pain reports than those in the neither group, which suggests “that each of these conditions independently contributes to increased pain,” the authors observed. Ultimately, they cited multiple linear regression models, which attributed sleep disturbances and TBI symptom severity as the primary contributors to pain presentation.

“It is well established that sleep disturbances and pain are inextricably linked,” they said. The results of this study serve to validate that connection “but also suggest this link may be even stronger in those with comorbid TBI and PTSD,” they added.

The researchers cited self-report data as a possible study limitation. They also conceded that comorbid depression and substance use disorder could both play a role in further exacerbating sleep disturbance and pain.

Future research should evaluate how TBI and PTSD, along with other unidentified comorbid conditions, may work together in exacerbating symptoms so that more effective treatment interventions can be developed to address sleep and pain disturbance following multiple traumas.

The authors had no relevant financial disclosures to report.

SOURCE: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.

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FROM THE JOURNAL OF CLINICAL SLEEP MEDICINE

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Key clinical point: The combination of traumatic brain injury and posttraumatic stress disorder is linked to a higher risk for sleep disturbances, pain, and light and noise sensitivities.

Major finding: Participants with comorbid TBI and PTSD and PTSD only had higher Insomnia Severity Index scores than those with TBI only or neither condition (P less than .001).

Study details: Retrospective medical record review.

Disclosures: The authors noted no relevant financial disclosures.

Source: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.

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