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Don’t delay palliative care for IPF patients
and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.
“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.
They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).
The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).
About 35% of these patients were being treated with antifibrotic medication. Most of the patients had comorbidities, with cardiovascular disease being the most common.
The dimensions of HRQOL studied were physical function, general health, vitality, mental health, social function, and bodily pain. These patients experienced a gradual impairment in HRQOL similar to that of patients with chronic obstructive pulmonary disease, but with a pronounced, rapid deterioration beginning in the last 2 years of life.
The symptom burden also intensified in the last 2 years of life and ramped up significantly in the last 6 months before death. NRS scores are on a scale of 0-10, from no symptoms to worst symptoms. In most clinical situations, NRS scores equal to greater than 4 trigger more comprehensive symptom assessment. The scores for symptoms for these patients during the last 6 months were dyspnea, 7.1 (standard deviation 2.8); tiredness, 6.0 (SD 2.5), cough, 5.0 (SD 3.5), pain with movement, 3.9 (SD 3.1), insomnia, 3.9 (SD 2.9), anxiety, 3.9 (SD 2.9), and depression, 3.6 (SD 3.1).
Investigators noted the steep change in the proportion of patients with MMRC scores greater than or equal to 3 (needing to stop walking after approximately 100 m or a few minutes because of breathlessness) beginning in the last 2 years of life.
The study limitations are its relatively small size, the self-reported data, and the lack of lung function measurements in most patients in the last 6 months of life.
The findings point to the urgent need for early palliative care in IPF patients, the investigators concluded. They noted that the sharp decline in HRQOL is similar to that seen in lung cancer patients, in contrast to the more gradual trend seen in COPD patients.
But there are common benefits of an early palliative program for all of these patients, they stressed. “Early integrated palliative care for patients with lung cancer has shown substantial benefits, such as lower depression scores, higher HRQOL, better communication of end-of-life care preferences, less aggressive care at the end of life, and longer overall survival. Similarly, a randomized trial demonstrated better control of dyspnea and a survival benefit with integrated palliative care in patients with COPD and interstitial lung disease. In addition to cancer patients, early integrated palliative care may reduce end-of-life acute care utilization, and allow patients with IPF to die in their preferred locations. Integrated palliative care in IPF patients seems to lower respiratory-related emergency room visits and hospitalizations and may allow more patients to die at home.”
The study was funded by The Academy of Finland and various Finnish nonprofit organizations funded the study.
SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.
and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.
“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.
They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).
The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).
About 35% of these patients were being treated with antifibrotic medication. Most of the patients had comorbidities, with cardiovascular disease being the most common.
The dimensions of HRQOL studied were physical function, general health, vitality, mental health, social function, and bodily pain. These patients experienced a gradual impairment in HRQOL similar to that of patients with chronic obstructive pulmonary disease, but with a pronounced, rapid deterioration beginning in the last 2 years of life.
The symptom burden also intensified in the last 2 years of life and ramped up significantly in the last 6 months before death. NRS scores are on a scale of 0-10, from no symptoms to worst symptoms. In most clinical situations, NRS scores equal to greater than 4 trigger more comprehensive symptom assessment. The scores for symptoms for these patients during the last 6 months were dyspnea, 7.1 (standard deviation 2.8); tiredness, 6.0 (SD 2.5), cough, 5.0 (SD 3.5), pain with movement, 3.9 (SD 3.1), insomnia, 3.9 (SD 2.9), anxiety, 3.9 (SD 2.9), and depression, 3.6 (SD 3.1).
Investigators noted the steep change in the proportion of patients with MMRC scores greater than or equal to 3 (needing to stop walking after approximately 100 m or a few minutes because of breathlessness) beginning in the last 2 years of life.
The study limitations are its relatively small size, the self-reported data, and the lack of lung function measurements in most patients in the last 6 months of life.
The findings point to the urgent need for early palliative care in IPF patients, the investigators concluded. They noted that the sharp decline in HRQOL is similar to that seen in lung cancer patients, in contrast to the more gradual trend seen in COPD patients.
But there are common benefits of an early palliative program for all of these patients, they stressed. “Early integrated palliative care for patients with lung cancer has shown substantial benefits, such as lower depression scores, higher HRQOL, better communication of end-of-life care preferences, less aggressive care at the end of life, and longer overall survival. Similarly, a randomized trial demonstrated better control of dyspnea and a survival benefit with integrated palliative care in patients with COPD and interstitial lung disease. In addition to cancer patients, early integrated palliative care may reduce end-of-life acute care utilization, and allow patients with IPF to die in their preferred locations. Integrated palliative care in IPF patients seems to lower respiratory-related emergency room visits and hospitalizations and may allow more patients to die at home.”
The study was funded by The Academy of Finland and various Finnish nonprofit organizations funded the study.
SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.
and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.
“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.
They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).
The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).
About 35% of these patients were being treated with antifibrotic medication. Most of the patients had comorbidities, with cardiovascular disease being the most common.
The dimensions of HRQOL studied were physical function, general health, vitality, mental health, social function, and bodily pain. These patients experienced a gradual impairment in HRQOL similar to that of patients with chronic obstructive pulmonary disease, but with a pronounced, rapid deterioration beginning in the last 2 years of life.
The symptom burden also intensified in the last 2 years of life and ramped up significantly in the last 6 months before death. NRS scores are on a scale of 0-10, from no symptoms to worst symptoms. In most clinical situations, NRS scores equal to greater than 4 trigger more comprehensive symptom assessment. The scores for symptoms for these patients during the last 6 months were dyspnea, 7.1 (standard deviation 2.8); tiredness, 6.0 (SD 2.5), cough, 5.0 (SD 3.5), pain with movement, 3.9 (SD 3.1), insomnia, 3.9 (SD 2.9), anxiety, 3.9 (SD 2.9), and depression, 3.6 (SD 3.1).
Investigators noted the steep change in the proportion of patients with MMRC scores greater than or equal to 3 (needing to stop walking after approximately 100 m or a few minutes because of breathlessness) beginning in the last 2 years of life.
The study limitations are its relatively small size, the self-reported data, and the lack of lung function measurements in most patients in the last 6 months of life.
The findings point to the urgent need for early palliative care in IPF patients, the investigators concluded. They noted that the sharp decline in HRQOL is similar to that seen in lung cancer patients, in contrast to the more gradual trend seen in COPD patients.
But there are common benefits of an early palliative program for all of these patients, they stressed. “Early integrated palliative care for patients with lung cancer has shown substantial benefits, such as lower depression scores, higher HRQOL, better communication of end-of-life care preferences, less aggressive care at the end of life, and longer overall survival. Similarly, a randomized trial demonstrated better control of dyspnea and a survival benefit with integrated palliative care in patients with COPD and interstitial lung disease. In addition to cancer patients, early integrated palliative care may reduce end-of-life acute care utilization, and allow patients with IPF to die in their preferred locations. Integrated palliative care in IPF patients seems to lower respiratory-related emergency room visits and hospitalizations and may allow more patients to die at home.”
The study was funded by The Academy of Finland and various Finnish nonprofit organizations funded the study.
SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.
FROM BMC PULMONARY MEDICINE
Direct-to-consumer telemedicine visits may lead to pediatric antibiotic overprescribing
(ARIs), according to a study of antibiotic prescriptions for ARIs across 3 clinical settings.
“These differences in antibiotic prescribing for children contrast with previous studies of DTC telemedicine quality among adult patients in which quality differences have been smaller or nonexistent,” wrote Kristin N. Ray, MD, of Children’s Hospital of Pittsburgh, and her coauthors. The study was published in Pediatrics.
To determine quality of care during pediatric DTC telemedicine visits, the researchers embarked on a retrospective cohort study using 2015–2016 claims data from a large national commercial health plan. They identified visits for ARIs and matched them across 3 settings: DTC telemedicine, urgent care, and PCP offices. The matched sample included 4,604 DTC telemedicine visits, 38,408 urgent care visits, and 485,201 PCP visits.
Their analysis showed that children were more likely to be prescribed antibiotics at DTC telemedicine visits than in other settings (52% versus 42% for urgent care and 31% for PCP, P less than .001). In addition, they were less likely to receive guideline-concordant antibiotic management (59% versus 67% and 78%, P less than .001). This was primarily attributed to “antibiotic prescribing for visits with viral ARI diagnoses that do not warrant antibiotics,” antibiotics were appropriately not prescribed in only 54% of those DTC telemedicine visits, compared with 66% for urgent care and 80% for PCP (P less than .001).
The authors shared the limitations of their study, including a lack of sociodemographic or clinical data stemming from a reliance on insurance claims. They also noted that their analysis was limited to a specific health plan and its contracted DTC telemedicine vendor, recognizing that “antibiotic prescribing among other DTC telemedicine companies, models, and populations may differ.”
The study was funded by the National Institutes of Health and supported in part by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and gifts from Melvin Hall. The authors reported no conflicts of interest.
SOURCE: Ray KN et al. Pediatrics. 2019 Apr 8. doi: 10.1542/peds.2018-2491.
These findings from this study illustrate the issues with direct-to-consumer (DTC) telemedicine, especially when treating children, according to Jeffrey S. Gerber, MD, medical director of the antimicrobial stewardship program at Children’s Hospital of Philadelphia.
The best way to get a 5-star rating after a DTC telemedicine visit is to prescribe an antibiotic, Dr. Gerber wrote, so it shouldn’t be surprising that doctors are handing them out at a higher rate than after an urgent care or a primary care visit. It should also be noted that this study covers a very specific privately insured population and that DTC telemedicine remains a “small piece of the pie,” for now, in terms of patient care.
But, he added, the most problematic element of this study may be that none of the 3 most common pediatric acute respiratory tract infection (ARTI) diagnoses should be followed with an immediate prescription, especially after a virtual visit.
“It could be argued that essentially no ARTI encounters should lead to antibiotic prescriptions solely on the basis of a DTC telemedicine visit,” he wrote, recognizing that – though there may be value for telemedicine in a screening capacity – the DTC version seems to be a “low quality encounter” at best and “a vehicle for antibiotic overuse” at worst.
These comments are adapted from an accompanying editorial (Pediatrics. 2019 Apr 8. doi: 10.1542/peds.2019-0631 ). Dr. Gerber reported receiving personal fees from Medtronic outside the submitted work.
These findings from this study illustrate the issues with direct-to-consumer (DTC) telemedicine, especially when treating children, according to Jeffrey S. Gerber, MD, medical director of the antimicrobial stewardship program at Children’s Hospital of Philadelphia.
The best way to get a 5-star rating after a DTC telemedicine visit is to prescribe an antibiotic, Dr. Gerber wrote, so it shouldn’t be surprising that doctors are handing them out at a higher rate than after an urgent care or a primary care visit. It should also be noted that this study covers a very specific privately insured population and that DTC telemedicine remains a “small piece of the pie,” for now, in terms of patient care.
But, he added, the most problematic element of this study may be that none of the 3 most common pediatric acute respiratory tract infection (ARTI) diagnoses should be followed with an immediate prescription, especially after a virtual visit.
“It could be argued that essentially no ARTI encounters should lead to antibiotic prescriptions solely on the basis of a DTC telemedicine visit,” he wrote, recognizing that – though there may be value for telemedicine in a screening capacity – the DTC version seems to be a “low quality encounter” at best and “a vehicle for antibiotic overuse” at worst.
These comments are adapted from an accompanying editorial (Pediatrics. 2019 Apr 8. doi: 10.1542/peds.2019-0631 ). Dr. Gerber reported receiving personal fees from Medtronic outside the submitted work.
These findings from this study illustrate the issues with direct-to-consumer (DTC) telemedicine, especially when treating children, according to Jeffrey S. Gerber, MD, medical director of the antimicrobial stewardship program at Children’s Hospital of Philadelphia.
The best way to get a 5-star rating after a DTC telemedicine visit is to prescribe an antibiotic, Dr. Gerber wrote, so it shouldn’t be surprising that doctors are handing them out at a higher rate than after an urgent care or a primary care visit. It should also be noted that this study covers a very specific privately insured population and that DTC telemedicine remains a “small piece of the pie,” for now, in terms of patient care.
But, he added, the most problematic element of this study may be that none of the 3 most common pediatric acute respiratory tract infection (ARTI) diagnoses should be followed with an immediate prescription, especially after a virtual visit.
“It could be argued that essentially no ARTI encounters should lead to antibiotic prescriptions solely on the basis of a DTC telemedicine visit,” he wrote, recognizing that – though there may be value for telemedicine in a screening capacity – the DTC version seems to be a “low quality encounter” at best and “a vehicle for antibiotic overuse” at worst.
These comments are adapted from an accompanying editorial (Pediatrics. 2019 Apr 8. doi: 10.1542/peds.2019-0631 ). Dr. Gerber reported receiving personal fees from Medtronic outside the submitted work.
(ARIs), according to a study of antibiotic prescriptions for ARIs across 3 clinical settings.
“These differences in antibiotic prescribing for children contrast with previous studies of DTC telemedicine quality among adult patients in which quality differences have been smaller or nonexistent,” wrote Kristin N. Ray, MD, of Children’s Hospital of Pittsburgh, and her coauthors. The study was published in Pediatrics.
To determine quality of care during pediatric DTC telemedicine visits, the researchers embarked on a retrospective cohort study using 2015–2016 claims data from a large national commercial health plan. They identified visits for ARIs and matched them across 3 settings: DTC telemedicine, urgent care, and PCP offices. The matched sample included 4,604 DTC telemedicine visits, 38,408 urgent care visits, and 485,201 PCP visits.
Their analysis showed that children were more likely to be prescribed antibiotics at DTC telemedicine visits than in other settings (52% versus 42% for urgent care and 31% for PCP, P less than .001). In addition, they were less likely to receive guideline-concordant antibiotic management (59% versus 67% and 78%, P less than .001). This was primarily attributed to “antibiotic prescribing for visits with viral ARI diagnoses that do not warrant antibiotics,” antibiotics were appropriately not prescribed in only 54% of those DTC telemedicine visits, compared with 66% for urgent care and 80% for PCP (P less than .001).
The authors shared the limitations of their study, including a lack of sociodemographic or clinical data stemming from a reliance on insurance claims. They also noted that their analysis was limited to a specific health plan and its contracted DTC telemedicine vendor, recognizing that “antibiotic prescribing among other DTC telemedicine companies, models, and populations may differ.”
The study was funded by the National Institutes of Health and supported in part by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and gifts from Melvin Hall. The authors reported no conflicts of interest.
SOURCE: Ray KN et al. Pediatrics. 2019 Apr 8. doi: 10.1542/peds.2018-2491.
(ARIs), according to a study of antibiotic prescriptions for ARIs across 3 clinical settings.
“These differences in antibiotic prescribing for children contrast with previous studies of DTC telemedicine quality among adult patients in which quality differences have been smaller or nonexistent,” wrote Kristin N. Ray, MD, of Children’s Hospital of Pittsburgh, and her coauthors. The study was published in Pediatrics.
To determine quality of care during pediatric DTC telemedicine visits, the researchers embarked on a retrospective cohort study using 2015–2016 claims data from a large national commercial health plan. They identified visits for ARIs and matched them across 3 settings: DTC telemedicine, urgent care, and PCP offices. The matched sample included 4,604 DTC telemedicine visits, 38,408 urgent care visits, and 485,201 PCP visits.
Their analysis showed that children were more likely to be prescribed antibiotics at DTC telemedicine visits than in other settings (52% versus 42% for urgent care and 31% for PCP, P less than .001). In addition, they were less likely to receive guideline-concordant antibiotic management (59% versus 67% and 78%, P less than .001). This was primarily attributed to “antibiotic prescribing for visits with viral ARI diagnoses that do not warrant antibiotics,” antibiotics were appropriately not prescribed in only 54% of those DTC telemedicine visits, compared with 66% for urgent care and 80% for PCP (P less than .001).
The authors shared the limitations of their study, including a lack of sociodemographic or clinical data stemming from a reliance on insurance claims. They also noted that their analysis was limited to a specific health plan and its contracted DTC telemedicine vendor, recognizing that “antibiotic prescribing among other DTC telemedicine companies, models, and populations may differ.”
The study was funded by the National Institutes of Health and supported in part by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and gifts from Melvin Hall. The authors reported no conflicts of interest.
SOURCE: Ray KN et al. Pediatrics. 2019 Apr 8. doi: 10.1542/peds.2018-2491.
FROM PEDIATRICS
Key clinical point: For children diagnosed with acute respiratory infections, antibiotic prescribing was higher and guideline-concordant antibiotic management was lower at direct-to-consumer (DTC) telemedicine visits.
Major finding: Children at DTC telemedicine visits were prescribed antibiotics for respiratory infections 52% of the time, compared with 42% at urgent care visits and 31% at primary care provider visits.
Study details: A retrospective cohort study of DTC telemedicine, urgent care, and primary care provider visits for acute respiratory infections and subsequent antibiotic prescriptions.
Disclosures: The study was funded by the National Institutes of Health and supported in part by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and gifts from Melvin Hall. The authors reported no conflicts of interest.
Source: Ray KN et al. Pediatrics. 2019 Apr 8. doi: 10.1542/peds.2018-2491.
Oscillatory ventilation reduced reintubation risk for preterm infants
Nasal high-frequency oscillatory ventilation, in a randomized trial of 206 preterm infants with respiratory failure.
Previous studies have supported the use of NHFOV as more effective for reducing CO2 and for lowering the risk of reintubation compared with NCPAP. But no randomized, controlled trials had compared the outcomes for preterm infants in particular, wrote Long Chen, MD, PhD, of Children’s Hospital of Chongqing Medical University, Chongqing, China, and colleagues.
Their study, published in Chest, was conducted at a single tertiary NICU in China between May 2017 and May 2018, and randomized infants with a gestational age less than 37 weeks to NHFOV (103 infants) or NCPAP (103 infants). Infants with major congenital abnormalities were excluded. The infants included 127 (61.7%) diagnosed with respiratory distress syndrome (RDS), 53 (25.7%) diagnosed with acute RDS (ARDS), and 26 (12.6%) diagnosed with both RDS and ARDS.
Overall, the reintubation rate within 6 hours was significantly lower among infants treated with NHFOV compared with those treated with NCPAP (15.5% vs. 34%, P = .002), and in the subset of infants with ARDS (23.5% vs. 52.6%, P = .032). Among infants with a gestational age of 32 weeks or less, reintuibation rates were also significantly lower among those treated with NHFOV (26.1% vs. 55.6%, P = .004).
In addition, PCO2 levels, 6 hours after extubation, were significantly lower among infants on NHFOV, compared with those on NCPAP (49.6 vs. 56.9 P = .00). The hospital stay, a secondary outcome, was significantly shorter among the infants treated with NHFOV, than those treated with NCPAP (22 days, vs. 27.6 days, P =.011).
Although the researchers observed some nasal trauma in NHFOV-treated patients, and intestinal dilation in both groups similar to side effects seen in previous studies, no feeding intolerance or skin lesions were associated with NHFOV. The study findings were consistent with those from previous studies, and suggested that the causes of respiratory failure might account for the differences between the treatment groups, they noted.
“RDS is primarily restrictive in the acute phase, and the high frequency oscillation over CPAP does not therefore bring any benefit. However, ARDS is both restrictive and obstructive in the acute phase due to the nature of ARDS,” and NHFOV is “able to improve oxygenation,” they added.
The study findings were limited by several factors including the use of data from a single center and the small number of infants younger than 28 weeks’ gestation, the researchers noted. However, they added, two international, multicenter, randomized controlled trials are in the works.
The study was supported by Social Livelihood Program of 38 Chongqing Science and Technology Commission, China. The researchers had no financial conflicts to disclose.
SOURCE: Long C et al. Chest. 2019; 155(4): 740-8.
Nasal high-frequency oscillatory ventilation, in a randomized trial of 206 preterm infants with respiratory failure.
Previous studies have supported the use of NHFOV as more effective for reducing CO2 and for lowering the risk of reintubation compared with NCPAP. But no randomized, controlled trials had compared the outcomes for preterm infants in particular, wrote Long Chen, MD, PhD, of Children’s Hospital of Chongqing Medical University, Chongqing, China, and colleagues.
Their study, published in Chest, was conducted at a single tertiary NICU in China between May 2017 and May 2018, and randomized infants with a gestational age less than 37 weeks to NHFOV (103 infants) or NCPAP (103 infants). Infants with major congenital abnormalities were excluded. The infants included 127 (61.7%) diagnosed with respiratory distress syndrome (RDS), 53 (25.7%) diagnosed with acute RDS (ARDS), and 26 (12.6%) diagnosed with both RDS and ARDS.
Overall, the reintubation rate within 6 hours was significantly lower among infants treated with NHFOV compared with those treated with NCPAP (15.5% vs. 34%, P = .002), and in the subset of infants with ARDS (23.5% vs. 52.6%, P = .032). Among infants with a gestational age of 32 weeks or less, reintuibation rates were also significantly lower among those treated with NHFOV (26.1% vs. 55.6%, P = .004).
In addition, PCO2 levels, 6 hours after extubation, were significantly lower among infants on NHFOV, compared with those on NCPAP (49.6 vs. 56.9 P = .00). The hospital stay, a secondary outcome, was significantly shorter among the infants treated with NHFOV, than those treated with NCPAP (22 days, vs. 27.6 days, P =.011).
Although the researchers observed some nasal trauma in NHFOV-treated patients, and intestinal dilation in both groups similar to side effects seen in previous studies, no feeding intolerance or skin lesions were associated with NHFOV. The study findings were consistent with those from previous studies, and suggested that the causes of respiratory failure might account for the differences between the treatment groups, they noted.
“RDS is primarily restrictive in the acute phase, and the high frequency oscillation over CPAP does not therefore bring any benefit. However, ARDS is both restrictive and obstructive in the acute phase due to the nature of ARDS,” and NHFOV is “able to improve oxygenation,” they added.
The study findings were limited by several factors including the use of data from a single center and the small number of infants younger than 28 weeks’ gestation, the researchers noted. However, they added, two international, multicenter, randomized controlled trials are in the works.
The study was supported by Social Livelihood Program of 38 Chongqing Science and Technology Commission, China. The researchers had no financial conflicts to disclose.
SOURCE: Long C et al. Chest. 2019; 155(4): 740-8.
Nasal high-frequency oscillatory ventilation, in a randomized trial of 206 preterm infants with respiratory failure.
Previous studies have supported the use of NHFOV as more effective for reducing CO2 and for lowering the risk of reintubation compared with NCPAP. But no randomized, controlled trials had compared the outcomes for preterm infants in particular, wrote Long Chen, MD, PhD, of Children’s Hospital of Chongqing Medical University, Chongqing, China, and colleagues.
Their study, published in Chest, was conducted at a single tertiary NICU in China between May 2017 and May 2018, and randomized infants with a gestational age less than 37 weeks to NHFOV (103 infants) or NCPAP (103 infants). Infants with major congenital abnormalities were excluded. The infants included 127 (61.7%) diagnosed with respiratory distress syndrome (RDS), 53 (25.7%) diagnosed with acute RDS (ARDS), and 26 (12.6%) diagnosed with both RDS and ARDS.
Overall, the reintubation rate within 6 hours was significantly lower among infants treated with NHFOV compared with those treated with NCPAP (15.5% vs. 34%, P = .002), and in the subset of infants with ARDS (23.5% vs. 52.6%, P = .032). Among infants with a gestational age of 32 weeks or less, reintuibation rates were also significantly lower among those treated with NHFOV (26.1% vs. 55.6%, P = .004).
In addition, PCO2 levels, 6 hours after extubation, were significantly lower among infants on NHFOV, compared with those on NCPAP (49.6 vs. 56.9 P = .00). The hospital stay, a secondary outcome, was significantly shorter among the infants treated with NHFOV, than those treated with NCPAP (22 days, vs. 27.6 days, P =.011).
Although the researchers observed some nasal trauma in NHFOV-treated patients, and intestinal dilation in both groups similar to side effects seen in previous studies, no feeding intolerance or skin lesions were associated with NHFOV. The study findings were consistent with those from previous studies, and suggested that the causes of respiratory failure might account for the differences between the treatment groups, they noted.
“RDS is primarily restrictive in the acute phase, and the high frequency oscillation over CPAP does not therefore bring any benefit. However, ARDS is both restrictive and obstructive in the acute phase due to the nature of ARDS,” and NHFOV is “able to improve oxygenation,” they added.
The study findings were limited by several factors including the use of data from a single center and the small number of infants younger than 28 weeks’ gestation, the researchers noted. However, they added, two international, multicenter, randomized controlled trials are in the works.
The study was supported by Social Livelihood Program of 38 Chongqing Science and Technology Commission, China. The researchers had no financial conflicts to disclose.
SOURCE: Long C et al. Chest. 2019; 155(4): 740-8.
FROM CHEST
Flu activity falling but still elevated
Measures of influenza activity fell again as the flu season continues to make its later-than-usual departure this year, according to the Centers for Disease Control and Prevention.
On the geographic front, the map of influenza-like illness (ILI) activity for the week ending March 30 shows that only 6 states are at level 10 on the CDC’s 1-10 scale, compared with 11 for the previous week, and that those same 6 states make up the entire membership of the high range of levels 8-10, which is down from 20 states a week ago, data from the CDC’s Outpatient ILI Surveillance Network show.
The proportion of outpatient visits for ILI, now at 3.2%, dropped for the sixth consecutive week after reaching its season high of 5.1% back in mid-February. The outpatient rate has now been at or above the national baseline of 2.2% for 19 weeks this season, the CDC’s influenza division said April 5, noting that the average for the past five seasons is 16 weeks.
Six flu-related pediatric deaths were reported in the week ending March 30, and the total is now 82 for the 2018-2019 season. Five of the six occurred during previous weeks of this season, and one occurred in the 2017-2018 season, the CDC said.
Measures of influenza activity fell again as the flu season continues to make its later-than-usual departure this year, according to the Centers for Disease Control and Prevention.
On the geographic front, the map of influenza-like illness (ILI) activity for the week ending March 30 shows that only 6 states are at level 10 on the CDC’s 1-10 scale, compared with 11 for the previous week, and that those same 6 states make up the entire membership of the high range of levels 8-10, which is down from 20 states a week ago, data from the CDC’s Outpatient ILI Surveillance Network show.
The proportion of outpatient visits for ILI, now at 3.2%, dropped for the sixth consecutive week after reaching its season high of 5.1% back in mid-February. The outpatient rate has now been at or above the national baseline of 2.2% for 19 weeks this season, the CDC’s influenza division said April 5, noting that the average for the past five seasons is 16 weeks.
Six flu-related pediatric deaths were reported in the week ending March 30, and the total is now 82 for the 2018-2019 season. Five of the six occurred during previous weeks of this season, and one occurred in the 2017-2018 season, the CDC said.
Measures of influenza activity fell again as the flu season continues to make its later-than-usual departure this year, according to the Centers for Disease Control and Prevention.
On the geographic front, the map of influenza-like illness (ILI) activity for the week ending March 30 shows that only 6 states are at level 10 on the CDC’s 1-10 scale, compared with 11 for the previous week, and that those same 6 states make up the entire membership of the high range of levels 8-10, which is down from 20 states a week ago, data from the CDC’s Outpatient ILI Surveillance Network show.
The proportion of outpatient visits for ILI, now at 3.2%, dropped for the sixth consecutive week after reaching its season high of 5.1% back in mid-February. The outpatient rate has now been at or above the national baseline of 2.2% for 19 weeks this season, the CDC’s influenza division said April 5, noting that the average for the past five seasons is 16 weeks.
Six flu-related pediatric deaths were reported in the week ending March 30, and the total is now 82 for the 2018-2019 season. Five of the six occurred during previous weeks of this season, and one occurred in the 2017-2018 season, the CDC said.
Trial Opens to Study New Drug for Opioid Cravings
Habitual use of opioids “rewires” the brain’s reward system. In the study, researchers will be testing ANS-6637 (Amygdala Neurosciences), a drug that may inhibit the dopamine surge of opioid use, without affecting the levels of dopamine needed for normal brain function.
The phase 1 trial will enroll up to 50 healthy adults aged 18 to 65 years. On the first day of the 10-day study, they will receive a single dose of midazolam, chosen to act as a template for liver metabolism. After a drug-free day 2, on days 3 through 7 they will receive 600 mg/d of ANS-6637. On day 8, the participants will be given the 2 drugs together to determine how the investigational drug affects midazolam levels, which also will help the researchers understand how ANS-6637 is processed in the body. The volunteers will return for a final outpatient visit after 1 week.
At present, few pharmacologic interventions target opioid-related cravings, says researcher Henry Masur, MD, chief of the Clinical Center’s Critical Care Medicine Department. If proven effective, the researchers say, ANS-6637 could be part of a comprehensive package of services, including harm reduction, opioid agonist therapy, and behavioral interventions.
The study is funded through NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, an “aggressive, trans-agency effort to speed scientific solutions” to the opioid crisis.
Habitual use of opioids “rewires” the brain’s reward system. In the study, researchers will be testing ANS-6637 (Amygdala Neurosciences), a drug that may inhibit the dopamine surge of opioid use, without affecting the levels of dopamine needed for normal brain function.
The phase 1 trial will enroll up to 50 healthy adults aged 18 to 65 years. On the first day of the 10-day study, they will receive a single dose of midazolam, chosen to act as a template for liver metabolism. After a drug-free day 2, on days 3 through 7 they will receive 600 mg/d of ANS-6637. On day 8, the participants will be given the 2 drugs together to determine how the investigational drug affects midazolam levels, which also will help the researchers understand how ANS-6637 is processed in the body. The volunteers will return for a final outpatient visit after 1 week.
At present, few pharmacologic interventions target opioid-related cravings, says researcher Henry Masur, MD, chief of the Clinical Center’s Critical Care Medicine Department. If proven effective, the researchers say, ANS-6637 could be part of a comprehensive package of services, including harm reduction, opioid agonist therapy, and behavioral interventions.
The study is funded through NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, an “aggressive, trans-agency effort to speed scientific solutions” to the opioid crisis.
Habitual use of opioids “rewires” the brain’s reward system. In the study, researchers will be testing ANS-6637 (Amygdala Neurosciences), a drug that may inhibit the dopamine surge of opioid use, without affecting the levels of dopamine needed for normal brain function.
The phase 1 trial will enroll up to 50 healthy adults aged 18 to 65 years. On the first day of the 10-day study, they will receive a single dose of midazolam, chosen to act as a template for liver metabolism. After a drug-free day 2, on days 3 through 7 they will receive 600 mg/d of ANS-6637. On day 8, the participants will be given the 2 drugs together to determine how the investigational drug affects midazolam levels, which also will help the researchers understand how ANS-6637 is processed in the body. The volunteers will return for a final outpatient visit after 1 week.
At present, few pharmacologic interventions target opioid-related cravings, says researcher Henry Masur, MD, chief of the Clinical Center’s Critical Care Medicine Department. If proven effective, the researchers say, ANS-6637 could be part of a comprehensive package of services, including harm reduction, opioid agonist therapy, and behavioral interventions.
The study is funded through NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, an “aggressive, trans-agency effort to speed scientific solutions” to the opioid crisis.
Making HIV Transmission a Rare Event
About 80% of new HIV transmissions are from people who do not know they have HIV or are not receiving regular care, according to a CDC report. That makes improvements in early detection and “rapid entry into care” key to ending the HIV epidemic within 10 years—the current US Department of Health and Human Services goal.
Recent studies have shown that viral suppression prevents sexual transmission of HIV, the researchers say. The studies found no HIV transmissions attributable to sex between HIV-discordant couples when the HIV-infected partner was maintaining viral suppression through treatment—even when the HIV-negative partner was not using preexposure prophylaxis. Those findings mean HIV transmission can become a “rare event,” the researchers say.
Today’s treatments have gotten simpler than the hills of pills that patients used to take. Sometimes the patient needs only a single-tablet regimen. Most people, according to the CDC, can achieve viral suppression within 6 months of starting treatment.
But many of the 1.1 million people with HIV infection are not effectively treated. In 2015, the CDC researchers say, 14.5% of people with HIV infection did not have a diagnosis, and 37.2% were not in care (receiving ≥ 1 CD4 tests in a measurement year). Nearly half were not virally suppressed. Lack of effective treatment results in worse outcomes and higher rates of transmission: It was associated with 38,700 new HIV infections in 2016.
The researchers used a model to estimate transmission rates in 2016 along the HIV continuum of care. Overall, the rate was 3.5 per 100 person-years. Among 9,600 people who were acutely infected and unaware of their infection, the rate was 16.1 per 100 person-years. Among 154,400 people who were nonacutely infected and unaware, the rate was 8.4.
Of the nearly 250,000 people who were aware of HIV infection but not in care, 16,500 transmissions were generated (6.6/100 person-years). Among the 125,300 who were receiving HIV care but not virally suppressed, 7,700 transmissions were generated (6.1).
The transmission rate was 0 for patients who were virally suppressed. The researchers note that 100% efficacy was assumed based on trial results for sexual transmission; no data are available on the efficacy of viral suppression on reducing HIV transmission from IV drug use.
Better detection and linkage to treatment will address most of the problem, but what about the patients who do not maintain viral suppression? Among patients in clinical care, about 80% were virally suppressed at their most recent visit, but about one-third did not sustain viral suppression over 1 year. For those patients, the researchers say, a tailored approach aimed at the barriers that are most relevant for the patient is critical to improving adherence.
The CDC recommends routine screening of all Americans aged 13 to 64 years at least once in their life and at least annual testing for those at high risk. In addition, the researchers say, it is important to spread the word that maintaining viral suppression prevents sexual transmission. Sharing this knowledge more generally might reduce the stigma associated with HIV and help engage patients in consistent care.
About 80% of new HIV transmissions are from people who do not know they have HIV or are not receiving regular care, according to a CDC report. That makes improvements in early detection and “rapid entry into care” key to ending the HIV epidemic within 10 years—the current US Department of Health and Human Services goal.
Recent studies have shown that viral suppression prevents sexual transmission of HIV, the researchers say. The studies found no HIV transmissions attributable to sex between HIV-discordant couples when the HIV-infected partner was maintaining viral suppression through treatment—even when the HIV-negative partner was not using preexposure prophylaxis. Those findings mean HIV transmission can become a “rare event,” the researchers say.
Today’s treatments have gotten simpler than the hills of pills that patients used to take. Sometimes the patient needs only a single-tablet regimen. Most people, according to the CDC, can achieve viral suppression within 6 months of starting treatment.
But many of the 1.1 million people with HIV infection are not effectively treated. In 2015, the CDC researchers say, 14.5% of people with HIV infection did not have a diagnosis, and 37.2% were not in care (receiving ≥ 1 CD4 tests in a measurement year). Nearly half were not virally suppressed. Lack of effective treatment results in worse outcomes and higher rates of transmission: It was associated with 38,700 new HIV infections in 2016.
The researchers used a model to estimate transmission rates in 2016 along the HIV continuum of care. Overall, the rate was 3.5 per 100 person-years. Among 9,600 people who were acutely infected and unaware of their infection, the rate was 16.1 per 100 person-years. Among 154,400 people who were nonacutely infected and unaware, the rate was 8.4.
Of the nearly 250,000 people who were aware of HIV infection but not in care, 16,500 transmissions were generated (6.6/100 person-years). Among the 125,300 who were receiving HIV care but not virally suppressed, 7,700 transmissions were generated (6.1).
The transmission rate was 0 for patients who were virally suppressed. The researchers note that 100% efficacy was assumed based on trial results for sexual transmission; no data are available on the efficacy of viral suppression on reducing HIV transmission from IV drug use.
Better detection and linkage to treatment will address most of the problem, but what about the patients who do not maintain viral suppression? Among patients in clinical care, about 80% were virally suppressed at their most recent visit, but about one-third did not sustain viral suppression over 1 year. For those patients, the researchers say, a tailored approach aimed at the barriers that are most relevant for the patient is critical to improving adherence.
The CDC recommends routine screening of all Americans aged 13 to 64 years at least once in their life and at least annual testing for those at high risk. In addition, the researchers say, it is important to spread the word that maintaining viral suppression prevents sexual transmission. Sharing this knowledge more generally might reduce the stigma associated with HIV and help engage patients in consistent care.
About 80% of new HIV transmissions are from people who do not know they have HIV or are not receiving regular care, according to a CDC report. That makes improvements in early detection and “rapid entry into care” key to ending the HIV epidemic within 10 years—the current US Department of Health and Human Services goal.
Recent studies have shown that viral suppression prevents sexual transmission of HIV, the researchers say. The studies found no HIV transmissions attributable to sex between HIV-discordant couples when the HIV-infected partner was maintaining viral suppression through treatment—even when the HIV-negative partner was not using preexposure prophylaxis. Those findings mean HIV transmission can become a “rare event,” the researchers say.
Today’s treatments have gotten simpler than the hills of pills that patients used to take. Sometimes the patient needs only a single-tablet regimen. Most people, according to the CDC, can achieve viral suppression within 6 months of starting treatment.
But many of the 1.1 million people with HIV infection are not effectively treated. In 2015, the CDC researchers say, 14.5% of people with HIV infection did not have a diagnosis, and 37.2% were not in care (receiving ≥ 1 CD4 tests in a measurement year). Nearly half were not virally suppressed. Lack of effective treatment results in worse outcomes and higher rates of transmission: It was associated with 38,700 new HIV infections in 2016.
The researchers used a model to estimate transmission rates in 2016 along the HIV continuum of care. Overall, the rate was 3.5 per 100 person-years. Among 9,600 people who were acutely infected and unaware of their infection, the rate was 16.1 per 100 person-years. Among 154,400 people who were nonacutely infected and unaware, the rate was 8.4.
Of the nearly 250,000 people who were aware of HIV infection but not in care, 16,500 transmissions were generated (6.6/100 person-years). Among the 125,300 who were receiving HIV care but not virally suppressed, 7,700 transmissions were generated (6.1).
The transmission rate was 0 for patients who were virally suppressed. The researchers note that 100% efficacy was assumed based on trial results for sexual transmission; no data are available on the efficacy of viral suppression on reducing HIV transmission from IV drug use.
Better detection and linkage to treatment will address most of the problem, but what about the patients who do not maintain viral suppression? Among patients in clinical care, about 80% were virally suppressed at their most recent visit, but about one-third did not sustain viral suppression over 1 year. For those patients, the researchers say, a tailored approach aimed at the barriers that are most relevant for the patient is critical to improving adherence.
The CDC recommends routine screening of all Americans aged 13 to 64 years at least once in their life and at least annual testing for those at high risk. In addition, the researchers say, it is important to spread the word that maintaining viral suppression prevents sexual transmission. Sharing this knowledge more generally might reduce the stigma associated with HIV and help engage patients in consistent care.
NIH to undertake first in-human trial of universal influenza vaccine
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is launching the first in-human trial of a universal influenza vaccine candidate.
The experimental vaccine, H1ssF_3928, is derived from the stem of an H1N1 virus and has a surface made from hemagglutinin and ferritin. By including only the stem of the virus, which changes less than the head, the vaccine should require fewer updates. A similar vaccine made from the same materials was shown to be safe and well tolerated in humans.
The clinical trial (NCT03814720) will be conducted at the NIH Clinical Center in Bethesda, Md., and will gradually enroll at least 53 healthy adults aged 18-70 years. The first 5 participants will receive one 20-mcg intramuscular injection of the vaccine; the other 48 participants will receive two 60-mcg vaccinations 16 weeks apart. Patients will return for 9-11 follow-ups over a 12- to 15-month period, and will provide blood samples for analysis of anti-influenza antibodies.
“Seasonal influenza is a perpetual public health challenge, and we continually face the possibility of an influenza pandemic resulting from the emergence and spread of novel influenza viruses. This phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in the press release.
Find the full press release on the NIH website.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is launching the first in-human trial of a universal influenza vaccine candidate.
The experimental vaccine, H1ssF_3928, is derived from the stem of an H1N1 virus and has a surface made from hemagglutinin and ferritin. By including only the stem of the virus, which changes less than the head, the vaccine should require fewer updates. A similar vaccine made from the same materials was shown to be safe and well tolerated in humans.
The clinical trial (NCT03814720) will be conducted at the NIH Clinical Center in Bethesda, Md., and will gradually enroll at least 53 healthy adults aged 18-70 years. The first 5 participants will receive one 20-mcg intramuscular injection of the vaccine; the other 48 participants will receive two 60-mcg vaccinations 16 weeks apart. Patients will return for 9-11 follow-ups over a 12- to 15-month period, and will provide blood samples for analysis of anti-influenza antibodies.
“Seasonal influenza is a perpetual public health challenge, and we continually face the possibility of an influenza pandemic resulting from the emergence and spread of novel influenza viruses. This phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in the press release.
Find the full press release on the NIH website.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is launching the first in-human trial of a universal influenza vaccine candidate.
The experimental vaccine, H1ssF_3928, is derived from the stem of an H1N1 virus and has a surface made from hemagglutinin and ferritin. By including only the stem of the virus, which changes less than the head, the vaccine should require fewer updates. A similar vaccine made from the same materials was shown to be safe and well tolerated in humans.
The clinical trial (NCT03814720) will be conducted at the NIH Clinical Center in Bethesda, Md., and will gradually enroll at least 53 healthy adults aged 18-70 years. The first 5 participants will receive one 20-mcg intramuscular injection of the vaccine; the other 48 participants will receive two 60-mcg vaccinations 16 weeks apart. Patients will return for 9-11 follow-ups over a 12- to 15-month period, and will provide blood samples for analysis of anti-influenza antibodies.
“Seasonal influenza is a perpetual public health challenge, and we continually face the possibility of an influenza pandemic resulting from the emergence and spread of novel influenza viruses. This phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in the press release.
Find the full press release on the NIH website.
FDA concerned about e-cigs/seizures in youth
the agency announced April 3.
Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”
In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.
Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.
Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.
The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
the agency announced April 3.
Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”
In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.
Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.
Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.
The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
the agency announced April 3.
Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”
In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.
Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.
Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.
The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
Noninfected children of HIV-positive mothers have high rates of obesity
NEW ORLEANS – than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.
Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.
In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.
For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).
These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.
Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.
SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).
NEW ORLEANS – than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.
Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.
In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.
For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).
These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.
Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.
SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).
NEW ORLEANS – than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.
Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.
In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.
For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).
These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.
Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.
SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).
REPORTING FROM ENDO 2019
Measles: Latest weekly count is the highest of the year
according to the Centers for Disease Control and Prevention.
The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.
The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.
“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.
In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.
In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.
according to the Centers for Disease Control and Prevention.
The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.
The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.
“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.
In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.
In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.
according to the Centers for Disease Control and Prevention.
The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.
The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.
“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.
In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.
In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.