Heidi Splete

Direct-acting antiviral (DAA) therapy significantly reduced the risk of death in patients with hepatitis C infections and a history of hepatocellular carcinoma, based on data from 797 individuals.

Previous studies have reported a benefit of direct-acting antiviral (DAA) therapy for reducing mortality in patients with hepatocellular carcinoma (HCC), but data on its impact in patients with complete responses to HCC therapy are limited, wrote Amit G. Singal, MD, of the University of Texas, Dallas, and colleagues.

In a study published in Gastroenterology, the researchers identified adult HCC patients who achieved complete treatment response between January 2013 and December 2017. The study included patients from 31 locations in the United States and Canada. Complete response to treatment was defined as “disappearance of arterial enhancement from all HCC lesions on contrast-enhanced cross-sectional imaging.”

A total of 383 (48.1%) of patients were randomized to DAA therapy, and 414 (51.9%) did not receive DAA treatment for their HCV infection after complete response to prior HCC therapy.

A total of 43 deaths occurred among DAA patients over 941 person-years of follow-up, compared with 103 deaths over 527 person-years of follow-up for the untreated controls. Overall, DAA therapy was associated with a significantly reduced risk of death (hazard ratio, 0.54), compared with no therapy. Of note, patients with a sustained virologic response showed a reduced risk of death (HR, 0.29), but those without a sustained virologic response to DAA therapy did not (HR, 1.13).

The findings support those from previous studies suggesting that DAA therapy may reduce mortality in patients with a history of HCC, the researchers said.

The study findings were limited by several factors, including potential confounding if DAA was given to patients with better prognoses, the researchers noted. Other limitations include the use of imaging in routine clinical care rather than centralized review, the loss of approximately 9% of the patients to follow-up, and the lack of data on hepatic decompensation during follow-up, the researchers said. However, the results were strengthened by the multicenter design, large cohort, and inclusion of untreated controls, and support the use of DAA therapies as “likely beneficial in HCV-infected patients with a history of HCC,” they concluded.

The study was funded in part by the National Cancer Institute and AbbVie. Dr. Singal disclosed relationships with companies including AbbVie, Gilead, Bayer, Eisai, Wako Diagnostics, Exact Sciences, Exelixis, Roche, Glycotest, and Bristol-Myers Squibb.

SOURCE: Singal AG et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.07.040.

Direct-acting antiviral (DAA) therapy significantly reduced the risk of death in patients with hepatitis C infections and a history of hepatocellular carcinoma, based on data from 797 individuals.

Previous studies have reported a benefit of direct-acting antiviral (DAA) therapy for reducing mortality in patients with hepatocellular carcinoma (HCC), but data on its impact in patients with complete responses to HCC therapy are limited, wrote Amit G. Singal, MD, of the University of Texas, Dallas, and colleagues.

In a study published in Gastroenterology, the researchers identified adult HCC patients who achieved complete treatment response between January 2013 and December 2017. The study included patients from 31 locations in the United States and Canada. Complete response to treatment was defined as “disappearance of arterial enhancement from all HCC lesions on contrast-enhanced cross-sectional imaging.”

A total of 383 (48.1%) of patients were randomized to DAA therapy, and 414 (51.9%) did not receive DAA treatment for their HCV infection after complete response to prior HCC therapy.

A total of 43 deaths occurred among DAA patients over 941 person-years of follow-up, compared with 103 deaths over 527 person-years of follow-up for the untreated controls. Overall, DAA therapy was associated with a significantly reduced risk of death (hazard ratio, 0.54), compared with no therapy. Of note, patients with a sustained virologic response showed a reduced risk of death (HR, 0.29), but those without a sustained virologic response to DAA therapy did not (HR, 1.13).

The findings support those from previous studies suggesting that DAA therapy may reduce mortality in patients with a history of HCC, the researchers said.

The study findings were limited by several factors, including potential confounding if DAA was given to patients with better prognoses, the researchers noted. Other limitations include the use of imaging in routine clinical care rather than centralized review, the loss of approximately 9% of the patients to follow-up, and the lack of data on hepatic decompensation during follow-up, the researchers said. However, the results were strengthened by the multicenter design, large cohort, and inclusion of untreated controls, and support the use of DAA therapies as “likely beneficial in HCV-infected patients with a history of HCC,” they concluded.

The study was funded in part by the National Cancer Institute and AbbVie. Dr. Singal disclosed relationships with companies including AbbVie, Gilead, Bayer, Eisai, Wako Diagnostics, Exact Sciences, Exelixis, Roche, Glycotest, and Bristol-Myers Squibb.

SOURCE: Singal AG et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.07.040.

Direct-acting antiviral (DAA) therapy significantly reduced the risk of death in patients with hepatitis C infections and a history of hepatocellular carcinoma, based on data from 797 individuals.

Previous studies have reported a benefit of direct-acting antiviral (DAA) therapy for reducing mortality in patients with hepatocellular carcinoma (HCC), but data on its impact in patients with complete responses to HCC therapy are limited, wrote Amit G. Singal, MD, of the University of Texas, Dallas, and colleagues.

In a study published in Gastroenterology, the researchers identified adult HCC patients who achieved complete treatment response between January 2013 and December 2017. The study included patients from 31 locations in the United States and Canada. Complete response to treatment was defined as “disappearance of arterial enhancement from all HCC lesions on contrast-enhanced cross-sectional imaging.”

A total of 383 (48.1%) of patients were randomized to DAA therapy, and 414 (51.9%) did not receive DAA treatment for their HCV infection after complete response to prior HCC therapy.

A total of 43 deaths occurred among DAA patients over 941 person-years of follow-up, compared with 103 deaths over 527 person-years of follow-up for the untreated controls. Overall, DAA therapy was associated with a significantly reduced risk of death (hazard ratio, 0.54), compared with no therapy. Of note, patients with a sustained virologic response showed a reduced risk of death (HR, 0.29), but those without a sustained virologic response to DAA therapy did not (HR, 1.13).

The findings support those from previous studies suggesting that DAA therapy may reduce mortality in patients with a history of HCC, the researchers said.

The study findings were limited by several factors, including potential confounding if DAA was given to patients with better prognoses, the researchers noted. Other limitations include the use of imaging in routine clinical care rather than centralized review, the loss of approximately 9% of the patients to follow-up, and the lack of data on hepatic decompensation during follow-up, the researchers said. However, the results were strengthened by the multicenter design, large cohort, and inclusion of untreated controls, and support the use of DAA therapies as “likely beneficial in HCV-infected patients with a history of HCC,” they concluded.

The study was funded in part by the National Cancer Institute and AbbVie. Dr. Singal disclosed relationships with companies including AbbVie, Gilead, Bayer, Eisai, Wako Diagnostics, Exact Sciences, Exelixis, Roche, Glycotest, and Bristol-Myers Squibb.

SOURCE: Singal AG et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.07.040.

Women with early breast cancer and a high genetic risk for recurrence at a distant site achieved greater freedom from recurrence when treated with chemoendocrine therapy than with endocrine therapy alone in a study of 1,389 women with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer.

“The 21-gene recurrence score (RS) assay provides prognostic information for distant recurrence in hormone-receptor–positive, ERBB2-negative early breast cancer that is independent of clinicopathologic features and is also predictive of chemotherapy benefit when the RS is high,” wrote Joseph A. Sparano, MD, of Montefiore Medical Center, New York, and his colleagues. However, little is known about how this risk score applies to women with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer, they said.

In the study published in JAMA Oncology, they identified 1,389 women with a recurrence score of 26-100 (the definition of a high recurrence risk). The average age of the patients was 56 years, and 71% were postmenopausal.

In addition to receiving endocrine therapy, the women were randomized to no chemotherapy (89 patients) or one of several chemotherapy regimens including docetaxel/cyclophosphamide (589 patients), anthracycline without a taxane (334 patients), an anthracycline and taxane (244 patients), cyclophosphamide/methotrexate/5-fluorouracil (52 patients), and other regimens (81 patients). Among those treated with chemotherapy, overall survival (OS) at 5 years was 96% and estimated rates of freedom from recurrence of breast cancer at a distant site, and from a distant and/or local regional site, at 5 years were 93% and 91%, respectively. At 5 years, the estimated rate of invasive disease–free survival (IDFS) was 88%.

When broken down by chemotherapy regimen, 5-year rates of freedom from recurrence of breast cancer at a distant site ranged from 92.3% to 95.5%, except for 88.5% for the cyclophosphamide/methotrexate/5-fluorouracil (CMF) group; the rate was 92.6% for patients in the no-chemotherapy group.

The 5-year rates of IDFS ranged from 84% to 91.3% in the chemotherapy groups, compared with 79.7% in the no-chemotherapy group.

The expected rates of distant recurrence in the overall patient population if treated with endocrine therapy alone was 78.8% at 5 years and 65.4% at 9 years, the researchers said. Rates among the patients with an RS of 26-30 if treated with endocrine therapy alone were 89.6% at 5 years and 80.6% at 9 years; rates for those with an RS of 31-100 were 70.7% and 54% for 5 and 9 years, respectively.

The study findings were limited by several factors including a lack of randomization to endocrine therapy alone and the relatively short follow-up period, the researchers noted. However, strengths include the large sample size and high rate of compliance with chemotherapy.

The results support data from previous studies and “add to the evidence base supporting the use of the 21-gene RS assay to guide the use of adjuvant chemotherapy in patients with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer,” they concluded.

The study was supported in part by the National Cancer Institute, the Canadian Cancer Society Research Institute, the Breast Cancer Research Foundation, the Komen Foundation, and the Breast Cancer Research Stamp issued by the United States Postal Service. Dr. Sparano disclosed grants from the National Cancer Institute. Of the remaining authors, several disclosed receiving personal or speaker fees from the assay manufacturer, Genomic Health; one author received funding from the company during the study.

SOURCE: Sparano J et al. JAMA Oncol. 2019 Sep 30. doi: 10.1001/jamaoncol.2019.4794.

Women with early breast cancer and a high genetic risk for recurrence at a distant site achieved greater freedom from recurrence when treated with chemoendocrine therapy than with endocrine therapy alone in a study of 1,389 women with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer.

“The 21-gene recurrence score (RS) assay provides prognostic information for distant recurrence in hormone-receptor–positive, ERBB2-negative early breast cancer that is independent of clinicopathologic features and is also predictive of chemotherapy benefit when the RS is high,” wrote Joseph A. Sparano, MD, of Montefiore Medical Center, New York, and his colleagues. However, little is known about how this risk score applies to women with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer, they said.

In the study published in JAMA Oncology, they identified 1,389 women with a recurrence score of 26-100 (the definition of a high recurrence risk). The average age of the patients was 56 years, and 71% were postmenopausal.

In addition to receiving endocrine therapy, the women were randomized to no chemotherapy (89 patients) or one of several chemotherapy regimens including docetaxel/cyclophosphamide (589 patients), anthracycline without a taxane (334 patients), an anthracycline and taxane (244 patients), cyclophosphamide/methotrexate/5-fluorouracil (52 patients), and other regimens (81 patients). Among those treated with chemotherapy, overall survival (OS) at 5 years was 96% and estimated rates of freedom from recurrence of breast cancer at a distant site, and from a distant and/or local regional site, at 5 years were 93% and 91%, respectively. At 5 years, the estimated rate of invasive disease–free survival (IDFS) was 88%.

When broken down by chemotherapy regimen, 5-year rates of freedom from recurrence of breast cancer at a distant site ranged from 92.3% to 95.5%, except for 88.5% for the cyclophosphamide/methotrexate/5-fluorouracil (CMF) group; the rate was 92.6% for patients in the no-chemotherapy group.

The 5-year rates of IDFS ranged from 84% to 91.3% in the chemotherapy groups, compared with 79.7% in the no-chemotherapy group.

The expected rates of distant recurrence in the overall patient population if treated with endocrine therapy alone was 78.8% at 5 years and 65.4% at 9 years, the researchers said. Rates among the patients with an RS of 26-30 if treated with endocrine therapy alone were 89.6% at 5 years and 80.6% at 9 years; rates for those with an RS of 31-100 were 70.7% and 54% for 5 and 9 years, respectively.

The study findings were limited by several factors including a lack of randomization to endocrine therapy alone and the relatively short follow-up period, the researchers noted. However, strengths include the large sample size and high rate of compliance with chemotherapy.

The results support data from previous studies and “add to the evidence base supporting the use of the 21-gene RS assay to guide the use of adjuvant chemotherapy in patients with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer,” they concluded.

The study was supported in part by the National Cancer Institute, the Canadian Cancer Society Research Institute, the Breast Cancer Research Foundation, the Komen Foundation, and the Breast Cancer Research Stamp issued by the United States Postal Service. Dr. Sparano disclosed grants from the National Cancer Institute. Of the remaining authors, several disclosed receiving personal or speaker fees from the assay manufacturer, Genomic Health; one author received funding from the company during the study.

SOURCE: Sparano J et al. JAMA Oncol. 2019 Sep 30. doi: 10.1001/jamaoncol.2019.4794.

Women with early breast cancer and a high genetic risk for recurrence at a distant site achieved greater freedom from recurrence when treated with chemoendocrine therapy than with endocrine therapy alone in a study of 1,389 women with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer.

“The 21-gene recurrence score (RS) assay provides prognostic information for distant recurrence in hormone-receptor–positive, ERBB2-negative early breast cancer that is independent of clinicopathologic features and is also predictive of chemotherapy benefit when the RS is high,” wrote Joseph A. Sparano, MD, of Montefiore Medical Center, New York, and his colleagues. However, little is known about how this risk score applies to women with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer, they said.

In the study published in JAMA Oncology, they identified 1,389 women with a recurrence score of 26-100 (the definition of a high recurrence risk). The average age of the patients was 56 years, and 71% were postmenopausal.

In addition to receiving endocrine therapy, the women were randomized to no chemotherapy (89 patients) or one of several chemotherapy regimens including docetaxel/cyclophosphamide (589 patients), anthracycline without a taxane (334 patients), an anthracycline and taxane (244 patients), cyclophosphamide/methotrexate/5-fluorouracil (52 patients), and other regimens (81 patients). Among those treated with chemotherapy, overall survival (OS) at 5 years was 96% and estimated rates of freedom from recurrence of breast cancer at a distant site, and from a distant and/or local regional site, at 5 years were 93% and 91%, respectively. At 5 years, the estimated rate of invasive disease–free survival (IDFS) was 88%.

When broken down by chemotherapy regimen, 5-year rates of freedom from recurrence of breast cancer at a distant site ranged from 92.3% to 95.5%, except for 88.5% for the cyclophosphamide/methotrexate/5-fluorouracil (CMF) group; the rate was 92.6% for patients in the no-chemotherapy group.

The 5-year rates of IDFS ranged from 84% to 91.3% in the chemotherapy groups, compared with 79.7% in the no-chemotherapy group.

The expected rates of distant recurrence in the overall patient population if treated with endocrine therapy alone was 78.8% at 5 years and 65.4% at 9 years, the researchers said. Rates among the patients with an RS of 26-30 if treated with endocrine therapy alone were 89.6% at 5 years and 80.6% at 9 years; rates for those with an RS of 31-100 were 70.7% and 54% for 5 and 9 years, respectively.

The study findings were limited by several factors including a lack of randomization to endocrine therapy alone and the relatively short follow-up period, the researchers noted. However, strengths include the large sample size and high rate of compliance with chemotherapy.

The results support data from previous studies and “add to the evidence base supporting the use of the 21-gene RS assay to guide the use of adjuvant chemotherapy in patients with hormone receptor–positive, ERBB2-negative, axillary node–negative breast cancer,” they concluded.

The study was supported in part by the National Cancer Institute, the Canadian Cancer Society Research Institute, the Breast Cancer Research Foundation, the Komen Foundation, and the Breast Cancer Research Stamp issued by the United States Postal Service. Dr. Sparano disclosed grants from the National Cancer Institute. Of the remaining authors, several disclosed receiving personal or speaker fees from the assay manufacturer, Genomic Health; one author received funding from the company during the study.

SOURCE: Sparano J et al. JAMA Oncol. 2019 Sep 30. doi: 10.1001/jamaoncol.2019.4794.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Almost half of black children with poorly controlled asthma showed a superior response to increased inhaled glucocorticoids over long-acting beta-agonists, based on data from 280 children aged 5-11 years with at least one grandparent identified as black.

Previous studies have suggested that long-acting beta₂-agonists (LABAs) may be more effective for patients with poorly controlled asthma, but such step-up therapy has not been well studied in black patients, wrote Michael E. Wechsler, MD, of National Jewish Health, Denver, and colleagues.

In a study published in the New England Journal of Medicine, the researchers reported results of two parallel BARD (Best African American Response to Asthma Drugs) trials conducted at nine centers between January 2014 and March 2016 of individuals with poorly controlled asthma. One trial included 280 children aged 5-11 years (average age, 8.5 years); the second trial included adolescents aged 12 years and older and adults (average age, 37 years) who had family backgrounds that were similar to those of the children.

The researchers randomized the children to four groups to compare the following protocols: doubling the dose of a glucocorticoid (fluticasone propionate) to a dose of 100 mcg, twice daily (the double-fluticasone group); doubling the dose of fluticasone to 100 mcg and adding 50 mcg of the LABA salmeterol (the salmeterol/double-fluticasone group); quintupling the dose of fluticasone to 250 mcg (the quintuple-fluticasone group); or quintupling the dose of fluticasone to 250 mcg and adding 50 mcg of salmeterol (the salmeterol/quintuple-fluticasone group). The trial consisted of a four-way crossover design with each treatment period lasting 14 weeks.

The primary outcome was a composite measure including asthma exacerbations, asthma control days, and percentage of predicted forced expiratory volume in the first second at the end of each treatment.

Overall, a superior response occurred in 53% of the salmeterol/double-fluticasone group, 41% of the double-fluticasone group, 43% of the salmeterol/quintuple fluticasone group, and 47% of the quintuple-fluticasone group.

The superior response was 46% for both groups when the researchers compared a quintupled dose of fluticasone propionate (250 mcg) with a two step–up strategy of adding salmeterol at a dose of 50 mcg and increasing the dose of fluticasone to 100 mcg.

“In contrast to black adults and white persons of all ages, almost half the children who had at least one grandparent who identified as black and who had poorly controlled asthma had a superior response to an increased dose of an inhaled glucocorticoid over the addition of a LABA,” Dr. Wechsler and coauthors wrote. No more than 12% of the children in any treatment group did not have a superior response. No significant differences in reports of respiratory tract infections or pneumonia were seen between the groups. Children younger than 8 years showed a decrease in the ratio of urinary cortisol to creatinine with an increased dose of inhaled glucocorticoids.

In the adolescent and adult study using the same treatment protocols, 20%-25% of patients did not have a differential outcome between treatments. “In adolescents and adults, the addition of a LABA was more likely to produce superior responses than increasing the dose of an inhaled glucocorticoid,” Dr. Wechsler and coauthors wrote.

The study findings were limited by several factors, including the inability to assess long-term effects on growth and inability to detect biomarkers associated with responses to specific therapies, the researchers noted. However, the results suggest that black children with poorly controlled asthma can benefit from additional inhaled glucocorticoids, and larger studies are needed to identify the best treatment for this patient population.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Wechsler reported relationships with companies including AstraZeneca, Equillium, Genentech, GlaxoSmithKline, Mylan, Novartis, Regeneron, resTORbio, Sanofi, and others. Coauthors identified relationships with numerous pharmaceutical companies.

SOURCE: Wechsler ME et al. N Engl J Med. 2019 Sep 25. doi: 10.1056/NEJMoa1905560.

Almost half of black children with poorly controlled asthma showed a superior response to increased inhaled glucocorticoids over long-acting beta-agonists, based on data from 280 children aged 5-11 years with at least one grandparent identified as black.

Previous studies have suggested that long-acting beta₂-agonists (LABAs) may be more effective for patients with poorly controlled asthma, but such step-up therapy has not been well studied in black patients, wrote Michael E. Wechsler, MD, of National Jewish Health, Denver, and colleagues.

In a study published in the New England Journal of Medicine, the researchers reported results of two parallel BARD (Best African American Response to Asthma Drugs) trials conducted at nine centers between January 2014 and March 2016 of individuals with poorly controlled asthma. One trial included 280 children aged 5-11 years (average age, 8.5 years); the second trial included adolescents aged 12 years and older and adults (average age, 37 years) who had family backgrounds that were similar to those of the children.

The researchers randomized the children to four groups to compare the following protocols: doubling the dose of a glucocorticoid (fluticasone propionate) to a dose of 100 mcg, twice daily (the double-fluticasone group); doubling the dose of fluticasone to 100 mcg and adding 50 mcg of the LABA salmeterol (the salmeterol/double-fluticasone group); quintupling the dose of fluticasone to 250 mcg (the quintuple-fluticasone group); or quintupling the dose of fluticasone to 250 mcg and adding 50 mcg of salmeterol (the salmeterol/quintuple-fluticasone group). The trial consisted of a four-way crossover design with each treatment period lasting 14 weeks.

The primary outcome was a composite measure including asthma exacerbations, asthma control days, and percentage of predicted forced expiratory volume in the first second at the end of each treatment.

Overall, a superior response occurred in 53% of the salmeterol/double-fluticasone group, 41% of the double-fluticasone group, 43% of the salmeterol/quintuple fluticasone group, and 47% of the quintuple-fluticasone group.

The superior response was 46% for both groups when the researchers compared a quintupled dose of fluticasone propionate (250 mcg) with a two step–up strategy of adding salmeterol at a dose of 50 mcg and increasing the dose of fluticasone to 100 mcg.

“In contrast to black adults and white persons of all ages, almost half the children who had at least one grandparent who identified as black and who had poorly controlled asthma had a superior response to an increased dose of an inhaled glucocorticoid over the addition of a LABA,” Dr. Wechsler and coauthors wrote. No more than 12% of the children in any treatment group did not have a superior response. No significant differences in reports of respiratory tract infections or pneumonia were seen between the groups. Children younger than 8 years showed a decrease in the ratio of urinary cortisol to creatinine with an increased dose of inhaled glucocorticoids.

In the adolescent and adult study using the same treatment protocols, 20%-25% of patients did not have a differential outcome between treatments. “In adolescents and adults, the addition of a LABA was more likely to produce superior responses than increasing the dose of an inhaled glucocorticoid,” Dr. Wechsler and coauthors wrote.

The study findings were limited by several factors, including the inability to assess long-term effects on growth and inability to detect biomarkers associated with responses to specific therapies, the researchers noted. However, the results suggest that black children with poorly controlled asthma can benefit from additional inhaled glucocorticoids, and larger studies are needed to identify the best treatment for this patient population.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Wechsler reported relationships with companies including AstraZeneca, Equillium, Genentech, GlaxoSmithKline, Mylan, Novartis, Regeneron, resTORbio, Sanofi, and others. Coauthors identified relationships with numerous pharmaceutical companies.

SOURCE: Wechsler ME et al. N Engl J Med. 2019 Sep 25. doi: 10.1056/NEJMoa1905560.

Almost half of black children with poorly controlled asthma showed a superior response to increased inhaled glucocorticoids over long-acting beta-agonists, based on data from 280 children aged 5-11 years with at least one grandparent identified as black.

Previous studies have suggested that long-acting beta₂-agonists (LABAs) may be more effective for patients with poorly controlled asthma, but such step-up therapy has not been well studied in black patients, wrote Michael E. Wechsler, MD, of National Jewish Health, Denver, and colleagues.

In a study published in the New England Journal of Medicine, the researchers reported results of two parallel BARD (Best African American Response to Asthma Drugs) trials conducted at nine centers between January 2014 and March 2016 of individuals with poorly controlled asthma. One trial included 280 children aged 5-11 years (average age, 8.5 years); the second trial included adolescents aged 12 years and older and adults (average age, 37 years) who had family backgrounds that were similar to those of the children.

The researchers randomized the children to four groups to compare the following protocols: doubling the dose of a glucocorticoid (fluticasone propionate) to a dose of 100 mcg, twice daily (the double-fluticasone group); doubling the dose of fluticasone to 100 mcg and adding 50 mcg of the LABA salmeterol (the salmeterol/double-fluticasone group); quintupling the dose of fluticasone to 250 mcg (the quintuple-fluticasone group); or quintupling the dose of fluticasone to 250 mcg and adding 50 mcg of salmeterol (the salmeterol/quintuple-fluticasone group). The trial consisted of a four-way crossover design with each treatment period lasting 14 weeks.

The primary outcome was a composite measure including asthma exacerbations, asthma control days, and percentage of predicted forced expiratory volume in the first second at the end of each treatment.

Overall, a superior response occurred in 53% of the salmeterol/double-fluticasone group, 41% of the double-fluticasone group, 43% of the salmeterol/quintuple fluticasone group, and 47% of the quintuple-fluticasone group.

The superior response was 46% for both groups when the researchers compared a quintupled dose of fluticasone propionate (250 mcg) with a two step–up strategy of adding salmeterol at a dose of 50 mcg and increasing the dose of fluticasone to 100 mcg.

“In contrast to black adults and white persons of all ages, almost half the children who had at least one grandparent who identified as black and who had poorly controlled asthma had a superior response to an increased dose of an inhaled glucocorticoid over the addition of a LABA,” Dr. Wechsler and coauthors wrote. No more than 12% of the children in any treatment group did not have a superior response. No significant differences in reports of respiratory tract infections or pneumonia were seen between the groups. Children younger than 8 years showed a decrease in the ratio of urinary cortisol to creatinine with an increased dose of inhaled glucocorticoids.

In the adolescent and adult study using the same treatment protocols, 20%-25% of patients did not have a differential outcome between treatments. “In adolescents and adults, the addition of a LABA was more likely to produce superior responses than increasing the dose of an inhaled glucocorticoid,” Dr. Wechsler and coauthors wrote.

The study findings were limited by several factors, including the inability to assess long-term effects on growth and inability to detect biomarkers associated with responses to specific therapies, the researchers noted. However, the results suggest that black children with poorly controlled asthma can benefit from additional inhaled glucocorticoids, and larger studies are needed to identify the best treatment for this patient population.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Wechsler reported relationships with companies including AstraZeneca, Equillium, Genentech, GlaxoSmithKline, Mylan, Novartis, Regeneron, resTORbio, Sanofi, and others. Coauthors identified relationships with numerous pharmaceutical companies.

SOURCE: Wechsler ME et al. N Engl J Med. 2019 Sep 25. doi: 10.1056/NEJMoa1905560.

American diets have improved in the last several decades, with declines in consumption of low-quality carbohydrates and increases in plant protein and healthy fats, based on data from a nationally representative sample of 43,996 adults.

Changes in the economy, food policies, and food processing can affect diet over time, but trends in consumption of macronutrients in the U.S. have not been well studied, wrote Zhilei Shan, MD, of Harvard T.H. Chan School of Public Health, Boston, and colleagues.

In a study published in JAMA, the researchers reviewed data from nine consecutive cycles of the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2016 to determine trends in macronutrient intake. The study population included adults aged 20 years and older who could provide at least 1 valid dietary recall questionnaire. The average age was 47 years, and 52% were women.

Overall, total carbohydrate consumption decreased from 52.5% to 50.5%, the estimated energy from high-quality carbohydrates increased from 7.42% to 8.65%, and the estimated energy from low-quality carbohydrates decreased from 45.1% to 41.8%. Total protein consumption increased from 15.5% to 16.4%, and plant protein consumption increased from 5.38% to 5.76%. Total fat consumption increased from 32.0% to 33.2%, including a 0.36% increase in saturated fatty acids from 11.5% to 11.9% and a 0.65% increase in polyunsaturated fatty acids from 7.58% to 8.23%.

Although the changes in total carbohydrates, total protein, and total fat were significant, 42% of energy intake came from low-quality carbohydrates and 10% came from saturated fat, the researchers noted. Also, the overall diet quality as measured by the Healthy Eating Index 2015 (HEI-2015) improved from 55.7 in 1999 to 57.7 in 2016. The HEI-2015 measures how diet data adheres to recommendations in the 2015-2020 Dietary Guidelines for Americans on a scale of 0-100.

“Improvements in intakes of whole grains and plant protein are encouraging, but how much do popular foods such as pizza, fast food sandwiches and burgers, and foods categorized as ‘snacks’ and ‘desserts’ contribute to the U.S. eating pattern?” wrote Linda Van Horn, PhD, RDN, and Marilyn C. Cornelis, PhD, of Northwestern University, Chicago, in an editorial accompanying the study. They cited a closer look at the NHANES data in the USDA’s “What We Eat in America” report and noted the differences in ethnicity with regard to macronutrient consumption.

“Non-Hispanic whites consume more alcohol, pizza, and fast food sandwiches (24% of total energy), while non-Hispanic blacks consume more salty snacks and sweet desserts (17% of total energy), and Hispanics consume more sugar-sweetened beverages (8% of total energy) and the least alcohol compared with the other racial/ethnic groups,” they said. “Public health efforts to educate, inform, and incent better adherence to the recommended nutrient-dense food groups are clearly needed,” they emphasized.

The study findings were limited by several factors, including the use of self-reports and changes in dietary assessments over time, the researchers noted. However, the results are strengthened by the large sample size and suggest improvements in the overall American diet, but also highlight the need for continuing public education and intervention, they said.

The study was supported by the National Institutes of Health and the Young Scientists Fund of the National Natural Science Foundation of China. Dr. Shan had no financial conflicts to disclose. Dr. Van Horn disclosed being a member of the 2020 US Dietary Guidelines Advisory Committee.

SOURCE: Shan Z et al. JAMA. 2019. doi: 10.1001/jama.2019.13771.

American diets have improved in the last several decades, with declines in consumption of low-quality carbohydrates and increases in plant protein and healthy fats, based on data from a nationally representative sample of 43,996 adults.

Changes in the economy, food policies, and food processing can affect diet over time, but trends in consumption of macronutrients in the U.S. have not been well studied, wrote Zhilei Shan, MD, of Harvard T.H. Chan School of Public Health, Boston, and colleagues.

In a study published in JAMA, the researchers reviewed data from nine consecutive cycles of the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2016 to determine trends in macronutrient intake. The study population included adults aged 20 years and older who could provide at least 1 valid dietary recall questionnaire. The average age was 47 years, and 52% were women.

Overall, total carbohydrate consumption decreased from 52.5% to 50.5%, the estimated energy from high-quality carbohydrates increased from 7.42% to 8.65%, and the estimated energy from low-quality carbohydrates decreased from 45.1% to 41.8%. Total protein consumption increased from 15.5% to 16.4%, and plant protein consumption increased from 5.38% to 5.76%. Total fat consumption increased from 32.0% to 33.2%, including a 0.36% increase in saturated fatty acids from 11.5% to 11.9% and a 0.65% increase in polyunsaturated fatty acids from 7.58% to 8.23%.

Although the changes in total carbohydrates, total protein, and total fat were significant, 42% of energy intake came from low-quality carbohydrates and 10% came from saturated fat, the researchers noted. Also, the overall diet quality as measured by the Healthy Eating Index 2015 (HEI-2015) improved from 55.7 in 1999 to 57.7 in 2016. The HEI-2015 measures how diet data adheres to recommendations in the 2015-2020 Dietary Guidelines for Americans on a scale of 0-100.

“Improvements in intakes of whole grains and plant protein are encouraging, but how much do popular foods such as pizza, fast food sandwiches and burgers, and foods categorized as ‘snacks’ and ‘desserts’ contribute to the U.S. eating pattern?” wrote Linda Van Horn, PhD, RDN, and Marilyn C. Cornelis, PhD, of Northwestern University, Chicago, in an editorial accompanying the study. They cited a closer look at the NHANES data in the USDA’s “What We Eat in America” report and noted the differences in ethnicity with regard to macronutrient consumption.

“Non-Hispanic whites consume more alcohol, pizza, and fast food sandwiches (24% of total energy), while non-Hispanic blacks consume more salty snacks and sweet desserts (17% of total energy), and Hispanics consume more sugar-sweetened beverages (8% of total energy) and the least alcohol compared with the other racial/ethnic groups,” they said. “Public health efforts to educate, inform, and incent better adherence to the recommended nutrient-dense food groups are clearly needed,” they emphasized.

The study findings were limited by several factors, including the use of self-reports and changes in dietary assessments over time, the researchers noted. However, the results are strengthened by the large sample size and suggest improvements in the overall American diet, but also highlight the need for continuing public education and intervention, they said.

The study was supported by the National Institutes of Health and the Young Scientists Fund of the National Natural Science Foundation of China. Dr. Shan had no financial conflicts to disclose. Dr. Van Horn disclosed being a member of the 2020 US Dietary Guidelines Advisory Committee.

SOURCE: Shan Z et al. JAMA. 2019. doi: 10.1001/jama.2019.13771.

American diets have improved in the last several decades, with declines in consumption of low-quality carbohydrates and increases in plant protein and healthy fats, based on data from a nationally representative sample of 43,996 adults.

Changes in the economy, food policies, and food processing can affect diet over time, but trends in consumption of macronutrients in the U.S. have not been well studied, wrote Zhilei Shan, MD, of Harvard T.H. Chan School of Public Health, Boston, and colleagues.

In a study published in JAMA, the researchers reviewed data from nine consecutive cycles of the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2016 to determine trends in macronutrient intake. The study population included adults aged 20 years and older who could provide at least 1 valid dietary recall questionnaire. The average age was 47 years, and 52% were women.

Overall, total carbohydrate consumption decreased from 52.5% to 50.5%, the estimated energy from high-quality carbohydrates increased from 7.42% to 8.65%, and the estimated energy from low-quality carbohydrates decreased from 45.1% to 41.8%. Total protein consumption increased from 15.5% to 16.4%, and plant protein consumption increased from 5.38% to 5.76%. Total fat consumption increased from 32.0% to 33.2%, including a 0.36% increase in saturated fatty acids from 11.5% to 11.9% and a 0.65% increase in polyunsaturated fatty acids from 7.58% to 8.23%.

Although the changes in total carbohydrates, total protein, and total fat were significant, 42% of energy intake came from low-quality carbohydrates and 10% came from saturated fat, the researchers noted. Also, the overall diet quality as measured by the Healthy Eating Index 2015 (HEI-2015) improved from 55.7 in 1999 to 57.7 in 2016. The HEI-2015 measures how diet data adheres to recommendations in the 2015-2020 Dietary Guidelines for Americans on a scale of 0-100.

“Improvements in intakes of whole grains and plant protein are encouraging, but how much do popular foods such as pizza, fast food sandwiches and burgers, and foods categorized as ‘snacks’ and ‘desserts’ contribute to the U.S. eating pattern?” wrote Linda Van Horn, PhD, RDN, and Marilyn C. Cornelis, PhD, of Northwestern University, Chicago, in an editorial accompanying the study. They cited a closer look at the NHANES data in the USDA’s “What We Eat in America” report and noted the differences in ethnicity with regard to macronutrient consumption.

“Non-Hispanic whites consume more alcohol, pizza, and fast food sandwiches (24% of total energy), while non-Hispanic blacks consume more salty snacks and sweet desserts (17% of total energy), and Hispanics consume more sugar-sweetened beverages (8% of total energy) and the least alcohol compared with the other racial/ethnic groups,” they said. “Public health efforts to educate, inform, and incent better adherence to the recommended nutrient-dense food groups are clearly needed,” they emphasized.

The study findings were limited by several factors, including the use of self-reports and changes in dietary assessments over time, the researchers noted. However, the results are strengthened by the large sample size and suggest improvements in the overall American diet, but also highlight the need for continuing public education and intervention, they said.

The study was supported by the National Institutes of Health and the Young Scientists Fund of the National Natural Science Foundation of China. Dr. Shan had no financial conflicts to disclose. Dr. Van Horn disclosed being a member of the 2020 US Dietary Guidelines Advisory Committee.

SOURCE: Shan Z et al. JAMA. 2019. doi: 10.1001/jama.2019.13771.

Long-term outcomes after tracheostomy are generally poor and health care costs are high, especially for older patients, findings of a large retrospective study suggest.

Andrei Malov/Thinkstock

Current outcome prediction tools to support decision making regarding tracheostomies are limited, wrote Anuj B. Mehta, MD, of National Jewish Health in Denver, and colleagues. “This study provides novel and in-depth insight into mortality and health care utilization following tracheostomy not previously described at the population-level.”

In a study published in Critical Care Medicine, the researchers reviewed data from 8,343 nonsurgical patients seen in California hospitals from 2012 to 2013 who received a tracheostomy for acute respiratory failure.

Overall, the 1-year mortality rate for patients who had tracheostomies (the primary outcome) was 46.5%, with in-hospital mortality of 18.9% and 30-day mortality of 22.1%. Pneumonia was the most common diagnosis for patients with respiratory failure (79%) and some had an additional diagnosis, such as severe sepsis (56%).

Patients aged 65 years and older had significantly higher mortality than those under 65 (54.7% vs. 36.5%). The average age of the patients was 65 years; approximately 46% were women and 48% were white. The median survival for adults aged 65 years and older was 175 days, compared with median survival of more than a year for younger patients.

Secondary outcomes included discharge destination, hospital readmission, and health care utilization. A majority (86%) of patients were discharged to a long-term care facility, while 11% were sent home and approximately 3% were discharged to other destinations.

Nearly two-thirds (60%) of patients were readmitted to the hospital within a year of tracheostomy, and readmission was more common among older adults, compared with younger (66% vs. 55%).

In addition, just over one-third of all patients (36%) spent more than 50% of their days alive in the hospital in short-term acute care, and this rate was significantly higher for patients aged 65 years and older, compared with those under 65 (43% vs. 29%). On average, the total hospital cost for patients who survived the first year after tracheostomy was $215,369, with no significant difference in average cost among age groups.

The study findings were limited by several factors including the use of data from a single state, possible misclassification of billing codes, and inability to measure quality of life, the researchers noted.

However, “our findings of high mortality, low median survival for older patients, high readmission rates, potentially burdensome cost, and informative outcome trajectories provide significant insight into long-term outcomes following tracheostomy,” they concluded.

Dr. Mehta and several colleagues reported receiving funding from the National Institutes of Health. The researchers had no financial conflicts to disclose.

SOURCE: Mehta AB et al. Crit Care Med. 2019 Aug 8. doi: 10.1097/CCM.0000000000003959.

Long-term outcomes after tracheostomy are generally poor and health care costs are high, especially for older patients, findings of a large retrospective study suggest.

Andrei Malov/Thinkstock

Current outcome prediction tools to support decision making regarding tracheostomies are limited, wrote Anuj B. Mehta, MD, of National Jewish Health in Denver, and colleagues. “This study provides novel and in-depth insight into mortality and health care utilization following tracheostomy not previously described at the population-level.”

In a study published in Critical Care Medicine, the researchers reviewed data from 8,343 nonsurgical patients seen in California hospitals from 2012 to 2013 who received a tracheostomy for acute respiratory failure.

Overall, the 1-year mortality rate for patients who had tracheostomies (the primary outcome) was 46.5%, with in-hospital mortality of 18.9% and 30-day mortality of 22.1%. Pneumonia was the most common diagnosis for patients with respiratory failure (79%) and some had an additional diagnosis, such as severe sepsis (56%).

Patients aged 65 years and older had significantly higher mortality than those under 65 (54.7% vs. 36.5%). The average age of the patients was 65 years; approximately 46% were women and 48% were white. The median survival for adults aged 65 years and older was 175 days, compared with median survival of more than a year for younger patients.

Secondary outcomes included discharge destination, hospital readmission, and health care utilization. A majority (86%) of patients were discharged to a long-term care facility, while 11% were sent home and approximately 3% were discharged to other destinations.

Nearly two-thirds (60%) of patients were readmitted to the hospital within a year of tracheostomy, and readmission was more common among older adults, compared with younger (66% vs. 55%).

In addition, just over one-third of all patients (36%) spent more than 50% of their days alive in the hospital in short-term acute care, and this rate was significantly higher for patients aged 65 years and older, compared with those under 65 (43% vs. 29%). On average, the total hospital cost for patients who survived the first year after tracheostomy was $215,369, with no significant difference in average cost among age groups.

The study findings were limited by several factors including the use of data from a single state, possible misclassification of billing codes, and inability to measure quality of life, the researchers noted.

However, “our findings of high mortality, low median survival for older patients, high readmission rates, potentially burdensome cost, and informative outcome trajectories provide significant insight into long-term outcomes following tracheostomy,” they concluded.

Dr. Mehta and several colleagues reported receiving funding from the National Institutes of Health. The researchers had no financial conflicts to disclose.

SOURCE: Mehta AB et al. Crit Care Med. 2019 Aug 8. doi: 10.1097/CCM.0000000000003959.

Long-term outcomes after tracheostomy are generally poor and health care costs are high, especially for older patients, findings of a large retrospective study suggest.

Andrei Malov/Thinkstock

Current outcome prediction tools to support decision making regarding tracheostomies are limited, wrote Anuj B. Mehta, MD, of National Jewish Health in Denver, and colleagues. “This study provides novel and in-depth insight into mortality and health care utilization following tracheostomy not previously described at the population-level.”

In a study published in Critical Care Medicine, the researchers reviewed data from 8,343 nonsurgical patients seen in California hospitals from 2012 to 2013 who received a tracheostomy for acute respiratory failure.

Overall, the 1-year mortality rate for patients who had tracheostomies (the primary outcome) was 46.5%, with in-hospital mortality of 18.9% and 30-day mortality of 22.1%. Pneumonia was the most common diagnosis for patients with respiratory failure (79%) and some had an additional diagnosis, such as severe sepsis (56%).

Patients aged 65 years and older had significantly higher mortality than those under 65 (54.7% vs. 36.5%). The average age of the patients was 65 years; approximately 46% were women and 48% were white. The median survival for adults aged 65 years and older was 175 days, compared with median survival of more than a year for younger patients.

Secondary outcomes included discharge destination, hospital readmission, and health care utilization. A majority (86%) of patients were discharged to a long-term care facility, while 11% were sent home and approximately 3% were discharged to other destinations.

Nearly two-thirds (60%) of patients were readmitted to the hospital within a year of tracheostomy, and readmission was more common among older adults, compared with younger (66% vs. 55%).

In addition, just over one-third of all patients (36%) spent more than 50% of their days alive in the hospital in short-term acute care, and this rate was significantly higher for patients aged 65 years and older, compared with those under 65 (43% vs. 29%). On average, the total hospital cost for patients who survived the first year after tracheostomy was $215,369, with no significant difference in average cost among age groups.

The study findings were limited by several factors including the use of data from a single state, possible misclassification of billing codes, and inability to measure quality of life, the researchers noted.

However, “our findings of high mortality, low median survival for older patients, high readmission rates, potentially burdensome cost, and informative outcome trajectories provide significant insight into long-term outcomes following tracheostomy,” they concluded.

Dr. Mehta and several colleagues reported receiving funding from the National Institutes of Health. The researchers had no financial conflicts to disclose.

SOURCE: Mehta AB et al. Crit Care Med. 2019 Aug 8. doi: 10.1097/CCM.0000000000003959.

Children with juvenile dermatomyositis showed significant growth failure and pubertal delay, based on data from a longitudinal cohort study.

welcomia/iStock/Getty Images Plus

“Both the inflammatory activity of this severe chronic rheumatic disease and the well-known side effects of corticosteroid treatment may interfere with normal growth and pubertal development of children,” wrote Ellen Nordal, MD, of the University Hospital of Northern Norway, Tromsø, and colleagues.

The goal in treating juvenile dermatomyositis (JDM) is to achieve inactive disease and prevent permanent damage, but long-term data on growth and puberty in JDM patients are limited, they wrote.

In a study published in Arthritis Care & Research, the investigators reviewed data from 196 children and followed them for 2 years. The patients were part of the Paediatric Rheumatology International Trials Organisation (PRINTO) observational cohort study.

Overall, the researchers identified growth failure, height deflection, and/or delayed puberty in 94 children (48%) at the last study visit.

Growth failure was present at baseline in 17% of girls and 10% of boys. Over the 2-year study period, height deflection increased to 25% of girls and 31% of boys, but this change was not significant. Height deflection was defined as a change in the height z score of less than –0.25 per year from baseline. However, body mass index increased significantly from baseline during the study.

Catch-up growth had occurred by the final study visit in some patients, based on parent-adjusted z scores over time. Girls with a disease duration of 12 months or more showed no catch-up growth at 2 years and had significantly lower parent-adjusted height z scores.

In addition, the researchers observed a delay in the onset of puberty (including pubertal tempo and menarche) in approximately 36% of both boys and girls. However, neither growth failure nor height deflection was significantly associated with delayed puberty in either sex.

“In follow-up, clinicians should therefore be aware of both the pubertal development and the growth of the child, assess the milestones of development, and ensure that the children reach as much as possible of their genetic potential,” the researchers wrote.

The study participants were younger than 18 years at study enrollment, and all were in an active disease phase, defined as needing to start or receive a major dose increase of corticosteroids and/or immunosuppressants. Patients were assessed at baseline, at 6 months and/or at 12 months, and during a final visit at approximately 26 months. During the study, approximately half of the participants (50.5%) received methotrexate, 30 (15.3%) received cyclosporine A, 10 (5.1%) received cyclophosphamide, and 27 (13.8%) received intravenous immunoglobulin.

The study findings were limited by several factors, including the short follow-up period for assessing pubertal development and the inability to analyze any impact of corticosteroid use prior to the study, the researchers noted. However, “the overall frequency of growth failure was not significantly higher at the final study visit 2 years after baseline, indicating that the very high doses of corticosteroid treatment given during the study period is reasonably well tolerated with regards to growth,” they wrote. But monitoring remains essential, especially for children with previous growth failure or with disease onset early in pubertal development.

The study was supported by the European Union, Helse Nord Research grants, and by IRCCS Istituto Giannina Gaslini. Five authors of the study reported financial relationships with pharmaceutical companies.

SOURCE: Nordal E et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24065.

Children with juvenile dermatomyositis showed significant growth failure and pubertal delay, based on data from a longitudinal cohort study.

welcomia/iStock/Getty Images Plus

“Both the inflammatory activity of this severe chronic rheumatic disease and the well-known side effects of corticosteroid treatment may interfere with normal growth and pubertal development of children,” wrote Ellen Nordal, MD, of the University Hospital of Northern Norway, Tromsø, and colleagues.

The goal in treating juvenile dermatomyositis (JDM) is to achieve inactive disease and prevent permanent damage, but long-term data on growth and puberty in JDM patients are limited, they wrote.

In a study published in Arthritis Care & Research, the investigators reviewed data from 196 children and followed them for 2 years. The patients were part of the Paediatric Rheumatology International Trials Organisation (PRINTO) observational cohort study.

Overall, the researchers identified growth failure, height deflection, and/or delayed puberty in 94 children (48%) at the last study visit.

Growth failure was present at baseline in 17% of girls and 10% of boys. Over the 2-year study period, height deflection increased to 25% of girls and 31% of boys, but this change was not significant. Height deflection was defined as a change in the height z score of less than –0.25 per year from baseline. However, body mass index increased significantly from baseline during the study.

Catch-up growth had occurred by the final study visit in some patients, based on parent-adjusted z scores over time. Girls with a disease duration of 12 months or more showed no catch-up growth at 2 years and had significantly lower parent-adjusted height z scores.

In addition, the researchers observed a delay in the onset of puberty (including pubertal tempo and menarche) in approximately 36% of both boys and girls. However, neither growth failure nor height deflection was significantly associated with delayed puberty in either sex.

“In follow-up, clinicians should therefore be aware of both the pubertal development and the growth of the child, assess the milestones of development, and ensure that the children reach as much as possible of their genetic potential,” the researchers wrote.

The study participants were younger than 18 years at study enrollment, and all were in an active disease phase, defined as needing to start or receive a major dose increase of corticosteroids and/or immunosuppressants. Patients were assessed at baseline, at 6 months and/or at 12 months, and during a final visit at approximately 26 months. During the study, approximately half of the participants (50.5%) received methotrexate, 30 (15.3%) received cyclosporine A, 10 (5.1%) received cyclophosphamide, and 27 (13.8%) received intravenous immunoglobulin.

The study findings were limited by several factors, including the short follow-up period for assessing pubertal development and the inability to analyze any impact of corticosteroid use prior to the study, the researchers noted. However, “the overall frequency of growth failure was not significantly higher at the final study visit 2 years after baseline, indicating that the very high doses of corticosteroid treatment given during the study period is reasonably well tolerated with regards to growth,” they wrote. But monitoring remains essential, especially for children with previous growth failure or with disease onset early in pubertal development.

The study was supported by the European Union, Helse Nord Research grants, and by IRCCS Istituto Giannina Gaslini. Five authors of the study reported financial relationships with pharmaceutical companies.

SOURCE: Nordal E et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24065.

Children with juvenile dermatomyositis showed significant growth failure and pubertal delay, based on data from a longitudinal cohort study.

welcomia/iStock/Getty Images Plus

“Both the inflammatory activity of this severe chronic rheumatic disease and the well-known side effects of corticosteroid treatment may interfere with normal growth and pubertal development of children,” wrote Ellen Nordal, MD, of the University Hospital of Northern Norway, Tromsø, and colleagues.

The goal in treating juvenile dermatomyositis (JDM) is to achieve inactive disease and prevent permanent damage, but long-term data on growth and puberty in JDM patients are limited, they wrote.

In a study published in Arthritis Care & Research, the investigators reviewed data from 196 children and followed them for 2 years. The patients were part of the Paediatric Rheumatology International Trials Organisation (PRINTO) observational cohort study.

Overall, the researchers identified growth failure, height deflection, and/or delayed puberty in 94 children (48%) at the last study visit.

Growth failure was present at baseline in 17% of girls and 10% of boys. Over the 2-year study period, height deflection increased to 25% of girls and 31% of boys, but this change was not significant. Height deflection was defined as a change in the height z score of less than –0.25 per year from baseline. However, body mass index increased significantly from baseline during the study.

Catch-up growth had occurred by the final study visit in some patients, based on parent-adjusted z scores over time. Girls with a disease duration of 12 months or more showed no catch-up growth at 2 years and had significantly lower parent-adjusted height z scores.

In addition, the researchers observed a delay in the onset of puberty (including pubertal tempo and menarche) in approximately 36% of both boys and girls. However, neither growth failure nor height deflection was significantly associated with delayed puberty in either sex.

“In follow-up, clinicians should therefore be aware of both the pubertal development and the growth of the child, assess the milestones of development, and ensure that the children reach as much as possible of their genetic potential,” the researchers wrote.

The study participants were younger than 18 years at study enrollment, and all were in an active disease phase, defined as needing to start or receive a major dose increase of corticosteroids and/or immunosuppressants. Patients were assessed at baseline, at 6 months and/or at 12 months, and during a final visit at approximately 26 months. During the study, approximately half of the participants (50.5%) received methotrexate, 30 (15.3%) received cyclosporine A, 10 (5.1%) received cyclophosphamide, and 27 (13.8%) received intravenous immunoglobulin.

The study findings were limited by several factors, including the short follow-up period for assessing pubertal development and the inability to analyze any impact of corticosteroid use prior to the study, the researchers noted. However, “the overall frequency of growth failure was not significantly higher at the final study visit 2 years after baseline, indicating that the very high doses of corticosteroid treatment given during the study period is reasonably well tolerated with regards to growth,” they wrote. But monitoring remains essential, especially for children with previous growth failure or with disease onset early in pubertal development.

The study was supported by the European Union, Helse Nord Research grants, and by IRCCS Istituto Giannina Gaslini. Five authors of the study reported financial relationships with pharmaceutical companies.

SOURCE: Nordal E et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24065.

About a third of peanut-allergic patients given oral immunotherapy (OIT) passed a peanut challenge when the therapy was reduced, based on data from a phase 2 randomized trial of individuals with confirmed peanut allergies.

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Previous studies have shown that desensitization to peanuts can be successful, but sustained response to oral immunotherapy after treatment reduction or discontinuation has not been well studied, wrote R. Sharon Chinthrajah, MD, of Stanford (Calif.)University, and colleagues.

“We found that OIT with peanut was able to desensitise people with peanut allergy to 4,000 mg of peanut protein, but that discontinuation of peanut, or even a reduction to 300 mg daily, increased the likelihood of regaining clinical reactivity to peanut,” they wrote. “With peanut allergy therapies in varying stages of clinical development, and some nearing [Food and Drug Administration] approval, vital questions remain regarding the durability of treatment effects and the appropriate maintenance doses.”

In the Peanut Oral Immunotherapy Study: Safety Efficacy and Discovery (POISED), published in The Lancet, the researchers randomized 120 participants to three groups:

• 60 patients built up to a maintenance dose of 4,000 mg of peanut protein for 104 weeks followed by total discontinuation (peanut-0).

• 35 patients built up to a maintenance dose of 4,000 mg of peanut protein for 104 weeks followed by a 300-mg maintenance dose of peanut protein in the form of peanut flour (peanut-300).

• 25 patients to an oat flour placebo.

All participants were trained on how and when to use epinephrine autoinjector devices to treat allergic symptoms such as respiratory problems (cough, shortness of breath, or change in voice), widespread hives or erythema, repetitive vomiting, persistent abdominal pain, angioedema of the face, or feeling faint.

The primary outcome was passing a double-blind, placebo-controlled, food challenge (DBPCFC) to 4,000 mg of peanut protein, which was measured at baseline and at weeks 104, 117, 130, 143, and 156.

SOURCE: Chinthrajah RS et al. Lancet. 2019 Sep 12. doi: 10.1016/S0140-6736(19)31793-3.

About a third of peanut-allergic patients given oral immunotherapy (OIT) passed a peanut challenge when the therapy was reduced, based on data from a phase 2 randomized trial of individuals with confirmed peanut allergies.

yktr/ThinkStock

Previous studies have shown that desensitization to peanuts can be successful, but sustained response to oral immunotherapy after treatment reduction or discontinuation has not been well studied, wrote R. Sharon Chinthrajah, MD, of Stanford (Calif.)University, and colleagues.

“We found that OIT with peanut was able to desensitise people with peanut allergy to 4,000 mg of peanut protein, but that discontinuation of peanut, or even a reduction to 300 mg daily, increased the likelihood of regaining clinical reactivity to peanut,” they wrote. “With peanut allergy therapies in varying stages of clinical development, and some nearing [Food and Drug Administration] approval, vital questions remain regarding the durability of treatment effects and the appropriate maintenance doses.”

In the Peanut Oral Immunotherapy Study: Safety Efficacy and Discovery (POISED), published in The Lancet, the researchers randomized 120 participants to three groups:

• 60 patients built up to a maintenance dose of 4,000 mg of peanut protein for 104 weeks followed by total discontinuation (peanut-0).

• 35 patients built up to a maintenance dose of 4,000 mg of peanut protein for 104 weeks followed by a 300-mg maintenance dose of peanut protein in the form of peanut flour (peanut-300).

• 25 patients to an oat flour placebo.

All participants were trained on how and when to use epinephrine autoinjector devices to treat allergic symptoms such as respiratory problems (cough, shortness of breath, or change in voice), widespread hives or erythema, repetitive vomiting, persistent abdominal pain, angioedema of the face, or feeling faint.

The primary outcome was passing a double-blind, placebo-controlled, food challenge (DBPCFC) to 4,000 mg of peanut protein, which was measured at baseline and at weeks 104, 117, 130, 143, and 156.

SOURCE: Chinthrajah RS et al. Lancet. 2019 Sep 12. doi: 10.1016/S0140-6736(19)31793-3.

About a third of peanut-allergic patients given oral immunotherapy (OIT) passed a peanut challenge when the therapy was reduced, based on data from a phase 2 randomized trial of individuals with confirmed peanut allergies.

yktr/ThinkStock

Previous studies have shown that desensitization to peanuts can be successful, but sustained response to oral immunotherapy after treatment reduction or discontinuation has not been well studied, wrote R. Sharon Chinthrajah, MD, of Stanford (Calif.)University, and colleagues.

“We found that OIT with peanut was able to desensitise people with peanut allergy to 4,000 mg of peanut protein, but that discontinuation of peanut, or even a reduction to 300 mg daily, increased the likelihood of regaining clinical reactivity to peanut,” they wrote. “With peanut allergy therapies in varying stages of clinical development, and some nearing [Food and Drug Administration] approval, vital questions remain regarding the durability of treatment effects and the appropriate maintenance doses.”

In the Peanut Oral Immunotherapy Study: Safety Efficacy and Discovery (POISED), published in The Lancet, the researchers randomized 120 participants to three groups:

• 60 patients built up to a maintenance dose of 4,000 mg of peanut protein for 104 weeks followed by total discontinuation (peanut-0).

• 35 patients built up to a maintenance dose of 4,000 mg of peanut protein for 104 weeks followed by a 300-mg maintenance dose of peanut protein in the form of peanut flour (peanut-300).

• 25 patients to an oat flour placebo.

All participants were trained on how and when to use epinephrine autoinjector devices to treat allergic symptoms such as respiratory problems (cough, shortness of breath, or change in voice), widespread hives or erythema, repetitive vomiting, persistent abdominal pain, angioedema of the face, or feeling faint.

The primary outcome was passing a double-blind, placebo-controlled, food challenge (DBPCFC) to 4,000 mg of peanut protein, which was measured at baseline and at weeks 104, 117, 130, 143, and 156.

SOURCE: Chinthrajah RS et al. Lancet. 2019 Sep 12. doi: 10.1016/S0140-6736(19)31793-3.

A majority of primary care physicians recommended the human papillomavirus (HPV) vaccine to children aged 11-12 years and older, and about half of them used a presumptive style to recommend the vaccine, based on survey responses from 530 clinicians.

“Because of the crucial role of provider recommendation in parental decisions to vaccinate, a great deal of research and intervention efforts have been focused on improving provider communication regarding HPV vaccination,” Allison Kempe, MD, of the University of Colorado and Children’s Hospital Colorado, Aurora, and her colleagues wrote in Pediatrics.

“A presumptive style of initiating HPV vaccine discussions uses words that convey an assumption of vaccination and does not discuss the HPV vaccine in a different manner than other adolescent vaccines,” the authors explained. By contrast, “a conversational style engages parents in an open-ended discussion about the HPV vaccine without linguistic presupposition of vaccination.” Findings from multiple studies have shown that the presumptive approach is associated with higher acceptance of the HPV vaccine, compared with the conversational approach.

The researchers examined survey responses from a nationally representative sample of 302 pediatricians and 228 family physicians. Almost all clinicians in both specialties (99% of pediatricians, 90% of FPs) said they strongly recommended the HPV vaccine for girls aged 15 years and older. Strong recommendations for the HPV vaccine were lowest in both specialties for boys aged 11-12 years (83% of pediatricians, 66% of FPs).

Significantly more pediatricians than FPs reported using a presumptive style when discussing the HPV vaccine (65% vs. 42%, respectively; P <.0001). Overall, 40% of the survey respondents used standing orders for HPV vaccination and 42% had electronic alerts in patients’ medical records to prompt an HPV vaccine discussion.

The proportion of pediatricians who reported a vaccine refusal or deferral rate of 50% or higher for patients aged 11-12 years was 10% for girls and 23% for boys; among FPs, those percentages were 27% for girls and 36% for boys.

In multivariate analysis, the factors associated with a 50% or higher refusal or deferral rate among 11- to 12-year-olds were similar for both genders and included “not strongly recommending [the vaccine] to 11- to 12-year-old patients, not … always using a presumptive recommendation style, strongly agreeing that they encounter less resistance to HPV vaccination from patients aged 13 years versus patients aged 11 years, and anticipating an uncomfortable discussion when recommending to 11- to 12-year-old patients,” the researchers wrote.

More physicians in both specialties made stronger recommendations for HPV vaccination for patients aged 13 years and older than for those aged 11 and 12 years. However, physicians might overestimate parent and patient resistance to a strong recommendation for the HPV vaccine. A strong recommendation, “delivered in the same way as for other adolescent vaccines and on same day as other adolescent vaccines, may be key to increasing acceptance among parents of 11- to 12-year-old patients,” Dr. Kempe and associates said.

The current two-dose vaccine schedule also promoted complete vaccination, according to a majority of pediatricians and FPs.

The study findings were limited by several factors, including the use of self-reports and the potential lack of generalizability of the survey responses. The results, however, were strengthened by the large, nationally representative sample and suggest that the number of physicians who strongly recommend HPV vaccination to 11- and 12-year-olds has increased over the past 5 years, they said.

“Increased use of available communication training materials and applications, as well as further development of evidence-based messages for parents, may be helpful in improving the way HPV is introduced,” the investigators concluded.

The study was supported by the Centers for Disease Control and Prevention. The researchers reported that they had no financial conflicts.

SOURCE: Kempe A et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1475.

A majority of primary care physicians recommended the human papillomavirus (HPV) vaccine to children aged 11-12 years and older, and about half of them used a presumptive style to recommend the vaccine, based on survey responses from 530 clinicians.

“Because of the crucial role of provider recommendation in parental decisions to vaccinate, a great deal of research and intervention efforts have been focused on improving provider communication regarding HPV vaccination,” Allison Kempe, MD, of the University of Colorado and Children’s Hospital Colorado, Aurora, and her colleagues wrote in Pediatrics.

“A presumptive style of initiating HPV vaccine discussions uses words that convey an assumption of vaccination and does not discuss the HPV vaccine in a different manner than other adolescent vaccines,” the authors explained. By contrast, “a conversational style engages parents in an open-ended discussion about the HPV vaccine without linguistic presupposition of vaccination.” Findings from multiple studies have shown that the presumptive approach is associated with higher acceptance of the HPV vaccine, compared with the conversational approach.

The researchers examined survey responses from a nationally representative sample of 302 pediatricians and 228 family physicians. Almost all clinicians in both specialties (99% of pediatricians, 90% of FPs) said they strongly recommended the HPV vaccine for girls aged 15 years and older. Strong recommendations for the HPV vaccine were lowest in both specialties for boys aged 11-12 years (83% of pediatricians, 66% of FPs).

Significantly more pediatricians than FPs reported using a presumptive style when discussing the HPV vaccine (65% vs. 42%, respectively; P <.0001). Overall, 40% of the survey respondents used standing orders for HPV vaccination and 42% had electronic alerts in patients’ medical records to prompt an HPV vaccine discussion.

The proportion of pediatricians who reported a vaccine refusal or deferral rate of 50% or higher for patients aged 11-12 years was 10% for girls and 23% for boys; among FPs, those percentages were 27% for girls and 36% for boys.

In multivariate analysis, the factors associated with a 50% or higher refusal or deferral rate among 11- to 12-year-olds were similar for both genders and included “not strongly recommending [the vaccine] to 11- to 12-year-old patients, not … always using a presumptive recommendation style, strongly agreeing that they encounter less resistance to HPV vaccination from patients aged 13 years versus patients aged 11 years, and anticipating an uncomfortable discussion when recommending to 11- to 12-year-old patients,” the researchers wrote.

More physicians in both specialties made stronger recommendations for HPV vaccination for patients aged 13 years and older than for those aged 11 and 12 years. However, physicians might overestimate parent and patient resistance to a strong recommendation for the HPV vaccine. A strong recommendation, “delivered in the same way as for other adolescent vaccines and on same day as other adolescent vaccines, may be key to increasing acceptance among parents of 11- to 12-year-old patients,” Dr. Kempe and associates said.

The current two-dose vaccine schedule also promoted complete vaccination, according to a majority of pediatricians and FPs.

The study findings were limited by several factors, including the use of self-reports and the potential lack of generalizability of the survey responses. The results, however, were strengthened by the large, nationally representative sample and suggest that the number of physicians who strongly recommend HPV vaccination to 11- and 12-year-olds has increased over the past 5 years, they said.

“Increased use of available communication training materials and applications, as well as further development of evidence-based messages for parents, may be helpful in improving the way HPV is introduced,” the investigators concluded.

The study was supported by the Centers for Disease Control and Prevention. The researchers reported that they had no financial conflicts.

SOURCE: Kempe A et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1475.

A majority of primary care physicians recommended the human papillomavirus (HPV) vaccine to children aged 11-12 years and older, and about half of them used a presumptive style to recommend the vaccine, based on survey responses from 530 clinicians.

“Because of the crucial role of provider recommendation in parental decisions to vaccinate, a great deal of research and intervention efforts have been focused on improving provider communication regarding HPV vaccination,” Allison Kempe, MD, of the University of Colorado and Children’s Hospital Colorado, Aurora, and her colleagues wrote in Pediatrics.

“A presumptive style of initiating HPV vaccine discussions uses words that convey an assumption of vaccination and does not discuss the HPV vaccine in a different manner than other adolescent vaccines,” the authors explained. By contrast, “a conversational style engages parents in an open-ended discussion about the HPV vaccine without linguistic presupposition of vaccination.” Findings from multiple studies have shown that the presumptive approach is associated with higher acceptance of the HPV vaccine, compared with the conversational approach.

The researchers examined survey responses from a nationally representative sample of 302 pediatricians and 228 family physicians. Almost all clinicians in both specialties (99% of pediatricians, 90% of FPs) said they strongly recommended the HPV vaccine for girls aged 15 years and older. Strong recommendations for the HPV vaccine were lowest in both specialties for boys aged 11-12 years (83% of pediatricians, 66% of FPs).

Significantly more pediatricians than FPs reported using a presumptive style when discussing the HPV vaccine (65% vs. 42%, respectively; P <.0001). Overall, 40% of the survey respondents used standing orders for HPV vaccination and 42% had electronic alerts in patients’ medical records to prompt an HPV vaccine discussion.

The proportion of pediatricians who reported a vaccine refusal or deferral rate of 50% or higher for patients aged 11-12 years was 10% for girls and 23% for boys; among FPs, those percentages were 27% for girls and 36% for boys.

In multivariate analysis, the factors associated with a 50% or higher refusal or deferral rate among 11- to 12-year-olds were similar for both genders and included “not strongly recommending [the vaccine] to 11- to 12-year-old patients, not … always using a presumptive recommendation style, strongly agreeing that they encounter less resistance to HPV vaccination from patients aged 13 years versus patients aged 11 years, and anticipating an uncomfortable discussion when recommending to 11- to 12-year-old patients,” the researchers wrote.

More physicians in both specialties made stronger recommendations for HPV vaccination for patients aged 13 years and older than for those aged 11 and 12 years. However, physicians might overestimate parent and patient resistance to a strong recommendation for the HPV vaccine. A strong recommendation, “delivered in the same way as for other adolescent vaccines and on same day as other adolescent vaccines, may be key to increasing acceptance among parents of 11- to 12-year-old patients,” Dr. Kempe and associates said.

The current two-dose vaccine schedule also promoted complete vaccination, according to a majority of pediatricians and FPs.

The study findings were limited by several factors, including the use of self-reports and the potential lack of generalizability of the survey responses. The results, however, were strengthened by the large, nationally representative sample and suggest that the number of physicians who strongly recommend HPV vaccination to 11- and 12-year-olds has increased over the past 5 years, they said.

“Increased use of available communication training materials and applications, as well as further development of evidence-based messages for parents, may be helpful in improving the way HPV is introduced,” the investigators concluded.

The study was supported by the Centers for Disease Control and Prevention. The researchers reported that they had no financial conflicts.

SOURCE: Kempe A et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1475.

Adolescent suicides can be prevented, and clinicians have a key role to play, Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.

AlexRaths/Thinkstock

“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”

Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.

Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.

She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.

Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).

The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.

In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.

“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.

In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.

The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.

“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.

The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”

This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.

Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.

Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.

Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).

The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.

Adolescent suicides can be prevented, and clinicians have a key role to play, Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.

AlexRaths/Thinkstock

“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”

Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.

Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.

She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.

Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).

The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.

In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.

“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.

In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.

The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.

“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.

The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”

This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.

Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.

Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.

Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).

The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.

Adolescent suicides can be prevented, and clinicians have a key role to play, Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.

AlexRaths/Thinkstock

“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”

Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.

Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.

She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.

Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).

The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.

In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.

“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.

In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.

The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.

“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.

The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”

This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.

Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.

Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.

Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).

The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.