Pediatrics

New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

Gestational exposure to grain products fortified with folic acid resulted in delayed thinning of the cerebral cortex, and thus may protect against later psychosis, according to results published in JAMA Psychiatry.

In a retrospective, observational cohort study of 292 patients aged 8-18 years, increases in cortical thickness were associated with folic acid exposure in the bilateral frontal and temporal regions of the brain (9.9%-11.6%; corrected P less than .001 to P = .03). Delayed, age-associated thinning in temporal and parietal regions was also observed (beta = –11.1 to –13.9; corrected P = .002), reported Hamdi Eryilmaz, PhD, of the department of psychiatry at Massachusetts General Hospital, Boston, and his coauthors.

The study authors first observed MRI scans in the Massachusetts General Hospital (MGH) cohort, which included the 292 patients aged 8-18 years, and then conducted subsequent analyses on two additional cohorts – the Philadelphia Neurodevelopmental Cohort (PNC) and the National Institutes of Health MRI Study of Normal Brain Development (NIH) cohort – to test the reliability and specificity of cortical development associations and the relevance of MRI changes to psychopathological characteristics, the authors wrote.

Using the U.S. implementation of folic acid fortification in grain foods in 1996 and 1997 to define exposure status, the investigators identified MRI scans of 97 prerollout (not exposed), 96 rollout (partly exposed), and 99 postrollout (fully exposed) unique individuals in the MGH group between January 2005 and March 2015, for patients born between January 1993 and December 2001. They also collected information on demographics; reason for MRI scan; and prior use of psychotropic medications, folic acid, or multivitamins.

The PNC cohort consisted of 861 patients, also aged 8-18 years, from community health settings in Philadelphia who had an MRI assessment and a clinical assessment of psychiatric symptoms. The NIH comparison cohort included 217 patients recruited from six health sites across the United States and born before the fortification rollout.

The MGH analysis contrasted mean cortical thickness and linear and quadratic models of age-associated change in cortical thickness within the fully exposed and nonexposed groups. PNC and NIH analyses evaluated quadratic associations of age with cortical thickness.

In the MGH cohort, increases in cortical thickness were associated with folic acid exposure in the bilateral frontal and temporal regions of the brain (9.9%-11.6%; corrected P less than .001 to P = .03), and delayed, age-associated thinning in the temporal and parietal regions was observed (corrected P = .002). Thickness was higher in the fully exposed group, compared with those in the nonexposed group. The effect was intermediate in the partly exposed group, Dr. Eryilmaz and his coauthors wrote.

In the PNC cohort, delayed, age-related thinning was observed in four clusters overlapping with the MGH analysis: left frontal, right inferior temporal, left inferior parietal, and right inferior parietal. In addition, onset of cortical thinning was found to be between 13.0 and 14.3 years of age in least-square regression analysis. In the comparison NIH cohort, though, only the left frontal cortex demonstrated significant quadratic thinning; the break point occurred at a significantly younger age, compared with those in the PNC group (P less than .001).

SOURCE: Eryilmaz H et al. JAMA Psychiatry. 2018 Jul 3. doi: 10.1001/jamapsychiatry.2018.1381.

Gestational exposure to grain products fortified with folic acid resulted in delayed thinning of the cerebral cortex, and thus may protect against later psychosis, according to results published in JAMA Psychiatry.

In a retrospective, observational cohort study of 292 patients aged 8-18 years, increases in cortical thickness were associated with folic acid exposure in the bilateral frontal and temporal regions of the brain (9.9%-11.6%; corrected P less than .001 to P = .03). Delayed, age-associated thinning in temporal and parietal regions was also observed (beta = –11.1 to –13.9; corrected P = .002), reported Hamdi Eryilmaz, PhD, of the department of psychiatry at Massachusetts General Hospital, Boston, and his coauthors.

The study authors first observed MRI scans in the Massachusetts General Hospital (MGH) cohort, which included the 292 patients aged 8-18 years, and then conducted subsequent analyses on two additional cohorts – the Philadelphia Neurodevelopmental Cohort (PNC) and the National Institutes of Health MRI Study of Normal Brain Development (NIH) cohort – to test the reliability and specificity of cortical development associations and the relevance of MRI changes to psychopathological characteristics, the authors wrote.

Using the U.S. implementation of folic acid fortification in grain foods in 1996 and 1997 to define exposure status, the investigators identified MRI scans of 97 prerollout (not exposed), 96 rollout (partly exposed), and 99 postrollout (fully exposed) unique individuals in the MGH group between January 2005 and March 2015, for patients born between January 1993 and December 2001. They also collected information on demographics; reason for MRI scan; and prior use of psychotropic medications, folic acid, or multivitamins.

The PNC cohort consisted of 861 patients, also aged 8-18 years, from community health settings in Philadelphia who had an MRI assessment and a clinical assessment of psychiatric symptoms. The NIH comparison cohort included 217 patients recruited from six health sites across the United States and born before the fortification rollout.

The MGH analysis contrasted mean cortical thickness and linear and quadratic models of age-associated change in cortical thickness within the fully exposed and nonexposed groups. PNC and NIH analyses evaluated quadratic associations of age with cortical thickness.

In the MGH cohort, increases in cortical thickness were associated with folic acid exposure in the bilateral frontal and temporal regions of the brain (9.9%-11.6%; corrected P less than .001 to P = .03), and delayed, age-associated thinning in the temporal and parietal regions was observed (corrected P = .002). Thickness was higher in the fully exposed group, compared with those in the nonexposed group. The effect was intermediate in the partly exposed group, Dr. Eryilmaz and his coauthors wrote.

In the PNC cohort, delayed, age-related thinning was observed in four clusters overlapping with the MGH analysis: left frontal, right inferior temporal, left inferior parietal, and right inferior parietal. In addition, onset of cortical thinning was found to be between 13.0 and 14.3 years of age in least-square regression analysis. In the comparison NIH cohort, though, only the left frontal cortex demonstrated significant quadratic thinning; the break point occurred at a significantly younger age, compared with those in the PNC group (P less than .001).

SOURCE: Eryilmaz H et al. JAMA Psychiatry. 2018 Jul 3. doi: 10.1001/jamapsychiatry.2018.1381.

Gestational exposure to grain products fortified with folic acid resulted in delayed thinning of the cerebral cortex, and thus may protect against later psychosis, according to results published in JAMA Psychiatry.

In a retrospective, observational cohort study of 292 patients aged 8-18 years, increases in cortical thickness were associated with folic acid exposure in the bilateral frontal and temporal regions of the brain (9.9%-11.6%; corrected P less than .001 to P = .03). Delayed, age-associated thinning in temporal and parietal regions was also observed (beta = –11.1 to –13.9; corrected P = .002), reported Hamdi Eryilmaz, PhD, of the department of psychiatry at Massachusetts General Hospital, Boston, and his coauthors.

The study authors first observed MRI scans in the Massachusetts General Hospital (MGH) cohort, which included the 292 patients aged 8-18 years, and then conducted subsequent analyses on two additional cohorts – the Philadelphia Neurodevelopmental Cohort (PNC) and the National Institutes of Health MRI Study of Normal Brain Development (NIH) cohort – to test the reliability and specificity of cortical development associations and the relevance of MRI changes to psychopathological characteristics, the authors wrote.

Using the U.S. implementation of folic acid fortification in grain foods in 1996 and 1997 to define exposure status, the investigators identified MRI scans of 97 prerollout (not exposed), 96 rollout (partly exposed), and 99 postrollout (fully exposed) unique individuals in the MGH group between January 2005 and March 2015, for patients born between January 1993 and December 2001. They also collected information on demographics; reason for MRI scan; and prior use of psychotropic medications, folic acid, or multivitamins.

The PNC cohort consisted of 861 patients, also aged 8-18 years, from community health settings in Philadelphia who had an MRI assessment and a clinical assessment of psychiatric symptoms. The NIH comparison cohort included 217 patients recruited from six health sites across the United States and born before the fortification rollout.

The MGH analysis contrasted mean cortical thickness and linear and quadratic models of age-associated change in cortical thickness within the fully exposed and nonexposed groups. PNC and NIH analyses evaluated quadratic associations of age with cortical thickness.

In the MGH cohort, increases in cortical thickness were associated with folic acid exposure in the bilateral frontal and temporal regions of the brain (9.9%-11.6%; corrected P less than .001 to P = .03), and delayed, age-associated thinning in the temporal and parietal regions was observed (corrected P = .002). Thickness was higher in the fully exposed group, compared with those in the nonexposed group. The effect was intermediate in the partly exposed group, Dr. Eryilmaz and his coauthors wrote.

In the PNC cohort, delayed, age-related thinning was observed in four clusters overlapping with the MGH analysis: left frontal, right inferior temporal, left inferior parietal, and right inferior parietal. In addition, onset of cortical thinning was found to be between 13.0 and 14.3 years of age in least-square regression analysis. In the comparison NIH cohort, though, only the left frontal cortex demonstrated significant quadratic thinning; the break point occurred at a significantly younger age, compared with those in the PNC group (P less than .001).

SOURCE: Eryilmaz H et al. JAMA Psychiatry. 2018 Jul 3. doi: 10.1001/jamapsychiatry.2018.1381.

Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.

Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.

This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.

“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.

The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.

Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.

After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.

Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.

Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.

By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.

These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.

“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.

The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.

SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.

Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.

Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.

This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.

“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.

The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.

Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.

After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.

Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.

Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.

By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.

These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.

“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.

The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.

SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.

Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.

Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.

This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.

“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.

The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.

Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.

After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.

Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.

Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.

By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.

These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.

“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.

The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.

SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.

LOS ANGELES—Sodium oxybate reduces cataplexy and excessive sleepiness in children with narcolepsy type 1, according to a study described at the 70th Annual Meeting of the American Academy of Neurology. The treatment’s safety profile in this population is similar to that in adults.

Although symptoms of narcolepsy often begin during childhood or adolescence, few studies have evaluated treatments for narcolepsy in pediatric patients. Sodium oxybate is approved for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy, but it had not previously been studied in a large pediatric narcolepsy trial. Chad Ruoff, MD, Clinical Assistant Professor of Psychiatry and Behavioral Sciences at the Stanford Center for Sleep Sciences and Medicine in California, and colleagues conducted a double-blind, placebo-controlled, randomized-withdrawal study to evaluate the efficacy and safety of sodium oxybate in pediatric patients with narcolepsy type 1.

A Randomized-Withdrawal Study

Eligible participants were children and adolescents between ages 7 and 16 who had been diagnosed with narcolepsy type 1 and had cataplexy. Patients who were on stable doses of sodium oxybate and patients who were sodium-oxybate-naïve were included. Patients with evidence of sleep-disordered breathing were excluded.

Sodium-oxybate-naïve participants were titrated to a stable dose. After a stable-dose period, all participants began a two-week, double-blind, placebo-controlled withdrawal period. The investigators randomized participants in equal groups to continue sodium oxybate or to be switched to placebo. At the end of the double-blind period, all participants received open-label sodium oxybate treatment. Efficacy assessments compared measurements during or at the end of the double-blind period with those taken the last two weeks of the stable-dose period. The study’s primary end point was change in weekly number of cataplexy attacks.

Study Was Terminated Early

Dr. Ruoff and colleagues randomized 63 participants. Approximately 41% of the population was between ages 7 and 11, 44% was female, and 38% was receiving sodium oxybate at baseline. A preplanned interim analysis of 35 participants indicated that sodium oxybate was effective, based on the primary end point result. The double-blind, randomized-withdrawal period thus was terminated early.

For the total group of 63 randomized participants, weekly cataplexy attacks were significantly increased in the placebo group (median, 12.7/week), compared with the sodium-oxybate-treated group (median, 0.3/week). Cataplexy severity, assessed using the Clinical Global Impression of Change (CGI-C), was worse in the placebo group than in the sodium-oxybate group. For 65% of participants in the placebo group, cataplexy was rated “much worse” or “very much worse,” compared with 17% of the sodium-oxybate group. Excessive sleepiness, assessed using the Epworth Sleepiness Scale for Children and Adolescents, also was worse in the placebo group (median increase, 3.0 points) than in the sodium-oxybate group (no change). In addition, the CGI-C for narcolepsy overall was worse in the placebo group.

Treatment-emergent adverse events occurring in more than 10% of the overall sample were enuresis, nausea, vomiting, headache, and decreased weight. These adverse events had been reported in previous trials of sodium oxybate in adults with narcolepsy.

The study was sponsored by Jazz Pharmaceuticals.

LOS ANGELES—Sodium oxybate reduces cataplexy and excessive sleepiness in children with narcolepsy type 1, according to a study described at the 70th Annual Meeting of the American Academy of Neurology. The treatment’s safety profile in this population is similar to that in adults.

Although symptoms of narcolepsy often begin during childhood or adolescence, few studies have evaluated treatments for narcolepsy in pediatric patients. Sodium oxybate is approved for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy, but it had not previously been studied in a large pediatric narcolepsy trial. Chad Ruoff, MD, Clinical Assistant Professor of Psychiatry and Behavioral Sciences at the Stanford Center for Sleep Sciences and Medicine in California, and colleagues conducted a double-blind, placebo-controlled, randomized-withdrawal study to evaluate the efficacy and safety of sodium oxybate in pediatric patients with narcolepsy type 1.

A Randomized-Withdrawal Study

Eligible participants were children and adolescents between ages 7 and 16 who had been diagnosed with narcolepsy type 1 and had cataplexy. Patients who were on stable doses of sodium oxybate and patients who were sodium-oxybate-naïve were included. Patients with evidence of sleep-disordered breathing were excluded.

Sodium-oxybate-naïve participants were titrated to a stable dose. After a stable-dose period, all participants began a two-week, double-blind, placebo-controlled withdrawal period. The investigators randomized participants in equal groups to continue sodium oxybate or to be switched to placebo. At the end of the double-blind period, all participants received open-label sodium oxybate treatment. Efficacy assessments compared measurements during or at the end of the double-blind period with those taken the last two weeks of the stable-dose period. The study’s primary end point was change in weekly number of cataplexy attacks.

Study Was Terminated Early

Dr. Ruoff and colleagues randomized 63 participants. Approximately 41% of the population was between ages 7 and 11, 44% was female, and 38% was receiving sodium oxybate at baseline. A preplanned interim analysis of 35 participants indicated that sodium oxybate was effective, based on the primary end point result. The double-blind, randomized-withdrawal period thus was terminated early.

For the total group of 63 randomized participants, weekly cataplexy attacks were significantly increased in the placebo group (median, 12.7/week), compared with the sodium-oxybate-treated group (median, 0.3/week). Cataplexy severity, assessed using the Clinical Global Impression of Change (CGI-C), was worse in the placebo group than in the sodium-oxybate group. For 65% of participants in the placebo group, cataplexy was rated “much worse” or “very much worse,” compared with 17% of the sodium-oxybate group. Excessive sleepiness, assessed using the Epworth Sleepiness Scale for Children and Adolescents, also was worse in the placebo group (median increase, 3.0 points) than in the sodium-oxybate group (no change). In addition, the CGI-C for narcolepsy overall was worse in the placebo group.

Treatment-emergent adverse events occurring in more than 10% of the overall sample were enuresis, nausea, vomiting, headache, and decreased weight. These adverse events had been reported in previous trials of sodium oxybate in adults with narcolepsy.

The study was sponsored by Jazz Pharmaceuticals.

LOS ANGELES—Sodium oxybate reduces cataplexy and excessive sleepiness in children with narcolepsy type 1, according to a study described at the 70th Annual Meeting of the American Academy of Neurology. The treatment’s safety profile in this population is similar to that in adults.

Although symptoms of narcolepsy often begin during childhood or adolescence, few studies have evaluated treatments for narcolepsy in pediatric patients. Sodium oxybate is approved for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy, but it had not previously been studied in a large pediatric narcolepsy trial. Chad Ruoff, MD, Clinical Assistant Professor of Psychiatry and Behavioral Sciences at the Stanford Center for Sleep Sciences and Medicine in California, and colleagues conducted a double-blind, placebo-controlled, randomized-withdrawal study to evaluate the efficacy and safety of sodium oxybate in pediatric patients with narcolepsy type 1.

A Randomized-Withdrawal Study

Eligible participants were children and adolescents between ages 7 and 16 who had been diagnosed with narcolepsy type 1 and had cataplexy. Patients who were on stable doses of sodium oxybate and patients who were sodium-oxybate-naïve were included. Patients with evidence of sleep-disordered breathing were excluded.

Sodium-oxybate-naïve participants were titrated to a stable dose. After a stable-dose period, all participants began a two-week, double-blind, placebo-controlled withdrawal period. The investigators randomized participants in equal groups to continue sodium oxybate or to be switched to placebo. At the end of the double-blind period, all participants received open-label sodium oxybate treatment. Efficacy assessments compared measurements during or at the end of the double-blind period with those taken the last two weeks of the stable-dose period. The study’s primary end point was change in weekly number of cataplexy attacks.

Study Was Terminated Early

Dr. Ruoff and colleagues randomized 63 participants. Approximately 41% of the population was between ages 7 and 11, 44% was female, and 38% was receiving sodium oxybate at baseline. A preplanned interim analysis of 35 participants indicated that sodium oxybate was effective, based on the primary end point result. The double-blind, randomized-withdrawal period thus was terminated early.

For the total group of 63 randomized participants, weekly cataplexy attacks were significantly increased in the placebo group (median, 12.7/week), compared with the sodium-oxybate-treated group (median, 0.3/week). Cataplexy severity, assessed using the Clinical Global Impression of Change (CGI-C), was worse in the placebo group than in the sodium-oxybate group. For 65% of participants in the placebo group, cataplexy was rated “much worse” or “very much worse,” compared with 17% of the sodium-oxybate group. Excessive sleepiness, assessed using the Epworth Sleepiness Scale for Children and Adolescents, also was worse in the placebo group (median increase, 3.0 points) than in the sodium-oxybate group (no change). In addition, the CGI-C for narcolepsy overall was worse in the placebo group.

Treatment-emergent adverse events occurring in more than 10% of the overall sample were enuresis, nausea, vomiting, headache, and decreased weight. These adverse events had been reported in previous trials of sodium oxybate in adults with narcolepsy.

The study was sponsored by Jazz Pharmaceuticals.

After years of decline, the overall death rate has risen 12% over the last 3 years among children and adolescents aged 10-19 years, driven by an increase in deaths caused by injury, according to the National Center for Health Statistics.

Mortality in this age group, which had dropped nearly 33% from 1999 to 2013, climbed from 29.6 per 100,000 population aged 10-19 years in 2013 to 33.1 per 100,000 in 2016, the last year for which data are available. Meanwhile, deaths from injuries – unintentional injuries, suicides, homicides, and legal intervention – went from 19.8 per 100,000 to 23.3, an increase of almost 18%, from 2013 to 2016, and the noninjury death rate “was relatively stable,” Sally C. Curtin and her associates at the NCHS Division of Vital Statistics said in a National Vital Statistics Report.

The recent surge in injury deaths was more substantial in the older half of the age group. The mortality rate for children aged 10-14 years went from a low of 6.4 per 100,000 in 2012 to 7.1 in 2016, an increase of 11%, while the rate for those aged 15-19 rose 19% as it jumped from 32.8 per 100,000 in 2013 to 39.0 in 2016, the investigators wrote in the report.

The rate of unintentional injury deaths in 10- to 19-year-olds shows the same pattern as all deaths and injury deaths: Decline from 1999 to 2013 and then a rise for the last 3 years. That recent rise also can be seen in the most common form of unintentional injury deaths, motor vehicle traffic accidents, and in poisoning deaths, although that uptick began a year later. Homicide deaths declined by one-third from 2007 to 2014 and then increased, while suicide rates have been rising since 2007, the investigators said. Legal intervention deaths, defined as those caused by law enforcement actions, were not included because of relatively small annual numbers.

“Although progress was made in reducing injury deaths among children and adolescents aged 10-19 years during 1999-2013, the recent upturn shows that persistent as well as emerging challenges remain. … Further reductions will require renewed focus and effort,” Ms. Curtin and her associates wrote.

rfranki@mdedge.com

SOURCE: Curtin SC et al. Natl Vital Stat Rep. 2018 Jun;67(4):1-16.


 

After years of decline, the overall death rate has risen 12% over the last 3 years among children and adolescents aged 10-19 years, driven by an increase in deaths caused by injury, according to the National Center for Health Statistics.

Mortality in this age group, which had dropped nearly 33% from 1999 to 2013, climbed from 29.6 per 100,000 population aged 10-19 years in 2013 to 33.1 per 100,000 in 2016, the last year for which data are available. Meanwhile, deaths from injuries – unintentional injuries, suicides, homicides, and legal intervention – went from 19.8 per 100,000 to 23.3, an increase of almost 18%, from 2013 to 2016, and the noninjury death rate “was relatively stable,” Sally C. Curtin and her associates at the NCHS Division of Vital Statistics said in a National Vital Statistics Report.

The recent surge in injury deaths was more substantial in the older half of the age group. The mortality rate for children aged 10-14 years went from a low of 6.4 per 100,000 in 2012 to 7.1 in 2016, an increase of 11%, while the rate for those aged 15-19 rose 19% as it jumped from 32.8 per 100,000 in 2013 to 39.0 in 2016, the investigators wrote in the report.

The rate of unintentional injury deaths in 10- to 19-year-olds shows the same pattern as all deaths and injury deaths: Decline from 1999 to 2013 and then a rise for the last 3 years. That recent rise also can be seen in the most common form of unintentional injury deaths, motor vehicle traffic accidents, and in poisoning deaths, although that uptick began a year later. Homicide deaths declined by one-third from 2007 to 2014 and then increased, while suicide rates have been rising since 2007, the investigators said. Legal intervention deaths, defined as those caused by law enforcement actions, were not included because of relatively small annual numbers.

“Although progress was made in reducing injury deaths among children and adolescents aged 10-19 years during 1999-2013, the recent upturn shows that persistent as well as emerging challenges remain. … Further reductions will require renewed focus and effort,” Ms. Curtin and her associates wrote.

rfranki@mdedge.com

SOURCE: Curtin SC et al. Natl Vital Stat Rep. 2018 Jun;67(4):1-16.


 

After years of decline, the overall death rate has risen 12% over the last 3 years among children and adolescents aged 10-19 years, driven by an increase in deaths caused by injury, according to the National Center for Health Statistics.

Mortality in this age group, which had dropped nearly 33% from 1999 to 2013, climbed from 29.6 per 100,000 population aged 10-19 years in 2013 to 33.1 per 100,000 in 2016, the last year for which data are available. Meanwhile, deaths from injuries – unintentional injuries, suicides, homicides, and legal intervention – went from 19.8 per 100,000 to 23.3, an increase of almost 18%, from 2013 to 2016, and the noninjury death rate “was relatively stable,” Sally C. Curtin and her associates at the NCHS Division of Vital Statistics said in a National Vital Statistics Report.

The recent surge in injury deaths was more substantial in the older half of the age group. The mortality rate for children aged 10-14 years went from a low of 6.4 per 100,000 in 2012 to 7.1 in 2016, an increase of 11%, while the rate for those aged 15-19 rose 19% as it jumped from 32.8 per 100,000 in 2013 to 39.0 in 2016, the investigators wrote in the report.

The rate of unintentional injury deaths in 10- to 19-year-olds shows the same pattern as all deaths and injury deaths: Decline from 1999 to 2013 and then a rise for the last 3 years. That recent rise also can be seen in the most common form of unintentional injury deaths, motor vehicle traffic accidents, and in poisoning deaths, although that uptick began a year later. Homicide deaths declined by one-third from 2007 to 2014 and then increased, while suicide rates have been rising since 2007, the investigators said. Legal intervention deaths, defined as those caused by law enforcement actions, were not included because of relatively small annual numbers.

“Although progress was made in reducing injury deaths among children and adolescents aged 10-19 years during 1999-2013, the recent upturn shows that persistent as well as emerging challenges remain. … Further reductions will require renewed focus and effort,” Ms. Curtin and her associates wrote.

rfranki@mdedge.com

SOURCE: Curtin SC et al. Natl Vital Stat Rep. 2018 Jun;67(4):1-16.


 

CASE Attempted suicide?

Ms. S, a 16-year-old Yemeni-American girl, is brought to the emergency department (ED) by her mother and brother after ingesting an overdose of painkillers and fainting. During the initial evaluation, Ms. S says she had in the past attempted suicide by knife. The medical team suspects that the current overdose is a suicide attempt, and they call the consultation-liaison (C-L) psychiatry/psychology team. Ms. S’s brother strongly denies that his sister had previously attempted suicide, stating, “She’s from a good family, and she is smart. She cannot feel that way.” He also requests the name of the clinician who documented this information in the medical record.

During the consultation, Ms. S reports that the previous morning, she developed strong abdominal pain and discovered that she was menstruating for the first time. She explains that she did not understand what was happening to her and that no one had discussed menstruation with her before. Ms. S took her mother’s opioid pain medication. Ms. S reports she took one pill, but when it did not immediately alleviate her pain, she ingested several more. After this, Ms. S says she went to play with her siblings, but gradually became dizzy and confused, and informed her sister and mother of this. The family was fasting in observance of Ramadan, and as they walked toward the mosque, Ms. S fainted, which prompted her family to bring her to the ED.

During the C-L consultation, Ms. S’s brother, who speaks English, is present, as is her mother, who speaks only Arabic and thus needs a phone interpreter. As the C-L team asks Ms. S a question, it is translated to her mother, and then Ms. S’s response is also translated, and then finally, the mother shares her own response. At times, her brother provides translation. Ms. S speaks in English, but often asks for the translation of words or questions.

Ms. S reports that she and her family emigrated from Yemen to the United States 9 months ago. Ms. S says that she enjoys school and is doing well academically. She denies experiencing any anxiety, worry, or stress related to her life in Yemen, her move to a new country, her parents’ health, school, or other domains. Ms. S also denies any history of depressive episodes or previous suicidal ideation, intention, or attempt, which contradicts her endorsement of a previous suicide attempt to one clinician when she was initially evaluated.

[polldaddy:10040204]

Continue to: The authors' observation

 

 

The authors’ observation

The C-L team determined that Ms. S did not meet criteria for major depressive disorder. She did not endorse current feelings of depression and denied anhedonia and other associated symptoms included in DSM-5 criteria for major depressive disorder or adjustment disorder with depressed mood (Table 1¹). Ms. S also denied having a history of depressive episodes or previous suicidal ideation, intention, or attempt, despite having said during the initial evaluation that she had a previous suicide attempt.

Although Ms. S and her family recently emigrated from Yemen, she did not report any symptoms consistent with an adjustment disorder with depression. Further, because she denied having any anxiety, worry, or stress related to her life in Yemen, her move to the United States, her parents’ health, school, or any other domains, she did not meet criteria for posttraumatic stress disorder, acute stress disorder (Table 2¹), or an anxiety disorder. Similarly, there was no evidence of a substance use disorder.

Accurate case conceptualization and diagnosis is particularly crucial in C-L services, where there is an urgency for clinical decision-making after an initial evaluation without the luxury of amending conceptualization in follow-up sessions. Providing a diagnosis for which a patient does not fully or accurately meet the criteria can have deleterious effects. An inaccurate diagnosis for Ms. S would have unnecessarily added the perceived stigma of a mental disorder to her medical record. Additionally, misdiagnosing or pathologizing a natural process of acculturation could have led to inappropriate or even harmful treatment.

The C-L team evaluated alternative explanations for Ms. S’s statements that suggested she was suicidal. First, they considered her mental status at the time she presented to the ED. An overdose of opioids alters mental status. Complicating reversal of opioid overdose is that some opioids have longer half-lives than naloxone, an opioid antagonist, so the individual can become reintoxicated. Similarly, some opioids are more potent and difficult to reverse.² An altered mental status may have limited Ms. S’s ability to comprehend and answer questions accurately when she first presented to the ED.

Continue to: Cultural factors and the clinical evaluation

 

 

Cultural factors and the clinical evaluation

Next, the C-L team considered Ms. S’s clinical picture as it related to her cultural background. Cultural factors interact with the clinical evaluation in a complex manner, influencing the way patients approach the encounter, the symptoms they report, and the language they use to describe their experiences. While these variables are thoroughly evaluated during comprehensive psychological assessments, within the inpatient consultation service, the goal for pediatric C-L clinicians is to conduct a focused assessment to answer specific and critically important questions about a youth’s psychological functioning. Thus, the fundamental challenge of inpatient consultation is to answer the referral question in a brief period and in a culturally informed manner, to appraise the referring medical team about the relevant clinical and cultural issues, with the goal of ethical and clinically sound decision-making.

The C-L team considered key cultural factors in its assessment of Ms. S (Table 3¹). Several issues were of concern. First, language is often cited as the top barrier to health care access by Arab Americans, even by those with competency in English.³ Ms. S spoke English, but she often asked for the translation of words or questions, and her mother spoke only Arabic, and was assisted by a phone interpreter to communicate with the clinicians caring for her daughter. Conducting the interview with the phone interpreter added complexity to the interactions, interrupted the natural flow of the conversation, and was felt to hinder openness of disclosure.

Experts in culture argue that even with access to interpreters, many words and phrases lack direct translation, and their implicit meaning may be difficult to reveal. Additionally, at times more significance is placed on nonverbal cues and unspoken expectations.⁴ This can create barriers to communication with clinicians, especially in the context of an inpatient psychiatric consultation, when thorough understanding of an adolescent and family often needs to occur in a single encounter, and clinicians may not appreciate the subtle nuances of nonverbal communication.

The language barrier also may have influenced Ms. S’s initial endorsement of a previous suicide attempt by knife because the medical staff first interviewed Ms. S without an interpreter. For instance, many medical and psychosocial providers probe patients regarding suicidality with questions such as “Have you ever hurt yourself?” or “Have you ever tried to hurt yourself?” It is possible that in another language, an individual might interpret that question as, “Have you ever gotten hurt?” This interpretation completely alters the meaning of the question and eliminates intention or motivation to harm oneself. Language ambiguity and lack of shared cultural understanding may have influenced Ms. S’s interpretation of and response to such questions. Ms. S and her family were perplexed by the C-L team’s reference to the knife and continued to deny the incident.

Continue to: Cultural attitudes to puberty

Cultural attitudes to puberty

Cultures vary with respect to education of sensitive topics such as puberty. The medical providers assumed that Ms. S was informed about the onset of menses. Therefore, they could not consider the strong impact of such an event on an unsuspecting adolescent. Many adolescent girls in Yemen have poor health and lack menstruation-related knowledge, and many are “prescribed” medications by their mothers without contacting a physician.⁵ Ms. S reported to the C-L team that no one from her family had discussed menstruation with her. She reported that since arriving at the hospital, nurses had educated her about menstruation, and that she was no longer afraid. She also noted that if she experienced such pain again, she would go to the hospital or “just deal with it.”

Family identification and attitudes toward mental health

Ms. S’s strong identification with her family and attitudes toward mental health may have limited what she chose to disclose regarding her experiences of loss related to leaving her country of origin, adjustment, and acculturation to the new environment, as well as feelings of sadness. Family has a central and critical role in Arab cultures. Commitment to a family’s well-being and enhancement of honor and status is highly valued and encouraged.⁴ Conversely, being concerned with individual needs may be a source of guilt and feelings of betraying the family.⁶ Arab Americans tend not to discuss personal problems with people outside their extended family, including counselors and therapists, partly because of cultural stigma against mental illness^7,8 and partly because revealing family problems to strangers (ie, clinicians) may be considered a cultural taboo⁹ and a threat to family honor.¹⁰ Although Ms. S was interviewed privately when she first came to the ED and also during the psychiatric consultation, the stigma of psychiatric problems¹¹ and possible concerns about protecting her family’s name may have influenced her readiness to reveal intimate information to “strangers.”

Additionally, family statements that appeared to imply negative beliefs about mental health would have strongly deterred Ms. S from expressing any psychological concerns. For example, Ms. S’s brother took offense when the C-L team said it was evaluating his sister because she had said she had previously attempted suicide.

The tenets of Islam may have provided a framework through which Ms. S interprets emotional concerns and may have defined her explanatory models of psychological stress. For instance, it is not uncommon among American Muslims to view mental health problems as rising from “loss of faith in God,”⁹ and suicidal ideation may not be disclosed because suicide is forbidden in Islam.¹² Therefore, it might be particularly difficult to assess suicidal ideation in a patient who is Muslim, especially those who are less acculturated to Western culture.¹³

Continue to: Directly asking Ms. S...

Directly asking Ms. S if she had thoughts of harming herself may have been too frightening or guilt-provoking for an adolescent with her background. Asking about passive expression of suicidal ideation would have been more culturally appropriate. For example, asking, “Do you wish that God would let you die?”¹² may have elicited more meaningful clinical information about Ms. S’s emotional state and possibly suicide risk.

Furthermore, Ms. S’s identification of coping strategies (ie, “just deal with it”) may have sounded limited to a Western clinician, but this may have been consistent with cultural norms of emotional expression of limiting complaints.⁴ Also, among Arab Americans, psychiatric symptoms often are expressed through somatization.^7,14 Expressing psychological pain through physical symptoms appears protective against public stigma. Public image and opinion is important, and behaviors that would reflect well to others are dictated by the family. These attitudes, beliefs, and values likely impact how Ms. S presented her psychological concerns.

[polldaddy:10040206]

The authors’ observations

Although inpatient hospitalization was initially considered, it was not pursued due to denial of past and current suicidal ideation or suicide attempts, the lack of comorbidity, age-appropriate functioning, and a supportive family environment. Similarly, due to the absence of acute psychiatric symptoms, partial hospitalization was not pursued. The C-L team evaluated treatment options with extreme caution and sensitivity because recommending the wrong treatment option could have deleterious effects on Ms. S and her family’s life. If inpatient hospitalization had been pursued, it could have likely caused the family unnecessary suffering and could have negatively affected familial relationships. Strong feelings of shame, betrayal, and guilt would be intensified, impairing the family’s cohesion, removing environmental and family supports, and putting Ms. S at further risk of developing more severe symptoms of low mood.

Although there were significant concerns about making the wrong recommendation to the family, the C-L team’s highest priority was Ms. S’s safety. Despite cultural concerns, the team would have recommended hospitalization if Ms. S’s clinical picture had warranted this decision.

Continue to: OUTCOME Culturally-appropriate outpatient therapy

 

 

OUTCOME Culturally-appropriate outpatient therapy

Due to the lack of substantial evidence of apparent risk for self-harm, the presence of a supportive family, and Ms. S’s high academic performance and future orientation, the C-L team concludes that Ms. S’s concerns were most likely the result of the challenges of acculturation related to the language barrier and a lack of health knowledge. However, the C-L team remains cautious that Ms. S may have minimized or denied her mental health concerns due to various cultural factors. The team recommends that Ms. S seek outpatient psychotherapy from a clinician who specializes in working with Arab American individuals and families in their native language. The C-L team communicates these conclusions to the medical team verbally and in writing.

The authors’ observations

Cultural issues experienced during this consultation may not generalize to other Arab American adolescents and their families because there is diversity even within groups that share common cultural characteristics. Nevertheless, this case underscores the challenge of accurately assessing suicide risk, and making a differential diagnosis in the presence of complex cultural data and the dilemmas clinicians may encounter when attempting to answer important referral questions such as, “Is this adolescent suicidal and in need of psychiatric hospitalization?”

Bottom Line 

Cultural factors and attitudes toward mental health and language barriers may play a large role in how patients answer clinical questions. Cultural issues may add a level of intricacy not easily resolved within the restrictions of an inpatient setting, and this complexity may influence clinical judgment, recommendations, and possibly health outcomes. Culturally appropriate psychotherapy is key for patients experiencing difficulty with acculturation.

Related Resources

• Adam B. Caring for Muslim patients: Understanding cultural and religious factors. Current Psychiatry. 2017;16(12):56-57.
• Nassar-McMillan SC, Hakim-Larson J. Counseling considerations among Arab Americans. Journal of Counseling & Development. 2003;81(2):150-159.  
• Sue DW. Multidimensional facets of cultural competence. The Counseling Psychologist. 2001;29(6):790-821. 

Drug Brand Name

Naloxone • Narcan

CASE Attempted suicide?

Ms. S, a 16-year-old Yemeni-American girl, is brought to the emergency department (ED) by her mother and brother after ingesting an overdose of painkillers and fainting. During the initial evaluation, Ms. S says she had in the past attempted suicide by knife. The medical team suspects that the current overdose is a suicide attempt, and they call the consultation-liaison (C-L) psychiatry/psychology team. Ms. S’s brother strongly denies that his sister had previously attempted suicide, stating, “She’s from a good family, and she is smart. She cannot feel that way.” He also requests the name of the clinician who documented this information in the medical record.

During the consultation, Ms. S reports that the previous morning, she developed strong abdominal pain and discovered that she was menstruating for the first time. She explains that she did not understand what was happening to her and that no one had discussed menstruation with her before. Ms. S took her mother’s opioid pain medication. Ms. S reports she took one pill, but when it did not immediately alleviate her pain, she ingested several more. After this, Ms. S says she went to play with her siblings, but gradually became dizzy and confused, and informed her sister and mother of this. The family was fasting in observance of Ramadan, and as they walked toward the mosque, Ms. S fainted, which prompted her family to bring her to the ED.

During the C-L consultation, Ms. S’s brother, who speaks English, is present, as is her mother, who speaks only Arabic and thus needs a phone interpreter. As the C-L team asks Ms. S a question, it is translated to her mother, and then Ms. S’s response is also translated, and then finally, the mother shares her own response. At times, her brother provides translation. Ms. S speaks in English, but often asks for the translation of words or questions.

Ms. S reports that she and her family emigrated from Yemen to the United States 9 months ago. Ms. S says that she enjoys school and is doing well academically. She denies experiencing any anxiety, worry, or stress related to her life in Yemen, her move to a new country, her parents’ health, school, or other domains. Ms. S also denies any history of depressive episodes or previous suicidal ideation, intention, or attempt, which contradicts her endorsement of a previous suicide attempt to one clinician when she was initially evaluated.

[polldaddy:10040204]

Continue to: The authors' observation

 

 

The authors’ observation

The C-L team determined that Ms. S did not meet criteria for major depressive disorder. She did not endorse current feelings of depression and denied anhedonia and other associated symptoms included in DSM-5 criteria for major depressive disorder or adjustment disorder with depressed mood (Table 1¹). Ms. S also denied having a history of depressive episodes or previous suicidal ideation, intention, or attempt, despite having said during the initial evaluation that she had a previous suicide attempt.

Although Ms. S and her family recently emigrated from Yemen, she did not report any symptoms consistent with an adjustment disorder with depression. Further, because she denied having any anxiety, worry, or stress related to her life in Yemen, her move to the United States, her parents’ health, school, or any other domains, she did not meet criteria for posttraumatic stress disorder, acute stress disorder (Table 2¹), or an anxiety disorder. Similarly, there was no evidence of a substance use disorder.

Accurate case conceptualization and diagnosis is particularly crucial in C-L services, where there is an urgency for clinical decision-making after an initial evaluation without the luxury of amending conceptualization in follow-up sessions. Providing a diagnosis for which a patient does not fully or accurately meet the criteria can have deleterious effects. An inaccurate diagnosis for Ms. S would have unnecessarily added the perceived stigma of a mental disorder to her medical record. Additionally, misdiagnosing or pathologizing a natural process of acculturation could have led to inappropriate or even harmful treatment.

The C-L team evaluated alternative explanations for Ms. S’s statements that suggested she was suicidal. First, they considered her mental status at the time she presented to the ED. An overdose of opioids alters mental status. Complicating reversal of opioid overdose is that some opioids have longer half-lives than naloxone, an opioid antagonist, so the individual can become reintoxicated. Similarly, some opioids are more potent and difficult to reverse.² An altered mental status may have limited Ms. S’s ability to comprehend and answer questions accurately when she first presented to the ED.

Continue to: Cultural factors and the clinical evaluation

 

 

Cultural factors and the clinical evaluation

Next, the C-L team considered Ms. S’s clinical picture as it related to her cultural background. Cultural factors interact with the clinical evaluation in a complex manner, influencing the way patients approach the encounter, the symptoms they report, and the language they use to describe their experiences. While these variables are thoroughly evaluated during comprehensive psychological assessments, within the inpatient consultation service, the goal for pediatric C-L clinicians is to conduct a focused assessment to answer specific and critically important questions about a youth’s psychological functioning. Thus, the fundamental challenge of inpatient consultation is to answer the referral question in a brief period and in a culturally informed manner, to appraise the referring medical team about the relevant clinical and cultural issues, with the goal of ethical and clinically sound decision-making.

The C-L team considered key cultural factors in its assessment of Ms. S (Table 3¹). Several issues were of concern. First, language is often cited as the top barrier to health care access by Arab Americans, even by those with competency in English.³ Ms. S spoke English, but she often asked for the translation of words or questions, and her mother spoke only Arabic, and was assisted by a phone interpreter to communicate with the clinicians caring for her daughter. Conducting the interview with the phone interpreter added complexity to the interactions, interrupted the natural flow of the conversation, and was felt to hinder openness of disclosure.

Experts in culture argue that even with access to interpreters, many words and phrases lack direct translation, and their implicit meaning may be difficult to reveal. Additionally, at times more significance is placed on nonverbal cues and unspoken expectations.⁴ This can create barriers to communication with clinicians, especially in the context of an inpatient psychiatric consultation, when thorough understanding of an adolescent and family often needs to occur in a single encounter, and clinicians may not appreciate the subtle nuances of nonverbal communication.

The language barrier also may have influenced Ms. S’s initial endorsement of a previous suicide attempt by knife because the medical staff first interviewed Ms. S without an interpreter. For instance, many medical and psychosocial providers probe patients regarding suicidality with questions such as “Have you ever hurt yourself?” or “Have you ever tried to hurt yourself?” It is possible that in another language, an individual might interpret that question as, “Have you ever gotten hurt?” This interpretation completely alters the meaning of the question and eliminates intention or motivation to harm oneself. Language ambiguity and lack of shared cultural understanding may have influenced Ms. S’s interpretation of and response to such questions. Ms. S and her family were perplexed by the C-L team’s reference to the knife and continued to deny the incident.

Continue to: Cultural attitudes to puberty

Cultural attitudes to puberty

Cultures vary with respect to education of sensitive topics such as puberty. The medical providers assumed that Ms. S was informed about the onset of menses. Therefore, they could not consider the strong impact of such an event on an unsuspecting adolescent. Many adolescent girls in Yemen have poor health and lack menstruation-related knowledge, and many are “prescribed” medications by their mothers without contacting a physician.⁵ Ms. S reported to the C-L team that no one from her family had discussed menstruation with her. She reported that since arriving at the hospital, nurses had educated her about menstruation, and that she was no longer afraid. She also noted that if she experienced such pain again, she would go to the hospital or “just deal with it.”

Family identification and attitudes toward mental health

Ms. S’s strong identification with her family and attitudes toward mental health may have limited what she chose to disclose regarding her experiences of loss related to leaving her country of origin, adjustment, and acculturation to the new environment, as well as feelings of sadness. Family has a central and critical role in Arab cultures. Commitment to a family’s well-being and enhancement of honor and status is highly valued and encouraged.⁴ Conversely, being concerned with individual needs may be a source of guilt and feelings of betraying the family.⁶ Arab Americans tend not to discuss personal problems with people outside their extended family, including counselors and therapists, partly because of cultural stigma against mental illness^7,8 and partly because revealing family problems to strangers (ie, clinicians) may be considered a cultural taboo⁹ and a threat to family honor.¹⁰ Although Ms. S was interviewed privately when she first came to the ED and also during the psychiatric consultation, the stigma of psychiatric problems¹¹ and possible concerns about protecting her family’s name may have influenced her readiness to reveal intimate information to “strangers.”

Additionally, family statements that appeared to imply negative beliefs about mental health would have strongly deterred Ms. S from expressing any psychological concerns. For example, Ms. S’s brother took offense when the C-L team said it was evaluating his sister because she had said she had previously attempted suicide.

The tenets of Islam may have provided a framework through which Ms. S interprets emotional concerns and may have defined her explanatory models of psychological stress. For instance, it is not uncommon among American Muslims to view mental health problems as rising from “loss of faith in God,”⁹ and suicidal ideation may not be disclosed because suicide is forbidden in Islam.¹² Therefore, it might be particularly difficult to assess suicidal ideation in a patient who is Muslim, especially those who are less acculturated to Western culture.¹³

Continue to: Directly asking Ms. S...

Directly asking Ms. S if she had thoughts of harming herself may have been too frightening or guilt-provoking for an adolescent with her background. Asking about passive expression of suicidal ideation would have been more culturally appropriate. For example, asking, “Do you wish that God would let you die?”¹² may have elicited more meaningful clinical information about Ms. S’s emotional state and possibly suicide risk.

Furthermore, Ms. S’s identification of coping strategies (ie, “just deal with it”) may have sounded limited to a Western clinician, but this may have been consistent with cultural norms of emotional expression of limiting complaints.⁴ Also, among Arab Americans, psychiatric symptoms often are expressed through somatization.^7,14 Expressing psychological pain through physical symptoms appears protective against public stigma. Public image and opinion is important, and behaviors that would reflect well to others are dictated by the family. These attitudes, beliefs, and values likely impact how Ms. S presented her psychological concerns.

[polldaddy:10040206]

The authors’ observations

Although inpatient hospitalization was initially considered, it was not pursued due to denial of past and current suicidal ideation or suicide attempts, the lack of comorbidity, age-appropriate functioning, and a supportive family environment. Similarly, due to the absence of acute psychiatric symptoms, partial hospitalization was not pursued. The C-L team evaluated treatment options with extreme caution and sensitivity because recommending the wrong treatment option could have deleterious effects on Ms. S and her family’s life. If inpatient hospitalization had been pursued, it could have likely caused the family unnecessary suffering and could have negatively affected familial relationships. Strong feelings of shame, betrayal, and guilt would be intensified, impairing the family’s cohesion, removing environmental and family supports, and putting Ms. S at further risk of developing more severe symptoms of low mood.

Although there were significant concerns about making the wrong recommendation to the family, the C-L team’s highest priority was Ms. S’s safety. Despite cultural concerns, the team would have recommended hospitalization if Ms. S’s clinical picture had warranted this decision.

Continue to: OUTCOME Culturally-appropriate outpatient therapy

 

 

OUTCOME Culturally-appropriate outpatient therapy

Due to the lack of substantial evidence of apparent risk for self-harm, the presence of a supportive family, and Ms. S’s high academic performance and future orientation, the C-L team concludes that Ms. S’s concerns were most likely the result of the challenges of acculturation related to the language barrier and a lack of health knowledge. However, the C-L team remains cautious that Ms. S may have minimized or denied her mental health concerns due to various cultural factors. The team recommends that Ms. S seek outpatient psychotherapy from a clinician who specializes in working with Arab American individuals and families in their native language. The C-L team communicates these conclusions to the medical team verbally and in writing.

The authors’ observations

Cultural issues experienced during this consultation may not generalize to other Arab American adolescents and their families because there is diversity even within groups that share common cultural characteristics. Nevertheless, this case underscores the challenge of accurately assessing suicide risk, and making a differential diagnosis in the presence of complex cultural data and the dilemmas clinicians may encounter when attempting to answer important referral questions such as, “Is this adolescent suicidal and in need of psychiatric hospitalization?”

Bottom Line 

Cultural factors and attitudes toward mental health and language barriers may play a large role in how patients answer clinical questions. Cultural issues may add a level of intricacy not easily resolved within the restrictions of an inpatient setting, and this complexity may influence clinical judgment, recommendations, and possibly health outcomes. Culturally appropriate psychotherapy is key for patients experiencing difficulty with acculturation.

Related Resources

• Adam B. Caring for Muslim patients: Understanding cultural and religious factors. Current Psychiatry. 2017;16(12):56-57.
• Nassar-McMillan SC, Hakim-Larson J. Counseling considerations among Arab Americans. Journal of Counseling & Development. 2003;81(2):150-159.  
• Sue DW. Multidimensional facets of cultural competence. The Counseling Psychologist. 2001;29(6):790-821. 

Drug Brand Name

Naloxone • Narcan

CASE Attempted suicide?

Ms. S, a 16-year-old Yemeni-American girl, is brought to the emergency department (ED) by her mother and brother after ingesting an overdose of painkillers and fainting. During the initial evaluation, Ms. S says she had in the past attempted suicide by knife. The medical team suspects that the current overdose is a suicide attempt, and they call the consultation-liaison (C-L) psychiatry/psychology team. Ms. S’s brother strongly denies that his sister had previously attempted suicide, stating, “She’s from a good family, and she is smart. She cannot feel that way.” He also requests the name of the clinician who documented this information in the medical record.

During the consultation, Ms. S reports that the previous morning, she developed strong abdominal pain and discovered that she was menstruating for the first time. She explains that she did not understand what was happening to her and that no one had discussed menstruation with her before. Ms. S took her mother’s opioid pain medication. Ms. S reports she took one pill, but when it did not immediately alleviate her pain, she ingested several more. After this, Ms. S says she went to play with her siblings, but gradually became dizzy and confused, and informed her sister and mother of this. The family was fasting in observance of Ramadan, and as they walked toward the mosque, Ms. S fainted, which prompted her family to bring her to the ED.

During the C-L consultation, Ms. S’s brother, who speaks English, is present, as is her mother, who speaks only Arabic and thus needs a phone interpreter. As the C-L team asks Ms. S a question, it is translated to her mother, and then Ms. S’s response is also translated, and then finally, the mother shares her own response. At times, her brother provides translation. Ms. S speaks in English, but often asks for the translation of words or questions.

Ms. S reports that she and her family emigrated from Yemen to the United States 9 months ago. Ms. S says that she enjoys school and is doing well academically. She denies experiencing any anxiety, worry, or stress related to her life in Yemen, her move to a new country, her parents’ health, school, or other domains. Ms. S also denies any history of depressive episodes or previous suicidal ideation, intention, or attempt, which contradicts her endorsement of a previous suicide attempt to one clinician when she was initially evaluated.

[polldaddy:10040204]

Continue to: The authors' observation

 

 

The authors’ observation

The C-L team determined that Ms. S did not meet criteria for major depressive disorder. She did not endorse current feelings of depression and denied anhedonia and other associated symptoms included in DSM-5 criteria for major depressive disorder or adjustment disorder with depressed mood (Table 1¹). Ms. S also denied having a history of depressive episodes or previous suicidal ideation, intention, or attempt, despite having said during the initial evaluation that she had a previous suicide attempt.

Although Ms. S and her family recently emigrated from Yemen, she did not report any symptoms consistent with an adjustment disorder with depression. Further, because she denied having any anxiety, worry, or stress related to her life in Yemen, her move to the United States, her parents’ health, school, or any other domains, she did not meet criteria for posttraumatic stress disorder, acute stress disorder (Table 2¹), or an anxiety disorder. Similarly, there was no evidence of a substance use disorder.

Accurate case conceptualization and diagnosis is particularly crucial in C-L services, where there is an urgency for clinical decision-making after an initial evaluation without the luxury of amending conceptualization in follow-up sessions. Providing a diagnosis for which a patient does not fully or accurately meet the criteria can have deleterious effects. An inaccurate diagnosis for Ms. S would have unnecessarily added the perceived stigma of a mental disorder to her medical record. Additionally, misdiagnosing or pathologizing a natural process of acculturation could have led to inappropriate or even harmful treatment.

The C-L team evaluated alternative explanations for Ms. S’s statements that suggested she was suicidal. First, they considered her mental status at the time she presented to the ED. An overdose of opioids alters mental status. Complicating reversal of opioid overdose is that some opioids have longer half-lives than naloxone, an opioid antagonist, so the individual can become reintoxicated. Similarly, some opioids are more potent and difficult to reverse.² An altered mental status may have limited Ms. S’s ability to comprehend and answer questions accurately when she first presented to the ED.

Continue to: Cultural factors and the clinical evaluation

 

 

Cultural factors and the clinical evaluation

Next, the C-L team considered Ms. S’s clinical picture as it related to her cultural background. Cultural factors interact with the clinical evaluation in a complex manner, influencing the way patients approach the encounter, the symptoms they report, and the language they use to describe their experiences. While these variables are thoroughly evaluated during comprehensive psychological assessments, within the inpatient consultation service, the goal for pediatric C-L clinicians is to conduct a focused assessment to answer specific and critically important questions about a youth’s psychological functioning. Thus, the fundamental challenge of inpatient consultation is to answer the referral question in a brief period and in a culturally informed manner, to appraise the referring medical team about the relevant clinical and cultural issues, with the goal of ethical and clinically sound decision-making.

The C-L team considered key cultural factors in its assessment of Ms. S (Table 3¹). Several issues were of concern. First, language is often cited as the top barrier to health care access by Arab Americans, even by those with competency in English.³ Ms. S spoke English, but she often asked for the translation of words or questions, and her mother spoke only Arabic, and was assisted by a phone interpreter to communicate with the clinicians caring for her daughter. Conducting the interview with the phone interpreter added complexity to the interactions, interrupted the natural flow of the conversation, and was felt to hinder openness of disclosure.

Experts in culture argue that even with access to interpreters, many words and phrases lack direct translation, and their implicit meaning may be difficult to reveal. Additionally, at times more significance is placed on nonverbal cues and unspoken expectations.⁴ This can create barriers to communication with clinicians, especially in the context of an inpatient psychiatric consultation, when thorough understanding of an adolescent and family often needs to occur in a single encounter, and clinicians may not appreciate the subtle nuances of nonverbal communication.

The language barrier also may have influenced Ms. S’s initial endorsement of a previous suicide attempt by knife because the medical staff first interviewed Ms. S without an interpreter. For instance, many medical and psychosocial providers probe patients regarding suicidality with questions such as “Have you ever hurt yourself?” or “Have you ever tried to hurt yourself?” It is possible that in another language, an individual might interpret that question as, “Have you ever gotten hurt?” This interpretation completely alters the meaning of the question and eliminates intention or motivation to harm oneself. Language ambiguity and lack of shared cultural understanding may have influenced Ms. S’s interpretation of and response to such questions. Ms. S and her family were perplexed by the C-L team’s reference to the knife and continued to deny the incident.

Continue to: Cultural attitudes to puberty

Cultural attitudes to puberty

Cultures vary with respect to education of sensitive topics such as puberty. The medical providers assumed that Ms. S was informed about the onset of menses. Therefore, they could not consider the strong impact of such an event on an unsuspecting adolescent. Many adolescent girls in Yemen have poor health and lack menstruation-related knowledge, and many are “prescribed” medications by their mothers without contacting a physician.⁵ Ms. S reported to the C-L team that no one from her family had discussed menstruation with her. She reported that since arriving at the hospital, nurses had educated her about menstruation, and that she was no longer afraid. She also noted that if she experienced such pain again, she would go to the hospital or “just deal with it.”

Family identification and attitudes toward mental health

Ms. S’s strong identification with her family and attitudes toward mental health may have limited what she chose to disclose regarding her experiences of loss related to leaving her country of origin, adjustment, and acculturation to the new environment, as well as feelings of sadness. Family has a central and critical role in Arab cultures. Commitment to a family’s well-being and enhancement of honor and status is highly valued and encouraged.⁴ Conversely, being concerned with individual needs may be a source of guilt and feelings of betraying the family.⁶ Arab Americans tend not to discuss personal problems with people outside their extended family, including counselors and therapists, partly because of cultural stigma against mental illness^7,8 and partly because revealing family problems to strangers (ie, clinicians) may be considered a cultural taboo⁹ and a threat to family honor.¹⁰ Although Ms. S was interviewed privately when she first came to the ED and also during the psychiatric consultation, the stigma of psychiatric problems¹¹ and possible concerns about protecting her family’s name may have influenced her readiness to reveal intimate information to “strangers.”

Additionally, family statements that appeared to imply negative beliefs about mental health would have strongly deterred Ms. S from expressing any psychological concerns. For example, Ms. S’s brother took offense when the C-L team said it was evaluating his sister because she had said she had previously attempted suicide.

The tenets of Islam may have provided a framework through which Ms. S interprets emotional concerns and may have defined her explanatory models of psychological stress. For instance, it is not uncommon among American Muslims to view mental health problems as rising from “loss of faith in God,”⁹ and suicidal ideation may not be disclosed because suicide is forbidden in Islam.¹² Therefore, it might be particularly difficult to assess suicidal ideation in a patient who is Muslim, especially those who are less acculturated to Western culture.¹³

Continue to: Directly asking Ms. S...

Directly asking Ms. S if she had thoughts of harming herself may have been too frightening or guilt-provoking for an adolescent with her background. Asking about passive expression of suicidal ideation would have been more culturally appropriate. For example, asking, “Do you wish that God would let you die?”¹² may have elicited more meaningful clinical information about Ms. S’s emotional state and possibly suicide risk.

Furthermore, Ms. S’s identification of coping strategies (ie, “just deal with it”) may have sounded limited to a Western clinician, but this may have been consistent with cultural norms of emotional expression of limiting complaints.⁴ Also, among Arab Americans, psychiatric symptoms often are expressed through somatization.^7,14 Expressing psychological pain through physical symptoms appears protective against public stigma. Public image and opinion is important, and behaviors that would reflect well to others are dictated by the family. These attitudes, beliefs, and values likely impact how Ms. S presented her psychological concerns.

[polldaddy:10040206]

The authors’ observations

Although inpatient hospitalization was initially considered, it was not pursued due to denial of past and current suicidal ideation or suicide attempts, the lack of comorbidity, age-appropriate functioning, and a supportive family environment. Similarly, due to the absence of acute psychiatric symptoms, partial hospitalization was not pursued. The C-L team evaluated treatment options with extreme caution and sensitivity because recommending the wrong treatment option could have deleterious effects on Ms. S and her family’s life. If inpatient hospitalization had been pursued, it could have likely caused the family unnecessary suffering and could have negatively affected familial relationships. Strong feelings of shame, betrayal, and guilt would be intensified, impairing the family’s cohesion, removing environmental and family supports, and putting Ms. S at further risk of developing more severe symptoms of low mood.

Although there were significant concerns about making the wrong recommendation to the family, the C-L team’s highest priority was Ms. S’s safety. Despite cultural concerns, the team would have recommended hospitalization if Ms. S’s clinical picture had warranted this decision.

Continue to: OUTCOME Culturally-appropriate outpatient therapy

 

 

OUTCOME Culturally-appropriate outpatient therapy

Due to the lack of substantial evidence of apparent risk for self-harm, the presence of a supportive family, and Ms. S’s high academic performance and future orientation, the C-L team concludes that Ms. S’s concerns were most likely the result of the challenges of acculturation related to the language barrier and a lack of health knowledge. However, the C-L team remains cautious that Ms. S may have minimized or denied her mental health concerns due to various cultural factors. The team recommends that Ms. S seek outpatient psychotherapy from a clinician who specializes in working with Arab American individuals and families in their native language. The C-L team communicates these conclusions to the medical team verbally and in writing.

The authors’ observations

Cultural issues experienced during this consultation may not generalize to other Arab American adolescents and their families because there is diversity even within groups that share common cultural characteristics. Nevertheless, this case underscores the challenge of accurately assessing suicide risk, and making a differential diagnosis in the presence of complex cultural data and the dilemmas clinicians may encounter when attempting to answer important referral questions such as, “Is this adolescent suicidal and in need of psychiatric hospitalization?”

Bottom Line 

Cultural factors and attitudes toward mental health and language barriers may play a large role in how patients answer clinical questions. Cultural issues may add a level of intricacy not easily resolved within the restrictions of an inpatient setting, and this complexity may influence clinical judgment, recommendations, and possibly health outcomes. Culturally appropriate psychotherapy is key for patients experiencing difficulty with acculturation.

Related Resources

• Adam B. Caring for Muslim patients: Understanding cultural and religious factors. Current Psychiatry. 2017;16(12):56-57.
• Nassar-McMillan SC, Hakim-Larson J. Counseling considerations among Arab Americans. Journal of Counseling & Development. 2003;81(2):150-159.  
• Sue DW. Multidimensional facets of cultural competence. The Counseling Psychologist. 2001;29(6):790-821. 

Drug Brand Name

Naloxone • Narcan

EVIDENCE SUMMARY

A 2016 systematic review and meta-analysis of 3 RCTs that included 3200 women with late preterm labor (between 34 weeks 0 days and 36 weeks 6 days) found that women who were given betamethasone had a significantly lower incidence of transient tachypnea of the newborn (number needed to treat [NNT]=37; relative risk [RR]=0.72; 95% confidence interval [CI], 0.56-0.92), severe respiratory distress syndrome (NNT=114; RR=0.60; 95% CI, 0.33-0.94), and use of surfactant (NNT=92; RR=0.61; 95% CI, 0.38-0.99).¹

A composite outcome measure also favors betamethasone

In addition to these 3 outcomes, the largest RCT in the meta-analysis evaluated a composite outcome and found that betamethasone improved it by 20%. The RCT, comparing 1427 women in the experimental arm with 1400 controls, found benefit to administering 12 mg betamethasone intramuscularly every 24 hours for 2 days for women at high risk of late preterm delivery.² Enrollment criteria included women with 3 cm dilation or 75% effacement, preterm premature rupture of membranes, or a planned delivery scheduled in the late preterm period.

The primary outcome was a composite score based on one or more of the following within 72 hours after birth: continuous positive airway pressure or high-flow nasal cannula for at least 2 continuous hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 4 continuous hours, mechanical ventilation, stillbirth or neonatal death, or the need for extracorporeal circulation membrane oxygenation. The betamethasone group had 165 women (11.6%) with the primary outcome compared with 202 (14.4%) in the control arm (NNT=34; RR=0.80; 95% CI, 0.66–0.97; P<.02).

Neonatal hypoglycemia may increase, but not dangerously

The same RCT explored the risks of late preterm betamethasone. There was no increase in chorioamnionitis nor neonatal sepsis in the betamethasone group.² Although neonatal hypoglycemia increased (24% vs 15%; number needed to harm=11.1; RR=1.60; 95% CI, 1.37-1.87; P<.001), no increase was seen in intermediate care nursery or ICU stays (41.8% vs 44.9%; RR=0.93; 95% CI, 0.85-1.01; P=.09) nor length of hospital stay (7 vs 8 days; P=.20).

Three letters to the editor questioned whether hypoglycemia from late-term corticosteroids may lead to long-term neurocognitive delays.³ The authors responded that meta-analyses of RCTs haven’t found an association between antenatal steroid use and neurocognitive delay and that studies that have found an association between hypoglycemia and neurocognitive delay looked at profound and prolonged hypoglycemia, which wasn’t seen in the late preterm betamethasone study.

Continue to: RECOMMENDATIONS

 

 

RECOMMENDATIONS

Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have published recommendations supporting corticosteroids for threatened late preterm delivery with certain caveats.^4-6 Because of a lack of evidence, maternity care providers shouldn’t give corticosteroids for threatened late preterm delivery to women with multiple gestation, diabetes, previous exposure to steroids during pregnancy, or pregnancies with major nonlethal fetal malformations.^4-6 Evidence doesn’t support tocolysis when steroids are given in the late preterm period.^4,5

EVIDENCE SUMMARY

A 2016 systematic review and meta-analysis of 3 RCTs that included 3200 women with late preterm labor (between 34 weeks 0 days and 36 weeks 6 days) found that women who were given betamethasone had a significantly lower incidence of transient tachypnea of the newborn (number needed to treat [NNT]=37; relative risk [RR]=0.72; 95% confidence interval [CI], 0.56-0.92), severe respiratory distress syndrome (NNT=114; RR=0.60; 95% CI, 0.33-0.94), and use of surfactant (NNT=92; RR=0.61; 95% CI, 0.38-0.99).¹

A composite outcome measure also favors betamethasone

In addition to these 3 outcomes, the largest RCT in the meta-analysis evaluated a composite outcome and found that betamethasone improved it by 20%. The RCT, comparing 1427 women in the experimental arm with 1400 controls, found benefit to administering 12 mg betamethasone intramuscularly every 24 hours for 2 days for women at high risk of late preterm delivery.² Enrollment criteria included women with 3 cm dilation or 75% effacement, preterm premature rupture of membranes, or a planned delivery scheduled in the late preterm period.

The primary outcome was a composite score based on one or more of the following within 72 hours after birth: continuous positive airway pressure or high-flow nasal cannula for at least 2 continuous hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 4 continuous hours, mechanical ventilation, stillbirth or neonatal death, or the need for extracorporeal circulation membrane oxygenation. The betamethasone group had 165 women (11.6%) with the primary outcome compared with 202 (14.4%) in the control arm (NNT=34; RR=0.80; 95% CI, 0.66–0.97; P<.02).

Neonatal hypoglycemia may increase, but not dangerously

The same RCT explored the risks of late preterm betamethasone. There was no increase in chorioamnionitis nor neonatal sepsis in the betamethasone group.² Although neonatal hypoglycemia increased (24% vs 15%; number needed to harm=11.1; RR=1.60; 95% CI, 1.37-1.87; P<.001), no increase was seen in intermediate care nursery or ICU stays (41.8% vs 44.9%; RR=0.93; 95% CI, 0.85-1.01; P=.09) nor length of hospital stay (7 vs 8 days; P=.20).

Three letters to the editor questioned whether hypoglycemia from late-term corticosteroids may lead to long-term neurocognitive delays.³ The authors responded that meta-analyses of RCTs haven’t found an association between antenatal steroid use and neurocognitive delay and that studies that have found an association between hypoglycemia and neurocognitive delay looked at profound and prolonged hypoglycemia, which wasn’t seen in the late preterm betamethasone study.

Continue to: RECOMMENDATIONS

 

 

RECOMMENDATIONS

Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have published recommendations supporting corticosteroids for threatened late preterm delivery with certain caveats.^4-6 Because of a lack of evidence, maternity care providers shouldn’t give corticosteroids for threatened late preterm delivery to women with multiple gestation, diabetes, previous exposure to steroids during pregnancy, or pregnancies with major nonlethal fetal malformations.^4-6 Evidence doesn’t support tocolysis when steroids are given in the late preterm period.^4,5

EVIDENCE SUMMARY

A 2016 systematic review and meta-analysis of 3 RCTs that included 3200 women with late preterm labor (between 34 weeks 0 days and 36 weeks 6 days) found that women who were given betamethasone had a significantly lower incidence of transient tachypnea of the newborn (number needed to treat [NNT]=37; relative risk [RR]=0.72; 95% confidence interval [CI], 0.56-0.92), severe respiratory distress syndrome (NNT=114; RR=0.60; 95% CI, 0.33-0.94), and use of surfactant (NNT=92; RR=0.61; 95% CI, 0.38-0.99).¹

A composite outcome measure also favors betamethasone

In addition to these 3 outcomes, the largest RCT in the meta-analysis evaluated a composite outcome and found that betamethasone improved it by 20%. The RCT, comparing 1427 women in the experimental arm with 1400 controls, found benefit to administering 12 mg betamethasone intramuscularly every 24 hours for 2 days for women at high risk of late preterm delivery.² Enrollment criteria included women with 3 cm dilation or 75% effacement, preterm premature rupture of membranes, or a planned delivery scheduled in the late preterm period.

The primary outcome was a composite score based on one or more of the following within 72 hours after birth: continuous positive airway pressure or high-flow nasal cannula for at least 2 continuous hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 4 continuous hours, mechanical ventilation, stillbirth or neonatal death, or the need for extracorporeal circulation membrane oxygenation. The betamethasone group had 165 women (11.6%) with the primary outcome compared with 202 (14.4%) in the control arm (NNT=34; RR=0.80; 95% CI, 0.66–0.97; P<.02).

Neonatal hypoglycemia may increase, but not dangerously

The same RCT explored the risks of late preterm betamethasone. There was no increase in chorioamnionitis nor neonatal sepsis in the betamethasone group.² Although neonatal hypoglycemia increased (24% vs 15%; number needed to harm=11.1; RR=1.60; 95% CI, 1.37-1.87; P<.001), no increase was seen in intermediate care nursery or ICU stays (41.8% vs 44.9%; RR=0.93; 95% CI, 0.85-1.01; P=.09) nor length of hospital stay (7 vs 8 days; P=.20).

Three letters to the editor questioned whether hypoglycemia from late-term corticosteroids may lead to long-term neurocognitive delays.³ The authors responded that meta-analyses of RCTs haven’t found an association between antenatal steroid use and neurocognitive delay and that studies that have found an association between hypoglycemia and neurocognitive delay looked at profound and prolonged hypoglycemia, which wasn’t seen in the late preterm betamethasone study.

Continue to: RECOMMENDATIONS

 

 

RECOMMENDATIONS

Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have published recommendations supporting corticosteroids for threatened late preterm delivery with certain caveats.^4-6 Because of a lack of evidence, maternity care providers shouldn’t give corticosteroids for threatened late preterm delivery to women with multiple gestation, diabetes, previous exposure to steroids during pregnancy, or pregnancies with major nonlethal fetal malformations.^4-6 Evidence doesn’t support tocolysis when steroids are given in the late preterm period.^4,5

For children with Crohn’s disease, fecal calprotectin levels below 300 mcg indicated mucosal healing, while values below 100 mcg signified deep healing in a multicenter, 151-patient study.

Sensitivity was 80% for mucosal healing and 71% for deep healing, while specificities were 81% and 92%, respectively, said Inbar Nakar of the Hebrew University of Jerusalem, with her associates. In line with prior studies, adding C-reactive protein (CRP) to fecal calprotectin improved neither sensitivity or specificity, the researchers wrote in Clinical Gastroenterology and Hepatology.

Bowel healing is a crucial goal in Crohn’s disease (CD). Because pediatric transmural healing had not been studied, the researchers analyzed data from the ImageKids study, a multicenter effort to develop magnetic resonance enterography (MRE) measures for CD patients aged 6-18 years. Participants averaged 14 years old with a standard deviation of 2 years. Assessments included MRE, complete ileocolonoscopic evaluation, CRP, and fecal calprotectin. The researchers defined mucosal healing as a Simple Endoscopic Severity Index in Crohn’s Disease score below 3, transmural healing as an MRE visual analog score below 20 mm, and deep healing as transmural plus mucosal healing.

Nearly one-third of patients had healing only in the mucosa or the bowel wall, but not both; 6% had mucosal healing but transmural inflammation, and 25% of children had transmural healing but mucosal inflammation. In addition, 14% of children had deep healing, and 55% of children had both mucosal and transmural inflammation. Those findings highlight “the discrepancy between mucosal and transmural inflammation and the importance of evaluating the disease by both ileocolonoscopy and imaging,” the researchers wrote.

Median calprotectin levels varied significantly by healing status (P less than .001). They were lowest (10 mcg/g) for deep healing, followed by either transmural or mucosal inflammation, and were highest (median, 810 mcg/g) when children had both mucosal and transmural inflammation. Calprotectin in children with deep healing had an area under the receiver operating characteristic curve value of 0.93 (95% confidence interval, 0.89- 0.98). In contrast, CRP level identified children with deep healing with an AUROC value of only 0.81 (95% CI, 0.71-0.90).

Although “calprotectin level is driven primarily by mucosal healing, [it] is still superior to CRP,” the investigators concluded. “Although a calprotectin cutoff [less than] 300 mcg/g predicted mucosal healing, a lower cutoff of [less than] 100 mcg/g may be more suitable to predict deep healing.” However, they emphasized that fecal calprotectin level is only moderately accurate in predicting mucosal or transmural healing in children with CD. They advised physicians to “be familiar with the predictive values of each cutoff before incorporating them in clinical decision making.”

An educational grant from AbbVie funded the ImageKids study. AbbVie was not otherwise involved in the study. Two coinvestigators disclosed ties to AbbVie and other pharmaceutical companies. There were no other disclosures.

SOURCE: Nakar I et al. Clin Gastroenterol Hepatol. 2018 Mar 2. doi: 10.1016/j.cgh.2018.01.024.

For children with Crohn’s disease, fecal calprotectin levels below 300 mcg indicated mucosal healing, while values below 100 mcg signified deep healing in a multicenter, 151-patient study.

Sensitivity was 80% for mucosal healing and 71% for deep healing, while specificities were 81% and 92%, respectively, said Inbar Nakar of the Hebrew University of Jerusalem, with her associates. In line with prior studies, adding C-reactive protein (CRP) to fecal calprotectin improved neither sensitivity or specificity, the researchers wrote in Clinical Gastroenterology and Hepatology.

Bowel healing is a crucial goal in Crohn’s disease (CD). Because pediatric transmural healing had not been studied, the researchers analyzed data from the ImageKids study, a multicenter effort to develop magnetic resonance enterography (MRE) measures for CD patients aged 6-18 years. Participants averaged 14 years old with a standard deviation of 2 years. Assessments included MRE, complete ileocolonoscopic evaluation, CRP, and fecal calprotectin. The researchers defined mucosal healing as a Simple Endoscopic Severity Index in Crohn’s Disease score below 3, transmural healing as an MRE visual analog score below 20 mm, and deep healing as transmural plus mucosal healing.

Nearly one-third of patients had healing only in the mucosa or the bowel wall, but not both; 6% had mucosal healing but transmural inflammation, and 25% of children had transmural healing but mucosal inflammation. In addition, 14% of children had deep healing, and 55% of children had both mucosal and transmural inflammation. Those findings highlight “the discrepancy between mucosal and transmural inflammation and the importance of evaluating the disease by both ileocolonoscopy and imaging,” the researchers wrote.

Median calprotectin levels varied significantly by healing status (P less than .001). They were lowest (10 mcg/g) for deep healing, followed by either transmural or mucosal inflammation, and were highest (median, 810 mcg/g) when children had both mucosal and transmural inflammation. Calprotectin in children with deep healing had an area under the receiver operating characteristic curve value of 0.93 (95% confidence interval, 0.89- 0.98). In contrast, CRP level identified children with deep healing with an AUROC value of only 0.81 (95% CI, 0.71-0.90).

Although “calprotectin level is driven primarily by mucosal healing, [it] is still superior to CRP,” the investigators concluded. “Although a calprotectin cutoff [less than] 300 mcg/g predicted mucosal healing, a lower cutoff of [less than] 100 mcg/g may be more suitable to predict deep healing.” However, they emphasized that fecal calprotectin level is only moderately accurate in predicting mucosal or transmural healing in children with CD. They advised physicians to “be familiar with the predictive values of each cutoff before incorporating them in clinical decision making.”

An educational grant from AbbVie funded the ImageKids study. AbbVie was not otherwise involved in the study. Two coinvestigators disclosed ties to AbbVie and other pharmaceutical companies. There were no other disclosures.

SOURCE: Nakar I et al. Clin Gastroenterol Hepatol. 2018 Mar 2. doi: 10.1016/j.cgh.2018.01.024.

For children with Crohn’s disease, fecal calprotectin levels below 300 mcg indicated mucosal healing, while values below 100 mcg signified deep healing in a multicenter, 151-patient study.

Sensitivity was 80% for mucosal healing and 71% for deep healing, while specificities were 81% and 92%, respectively, said Inbar Nakar of the Hebrew University of Jerusalem, with her associates. In line with prior studies, adding C-reactive protein (CRP) to fecal calprotectin improved neither sensitivity or specificity, the researchers wrote in Clinical Gastroenterology and Hepatology.

Bowel healing is a crucial goal in Crohn’s disease (CD). Because pediatric transmural healing had not been studied, the researchers analyzed data from the ImageKids study, a multicenter effort to develop magnetic resonance enterography (MRE) measures for CD patients aged 6-18 years. Participants averaged 14 years old with a standard deviation of 2 years. Assessments included MRE, complete ileocolonoscopic evaluation, CRP, and fecal calprotectin. The researchers defined mucosal healing as a Simple Endoscopic Severity Index in Crohn’s Disease score below 3, transmural healing as an MRE visual analog score below 20 mm, and deep healing as transmural plus mucosal healing.

Nearly one-third of patients had healing only in the mucosa or the bowel wall, but not both; 6% had mucosal healing but transmural inflammation, and 25% of children had transmural healing but mucosal inflammation. In addition, 14% of children had deep healing, and 55% of children had both mucosal and transmural inflammation. Those findings highlight “the discrepancy between mucosal and transmural inflammation and the importance of evaluating the disease by both ileocolonoscopy and imaging,” the researchers wrote.

Median calprotectin levels varied significantly by healing status (P less than .001). They were lowest (10 mcg/g) for deep healing, followed by either transmural or mucosal inflammation, and were highest (median, 810 mcg/g) when children had both mucosal and transmural inflammation. Calprotectin in children with deep healing had an area under the receiver operating characteristic curve value of 0.93 (95% confidence interval, 0.89- 0.98). In contrast, CRP level identified children with deep healing with an AUROC value of only 0.81 (95% CI, 0.71-0.90).

Although “calprotectin level is driven primarily by mucosal healing, [it] is still superior to CRP,” the investigators concluded. “Although a calprotectin cutoff [less than] 300 mcg/g predicted mucosal healing, a lower cutoff of [less than] 100 mcg/g may be more suitable to predict deep healing.” However, they emphasized that fecal calprotectin level is only moderately accurate in predicting mucosal or transmural healing in children with CD. They advised physicians to “be familiar with the predictive values of each cutoff before incorporating them in clinical decision making.”

An educational grant from AbbVie funded the ImageKids study. AbbVie was not otherwise involved in the study. Two coinvestigators disclosed ties to AbbVie and other pharmaceutical companies. There were no other disclosures.

SOURCE: Nakar I et al. Clin Gastroenterol Hepatol. 2018 Mar 2. doi: 10.1016/j.cgh.2018.01.024.

AMSTERDAM – Rather than waiting for other drugs or immunotherapies to fail, an immediate up-front but time-limited course of an interleukin-1 receptor (IL-1R) antagonist induced rapid and sustained remissions in most children with systemic juvenile idiopathic arthritis (JIA), according to 5-year data presented at the European Congress of Rheumatology.

In the latest follow-up of a protocol first described in 2014, over 90% of patients still had inactive disease, 75% of whom were completely off therapy, reported Sebastiaan J. Vastert, MD, PhD, of the division of pediatrics at University Medical Center, Utrecht, the Netherlands.

AMSTERDAM – Rather than waiting for other drugs or immunotherapies to fail, an immediate up-front but time-limited course of an interleukin-1 receptor (IL-1R) antagonist induced rapid and sustained remissions in most children with systemic juvenile idiopathic arthritis (JIA), according to 5-year data presented at the European Congress of Rheumatology.

In the latest follow-up of a protocol first described in 2014, over 90% of patients still had inactive disease, 75% of whom were completely off therapy, reported Sebastiaan J. Vastert, MD, PhD, of the division of pediatrics at University Medical Center, Utrecht, the Netherlands.

AMSTERDAM – Rather than waiting for other drugs or immunotherapies to fail, an immediate up-front but time-limited course of an interleukin-1 receptor (IL-1R) antagonist induced rapid and sustained remissions in most children with systemic juvenile idiopathic arthritis (JIA), according to 5-year data presented at the European Congress of Rheumatology.

In the latest follow-up of a protocol first described in 2014, over 90% of patients still had inactive disease, 75% of whom were completely off therapy, reported Sebastiaan J. Vastert, MD, PhD, of the division of pediatrics at University Medical Center, Utrecht, the Netherlands.

The Food and Drug Administration has approved glycopyrronium tosylate, an anticholinergic for the topical treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older.

Glycopyrronium, which is formulated in a cloth wipe, will be marketed as Qbrexza and is expected to be available in October, according to the approval announcement June 29, which was made by Dermira, the manufacturer. The instructions for use section in the prescribing information states that patients are advised to use one cloth to apply the medication to both axillae, wiping the cloth across each underarm. Each cloth, intended for single use, is pre-moistened with 2.4% glycopyrronium solution.

Glycopyrronium blocks sweat production “by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation,” the company said in a February press release.

The approval was based on the results of two phase 3 clinical studies, ATMOS-1 and ATMOS-2, which were multicenter, randomized, double-blind, vehicle-controlled, 4-week studies in patients 9 years of age or older with primary axillary hyperhidrosis for 6 months or longer. Study subjects had production of at least 50 mg of underarm sweat over 5 minutes, and scores of four or higher on the 11-point Axillary Sweating Daily Diary (ASDD) or the Children’s ASDD (ASDD-C) – an instrument developed by the company in consultation with the FDA – and scores of three or four on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). In total, 463 patients were randomized to receive glycopyrronium and 234 to vehicle. Forty four of these patients were aged 9-16 years, with 25 receiving glycopyrronium and 19 receiving vehicle.

According to the February release, the ASDD/ASDD-C severity scale responder rates were about 60% in the pediatric and adult groups treated with glycopyrronium, compared with 13.0% and 28.8% for children and adults, respectively, in the vehicle group. At week 4, the median absolute change in sweat production was a reduction of 64.2 mg in children and a reduction of 80.6 mg among adults treated with glycopyrronium, compared with reductions of 53.7 mg and 62 mg among those in the vehicle group, respectively.

In the glycopyrronium-treated group, almost 80% of the pediatric patients and 74.3% of the adults experienced at least a 50% reduction in sweat production at week 4, compared with almost 55% and 53%, respectively, in the vehicle group.

Among pediatric patients, the mean decrease from baseline in the Children’s Dermatology Quality of Life Index was 8.1 in glycopyrronium-treated patients, compared with 1.9 in the vehicle group. In adults, scores on the Dermatology Life Quality Index measure were reduced by 8.4 and 4.7 in glycopyrronium- and vehicle-treated adult patients, respectively.

Nearly 57% of adults and 44% of pediatric patients treated with glycopyrronium experienced treatment-emergent adverse events, compared with 34.3% of adults and 10.5% of the pediatric patients in the vehicle group. The majority were related to anticholinergic activity and were mild, and rarely led to drug discontinuation, according to the company.

The press release announcing the approval stated that the most common adverse effects observed after application of glycopyrronium were dry mouth, mydriasis, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. Erythema, burning/stinging, and pruritus were the most common skin reactions.

The product is contraindicated in patients with glaucoma, paralytic ileus, and other medical conditions that can be exacerbated by its anticholinergic effects, according to the prescribing information. Patients should be advised that they should wash their hands thoroughly after application, and that it can cause temporary dilation of the pupils and blurred vision if glycopyrronium comes into contact with their eyes.

ilacy@mdedge.com

The Food and Drug Administration has approved glycopyrronium tosylate, an anticholinergic for the topical treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older.

Glycopyrronium, which is formulated in a cloth wipe, will be marketed as Qbrexza and is expected to be available in October, according to the approval announcement June 29, which was made by Dermira, the manufacturer. The instructions for use section in the prescribing information states that patients are advised to use one cloth to apply the medication to both axillae, wiping the cloth across each underarm. Each cloth, intended for single use, is pre-moistened with 2.4% glycopyrronium solution.

Glycopyrronium blocks sweat production “by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation,” the company said in a February press release.

The approval was based on the results of two phase 3 clinical studies, ATMOS-1 and ATMOS-2, which were multicenter, randomized, double-blind, vehicle-controlled, 4-week studies in patients 9 years of age or older with primary axillary hyperhidrosis for 6 months or longer. Study subjects had production of at least 50 mg of underarm sweat over 5 minutes, and scores of four or higher on the 11-point Axillary Sweating Daily Diary (ASDD) or the Children’s ASDD (ASDD-C) – an instrument developed by the company in consultation with the FDA – and scores of three or four on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). In total, 463 patients were randomized to receive glycopyrronium and 234 to vehicle. Forty four of these patients were aged 9-16 years, with 25 receiving glycopyrronium and 19 receiving vehicle.

According to the February release, the ASDD/ASDD-C severity scale responder rates were about 60% in the pediatric and adult groups treated with glycopyrronium, compared with 13.0% and 28.8% for children and adults, respectively, in the vehicle group. At week 4, the median absolute change in sweat production was a reduction of 64.2 mg in children and a reduction of 80.6 mg among adults treated with glycopyrronium, compared with reductions of 53.7 mg and 62 mg among those in the vehicle group, respectively.

In the glycopyrronium-treated group, almost 80% of the pediatric patients and 74.3% of the adults experienced at least a 50% reduction in sweat production at week 4, compared with almost 55% and 53%, respectively, in the vehicle group.

Among pediatric patients, the mean decrease from baseline in the Children’s Dermatology Quality of Life Index was 8.1 in glycopyrronium-treated patients, compared with 1.9 in the vehicle group. In adults, scores on the Dermatology Life Quality Index measure were reduced by 8.4 and 4.7 in glycopyrronium- and vehicle-treated adult patients, respectively.

Nearly 57% of adults and 44% of pediatric patients treated with glycopyrronium experienced treatment-emergent adverse events, compared with 34.3% of adults and 10.5% of the pediatric patients in the vehicle group. The majority were related to anticholinergic activity and were mild, and rarely led to drug discontinuation, according to the company.

The press release announcing the approval stated that the most common adverse effects observed after application of glycopyrronium were dry mouth, mydriasis, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. Erythema, burning/stinging, and pruritus were the most common skin reactions.

The product is contraindicated in patients with glaucoma, paralytic ileus, and other medical conditions that can be exacerbated by its anticholinergic effects, according to the prescribing information. Patients should be advised that they should wash their hands thoroughly after application, and that it can cause temporary dilation of the pupils and blurred vision if glycopyrronium comes into contact with their eyes.

ilacy@mdedge.com

The Food and Drug Administration has approved glycopyrronium tosylate, an anticholinergic for the topical treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older.

Glycopyrronium, which is formulated in a cloth wipe, will be marketed as Qbrexza and is expected to be available in October, according to the approval announcement June 29, which was made by Dermira, the manufacturer. The instructions for use section in the prescribing information states that patients are advised to use one cloth to apply the medication to both axillae, wiping the cloth across each underarm. Each cloth, intended for single use, is pre-moistened with 2.4% glycopyrronium solution.

Glycopyrronium blocks sweat production “by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation,” the company said in a February press release.

The approval was based on the results of two phase 3 clinical studies, ATMOS-1 and ATMOS-2, which were multicenter, randomized, double-blind, vehicle-controlled, 4-week studies in patients 9 years of age or older with primary axillary hyperhidrosis for 6 months or longer. Study subjects had production of at least 50 mg of underarm sweat over 5 minutes, and scores of four or higher on the 11-point Axillary Sweating Daily Diary (ASDD) or the Children’s ASDD (ASDD-C) – an instrument developed by the company in consultation with the FDA – and scores of three or four on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). In total, 463 patients were randomized to receive glycopyrronium and 234 to vehicle. Forty four of these patients were aged 9-16 years, with 25 receiving glycopyrronium and 19 receiving vehicle.

According to the February release, the ASDD/ASDD-C severity scale responder rates were about 60% in the pediatric and adult groups treated with glycopyrronium, compared with 13.0% and 28.8% for children and adults, respectively, in the vehicle group. At week 4, the median absolute change in sweat production was a reduction of 64.2 mg in children and a reduction of 80.6 mg among adults treated with glycopyrronium, compared with reductions of 53.7 mg and 62 mg among those in the vehicle group, respectively.

In the glycopyrronium-treated group, almost 80% of the pediatric patients and 74.3% of the adults experienced at least a 50% reduction in sweat production at week 4, compared with almost 55% and 53%, respectively, in the vehicle group.

Among pediatric patients, the mean decrease from baseline in the Children’s Dermatology Quality of Life Index was 8.1 in glycopyrronium-treated patients, compared with 1.9 in the vehicle group. In adults, scores on the Dermatology Life Quality Index measure were reduced by 8.4 and 4.7 in glycopyrronium- and vehicle-treated adult patients, respectively.

Nearly 57% of adults and 44% of pediatric patients treated with glycopyrronium experienced treatment-emergent adverse events, compared with 34.3% of adults and 10.5% of the pediatric patients in the vehicle group. The majority were related to anticholinergic activity and were mild, and rarely led to drug discontinuation, according to the company.

The press release announcing the approval stated that the most common adverse effects observed after application of glycopyrronium were dry mouth, mydriasis, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. Erythema, burning/stinging, and pruritus were the most common skin reactions.

The product is contraindicated in patients with glaucoma, paralytic ileus, and other medical conditions that can be exacerbated by its anticholinergic effects, according to the prescribing information. Patients should be advised that they should wash their hands thoroughly after application, and that it can cause temporary dilation of the pupils and blurred vision if glycopyrronium comes into contact with their eyes.

ilacy@mdedge.com