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CDC: Beware Brazil yellow fever outbreak
The Centers for Disease Control and Prevention recommends that travelers who haven’t been vaccinated against yellow fever should avoid travel to Brazil, according to a media teleconference by CDC officials.
“The most important new recommendation ... is that travelers should not go to these yellow fever hot spots in Brazil, unless they are vaccinated,” stated Martin Cetron, MD, director of the Division of Global Migration and Quarantine at the CDC. “Health officials in Brazil recently confirmed more than 920 cases of yellow fever, including more than 300 deaths, during this outbreak” he added.
Since the beginning of 2018, 10 travel-related cases of yellow fever have been reported among international travelers returning from Brazil. Four of these travelers died. All 10 travelers had not received the yellow fever vaccine. Of these 10 travelers, 8 acquired the disease on Ilha Grande, an island off the coast of Rio De Janeiro that is popular among tourists.
The CDC is urging travelers to get vaccinated because of the potentially fatal effects of yellow fever. Vaccinations are recommended for any eligible person 9 months of age or older traveling to Brazil, specifically Espírito Santo, São Paulo, and Rio de Janeiro states, and certain cities in Bahia state, as well as Ilha Grande in particular.
Individuals heading to Brazil should receive the vaccination at least 10 days before travel. If a traveler is unvaccinated and cannot get the vaccination in the appropriate amount of time, areas where vaccination is recommended should be avoided.
The Food and Drug Administration–approved yellow fever vaccine, YF-VAX, is not currently available because of manufacturing issues. Stamaril, another yellow fever vaccine, is available at a limited number of yellow fever vaccination clinics in the United States.
In light of these supply issues, the CDC has provided resources to locate yellow fever vaccination clinics.
Dr. Cetron reemphasized that unvaccinated individuals planning to vacation in Brazil may want to reconsider their travel plans.
“People who have never been vaccinated against yellow fever should not travel to the areas in Brazil affected by the outbreak. Particularly the hot spot of Ilha Grande.”
Information for clinicians and travelers is available on the travel notice portion of the CDC site. The travel notice for Brazil includes a map of the yellow fever–affected areas in Brazil, as well as other informational resources.
The related CDC Morbidity and Mortality Weekly Report is available online.
The Centers for Disease Control and Prevention recommends that travelers who haven’t been vaccinated against yellow fever should avoid travel to Brazil, according to a media teleconference by CDC officials.
“The most important new recommendation ... is that travelers should not go to these yellow fever hot spots in Brazil, unless they are vaccinated,” stated Martin Cetron, MD, director of the Division of Global Migration and Quarantine at the CDC. “Health officials in Brazil recently confirmed more than 920 cases of yellow fever, including more than 300 deaths, during this outbreak” he added.
Since the beginning of 2018, 10 travel-related cases of yellow fever have been reported among international travelers returning from Brazil. Four of these travelers died. All 10 travelers had not received the yellow fever vaccine. Of these 10 travelers, 8 acquired the disease on Ilha Grande, an island off the coast of Rio De Janeiro that is popular among tourists.
The CDC is urging travelers to get vaccinated because of the potentially fatal effects of yellow fever. Vaccinations are recommended for any eligible person 9 months of age or older traveling to Brazil, specifically Espírito Santo, São Paulo, and Rio de Janeiro states, and certain cities in Bahia state, as well as Ilha Grande in particular.
Individuals heading to Brazil should receive the vaccination at least 10 days before travel. If a traveler is unvaccinated and cannot get the vaccination in the appropriate amount of time, areas where vaccination is recommended should be avoided.
The Food and Drug Administration–approved yellow fever vaccine, YF-VAX, is not currently available because of manufacturing issues. Stamaril, another yellow fever vaccine, is available at a limited number of yellow fever vaccination clinics in the United States.
In light of these supply issues, the CDC has provided resources to locate yellow fever vaccination clinics.
Dr. Cetron reemphasized that unvaccinated individuals planning to vacation in Brazil may want to reconsider their travel plans.
“People who have never been vaccinated against yellow fever should not travel to the areas in Brazil affected by the outbreak. Particularly the hot spot of Ilha Grande.”
Information for clinicians and travelers is available on the travel notice portion of the CDC site. The travel notice for Brazil includes a map of the yellow fever–affected areas in Brazil, as well as other informational resources.
The related CDC Morbidity and Mortality Weekly Report is available online.
The Centers for Disease Control and Prevention recommends that travelers who haven’t been vaccinated against yellow fever should avoid travel to Brazil, according to a media teleconference by CDC officials.
“The most important new recommendation ... is that travelers should not go to these yellow fever hot spots in Brazil, unless they are vaccinated,” stated Martin Cetron, MD, director of the Division of Global Migration and Quarantine at the CDC. “Health officials in Brazil recently confirmed more than 920 cases of yellow fever, including more than 300 deaths, during this outbreak” he added.
Since the beginning of 2018, 10 travel-related cases of yellow fever have been reported among international travelers returning from Brazil. Four of these travelers died. All 10 travelers had not received the yellow fever vaccine. Of these 10 travelers, 8 acquired the disease on Ilha Grande, an island off the coast of Rio De Janeiro that is popular among tourists.
The CDC is urging travelers to get vaccinated because of the potentially fatal effects of yellow fever. Vaccinations are recommended for any eligible person 9 months of age or older traveling to Brazil, specifically Espírito Santo, São Paulo, and Rio de Janeiro states, and certain cities in Bahia state, as well as Ilha Grande in particular.
Individuals heading to Brazil should receive the vaccination at least 10 days before travel. If a traveler is unvaccinated and cannot get the vaccination in the appropriate amount of time, areas where vaccination is recommended should be avoided.
The Food and Drug Administration–approved yellow fever vaccine, YF-VAX, is not currently available because of manufacturing issues. Stamaril, another yellow fever vaccine, is available at a limited number of yellow fever vaccination clinics in the United States.
In light of these supply issues, the CDC has provided resources to locate yellow fever vaccination clinics.
Dr. Cetron reemphasized that unvaccinated individuals planning to vacation in Brazil may want to reconsider their travel plans.
“People who have never been vaccinated against yellow fever should not travel to the areas in Brazil affected by the outbreak. Particularly the hot spot of Ilha Grande.”
Information for clinicians and travelers is available on the travel notice portion of the CDC site. The travel notice for Brazil includes a map of the yellow fever–affected areas in Brazil, as well as other informational resources.
The related CDC Morbidity and Mortality Weekly Report is available online.
Ultrasound study supports deep Koebner mechanism in PsA pathology
An ultrasonographic study describing the greater presence of thicker digital accessory pulleys in patients with psoriatic arthritis (PsA) than in those with only psoriatic skin disease, rheumatoid arthritis, or no pathology has lent more evidence for a “deep Koebner” response mechanism in the development of joint disease in people with psoriasis.
“The thicker pulleys in RA compared with HCs [healthy controls] might point towards a nonspecific effect of a chronic autoimmune tenosynovitis on the adjacent pulleys,” Ilaria Tinazzi, PhD, of the Sacro Cuore-Don Calabria Hospital, Verona, Italy, and her colleagues wrote in Annals of the Rheumatic Diseases. “However, the greater magnitude of pulley thickening in PsA, especially in the setting of dactylitis, suggests an intrinsic pathology in the pulley contributing to PsA-related tenosynovitis.”
Dr. Tinazzi and her research team found that the pulleys in patients with PsA were thicker in every digit than they were in patients with RA and healthy controls, but pulley thickness also differed for each group of patients when compared with one another. Patients with RA had thicker pulleys than did healthy controls, particularly in the A1 pulley, but showed no differences in the A2 and A4 pulleys of the second and fourth digit. Even patients with only psoriasis had thicker pulleys than did the healthy controls. Patients with PsA exhibited thicker A1 and A4 pulleys, compared with patients with only psoriasis, while A2 pulleys displayed no statistical difference. Among PsA patients, 165 of 243 (68%) pulleys were thickened, whereas only 41 of 243 (17%) were thickened among RA patients (P less than .001). A multiple-regression analysis revealed that only PsA was associated with the number of thickened pulleys (odds ratio, 4.8; 95% confidence interval, 3.3-6.3; P = .001).
The size of the study population and the method for defining pulley thickness limited the study. Measurements were taken only in three digits of the dominant hand of each patient. Among PsA patients, only those with hand involvement participated in the study, which may limit the translation of the results to all PsA patients. Additionally, whether pulley changes trigger PsA tenosynovitis or whether it is a reactive process needs additional investigation.
The results of the study suggest that accessory pulleys are subjected to high physical stress and that they exhibit deep Koebner effects and thicken in response, Dr. Tinazzi and her associates wrote.
“Indeed, these findings suggest that such a mechanism is possible given the frequency of thickening of these structures in PsA” wrote Dr. Tinazzi and her associates. “It will be important to show that such changes are present in early PsA where their presence would support the idea of early biomechanical alterations in tendon function that could contribute to dactylitic tenosynovitis.”
This study received no external funding. Several of the researchers have received grants or honoraria from pharmaceutical companies.
SOURCE: Tinazzi I et al. Ann Rheum Dis. 2018 Mar 6. doi: 10.1136/annrheumdis-2017-212681.
An ultrasonographic study describing the greater presence of thicker digital accessory pulleys in patients with psoriatic arthritis (PsA) than in those with only psoriatic skin disease, rheumatoid arthritis, or no pathology has lent more evidence for a “deep Koebner” response mechanism in the development of joint disease in people with psoriasis.
“The thicker pulleys in RA compared with HCs [healthy controls] might point towards a nonspecific effect of a chronic autoimmune tenosynovitis on the adjacent pulleys,” Ilaria Tinazzi, PhD, of the Sacro Cuore-Don Calabria Hospital, Verona, Italy, and her colleagues wrote in Annals of the Rheumatic Diseases. “However, the greater magnitude of pulley thickening in PsA, especially in the setting of dactylitis, suggests an intrinsic pathology in the pulley contributing to PsA-related tenosynovitis.”
Dr. Tinazzi and her research team found that the pulleys in patients with PsA were thicker in every digit than they were in patients with RA and healthy controls, but pulley thickness also differed for each group of patients when compared with one another. Patients with RA had thicker pulleys than did healthy controls, particularly in the A1 pulley, but showed no differences in the A2 and A4 pulleys of the second and fourth digit. Even patients with only psoriasis had thicker pulleys than did the healthy controls. Patients with PsA exhibited thicker A1 and A4 pulleys, compared with patients with only psoriasis, while A2 pulleys displayed no statistical difference. Among PsA patients, 165 of 243 (68%) pulleys were thickened, whereas only 41 of 243 (17%) were thickened among RA patients (P less than .001). A multiple-regression analysis revealed that only PsA was associated with the number of thickened pulleys (odds ratio, 4.8; 95% confidence interval, 3.3-6.3; P = .001).
The size of the study population and the method for defining pulley thickness limited the study. Measurements were taken only in three digits of the dominant hand of each patient. Among PsA patients, only those with hand involvement participated in the study, which may limit the translation of the results to all PsA patients. Additionally, whether pulley changes trigger PsA tenosynovitis or whether it is a reactive process needs additional investigation.
The results of the study suggest that accessory pulleys are subjected to high physical stress and that they exhibit deep Koebner effects and thicken in response, Dr. Tinazzi and her associates wrote.
“Indeed, these findings suggest that such a mechanism is possible given the frequency of thickening of these structures in PsA” wrote Dr. Tinazzi and her associates. “It will be important to show that such changes are present in early PsA where their presence would support the idea of early biomechanical alterations in tendon function that could contribute to dactylitic tenosynovitis.”
This study received no external funding. Several of the researchers have received grants or honoraria from pharmaceutical companies.
SOURCE: Tinazzi I et al. Ann Rheum Dis. 2018 Mar 6. doi: 10.1136/annrheumdis-2017-212681.
An ultrasonographic study describing the greater presence of thicker digital accessory pulleys in patients with psoriatic arthritis (PsA) than in those with only psoriatic skin disease, rheumatoid arthritis, or no pathology has lent more evidence for a “deep Koebner” response mechanism in the development of joint disease in people with psoriasis.
“The thicker pulleys in RA compared with HCs [healthy controls] might point towards a nonspecific effect of a chronic autoimmune tenosynovitis on the adjacent pulleys,” Ilaria Tinazzi, PhD, of the Sacro Cuore-Don Calabria Hospital, Verona, Italy, and her colleagues wrote in Annals of the Rheumatic Diseases. “However, the greater magnitude of pulley thickening in PsA, especially in the setting of dactylitis, suggests an intrinsic pathology in the pulley contributing to PsA-related tenosynovitis.”
Dr. Tinazzi and her research team found that the pulleys in patients with PsA were thicker in every digit than they were in patients with RA and healthy controls, but pulley thickness also differed for each group of patients when compared with one another. Patients with RA had thicker pulleys than did healthy controls, particularly in the A1 pulley, but showed no differences in the A2 and A4 pulleys of the second and fourth digit. Even patients with only psoriasis had thicker pulleys than did the healthy controls. Patients with PsA exhibited thicker A1 and A4 pulleys, compared with patients with only psoriasis, while A2 pulleys displayed no statistical difference. Among PsA patients, 165 of 243 (68%) pulleys were thickened, whereas only 41 of 243 (17%) were thickened among RA patients (P less than .001). A multiple-regression analysis revealed that only PsA was associated with the number of thickened pulleys (odds ratio, 4.8; 95% confidence interval, 3.3-6.3; P = .001).
The size of the study population and the method for defining pulley thickness limited the study. Measurements were taken only in three digits of the dominant hand of each patient. Among PsA patients, only those with hand involvement participated in the study, which may limit the translation of the results to all PsA patients. Additionally, whether pulley changes trigger PsA tenosynovitis or whether it is a reactive process needs additional investigation.
The results of the study suggest that accessory pulleys are subjected to high physical stress and that they exhibit deep Koebner effects and thicken in response, Dr. Tinazzi and her associates wrote.
“Indeed, these findings suggest that such a mechanism is possible given the frequency of thickening of these structures in PsA” wrote Dr. Tinazzi and her associates. “It will be important to show that such changes are present in early PsA where their presence would support the idea of early biomechanical alterations in tendon function that could contribute to dactylitic tenosynovitis.”
This study received no external funding. Several of the researchers have received grants or honoraria from pharmaceutical companies.
SOURCE: Tinazzi I et al. Ann Rheum Dis. 2018 Mar 6. doi: 10.1136/annrheumdis-2017-212681.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point: Patients with psoriatic arthritis have thicker accessory pulleys in their digits than do those with rheumatoid arthritis, psoriasis only, or no inflammatory rheumatologic disease.
Major finding: More accessory pulleys were thickened in the PsA group than in the rheumatoid arthritis group (68% vs. 17%; P less than .001).
Study details: An ultrasonographic study of digital pulley thickness in 96 patients with PsA, RA, psoriasis only, or no inflammatory rheumatologic disease.
Disclosures: This study received no external funding. Several of the researchers have received grants or honoraria from pharmaceutical companies.
Source: Tinazzi I et al. Ann Rheum Dis. 2018 Mar 6. doi: 10.1136/annrheumdis-2017-212681.
Bariatric surgery may adversely affect newborns
Bariatric surgery can offer a variety of benefits to mothers and improve neonatal outcomes but also offers substantial risk, according to a systematic literature review.
“Bariatric surgery, with patients matched for presurgery body mass index [BMI], resulted in a reduction in gestational diabetes mellitus, large-for-gestational-age infants, large babies (composite of large for gestational age and macrosomia), gestational hypertension, all hypertensive disorders, postpartum hemorrhage, and cesarean delivery rates,” wrote Wilson Kwong, MD, of the University of Toronto, and his colleagues. “However, there was an increase in small-for-gestational age infants, intrauterine growth restriction, small babies (composite of small for gestational age and intrauterine growth restriction), and preterm deliveries.”
Dr. Kwong and his research team developed this study to investigate the benefits and risks of bariatric surgery on neonatal outcomes. They designed a systematic review that involved a literature search of 2,616 abstracts using MEDLINE, Embase, Cochrane, Web of Science, and PubMed. They searched all from initiation of the databases to Dec. 12, 2016. Ultimately, this yielded 20 cohort studies and approximately 2.8 million subjects for review and meta-analysis. From this data, pooled odds ratios were estimated, as well as the number needed to benefit (NNTB) and the number need to harm (NNTH) to display the pooled absolute risk difference.
The results of the primary analysis, in which BMIs were similar between control subjects and the presurgery BMIs of women receiving treatment, yielded positives for mothers who underwent bariatric surgery and their newborns. As stated by Dr. Kwong and his research team, newborns were less likely to be large-for-gestational-age babies or deal with macrosomia (odds ratio, 0.36; 95% confidence interval, 0.20-0.66; NNTB, 7) and mothers were less likely to experience hypertensive disorders (OR, 0.38; 95% CI, 0.27-0.53, NNTB, 8) and postpartum hemorrhage (OR, 0.32; 95% CI, 0.08-1.37; NNTB, 9).
Despite the positives, the risk for harm was higher in a number of outcomes. Babies were more likely to be small for gestational age, have intrauterine growth restriction (OR, 2.16; 95% CI, 1.34-3.48; NNTH, 21) ,and be delivered preterm (OR, 1.35; 95% CI, 1.02-1.79; NNTH, 35).
A secondary analysis revealed that malabsorptive surgeries resulted in a significantly greater decrease (P = .012) in large babies (OR, 0.28; 95% CI, 0.22-0.36), compared with restrictive surgeries (OR, 0.50; 95% CI, 0.35-0.73). This analysis also revealed that malabsorptive bariatric surgeries corresponded to an increase in the number of small babies (OR, 2.39; 95% CI, 1.94-2.94; P = .023).
The increased risk of smaller babies may be caused by micronutrient deficiencies in pregnancy, according to Dr. Kwong. Nutritional deficiencies are reported in up to 80% of bariatric surgery patients, malabsorptive patients in particular.
“Common nutrient deficiencies after bariatric surgery include protein, B vitamins, fat-soluble vitamins, essential fatty acids, and minerals (zinc and copper), which may persist throughout pregnancy,” wrote Dr. Kwong and his colleagues.
Similar nutrient deficiencies have been identified in a case study of a woman who underwent a duodenal switch published in the Journal of Obstetrics & Gynaecology Canada. After several failed pregnancies from complications from malnutrition, the patient presented herself to physicians 10 weeks into her next pregnancy and was found to be deficient in vitamins A, D, E, and K, and minerals iron and zinc. After supplementation with a daily nutritional drink containing vitamins and protein, her vitamin levels were near normal at week 24. She eventually delivered a healthy newborn with normal-appearing features. The researchers from this study recommended that patients seeking bariatric surgery should avoid malabsorptive surgeries and defer to less extreme surgical methods.
A strength of the systematic review was the matching of studies based on presurgery and prepregnancy BMI. This was a departure from previous studies that combined all studies. Additionally, this study compared the outcomes based on the type of data source that was used. Despite these strengths, the design and results of the studies in the analysis limited the results of the review. None of the included studies were randomized; instead, they consisted of observational cohort studies, which are prone for confounding by indication.
“In counseling patients of childbearing potential who are interested in pursuing bariatric surgery, a discussion of both possible benefits and risks on pregnancy outcomes must take place,” cautioned Dr. Kwong and his associates. “Future studies should explore the causes of these potential adverse pregnancy outcomes and develop strategies that may prevent them.”
All authors affiliated with the study had no relevant financial conflicts of interest to report.
SOURCE: Kwong W et al. Am J Obstet Gynecol. 2018 Feb 15. doi: 10.1016/j.ajog.2018.02.003.
Bariatric surgery can offer a variety of benefits to mothers and improve neonatal outcomes but also offers substantial risk, according to a systematic literature review.
“Bariatric surgery, with patients matched for presurgery body mass index [BMI], resulted in a reduction in gestational diabetes mellitus, large-for-gestational-age infants, large babies (composite of large for gestational age and macrosomia), gestational hypertension, all hypertensive disorders, postpartum hemorrhage, and cesarean delivery rates,” wrote Wilson Kwong, MD, of the University of Toronto, and his colleagues. “However, there was an increase in small-for-gestational age infants, intrauterine growth restriction, small babies (composite of small for gestational age and intrauterine growth restriction), and preterm deliveries.”
Dr. Kwong and his research team developed this study to investigate the benefits and risks of bariatric surgery on neonatal outcomes. They designed a systematic review that involved a literature search of 2,616 abstracts using MEDLINE, Embase, Cochrane, Web of Science, and PubMed. They searched all from initiation of the databases to Dec. 12, 2016. Ultimately, this yielded 20 cohort studies and approximately 2.8 million subjects for review and meta-analysis. From this data, pooled odds ratios were estimated, as well as the number needed to benefit (NNTB) and the number need to harm (NNTH) to display the pooled absolute risk difference.
The results of the primary analysis, in which BMIs were similar between control subjects and the presurgery BMIs of women receiving treatment, yielded positives for mothers who underwent bariatric surgery and their newborns. As stated by Dr. Kwong and his research team, newborns were less likely to be large-for-gestational-age babies or deal with macrosomia (odds ratio, 0.36; 95% confidence interval, 0.20-0.66; NNTB, 7) and mothers were less likely to experience hypertensive disorders (OR, 0.38; 95% CI, 0.27-0.53, NNTB, 8) and postpartum hemorrhage (OR, 0.32; 95% CI, 0.08-1.37; NNTB, 9).
Despite the positives, the risk for harm was higher in a number of outcomes. Babies were more likely to be small for gestational age, have intrauterine growth restriction (OR, 2.16; 95% CI, 1.34-3.48; NNTH, 21) ,and be delivered preterm (OR, 1.35; 95% CI, 1.02-1.79; NNTH, 35).
A secondary analysis revealed that malabsorptive surgeries resulted in a significantly greater decrease (P = .012) in large babies (OR, 0.28; 95% CI, 0.22-0.36), compared with restrictive surgeries (OR, 0.50; 95% CI, 0.35-0.73). This analysis also revealed that malabsorptive bariatric surgeries corresponded to an increase in the number of small babies (OR, 2.39; 95% CI, 1.94-2.94; P = .023).
The increased risk of smaller babies may be caused by micronutrient deficiencies in pregnancy, according to Dr. Kwong. Nutritional deficiencies are reported in up to 80% of bariatric surgery patients, malabsorptive patients in particular.
“Common nutrient deficiencies after bariatric surgery include protein, B vitamins, fat-soluble vitamins, essential fatty acids, and minerals (zinc and copper), which may persist throughout pregnancy,” wrote Dr. Kwong and his colleagues.
Similar nutrient deficiencies have been identified in a case study of a woman who underwent a duodenal switch published in the Journal of Obstetrics & Gynaecology Canada. After several failed pregnancies from complications from malnutrition, the patient presented herself to physicians 10 weeks into her next pregnancy and was found to be deficient in vitamins A, D, E, and K, and minerals iron and zinc. After supplementation with a daily nutritional drink containing vitamins and protein, her vitamin levels were near normal at week 24. She eventually delivered a healthy newborn with normal-appearing features. The researchers from this study recommended that patients seeking bariatric surgery should avoid malabsorptive surgeries and defer to less extreme surgical methods.
A strength of the systematic review was the matching of studies based on presurgery and prepregnancy BMI. This was a departure from previous studies that combined all studies. Additionally, this study compared the outcomes based on the type of data source that was used. Despite these strengths, the design and results of the studies in the analysis limited the results of the review. None of the included studies were randomized; instead, they consisted of observational cohort studies, which are prone for confounding by indication.
“In counseling patients of childbearing potential who are interested in pursuing bariatric surgery, a discussion of both possible benefits and risks on pregnancy outcomes must take place,” cautioned Dr. Kwong and his associates. “Future studies should explore the causes of these potential adverse pregnancy outcomes and develop strategies that may prevent them.”
All authors affiliated with the study had no relevant financial conflicts of interest to report.
SOURCE: Kwong W et al. Am J Obstet Gynecol. 2018 Feb 15. doi: 10.1016/j.ajog.2018.02.003.
Bariatric surgery can offer a variety of benefits to mothers and improve neonatal outcomes but also offers substantial risk, according to a systematic literature review.
“Bariatric surgery, with patients matched for presurgery body mass index [BMI], resulted in a reduction in gestational diabetes mellitus, large-for-gestational-age infants, large babies (composite of large for gestational age and macrosomia), gestational hypertension, all hypertensive disorders, postpartum hemorrhage, and cesarean delivery rates,” wrote Wilson Kwong, MD, of the University of Toronto, and his colleagues. “However, there was an increase in small-for-gestational age infants, intrauterine growth restriction, small babies (composite of small for gestational age and intrauterine growth restriction), and preterm deliveries.”
Dr. Kwong and his research team developed this study to investigate the benefits and risks of bariatric surgery on neonatal outcomes. They designed a systematic review that involved a literature search of 2,616 abstracts using MEDLINE, Embase, Cochrane, Web of Science, and PubMed. They searched all from initiation of the databases to Dec. 12, 2016. Ultimately, this yielded 20 cohort studies and approximately 2.8 million subjects for review and meta-analysis. From this data, pooled odds ratios were estimated, as well as the number needed to benefit (NNTB) and the number need to harm (NNTH) to display the pooled absolute risk difference.
The results of the primary analysis, in which BMIs were similar between control subjects and the presurgery BMIs of women receiving treatment, yielded positives for mothers who underwent bariatric surgery and their newborns. As stated by Dr. Kwong and his research team, newborns were less likely to be large-for-gestational-age babies or deal with macrosomia (odds ratio, 0.36; 95% confidence interval, 0.20-0.66; NNTB, 7) and mothers were less likely to experience hypertensive disorders (OR, 0.38; 95% CI, 0.27-0.53, NNTB, 8) and postpartum hemorrhage (OR, 0.32; 95% CI, 0.08-1.37; NNTB, 9).
Despite the positives, the risk for harm was higher in a number of outcomes. Babies were more likely to be small for gestational age, have intrauterine growth restriction (OR, 2.16; 95% CI, 1.34-3.48; NNTH, 21) ,and be delivered preterm (OR, 1.35; 95% CI, 1.02-1.79; NNTH, 35).
A secondary analysis revealed that malabsorptive surgeries resulted in a significantly greater decrease (P = .012) in large babies (OR, 0.28; 95% CI, 0.22-0.36), compared with restrictive surgeries (OR, 0.50; 95% CI, 0.35-0.73). This analysis also revealed that malabsorptive bariatric surgeries corresponded to an increase in the number of small babies (OR, 2.39; 95% CI, 1.94-2.94; P = .023).
The increased risk of smaller babies may be caused by micronutrient deficiencies in pregnancy, according to Dr. Kwong. Nutritional deficiencies are reported in up to 80% of bariatric surgery patients, malabsorptive patients in particular.
“Common nutrient deficiencies after bariatric surgery include protein, B vitamins, fat-soluble vitamins, essential fatty acids, and minerals (zinc and copper), which may persist throughout pregnancy,” wrote Dr. Kwong and his colleagues.
Similar nutrient deficiencies have been identified in a case study of a woman who underwent a duodenal switch published in the Journal of Obstetrics & Gynaecology Canada. After several failed pregnancies from complications from malnutrition, the patient presented herself to physicians 10 weeks into her next pregnancy and was found to be deficient in vitamins A, D, E, and K, and minerals iron and zinc. After supplementation with a daily nutritional drink containing vitamins and protein, her vitamin levels were near normal at week 24. She eventually delivered a healthy newborn with normal-appearing features. The researchers from this study recommended that patients seeking bariatric surgery should avoid malabsorptive surgeries and defer to less extreme surgical methods.
A strength of the systematic review was the matching of studies based on presurgery and prepregnancy BMI. This was a departure from previous studies that combined all studies. Additionally, this study compared the outcomes based on the type of data source that was used. Despite these strengths, the design and results of the studies in the analysis limited the results of the review. None of the included studies were randomized; instead, they consisted of observational cohort studies, which are prone for confounding by indication.
“In counseling patients of childbearing potential who are interested in pursuing bariatric surgery, a discussion of both possible benefits and risks on pregnancy outcomes must take place,” cautioned Dr. Kwong and his associates. “Future studies should explore the causes of these potential adverse pregnancy outcomes and develop strategies that may prevent them.”
All authors affiliated with the study had no relevant financial conflicts of interest to report.
SOURCE: Kwong W et al. Am J Obstet Gynecol. 2018 Feb 15. doi: 10.1016/j.ajog.2018.02.003.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Key clinical point: Bariatric surgery can offer a variety of benefits to mothers and improve neonatal outcomes but also offers substantial risk.
Major finding: Babies were more likely to be small (OR, 2.16; 95% CI, 1.34-3.48; number needed to harm, 21) and be delivered preterm (OR, 1.35; 95% CI, 1.02-1.79; NNTH, 35).
Study details: A systematic literature search of 20 cohort studies and approximately 2.8 million subjects using MEDLINE, Embase, Cochrane, Web of Science, and PubMed from the date of the databases’ inception to Dec. 12, 2016.
Disclosures: All authors affiliated with the study had no relevant financial conflicts of interest to report.
Source: Kwong W et al. Am J Obstet Gynecol. 2018 Feb 15. doi: 10.1016/j.ajog.2018.02.003.
FDA approves continuous glucose monitor with AI assistant
between the ages of 14 and 75 years old.
The first CGM to use artificial intelligence for this purpose, the Guardian Connect system is intended to help people with diabetes who use multiple daily injections of insulin to manage their diabetes by helping them prevent hyperglycemia and hypoglycemia, according to a statement from Medtronic.
Guardian Connect utilizes a predictive algorithm that alerts patients of significant swings in blood glucose levels up to 60 minutes prior to the event. When combined with the Guardian Sensor 3, which is placed on the abdomen to monitor blood glucose levels, the Guardian Connect system was accurate and was able to alert patients about 98.5% of hypoglycemic events, according to the results of a clinical trial. This information can also be shared and monitored with care takers and family member in real time or via text message.
Perhaps the most intriguing aspect of using the Guardian Connect system is exclusive access to the Sugar.IQ smart diabetes assistant. Utilizing artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how patient’s blood glucose levels respond to factors like food intake, insulin dosages, and daily routines. The combination of continuous monitoring and real-time analysis may be able to identify patterns and lead to personalized insights that will help patients with diabetes keep their blood glucose levels under control.
“Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors,” Timothy Bailey, MD, the director of the AMCR Institute and a clinical associate professor at University of California, San Diego, said in a statement. “Newer sensors paired with intelligent algorithms that help to both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensible for people who inject insulin. Greater utilization of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia,” he said.
Similar products have been approved in the last 6 months, but they have not utilized artificial intelligence and continuous analysis.
No serious adverse events were reported in the clinical trial of Guardian Connect, but less serious adverse events were observed, including gastroenteritis, upper respiratory infection, worsening of benign prostatic hyperplasia, rash, and blisters.
Guardian Connect should be available commercially sometime this summer.
between the ages of 14 and 75 years old.
The first CGM to use artificial intelligence for this purpose, the Guardian Connect system is intended to help people with diabetes who use multiple daily injections of insulin to manage their diabetes by helping them prevent hyperglycemia and hypoglycemia, according to a statement from Medtronic.
Guardian Connect utilizes a predictive algorithm that alerts patients of significant swings in blood glucose levels up to 60 minutes prior to the event. When combined with the Guardian Sensor 3, which is placed on the abdomen to monitor blood glucose levels, the Guardian Connect system was accurate and was able to alert patients about 98.5% of hypoglycemic events, according to the results of a clinical trial. This information can also be shared and monitored with care takers and family member in real time or via text message.
Perhaps the most intriguing aspect of using the Guardian Connect system is exclusive access to the Sugar.IQ smart diabetes assistant. Utilizing artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how patient’s blood glucose levels respond to factors like food intake, insulin dosages, and daily routines. The combination of continuous monitoring and real-time analysis may be able to identify patterns and lead to personalized insights that will help patients with diabetes keep their blood glucose levels under control.
“Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors,” Timothy Bailey, MD, the director of the AMCR Institute and a clinical associate professor at University of California, San Diego, said in a statement. “Newer sensors paired with intelligent algorithms that help to both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensible for people who inject insulin. Greater utilization of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia,” he said.
Similar products have been approved in the last 6 months, but they have not utilized artificial intelligence and continuous analysis.
No serious adverse events were reported in the clinical trial of Guardian Connect, but less serious adverse events were observed, including gastroenteritis, upper respiratory infection, worsening of benign prostatic hyperplasia, rash, and blisters.
Guardian Connect should be available commercially sometime this summer.
between the ages of 14 and 75 years old.
The first CGM to use artificial intelligence for this purpose, the Guardian Connect system is intended to help people with diabetes who use multiple daily injections of insulin to manage their diabetes by helping them prevent hyperglycemia and hypoglycemia, according to a statement from Medtronic.
Guardian Connect utilizes a predictive algorithm that alerts patients of significant swings in blood glucose levels up to 60 minutes prior to the event. When combined with the Guardian Sensor 3, which is placed on the abdomen to monitor blood glucose levels, the Guardian Connect system was accurate and was able to alert patients about 98.5% of hypoglycemic events, according to the results of a clinical trial. This information can also be shared and monitored with care takers and family member in real time or via text message.
Perhaps the most intriguing aspect of using the Guardian Connect system is exclusive access to the Sugar.IQ smart diabetes assistant. Utilizing artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how patient’s blood glucose levels respond to factors like food intake, insulin dosages, and daily routines. The combination of continuous monitoring and real-time analysis may be able to identify patterns and lead to personalized insights that will help patients with diabetes keep their blood glucose levels under control.
“Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors,” Timothy Bailey, MD, the director of the AMCR Institute and a clinical associate professor at University of California, San Diego, said in a statement. “Newer sensors paired with intelligent algorithms that help to both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensible for people who inject insulin. Greater utilization of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia,” he said.
Similar products have been approved in the last 6 months, but they have not utilized artificial intelligence and continuous analysis.
No serious adverse events were reported in the clinical trial of Guardian Connect, but less serious adverse events were observed, including gastroenteritis, upper respiratory infection, worsening of benign prostatic hyperplasia, rash, and blisters.
Guardian Connect should be available commercially sometime this summer.
Tofacitinib: FDA panel recommends ulcerative colitis indication
SILVER SPRING, MD. – Federal advisors to the Food and Drug Administration on March 8 voted unanimously to recommend approval of an additional indication for tofacitinib (Xeljanz), this time for ulcerative colitis.
Members of the Gastrointestinal Drugs Advisory Committee unanimously voted to recommend two different dosing regimens: 10 mg twice daily for 16 weeks in patients who have not experienced a therapeutic benefit after 8 weeks of treatment, as well as 10 mg twice daily for patients who have an inadequate or loss of response to TNF-blocker therapy, based on the results of several phase 3 clinical trials.
The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials (N Engl J Med 2017;376:1723-36), including a phase 2 study; two identical phase 3 induction trials (OCTAVE Induction 1 and OCTAVE Induction 2); a 53-week, phase 3 maintenance trial (OCTAVE Sustain); and an open-label extension study.
The induction trials enrolled a total of 1,139 patients with moderate to severe UC. Patients in both studies were administered tofacitinib 10 mg twice daily or placebo and were assessed after 8 weeks to judge clinical response. Patients in both studies displayed notable remission rates (18.5% and 16.6%), compared with placebo, according to Eric Maller, MD, executive director of the UC development program at Pfizer.
Patients who did not achieve remission but showed some clinical response (decrease in Mayo score of at least 3 points) were then enrolled in the 53-week OCTAVE Sustain, where they were randomized to receive tofacitinib 10 mg twice daily, 5 mg twice daily, or placebo.
During maintenance treatment, both 5-mg and 10-mg doses demonstrated substantial treatment benefits, with 32.4% and 41.0% of patients achieving remission, an increase of 22.0% and 30.7%, compared with placebo, respectively.
As part of the maintenance study, Pfizer analyzed patients with or without prior tumor necrosis factor–blocker failure. This analysis revealed that patients who had previously failed TNF-blocker therapy experienced a greater treatment benefit than those who had not. While the benefit was noticeable in both dosage groups, patients taking the 10-mg dose experienced the greatest benefit, with 70% increase in remission rates, 39% increase in mucosal healing, and 75% increase in steroid-free remission among baseline remitters, compared with patients in the 5-mg group, Dr. Maller said.
Researchers also looked at a subgroup of 295 patients who had no clinical response to tofacitinib 10 mg twice daily after 8 weeks and subsequently treated them for an additional 8 weeks, as part of an open-label extension study. After the additional 8 weeks of treatment, over half (51.2%) displayed clinical responses and 8.6% were in remission.
“This is a desperate patient population. These are impressive results,” stated Darrell Pardi, MD, vice chair of the advisory committee and professor of medicine at the Mayo Clinic, Rochester, Minn.
Serious adverse events were seen in 4% of tofacitinib-treated patients in the induction trials, compared with 6% of placebo-treated patients, according to Lesley Hanes, MD, medical officer with the FDA Center for Drug Evaluation and Research.
Adverse events appeared to be dose dependent, with risk of deaths and malignancies (excluding nonmelanoma skin cancer), opportunistic infections, herpes zoster infection, “possible” drug-induced liver injury, and cardiovascular and thromboembolic events more common with the 10-mg dose, Dr. Hanes said.
“I think the safety concerns, though, they are dose dependent, the difference between the 5 [mg] and 10 [mg] were not large,” according to Dr. Pardi. “Several of these are mitigatable by dermatologic exam or, hopefully, a vaccine.”
Several of the advisory committee members submitted conflict of interest waivers. Chair Jean-Pierre Raufman, MD, and vice chair Darrell Pardi, MD, disclosed funding from competing pharmaceutical manufacturers.
Visit www.gastro.org/IBD for patient education guides that you can share with your ulcerative colitis patients.
SILVER SPRING, MD. – Federal advisors to the Food and Drug Administration on March 8 voted unanimously to recommend approval of an additional indication for tofacitinib (Xeljanz), this time for ulcerative colitis.
Members of the Gastrointestinal Drugs Advisory Committee unanimously voted to recommend two different dosing regimens: 10 mg twice daily for 16 weeks in patients who have not experienced a therapeutic benefit after 8 weeks of treatment, as well as 10 mg twice daily for patients who have an inadequate or loss of response to TNF-blocker therapy, based on the results of several phase 3 clinical trials.
The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials (N Engl J Med 2017;376:1723-36), including a phase 2 study; two identical phase 3 induction trials (OCTAVE Induction 1 and OCTAVE Induction 2); a 53-week, phase 3 maintenance trial (OCTAVE Sustain); and an open-label extension study.
The induction trials enrolled a total of 1,139 patients with moderate to severe UC. Patients in both studies were administered tofacitinib 10 mg twice daily or placebo and were assessed after 8 weeks to judge clinical response. Patients in both studies displayed notable remission rates (18.5% and 16.6%), compared with placebo, according to Eric Maller, MD, executive director of the UC development program at Pfizer.
Patients who did not achieve remission but showed some clinical response (decrease in Mayo score of at least 3 points) were then enrolled in the 53-week OCTAVE Sustain, where they were randomized to receive tofacitinib 10 mg twice daily, 5 mg twice daily, or placebo.
During maintenance treatment, both 5-mg and 10-mg doses demonstrated substantial treatment benefits, with 32.4% and 41.0% of patients achieving remission, an increase of 22.0% and 30.7%, compared with placebo, respectively.
As part of the maintenance study, Pfizer analyzed patients with or without prior tumor necrosis factor–blocker failure. This analysis revealed that patients who had previously failed TNF-blocker therapy experienced a greater treatment benefit than those who had not. While the benefit was noticeable in both dosage groups, patients taking the 10-mg dose experienced the greatest benefit, with 70% increase in remission rates, 39% increase in mucosal healing, and 75% increase in steroid-free remission among baseline remitters, compared with patients in the 5-mg group, Dr. Maller said.
Researchers also looked at a subgroup of 295 patients who had no clinical response to tofacitinib 10 mg twice daily after 8 weeks and subsequently treated them for an additional 8 weeks, as part of an open-label extension study. After the additional 8 weeks of treatment, over half (51.2%) displayed clinical responses and 8.6% were in remission.
“This is a desperate patient population. These are impressive results,” stated Darrell Pardi, MD, vice chair of the advisory committee and professor of medicine at the Mayo Clinic, Rochester, Minn.
Serious adverse events were seen in 4% of tofacitinib-treated patients in the induction trials, compared with 6% of placebo-treated patients, according to Lesley Hanes, MD, medical officer with the FDA Center for Drug Evaluation and Research.
Adverse events appeared to be dose dependent, with risk of deaths and malignancies (excluding nonmelanoma skin cancer), opportunistic infections, herpes zoster infection, “possible” drug-induced liver injury, and cardiovascular and thromboembolic events more common with the 10-mg dose, Dr. Hanes said.
“I think the safety concerns, though, they are dose dependent, the difference between the 5 [mg] and 10 [mg] were not large,” according to Dr. Pardi. “Several of these are mitigatable by dermatologic exam or, hopefully, a vaccine.”
Several of the advisory committee members submitted conflict of interest waivers. Chair Jean-Pierre Raufman, MD, and vice chair Darrell Pardi, MD, disclosed funding from competing pharmaceutical manufacturers.
Visit www.gastro.org/IBD for patient education guides that you can share with your ulcerative colitis patients.
SILVER SPRING, MD. – Federal advisors to the Food and Drug Administration on March 8 voted unanimously to recommend approval of an additional indication for tofacitinib (Xeljanz), this time for ulcerative colitis.
Members of the Gastrointestinal Drugs Advisory Committee unanimously voted to recommend two different dosing regimens: 10 mg twice daily for 16 weeks in patients who have not experienced a therapeutic benefit after 8 weeks of treatment, as well as 10 mg twice daily for patients who have an inadequate or loss of response to TNF-blocker therapy, based on the results of several phase 3 clinical trials.
The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials (N Engl J Med 2017;376:1723-36), including a phase 2 study; two identical phase 3 induction trials (OCTAVE Induction 1 and OCTAVE Induction 2); a 53-week, phase 3 maintenance trial (OCTAVE Sustain); and an open-label extension study.
The induction trials enrolled a total of 1,139 patients with moderate to severe UC. Patients in both studies were administered tofacitinib 10 mg twice daily or placebo and were assessed after 8 weeks to judge clinical response. Patients in both studies displayed notable remission rates (18.5% and 16.6%), compared with placebo, according to Eric Maller, MD, executive director of the UC development program at Pfizer.
Patients who did not achieve remission but showed some clinical response (decrease in Mayo score of at least 3 points) were then enrolled in the 53-week OCTAVE Sustain, where they were randomized to receive tofacitinib 10 mg twice daily, 5 mg twice daily, or placebo.
During maintenance treatment, both 5-mg and 10-mg doses demonstrated substantial treatment benefits, with 32.4% and 41.0% of patients achieving remission, an increase of 22.0% and 30.7%, compared with placebo, respectively.
As part of the maintenance study, Pfizer analyzed patients with or without prior tumor necrosis factor–blocker failure. This analysis revealed that patients who had previously failed TNF-blocker therapy experienced a greater treatment benefit than those who had not. While the benefit was noticeable in both dosage groups, patients taking the 10-mg dose experienced the greatest benefit, with 70% increase in remission rates, 39% increase in mucosal healing, and 75% increase in steroid-free remission among baseline remitters, compared with patients in the 5-mg group, Dr. Maller said.
Researchers also looked at a subgroup of 295 patients who had no clinical response to tofacitinib 10 mg twice daily after 8 weeks and subsequently treated them for an additional 8 weeks, as part of an open-label extension study. After the additional 8 weeks of treatment, over half (51.2%) displayed clinical responses and 8.6% were in remission.
“This is a desperate patient population. These are impressive results,” stated Darrell Pardi, MD, vice chair of the advisory committee and professor of medicine at the Mayo Clinic, Rochester, Minn.
Serious adverse events were seen in 4% of tofacitinib-treated patients in the induction trials, compared with 6% of placebo-treated patients, according to Lesley Hanes, MD, medical officer with the FDA Center for Drug Evaluation and Research.
Adverse events appeared to be dose dependent, with risk of deaths and malignancies (excluding nonmelanoma skin cancer), opportunistic infections, herpes zoster infection, “possible” drug-induced liver injury, and cardiovascular and thromboembolic events more common with the 10-mg dose, Dr. Hanes said.
“I think the safety concerns, though, they are dose dependent, the difference between the 5 [mg] and 10 [mg] were not large,” according to Dr. Pardi. “Several of these are mitigatable by dermatologic exam or, hopefully, a vaccine.”
Several of the advisory committee members submitted conflict of interest waivers. Chair Jean-Pierre Raufman, MD, and vice chair Darrell Pardi, MD, disclosed funding from competing pharmaceutical manufacturers.
Visit www.gastro.org/IBD for patient education guides that you can share with your ulcerative colitis patients.
REPORTING FROM AN FDA ADVISORY COMMITTEE MEETING
Xeljanz: FDA panel recommends ulcerative colitis indication
SILVER SPRING, MD. – Federal advisors to the Food and Drug Administration on March 8 voted unanimously to recommend approval of an additional indication for tofacitinib (Xeljanz), this time for ulcerative colitis.
Members of the Gastrointestinal Drugs Advisory Committee unanimously voted to recommend two different dosing regimens: 10 mg twice daily for 16 weeks in patients who have not experienced a therapeutic benefit after 8 weeks of treatment, as well as 10 mg twice daily for patients who have an inadequate or loss of response to TNF-blocker therapy, based on the results of several phase 3 clinical trials.
The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials (N Engl J Med 2017;376:1723-36), including a phase 2 study, two identical phase 3 induction trials (OCTAVE Induction 1 and OCTAVE Induction 2), a 53-week, phase 3 maintenance trial (OCTAVE Sustain), and an open-label extension study.
The induction trials enrolled a total of 1,139 patients with moderate to severe UC. Patients in both studies were administered tofacitinib 10 mg twice daily or placebo and were assessed after 8 weeks to judge clinical response. Patients in both studies displayed notable remission rates (18.5% and 16.6%), compared with placebo, according to Eric Maller, MD, executive director of the UC development program at Pfizer.*
Patients who did not achieve remission, but showed some clinical response (decrease in Mayo score of at least 3 points), were then enrolled in the 53-week OCTAVE Sustain, where they were randomized to receive tofacitinib 10 mg twice daily, 5 mg twice daily, or placebo.
During maintenance treatment, both 5 mg and 10 mg doses demonstrated substantial treatment benefits, with 32.4% and 41.0% of patients achieving remission, an increase of 22.0% and 30.7%, compared with placebo, respectively.
As part of the maintenance study, Pfizer analyzed patients with or without prior TNF-blocker failure. This analysis revealed that patients who had previously failed TNF-blocker therapy experienced a greater treatment benefit than those who had not. While the benefit was noticeable in both dosage groups, patients taking the 10-mg dose experienced the greatest benefit, with 70% increase in remission rates, 39% increase in mucosal healing, and 75% increase in steroid-free remission among baseline remitters, compared with patients in the 5-mg group, Dr. Maller said.
Researchers also looked at a subgroup of 295 patients as part of an open-label extension study who had no clinical response to tofacitinib 10 mg twice daily after 8 weeks and subsequently treated them for an additional 8 weeks. After the additional 8 weeks of treatment, over half (51.2%) displayed clinical responses and 8.6% were in remission.
“This is a desperate patient population. These are impressive results,” stated Darrell Pardi, MD, vice chair of the advisory committee and professor of medicine at the Mayo Clinic, Rochester, Minn.
Serious adverse events were seen in 4% of tofacitinib-treated patients in the induction trials, compared with 6% of placebo-treated, according to Lesley Hanes, MD, medical officer with the FDA Center for Drug Evaluation and Research.
Adverse events appeared to be dose dependent, with risk of deaths and malignancies (excluding nonmelanoma skin cancer), opportunistic infections, herpes zoster infection (HZ), “possible” drug-induced liver injury, and cardiovascular and thromboembolic events more common with the 10-mg dose, Dr. Hanes said.
“I think the safety concerns, though, they are dose dependent, the difference between the 5 [mg] and 10 [mg] were not large,” according to Dr. Pardi. “Several of these are mitigatable by dermatologic exam or, hopefully, a vaccine.”
Several of the advisory committee members submitted conflict of interest waivers. Chair and vice chair Jean-Pierre Raufman, MD, and Darrell Pardi, MD, disclosed funding from competing pharmaceutical manufacturers.
*This article was updated on March 12, 2018.
SILVER SPRING, MD. – Federal advisors to the Food and Drug Administration on March 8 voted unanimously to recommend approval of an additional indication for tofacitinib (Xeljanz), this time for ulcerative colitis.
Members of the Gastrointestinal Drugs Advisory Committee unanimously voted to recommend two different dosing regimens: 10 mg twice daily for 16 weeks in patients who have not experienced a therapeutic benefit after 8 weeks of treatment, as well as 10 mg twice daily for patients who have an inadequate or loss of response to TNF-blocker therapy, based on the results of several phase 3 clinical trials.
The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials (N Engl J Med 2017;376:1723-36), including a phase 2 study, two identical phase 3 induction trials (OCTAVE Induction 1 and OCTAVE Induction 2), a 53-week, phase 3 maintenance trial (OCTAVE Sustain), and an open-label extension study.
The induction trials enrolled a total of 1,139 patients with moderate to severe UC. Patients in both studies were administered tofacitinib 10 mg twice daily or placebo and were assessed after 8 weeks to judge clinical response. Patients in both studies displayed notable remission rates (18.5% and 16.6%), compared with placebo, according to Eric Maller, MD, executive director of the UC development program at Pfizer.*
Patients who did not achieve remission, but showed some clinical response (decrease in Mayo score of at least 3 points), were then enrolled in the 53-week OCTAVE Sustain, where they were randomized to receive tofacitinib 10 mg twice daily, 5 mg twice daily, or placebo.
During maintenance treatment, both 5 mg and 10 mg doses demonstrated substantial treatment benefits, with 32.4% and 41.0% of patients achieving remission, an increase of 22.0% and 30.7%, compared with placebo, respectively.
As part of the maintenance study, Pfizer analyzed patients with or without prior TNF-blocker failure. This analysis revealed that patients who had previously failed TNF-blocker therapy experienced a greater treatment benefit than those who had not. While the benefit was noticeable in both dosage groups, patients taking the 10-mg dose experienced the greatest benefit, with 70% increase in remission rates, 39% increase in mucosal healing, and 75% increase in steroid-free remission among baseline remitters, compared with patients in the 5-mg group, Dr. Maller said.
Researchers also looked at a subgroup of 295 patients as part of an open-label extension study who had no clinical response to tofacitinib 10 mg twice daily after 8 weeks and subsequently treated them for an additional 8 weeks. After the additional 8 weeks of treatment, over half (51.2%) displayed clinical responses and 8.6% were in remission.
“This is a desperate patient population. These are impressive results,” stated Darrell Pardi, MD, vice chair of the advisory committee and professor of medicine at the Mayo Clinic, Rochester, Minn.
Serious adverse events were seen in 4% of tofacitinib-treated patients in the induction trials, compared with 6% of placebo-treated, according to Lesley Hanes, MD, medical officer with the FDA Center for Drug Evaluation and Research.
Adverse events appeared to be dose dependent, with risk of deaths and malignancies (excluding nonmelanoma skin cancer), opportunistic infections, herpes zoster infection (HZ), “possible” drug-induced liver injury, and cardiovascular and thromboembolic events more common with the 10-mg dose, Dr. Hanes said.
“I think the safety concerns, though, they are dose dependent, the difference between the 5 [mg] and 10 [mg] were not large,” according to Dr. Pardi. “Several of these are mitigatable by dermatologic exam or, hopefully, a vaccine.”
Several of the advisory committee members submitted conflict of interest waivers. Chair and vice chair Jean-Pierre Raufman, MD, and Darrell Pardi, MD, disclosed funding from competing pharmaceutical manufacturers.
*This article was updated on March 12, 2018.
SILVER SPRING, MD. – Federal advisors to the Food and Drug Administration on March 8 voted unanimously to recommend approval of an additional indication for tofacitinib (Xeljanz), this time for ulcerative colitis.
Members of the Gastrointestinal Drugs Advisory Committee unanimously voted to recommend two different dosing regimens: 10 mg twice daily for 16 weeks in patients who have not experienced a therapeutic benefit after 8 weeks of treatment, as well as 10 mg twice daily for patients who have an inadequate or loss of response to TNF-blocker therapy, based on the results of several phase 3 clinical trials.
The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials (N Engl J Med 2017;376:1723-36), including a phase 2 study, two identical phase 3 induction trials (OCTAVE Induction 1 and OCTAVE Induction 2), a 53-week, phase 3 maintenance trial (OCTAVE Sustain), and an open-label extension study.
The induction trials enrolled a total of 1,139 patients with moderate to severe UC. Patients in both studies were administered tofacitinib 10 mg twice daily or placebo and were assessed after 8 weeks to judge clinical response. Patients in both studies displayed notable remission rates (18.5% and 16.6%), compared with placebo, according to Eric Maller, MD, executive director of the UC development program at Pfizer.*
Patients who did not achieve remission, but showed some clinical response (decrease in Mayo score of at least 3 points), were then enrolled in the 53-week OCTAVE Sustain, where they were randomized to receive tofacitinib 10 mg twice daily, 5 mg twice daily, or placebo.
During maintenance treatment, both 5 mg and 10 mg doses demonstrated substantial treatment benefits, with 32.4% and 41.0% of patients achieving remission, an increase of 22.0% and 30.7%, compared with placebo, respectively.
As part of the maintenance study, Pfizer analyzed patients with or without prior TNF-blocker failure. This analysis revealed that patients who had previously failed TNF-blocker therapy experienced a greater treatment benefit than those who had not. While the benefit was noticeable in both dosage groups, patients taking the 10-mg dose experienced the greatest benefit, with 70% increase in remission rates, 39% increase in mucosal healing, and 75% increase in steroid-free remission among baseline remitters, compared with patients in the 5-mg group, Dr. Maller said.
Researchers also looked at a subgroup of 295 patients as part of an open-label extension study who had no clinical response to tofacitinib 10 mg twice daily after 8 weeks and subsequently treated them for an additional 8 weeks. After the additional 8 weeks of treatment, over half (51.2%) displayed clinical responses and 8.6% were in remission.
“This is a desperate patient population. These are impressive results,” stated Darrell Pardi, MD, vice chair of the advisory committee and professor of medicine at the Mayo Clinic, Rochester, Minn.
Serious adverse events were seen in 4% of tofacitinib-treated patients in the induction trials, compared with 6% of placebo-treated, according to Lesley Hanes, MD, medical officer with the FDA Center for Drug Evaluation and Research.
Adverse events appeared to be dose dependent, with risk of deaths and malignancies (excluding nonmelanoma skin cancer), opportunistic infections, herpes zoster infection (HZ), “possible” drug-induced liver injury, and cardiovascular and thromboembolic events more common with the 10-mg dose, Dr. Hanes said.
“I think the safety concerns, though, they are dose dependent, the difference between the 5 [mg] and 10 [mg] were not large,” according to Dr. Pardi. “Several of these are mitigatable by dermatologic exam or, hopefully, a vaccine.”
Several of the advisory committee members submitted conflict of interest waivers. Chair and vice chair Jean-Pierre Raufman, MD, and Darrell Pardi, MD, disclosed funding from competing pharmaceutical manufacturers.
*This article was updated on March 12, 2018.
REPORTING FROM AN FDA ADVISORY COMMITTEE MEETING
FDA approves new treatment for multidrug-resistant HIV
The Food and Drug Administration Feb. 6 approved ibalizumab-uiyk (Trogarzo) to treat multidrug-resistant HIV (MDR HIV) in adults, the agency announced.
“While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug-resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” Jeff Murray, MD, deputy director of the FDA Division of Antiviral Products, said in a statement. “Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.”
Ibalizumab-uiyk, an HIV-1 inhibitor, was approved based on the results of a phase 3, single-arm study of 40 patients with MDR-HIV-1 who had high virus levels in their blood despite antiretroviral treatment. To be included in the study, all patients had to have received highly active antiretroviral therapy for at least 6 months prior. Over 24 weeks, patients were monitored to compare previous, infective treatments with ibalizumab-uiyk in conjunction with an optimized background regimen of antiretroviral drugs.
The majority of patients showed a significant decrease in their HIV-RNA levels 1 week after ibalizumab-uiyk was added to their previous drug regimens. After 24 weeks of treatment with ibalizumab-uiyk, in conjunction with other antiretroviral drugs, 43% of patients achieved HIV RNA suppression.
Ibalizumab-uiyk was granted Fast Track, Priority Review, and Breakthrough Therapy designations from the FDA. In addition, it was granted Orphan Drug designation, a program that encourages the development of drugs to treat rare diseases.
Ibalizumab-uiyk is administered once every 14 days in conjunction with other retroviral medications.
The most common adverse reactions to ibalizumab-uiyk were diarrhea, dizziness, nausea, and rash. Less common, and more severe, reactions were changes in the immune system.
Ibalizumab-uiyk will be marketed by Taimed Biologics USA.
The Food and Drug Administration Feb. 6 approved ibalizumab-uiyk (Trogarzo) to treat multidrug-resistant HIV (MDR HIV) in adults, the agency announced.
“While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug-resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” Jeff Murray, MD, deputy director of the FDA Division of Antiviral Products, said in a statement. “Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.”
Ibalizumab-uiyk, an HIV-1 inhibitor, was approved based on the results of a phase 3, single-arm study of 40 patients with MDR-HIV-1 who had high virus levels in their blood despite antiretroviral treatment. To be included in the study, all patients had to have received highly active antiretroviral therapy for at least 6 months prior. Over 24 weeks, patients were monitored to compare previous, infective treatments with ibalizumab-uiyk in conjunction with an optimized background regimen of antiretroviral drugs.
The majority of patients showed a significant decrease in their HIV-RNA levels 1 week after ibalizumab-uiyk was added to their previous drug regimens. After 24 weeks of treatment with ibalizumab-uiyk, in conjunction with other antiretroviral drugs, 43% of patients achieved HIV RNA suppression.
Ibalizumab-uiyk was granted Fast Track, Priority Review, and Breakthrough Therapy designations from the FDA. In addition, it was granted Orphan Drug designation, a program that encourages the development of drugs to treat rare diseases.
Ibalizumab-uiyk is administered once every 14 days in conjunction with other retroviral medications.
The most common adverse reactions to ibalizumab-uiyk were diarrhea, dizziness, nausea, and rash. Less common, and more severe, reactions were changes in the immune system.
Ibalizumab-uiyk will be marketed by Taimed Biologics USA.
The Food and Drug Administration Feb. 6 approved ibalizumab-uiyk (Trogarzo) to treat multidrug-resistant HIV (MDR HIV) in adults, the agency announced.
“While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug-resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” Jeff Murray, MD, deputy director of the FDA Division of Antiviral Products, said in a statement. “Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.”
Ibalizumab-uiyk, an HIV-1 inhibitor, was approved based on the results of a phase 3, single-arm study of 40 patients with MDR-HIV-1 who had high virus levels in their blood despite antiretroviral treatment. To be included in the study, all patients had to have received highly active antiretroviral therapy for at least 6 months prior. Over 24 weeks, patients were monitored to compare previous, infective treatments with ibalizumab-uiyk in conjunction with an optimized background regimen of antiretroviral drugs.
The majority of patients showed a significant decrease in their HIV-RNA levels 1 week after ibalizumab-uiyk was added to their previous drug regimens. After 24 weeks of treatment with ibalizumab-uiyk, in conjunction with other antiretroviral drugs, 43% of patients achieved HIV RNA suppression.
Ibalizumab-uiyk was granted Fast Track, Priority Review, and Breakthrough Therapy designations from the FDA. In addition, it was granted Orphan Drug designation, a program that encourages the development of drugs to treat rare diseases.
Ibalizumab-uiyk is administered once every 14 days in conjunction with other retroviral medications.
The most common adverse reactions to ibalizumab-uiyk were diarrhea, dizziness, nausea, and rash. Less common, and more severe, reactions were changes in the immune system.
Ibalizumab-uiyk will be marketed by Taimed Biologics USA.
PICU, hospital admissions up due to opioid ingestion
Hospitalization and pediatric ICU admission rates for pediatric opioid-related ingestion are increasing, along with hospitalization costs, according to a retrospective cohort study.
“In this study, we demonstrate a significant and steady increase in the diagnosis of opioid ingestion and poisoning across all age groups in U.S. children’s hospitals from 2004 to 2015,” wrote Jason Kane, MD, of the University of Chicago, and his associates. “Not only did the absolute number of opioid-related admissions increase but the rate of both hospital and PICU [pediatric ICU] admissions increased as well.”
Using the Pediatric Health Information System database, the research team performed a retrospective cohort study of children aged 1-17 years who had been admitted to a PICU between Jan. 1, 2004, and Sep. 30, 2015. For statistical analysis, the years were grouped into separate epochs: 2004-2007, 2008-2011, and 2012-2015.
Of the 4,175,624 admissions to 31 different children’s hospitals around the United States, 3,647 (0.09%) were due to opioid-related conditions. Across the three epochs of the study, the number of opioid-related hospitalizations more than doubled from 797 to 1,504 and concurrently increased the rate of hospital admissions from 6.7 per 10,000 in 2004 to 10.9 per 10,000 in 2015 (P less than .001).
Similar to the trends in overall hospital admissions and hospital admission rates, admission to the PICU and PICU admission rates also increased. Of the 3,647 children admitted for opioid-related issues, 1,564 (43%) were subsequently admitted to the PICU. PICU admission rates also increased from 25 to 36 per 10,000 admissions (P less than .001).While the majority of opioid-related hospitalizations are associated with children aged 12-17 years, children under the age of 6 years accounted for one-third of these hospitalizations. Many PICU admissions are severe enough to warrant mechanical ventilator support (37%, P less than .001) and vasopressors (20%, P less than .001).
The opioids ingested prior to hospital admission varied between age groups, with 20% (243 of 1,249) patients aged 1-5 years ingesting methadone, compared with 10% (218 of 2,223) of patients aged 12-17 years. Heroin was much more common in this group, accounting for 4.4% (99 of 2,223) of patient hospitalizations.
In addition to the human cost of pediatric hospital admissions, there is a significant economic cost on the health care system. The median cost for PICU admission was $4,931. Although these costs have been dropping for the better part of a decade ($6,523 in 2004-2007 to $4,552 in 2012-2015, P less than .001), it still represents a substantial problem. In addition, admission rates are increasing, which will only place a heavier burden on the health care system, according to Dr. Kane and his associates.
Perhaps one positive point from this study is that although hospitalizations and intensive care rates have gone up, mortality decreased over time from 2.8% in 2004-2007 to 1.3% in 2012-2015.
A possible limitation of the data in this study is that it provides data from subjects whose data is accessible to the researcher, rather than those strategically selected. In addition, referral bias may reduce the ability to generalize the information to non–tertiary care children’s hospitals.
“The current U.S. opioid crisis is negatively impacting pediatric patients as the rate of hospitalization and PICU care for the ingestion of opioids by children continues to increase over time,” wrote Dr. Kane and his associates. “Current efforts to reduce prescription opioid use in adults have not curtailed the incidence of pediatric opioid ingestion, and additional efforts are needed to reduce preventable opioid exposure in children.”
This study had no external funding. Dr. Allison H. Bartlett has served as a consultant member of the CVS Caremark National Pharmacy and Therapeutics Committee. All other authors had no relevant financial disclosures to report.
SOURCE: Kane JM et al. Pediatrics. 2018 Mar 5;141(4):e20173335.
The opioid crisis in the United States is staggering. As of 2016, an estimated 2.4 million Americans were considered to have an opioid use disorder, either from prescription drug misuse or heroin addiction. This number includes 0.6% of adolescents (12- to 17-year-olds) and 1.1% of young adults (18- to 25-year-olds). And 33,000 Americans died from opioid overdose in 2015. Despite the best attempts to control the supply of drugs and increase access to treatment, overdose deaths have doubled in the past 10 years. While the overdose death rate has plateaued among children under the age of 18, and misuse rates have dropped among 12th graders, opioid-related hospitalizations are increasing in preschool-age children and adolescents.
Prior to the work of Kane et al., little was known about critical care resource usage among pediatric patients admitted to pediatric ICUs across the country. They found that hospitalization rates were up, with over one-third of patients requiring mechanical ventilation and about 20% needing vasopressors. Perhaps one of the most important findings is that methadone accounted for nearly 20% of opioids ingested, displaying how adults being treated for their own opioid use disorder can put the children they live with at risk.
As the opioid crisis has worsened and overdoses have increased, the Council of Economic Advisers attempted to measure the societal costs of opioid overdoses using the “value of a statistical life” analytic method. This considers activities other than just lost work productivity and earnings, such as volunteering and raising a family. Using the value of a statistical life method, the Council determined that the true cost to society was nearly $504 billion, which included both fatal and nonfatal overdoses, and is approximately 2.8% of the 2015 U.S. gross domestic product.
Clearly, opioid abuse is both an emotional and financial burden to individual families and society as a whole. Pediatricians must help combat the ongoing opioid crisis in this country by addressing the needs of pediatric patients.
Sheryl A. Ryan, MD, is a pediatrician at Penn State Health Children’s Hospital, Milton S. Hershey Medical Center in Hershey, Pa. She wrote this commentary to the article by Kane et al. (Pediatrics. 2018 Mar. 5;41(4):e20174129). There was no external funding for this commentary, and Dr. Ryan said she had no relevant financial disclosures.
The opioid crisis in the United States is staggering. As of 2016, an estimated 2.4 million Americans were considered to have an opioid use disorder, either from prescription drug misuse or heroin addiction. This number includes 0.6% of adolescents (12- to 17-year-olds) and 1.1% of young adults (18- to 25-year-olds). And 33,000 Americans died from opioid overdose in 2015. Despite the best attempts to control the supply of drugs and increase access to treatment, overdose deaths have doubled in the past 10 years. While the overdose death rate has plateaued among children under the age of 18, and misuse rates have dropped among 12th graders, opioid-related hospitalizations are increasing in preschool-age children and adolescents.
Prior to the work of Kane et al., little was known about critical care resource usage among pediatric patients admitted to pediatric ICUs across the country. They found that hospitalization rates were up, with over one-third of patients requiring mechanical ventilation and about 20% needing vasopressors. Perhaps one of the most important findings is that methadone accounted for nearly 20% of opioids ingested, displaying how adults being treated for their own opioid use disorder can put the children they live with at risk.
As the opioid crisis has worsened and overdoses have increased, the Council of Economic Advisers attempted to measure the societal costs of opioid overdoses using the “value of a statistical life” analytic method. This considers activities other than just lost work productivity and earnings, such as volunteering and raising a family. Using the value of a statistical life method, the Council determined that the true cost to society was nearly $504 billion, which included both fatal and nonfatal overdoses, and is approximately 2.8% of the 2015 U.S. gross domestic product.
Clearly, opioid abuse is both an emotional and financial burden to individual families and society as a whole. Pediatricians must help combat the ongoing opioid crisis in this country by addressing the needs of pediatric patients.
Sheryl A. Ryan, MD, is a pediatrician at Penn State Health Children’s Hospital, Milton S. Hershey Medical Center in Hershey, Pa. She wrote this commentary to the article by Kane et al. (Pediatrics. 2018 Mar. 5;41(4):e20174129). There was no external funding for this commentary, and Dr. Ryan said she had no relevant financial disclosures.
The opioid crisis in the United States is staggering. As of 2016, an estimated 2.4 million Americans were considered to have an opioid use disorder, either from prescription drug misuse or heroin addiction. This number includes 0.6% of adolescents (12- to 17-year-olds) and 1.1% of young adults (18- to 25-year-olds). And 33,000 Americans died from opioid overdose in 2015. Despite the best attempts to control the supply of drugs and increase access to treatment, overdose deaths have doubled in the past 10 years. While the overdose death rate has plateaued among children under the age of 18, and misuse rates have dropped among 12th graders, opioid-related hospitalizations are increasing in preschool-age children and adolescents.
Prior to the work of Kane et al., little was known about critical care resource usage among pediatric patients admitted to pediatric ICUs across the country. They found that hospitalization rates were up, with over one-third of patients requiring mechanical ventilation and about 20% needing vasopressors. Perhaps one of the most important findings is that methadone accounted for nearly 20% of opioids ingested, displaying how adults being treated for their own opioid use disorder can put the children they live with at risk.
As the opioid crisis has worsened and overdoses have increased, the Council of Economic Advisers attempted to measure the societal costs of opioid overdoses using the “value of a statistical life” analytic method. This considers activities other than just lost work productivity and earnings, such as volunteering and raising a family. Using the value of a statistical life method, the Council determined that the true cost to society was nearly $504 billion, which included both fatal and nonfatal overdoses, and is approximately 2.8% of the 2015 U.S. gross domestic product.
Clearly, opioid abuse is both an emotional and financial burden to individual families and society as a whole. Pediatricians must help combat the ongoing opioid crisis in this country by addressing the needs of pediatric patients.
Sheryl A. Ryan, MD, is a pediatrician at Penn State Health Children’s Hospital, Milton S. Hershey Medical Center in Hershey, Pa. She wrote this commentary to the article by Kane et al. (Pediatrics. 2018 Mar. 5;41(4):e20174129). There was no external funding for this commentary, and Dr. Ryan said she had no relevant financial disclosures.
Hospitalization and pediatric ICU admission rates for pediatric opioid-related ingestion are increasing, along with hospitalization costs, according to a retrospective cohort study.
“In this study, we demonstrate a significant and steady increase in the diagnosis of opioid ingestion and poisoning across all age groups in U.S. children’s hospitals from 2004 to 2015,” wrote Jason Kane, MD, of the University of Chicago, and his associates. “Not only did the absolute number of opioid-related admissions increase but the rate of both hospital and PICU [pediatric ICU] admissions increased as well.”
Using the Pediatric Health Information System database, the research team performed a retrospective cohort study of children aged 1-17 years who had been admitted to a PICU between Jan. 1, 2004, and Sep. 30, 2015. For statistical analysis, the years were grouped into separate epochs: 2004-2007, 2008-2011, and 2012-2015.
Of the 4,175,624 admissions to 31 different children’s hospitals around the United States, 3,647 (0.09%) were due to opioid-related conditions. Across the three epochs of the study, the number of opioid-related hospitalizations more than doubled from 797 to 1,504 and concurrently increased the rate of hospital admissions from 6.7 per 10,000 in 2004 to 10.9 per 10,000 in 2015 (P less than .001).
Similar to the trends in overall hospital admissions and hospital admission rates, admission to the PICU and PICU admission rates also increased. Of the 3,647 children admitted for opioid-related issues, 1,564 (43%) were subsequently admitted to the PICU. PICU admission rates also increased from 25 to 36 per 10,000 admissions (P less than .001).While the majority of opioid-related hospitalizations are associated with children aged 12-17 years, children under the age of 6 years accounted for one-third of these hospitalizations. Many PICU admissions are severe enough to warrant mechanical ventilator support (37%, P less than .001) and vasopressors (20%, P less than .001).
The opioids ingested prior to hospital admission varied between age groups, with 20% (243 of 1,249) patients aged 1-5 years ingesting methadone, compared with 10% (218 of 2,223) of patients aged 12-17 years. Heroin was much more common in this group, accounting for 4.4% (99 of 2,223) of patient hospitalizations.
In addition to the human cost of pediatric hospital admissions, there is a significant economic cost on the health care system. The median cost for PICU admission was $4,931. Although these costs have been dropping for the better part of a decade ($6,523 in 2004-2007 to $4,552 in 2012-2015, P less than .001), it still represents a substantial problem. In addition, admission rates are increasing, which will only place a heavier burden on the health care system, according to Dr. Kane and his associates.
Perhaps one positive point from this study is that although hospitalizations and intensive care rates have gone up, mortality decreased over time from 2.8% in 2004-2007 to 1.3% in 2012-2015.
A possible limitation of the data in this study is that it provides data from subjects whose data is accessible to the researcher, rather than those strategically selected. In addition, referral bias may reduce the ability to generalize the information to non–tertiary care children’s hospitals.
“The current U.S. opioid crisis is negatively impacting pediatric patients as the rate of hospitalization and PICU care for the ingestion of opioids by children continues to increase over time,” wrote Dr. Kane and his associates. “Current efforts to reduce prescription opioid use in adults have not curtailed the incidence of pediatric opioid ingestion, and additional efforts are needed to reduce preventable opioid exposure in children.”
This study had no external funding. Dr. Allison H. Bartlett has served as a consultant member of the CVS Caremark National Pharmacy and Therapeutics Committee. All other authors had no relevant financial disclosures to report.
SOURCE: Kane JM et al. Pediatrics. 2018 Mar 5;141(4):e20173335.
Hospitalization and pediatric ICU admission rates for pediatric opioid-related ingestion are increasing, along with hospitalization costs, according to a retrospective cohort study.
“In this study, we demonstrate a significant and steady increase in the diagnosis of opioid ingestion and poisoning across all age groups in U.S. children’s hospitals from 2004 to 2015,” wrote Jason Kane, MD, of the University of Chicago, and his associates. “Not only did the absolute number of opioid-related admissions increase but the rate of both hospital and PICU [pediatric ICU] admissions increased as well.”
Using the Pediatric Health Information System database, the research team performed a retrospective cohort study of children aged 1-17 years who had been admitted to a PICU between Jan. 1, 2004, and Sep. 30, 2015. For statistical analysis, the years were grouped into separate epochs: 2004-2007, 2008-2011, and 2012-2015.
Of the 4,175,624 admissions to 31 different children’s hospitals around the United States, 3,647 (0.09%) were due to opioid-related conditions. Across the three epochs of the study, the number of opioid-related hospitalizations more than doubled from 797 to 1,504 and concurrently increased the rate of hospital admissions from 6.7 per 10,000 in 2004 to 10.9 per 10,000 in 2015 (P less than .001).
Similar to the trends in overall hospital admissions and hospital admission rates, admission to the PICU and PICU admission rates also increased. Of the 3,647 children admitted for opioid-related issues, 1,564 (43%) were subsequently admitted to the PICU. PICU admission rates also increased from 25 to 36 per 10,000 admissions (P less than .001).While the majority of opioid-related hospitalizations are associated with children aged 12-17 years, children under the age of 6 years accounted for one-third of these hospitalizations. Many PICU admissions are severe enough to warrant mechanical ventilator support (37%, P less than .001) and vasopressors (20%, P less than .001).
The opioids ingested prior to hospital admission varied between age groups, with 20% (243 of 1,249) patients aged 1-5 years ingesting methadone, compared with 10% (218 of 2,223) of patients aged 12-17 years. Heroin was much more common in this group, accounting for 4.4% (99 of 2,223) of patient hospitalizations.
In addition to the human cost of pediatric hospital admissions, there is a significant economic cost on the health care system. The median cost for PICU admission was $4,931. Although these costs have been dropping for the better part of a decade ($6,523 in 2004-2007 to $4,552 in 2012-2015, P less than .001), it still represents a substantial problem. In addition, admission rates are increasing, which will only place a heavier burden on the health care system, according to Dr. Kane and his associates.
Perhaps one positive point from this study is that although hospitalizations and intensive care rates have gone up, mortality decreased over time from 2.8% in 2004-2007 to 1.3% in 2012-2015.
A possible limitation of the data in this study is that it provides data from subjects whose data is accessible to the researcher, rather than those strategically selected. In addition, referral bias may reduce the ability to generalize the information to non–tertiary care children’s hospitals.
“The current U.S. opioid crisis is negatively impacting pediatric patients as the rate of hospitalization and PICU care for the ingestion of opioids by children continues to increase over time,” wrote Dr. Kane and his associates. “Current efforts to reduce prescription opioid use in adults have not curtailed the incidence of pediatric opioid ingestion, and additional efforts are needed to reduce preventable opioid exposure in children.”
This study had no external funding. Dr. Allison H. Bartlett has served as a consultant member of the CVS Caremark National Pharmacy and Therapeutics Committee. All other authors had no relevant financial disclosures to report.
SOURCE: Kane JM et al. Pediatrics. 2018 Mar 5;141(4):e20173335.
FROM PEDIATRICS
Key clinical point: The rate of hospitalizations and pediatric ICU admissions are up due to opioid ingestion.
Major finding: Over 40% of pediatric patients admitted to hospitals required PICU care.
Study details: A retrospective cohort study of children aged 1-17 years who were admitted to a PICU between Jan. 1, 2004, and Sep. 30, 2015.
Disclosures: This study had no external funding. Dr. Allison H. Bartlett has served as a consultant member of the CVS Caremark National Pharmacy and Therapeutics Committee. All other authors had no relevant financial disclosures to report.
Source: Kane JM et al. Pediatrics. 2018 Mar. 5;141(4):e20173335.
2 new influenza strains recommended for next season
SILVER SPRING, MD. – In an effort to better match the vaccine to the virus, federal advisors have recommended two new strains be swapped into the 2018-2019 quadrivalent influenza vaccine.
Singapore A(H3N2) and the B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) are recommended be added to A/Michigan/45/2015 (H1N1)pdm09-like virus and B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) for the upcoming season, according to a near-unanimous vote at a meeting of the Food and Drug Administration Vaccines and Related Biological Products Advisory Committee.
Trivalent vaccines should include the same strains, with the exception of B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage), the committee recommended.
The panel voted separately on the strains, and all votes were unanimous, except for the vote on the B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) in the trivalent vaccine, which was supported with 11 positive votes with 1 abstention.
The advisory committee’s recommendation is identical to the recommendations recently made by the World Health Organization for next season’s influenza vaccines in the Northern Hemisphere. The WHO recommended that trivalent vaccines contain A/Michigan/45/2015 (H1N1)pdm09-like virus, A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage). WHO also recommended that quadrivalent vaccines contain all of the above strains and B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) as the second influenza B strain.
Most of the influenza activity in the United States this season is due to influenza A (H3N2) viruses (67%), according to Lisa Grohskopf, MD, associate chief for policy & liaison in the Influenza Division at the Centers for Disease Control and Prevention. Fortunately, the majority of circulating strains are similar to those contained in the 2017-2018 vaccine. Only strains with B/Victoria lineage displayed antigenic drift, but represented less than 1% of all circulating viruses.
Hospitalization rates for laboratory-confirmed influenza this season have been markedly higher among people aged 65 years and older, compared with younger age groups, and have increased since last season. As of Feb. 17, the preliminary estimate of hospitalizations in this age group was 322.7 cases per 100,000 people, compared with about 290.5 per 100,000 during the 2016-2017 season. There have been 97 pediatric deaths associated with influenza, compared with 110 reported during the 2016-2017 season, 93 during 2015-2016, and 148 during 2014-2015.
These data are not final because the flu season is still ongoing, but a full analysis will be provided at the end of the season, Dr. Grohskopf pointed out.With H3N2 strains of influenza A predominating, questions on the effectiveness of the newly recommended Singapore A(H3N2) were raised by the committee. Jacqueline Katz, PhD, director of the WHO Collaborating Center for Surveillance, Epidemiology, and Control of Influenza, reassured the committee.
“Yes, in fact, it does cover them very well. The majority of the viruses that we’ve tested at the CDC were that emerging 3C2a2 [clade of H3N2] group, and the Singapore virus covered those very well. In general, that’s why we went with Singapore,” she said.
Dr. Katz added that one of the reasons Singapore is so effective is because of its position in the lineage of these flu strains. “It’s at the base of the [phylogenetic] tree; it’s not on the tip of the tree where things are changing, so it’s a more conservative selection.”
The CDC estimate of current vaccine effectiveness (VE) against influenza A (H3N2) viruses is 25%, as of Feb. 3. Effectiveness is even higher for all influenza viruses, with an estimated VE of 36%, indicating that the flu vaccine reduced a person’s risk of having to seek medical care at a doctor’s office for flu illness by 36% (MMWR. 2018;67:180-5).
While the FDA usually follows the recommendations of its panel members, it is not obligated to do so. None of the committee members disclosed relevant financial conflicts of interest.
SILVER SPRING, MD. – In an effort to better match the vaccine to the virus, federal advisors have recommended two new strains be swapped into the 2018-2019 quadrivalent influenza vaccine.
Singapore A(H3N2) and the B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) are recommended be added to A/Michigan/45/2015 (H1N1)pdm09-like virus and B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) for the upcoming season, according to a near-unanimous vote at a meeting of the Food and Drug Administration Vaccines and Related Biological Products Advisory Committee.
Trivalent vaccines should include the same strains, with the exception of B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage), the committee recommended.
The panel voted separately on the strains, and all votes were unanimous, except for the vote on the B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) in the trivalent vaccine, which was supported with 11 positive votes with 1 abstention.
The advisory committee’s recommendation is identical to the recommendations recently made by the World Health Organization for next season’s influenza vaccines in the Northern Hemisphere. The WHO recommended that trivalent vaccines contain A/Michigan/45/2015 (H1N1)pdm09-like virus, A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage). WHO also recommended that quadrivalent vaccines contain all of the above strains and B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) as the second influenza B strain.
Most of the influenza activity in the United States this season is due to influenza A (H3N2) viruses (67%), according to Lisa Grohskopf, MD, associate chief for policy & liaison in the Influenza Division at the Centers for Disease Control and Prevention. Fortunately, the majority of circulating strains are similar to those contained in the 2017-2018 vaccine. Only strains with B/Victoria lineage displayed antigenic drift, but represented less than 1% of all circulating viruses.
Hospitalization rates for laboratory-confirmed influenza this season have been markedly higher among people aged 65 years and older, compared with younger age groups, and have increased since last season. As of Feb. 17, the preliminary estimate of hospitalizations in this age group was 322.7 cases per 100,000 people, compared with about 290.5 per 100,000 during the 2016-2017 season. There have been 97 pediatric deaths associated with influenza, compared with 110 reported during the 2016-2017 season, 93 during 2015-2016, and 148 during 2014-2015.
These data are not final because the flu season is still ongoing, but a full analysis will be provided at the end of the season, Dr. Grohskopf pointed out.With H3N2 strains of influenza A predominating, questions on the effectiveness of the newly recommended Singapore A(H3N2) were raised by the committee. Jacqueline Katz, PhD, director of the WHO Collaborating Center for Surveillance, Epidemiology, and Control of Influenza, reassured the committee.
“Yes, in fact, it does cover them very well. The majority of the viruses that we’ve tested at the CDC were that emerging 3C2a2 [clade of H3N2] group, and the Singapore virus covered those very well. In general, that’s why we went with Singapore,” she said.
Dr. Katz added that one of the reasons Singapore is so effective is because of its position in the lineage of these flu strains. “It’s at the base of the [phylogenetic] tree; it’s not on the tip of the tree where things are changing, so it’s a more conservative selection.”
The CDC estimate of current vaccine effectiveness (VE) against influenza A (H3N2) viruses is 25%, as of Feb. 3. Effectiveness is even higher for all influenza viruses, with an estimated VE of 36%, indicating that the flu vaccine reduced a person’s risk of having to seek medical care at a doctor’s office for flu illness by 36% (MMWR. 2018;67:180-5).
While the FDA usually follows the recommendations of its panel members, it is not obligated to do so. None of the committee members disclosed relevant financial conflicts of interest.
SILVER SPRING, MD. – In an effort to better match the vaccine to the virus, federal advisors have recommended two new strains be swapped into the 2018-2019 quadrivalent influenza vaccine.
Singapore A(H3N2) and the B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) are recommended be added to A/Michigan/45/2015 (H1N1)pdm09-like virus and B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) for the upcoming season, according to a near-unanimous vote at a meeting of the Food and Drug Administration Vaccines and Related Biological Products Advisory Committee.
Trivalent vaccines should include the same strains, with the exception of B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage), the committee recommended.
The panel voted separately on the strains, and all votes were unanimous, except for the vote on the B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) in the trivalent vaccine, which was supported with 11 positive votes with 1 abstention.
The advisory committee’s recommendation is identical to the recommendations recently made by the World Health Organization for next season’s influenza vaccines in the Northern Hemisphere. The WHO recommended that trivalent vaccines contain A/Michigan/45/2015 (H1N1)pdm09-like virus, A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage). WHO also recommended that quadrivalent vaccines contain all of the above strains and B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) as the second influenza B strain.
Most of the influenza activity in the United States this season is due to influenza A (H3N2) viruses (67%), according to Lisa Grohskopf, MD, associate chief for policy & liaison in the Influenza Division at the Centers for Disease Control and Prevention. Fortunately, the majority of circulating strains are similar to those contained in the 2017-2018 vaccine. Only strains with B/Victoria lineage displayed antigenic drift, but represented less than 1% of all circulating viruses.
Hospitalization rates for laboratory-confirmed influenza this season have been markedly higher among people aged 65 years and older, compared with younger age groups, and have increased since last season. As of Feb. 17, the preliminary estimate of hospitalizations in this age group was 322.7 cases per 100,000 people, compared with about 290.5 per 100,000 during the 2016-2017 season. There have been 97 pediatric deaths associated with influenza, compared with 110 reported during the 2016-2017 season, 93 during 2015-2016, and 148 during 2014-2015.
These data are not final because the flu season is still ongoing, but a full analysis will be provided at the end of the season, Dr. Grohskopf pointed out.With H3N2 strains of influenza A predominating, questions on the effectiveness of the newly recommended Singapore A(H3N2) were raised by the committee. Jacqueline Katz, PhD, director of the WHO Collaborating Center for Surveillance, Epidemiology, and Control of Influenza, reassured the committee.
“Yes, in fact, it does cover them very well. The majority of the viruses that we’ve tested at the CDC were that emerging 3C2a2 [clade of H3N2] group, and the Singapore virus covered those very well. In general, that’s why we went with Singapore,” she said.
Dr. Katz added that one of the reasons Singapore is so effective is because of its position in the lineage of these flu strains. “It’s at the base of the [phylogenetic] tree; it’s not on the tip of the tree where things are changing, so it’s a more conservative selection.”
The CDC estimate of current vaccine effectiveness (VE) against influenza A (H3N2) viruses is 25%, as of Feb. 3. Effectiveness is even higher for all influenza viruses, with an estimated VE of 36%, indicating that the flu vaccine reduced a person’s risk of having to seek medical care at a doctor’s office for flu illness by 36% (MMWR. 2018;67:180-5).
While the FDA usually follows the recommendations of its panel members, it is not obligated to do so. None of the committee members disclosed relevant financial conflicts of interest.
REPORTING FROM AN FDA ADVISORY COMMITTEE MEETING
Hospitalists focus on POCUS
Point-of-care ultrasound (POCUS) is proving to be an increasing useful diagnostic tool for clinicians at the bedside, and many hospitalists have expressed interest in learning best practices in the use of the technology.
To that end, the Society of Hospital Medicine (SHM) is offering a half-day POCUS pre-course at Hospital Medicine 2018 this April in Orlando, with the intent of helping hospitalists learn how best to use POCUS in clinical settings.
“The agenda is really designed to teach people the basics of point-of-care ultrasound,” said Nilam J. Soni, MD, MSc, of the University of Texas at San Antonio and South Texas Veterans Health Care System, also in San Antonio, and a coinstructor of the POCUS pre-course. “It’s designed for the novice learner who has no prior experience in using ultrasound.”
Dr. Soni and his coinstructor, Ricardo Antonio Franco-Sadud, MD, of the Medical College of Wisconsin, Milwaukee, will lead attendees through the basics of “Point-of-Care Ultrasound for the Hospitalist” at HM18. Dr. Soni has taught a version of this course for almost a decade and is the assistant director of POCUS training programs with Veterans Affairs’ Simulation Learning Education and Research Network (SimLEARN). The pre-course is a 4.5-hour, multimodal class that involves hands-on training to teach the fundamentals of how to evaluate patients using POCUS.
With this course, Dr. Soni said, SHM is addressing training needs from “above and below.”
“Medical students, residents, fellows – basically doctors in training, whether they are student residents or getting ultrasound instruction in their basic training – when these kids graduate, they are pretty good,” he said. “But what about all the doctors who graduated long ago? They didn’t get any POCUS training. That’s where SHM, CHEST, and some of the other societies come in to play. We can offer these courses for training.”
Ultrasound training and credentialing has become a focus for SHM as interest has grown among clinicians. The Journal of Hospital Medicine recently released a consensus statement, “Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures,” which offers recommendations for credentialing hospitalists in ultrasound guidance and proposes initial and ongoing pathways to improve how hospitalists perform these procedures. The statement emphasizes how ultrasound guidance is increasingly essential to six bedside procedures that are core competencies of hospitalists: abdominal paracentesis, arterial catheter placement, arthrocentesis, central venous catheter placement, lumbar puncture, and thoracentesis.
According to Brian P. Lucas, MD, of Rush Medical College, Chicago, and lead author of the position statement, SHM’s Education Committee convened a POCUS Task Force to take on the project as American Board of Internal Medicine (ABIM) diplomates are no longer expected as part of their residency training to manually perform certain bedside procedures, with or without ultrasound guidance. SHM’s Board of Directors gave final approval on the statement in September 2017.
“There is much variation in the training and experience of both bedside procedures and point-of-care ultrasound. Many practicing hospitalists, for example, have no experience using ultrasound guidance for central lines,” Dr. Lucas said. “How then should hospitals initially, and then biennially, vet hospitalists’ competence in the performance of ultrasound-guided bedside procedures? This nationwide collaborative of experts, educators and front-line providers puts forth some recommendations to this very thorny problem.”
SHM also offers, in collaboration with the American College of Chest Physicians, a Point-of-Care Ultrasound Certificate of Completion for clinicians. The program is designed primarily to educate hospitalists and other providers caring for acutely ill patients, and requires attendance at a series of training programs within the course of 3 years, at the end of which a clinician must complete a comprehensive skills and knowledge assessment to obtain the certificate.
Focus on POCUS
Although medical societies recognize the growing demand, and are offering more ultrasound training, many hospitalists may not be familiar with POCUS specifically and the benefits of utilizing a bedside ultrasound exam, Dr. Soni noted.
“When we talk about point-of-care ultrasound, how is it different from what everyone else thinks about ultrasound? Specifically, it’s a point-of-care bedside exam” Dr. Soni explained. “So, the same provider – whether it’s a physician, nurse practitioner, or PA – who is taking care of a patient, can use ultrasound at the bedside to evaluate specific things in the patient’s body and answer very focused questions.”
The ability to have a hospitalist immediately use an imaging technique at a patient’s bedside can be invaluable, because it allows the clinician to provide a fairly accurate diagnosis in conjunction with patient input. This is much more effective than the traditional process of ultrasound imaging, Dr. Soni said.
“If you go to your primary care doctor [who orders] an ultrasound, you go to the radiology department and the technician captures the images,” he said. “Then the radiologist, who never even sees the patient, reads the ultrasound images with little to no clinical data.” The compartmentalization of the treating clinician, patient, and radiologist leaves the latter without critical information when reading an ultrasound. POCUS can potentially overcome this problematic situation, Dr. Soni suggested.
The HM18 POCUS pre-course has four objectives:
1. Recognize the fundamentals of ultrasound and the basic operation of an ultrasound machine (“knobology”).
2. Differentiate between the different types of ultrasound transducers and determine which is most appropriate for different POCUS applications.
3. Exhibit proper techniques on focused cardiac and lung ultrasound exams and be able to recognize thoracic pathologies from abnormal ultrasound results.
4. Identify and understand normal sonographic appearance of solid abdominal organs and vasculature of the neck and lower extremities and the ability to interpret abnormal ultrasounds to identify pathologies.
While all attendees can expect to learn a new skill that will improve their practice, POCUS training will specifically benefit hospitalists and the institutions in which they work, Dr. Soni said.
“Hospitalists, by nature, work for the hospital. In most cases, hospitalists are subsidized by the hospital. Because of that, the bigger gain from using ultrasound is not in the billing,” he said. “You can bill for focused ultrasound exams of the lungs, heart, abdomen, etc., and you might get a professional fee of $30-$40. But the bigger win in all of this, financially, is giving people more efficient health care. If we can prevent one complication from a bedside procedure or expedite a patient’s care and get them better sooner, we can save the hospital and the system money.”
The SHM is accredited to provide continuing medical education for physicians by the Accreditation Council for Continuing Medical Education. This live activity course will count for a maximum of 4.75 AMA PRA Category 1 Credits.
Point-of-Care Ultrasound for the Hospitalist
Sunday, April 8, 7:30 a.m.–12:15 p.m.
Point-of-care ultrasound (POCUS) is proving to be an increasing useful diagnostic tool for clinicians at the bedside, and many hospitalists have expressed interest in learning best practices in the use of the technology.
To that end, the Society of Hospital Medicine (SHM) is offering a half-day POCUS pre-course at Hospital Medicine 2018 this April in Orlando, with the intent of helping hospitalists learn how best to use POCUS in clinical settings.
“The agenda is really designed to teach people the basics of point-of-care ultrasound,” said Nilam J. Soni, MD, MSc, of the University of Texas at San Antonio and South Texas Veterans Health Care System, also in San Antonio, and a coinstructor of the POCUS pre-course. “It’s designed for the novice learner who has no prior experience in using ultrasound.”
Dr. Soni and his coinstructor, Ricardo Antonio Franco-Sadud, MD, of the Medical College of Wisconsin, Milwaukee, will lead attendees through the basics of “Point-of-Care Ultrasound for the Hospitalist” at HM18. Dr. Soni has taught a version of this course for almost a decade and is the assistant director of POCUS training programs with Veterans Affairs’ Simulation Learning Education and Research Network (SimLEARN). The pre-course is a 4.5-hour, multimodal class that involves hands-on training to teach the fundamentals of how to evaluate patients using POCUS.
With this course, Dr. Soni said, SHM is addressing training needs from “above and below.”
“Medical students, residents, fellows – basically doctors in training, whether they are student residents or getting ultrasound instruction in their basic training – when these kids graduate, they are pretty good,” he said. “But what about all the doctors who graduated long ago? They didn’t get any POCUS training. That’s where SHM, CHEST, and some of the other societies come in to play. We can offer these courses for training.”
Ultrasound training and credentialing has become a focus for SHM as interest has grown among clinicians. The Journal of Hospital Medicine recently released a consensus statement, “Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures,” which offers recommendations for credentialing hospitalists in ultrasound guidance and proposes initial and ongoing pathways to improve how hospitalists perform these procedures. The statement emphasizes how ultrasound guidance is increasingly essential to six bedside procedures that are core competencies of hospitalists: abdominal paracentesis, arterial catheter placement, arthrocentesis, central venous catheter placement, lumbar puncture, and thoracentesis.
According to Brian P. Lucas, MD, of Rush Medical College, Chicago, and lead author of the position statement, SHM’s Education Committee convened a POCUS Task Force to take on the project as American Board of Internal Medicine (ABIM) diplomates are no longer expected as part of their residency training to manually perform certain bedside procedures, with or without ultrasound guidance. SHM’s Board of Directors gave final approval on the statement in September 2017.
“There is much variation in the training and experience of both bedside procedures and point-of-care ultrasound. Many practicing hospitalists, for example, have no experience using ultrasound guidance for central lines,” Dr. Lucas said. “How then should hospitals initially, and then biennially, vet hospitalists’ competence in the performance of ultrasound-guided bedside procedures? This nationwide collaborative of experts, educators and front-line providers puts forth some recommendations to this very thorny problem.”
SHM also offers, in collaboration with the American College of Chest Physicians, a Point-of-Care Ultrasound Certificate of Completion for clinicians. The program is designed primarily to educate hospitalists and other providers caring for acutely ill patients, and requires attendance at a series of training programs within the course of 3 years, at the end of which a clinician must complete a comprehensive skills and knowledge assessment to obtain the certificate.
Focus on POCUS
Although medical societies recognize the growing demand, and are offering more ultrasound training, many hospitalists may not be familiar with POCUS specifically and the benefits of utilizing a bedside ultrasound exam, Dr. Soni noted.
“When we talk about point-of-care ultrasound, how is it different from what everyone else thinks about ultrasound? Specifically, it’s a point-of-care bedside exam” Dr. Soni explained. “So, the same provider – whether it’s a physician, nurse practitioner, or PA – who is taking care of a patient, can use ultrasound at the bedside to evaluate specific things in the patient’s body and answer very focused questions.”
The ability to have a hospitalist immediately use an imaging technique at a patient’s bedside can be invaluable, because it allows the clinician to provide a fairly accurate diagnosis in conjunction with patient input. This is much more effective than the traditional process of ultrasound imaging, Dr. Soni said.
“If you go to your primary care doctor [who orders] an ultrasound, you go to the radiology department and the technician captures the images,” he said. “Then the radiologist, who never even sees the patient, reads the ultrasound images with little to no clinical data.” The compartmentalization of the treating clinician, patient, and radiologist leaves the latter without critical information when reading an ultrasound. POCUS can potentially overcome this problematic situation, Dr. Soni suggested.
The HM18 POCUS pre-course has four objectives:
1. Recognize the fundamentals of ultrasound and the basic operation of an ultrasound machine (“knobology”).
2. Differentiate between the different types of ultrasound transducers and determine which is most appropriate for different POCUS applications.
3. Exhibit proper techniques on focused cardiac and lung ultrasound exams and be able to recognize thoracic pathologies from abnormal ultrasound results.
4. Identify and understand normal sonographic appearance of solid abdominal organs and vasculature of the neck and lower extremities and the ability to interpret abnormal ultrasounds to identify pathologies.
While all attendees can expect to learn a new skill that will improve their practice, POCUS training will specifically benefit hospitalists and the institutions in which they work, Dr. Soni said.
“Hospitalists, by nature, work for the hospital. In most cases, hospitalists are subsidized by the hospital. Because of that, the bigger gain from using ultrasound is not in the billing,” he said. “You can bill for focused ultrasound exams of the lungs, heart, abdomen, etc., and you might get a professional fee of $30-$40. But the bigger win in all of this, financially, is giving people more efficient health care. If we can prevent one complication from a bedside procedure or expedite a patient’s care and get them better sooner, we can save the hospital and the system money.”
The SHM is accredited to provide continuing medical education for physicians by the Accreditation Council for Continuing Medical Education. This live activity course will count for a maximum of 4.75 AMA PRA Category 1 Credits.
Point-of-Care Ultrasound for the Hospitalist
Sunday, April 8, 7:30 a.m.–12:15 p.m.
Point-of-care ultrasound (POCUS) is proving to be an increasing useful diagnostic tool for clinicians at the bedside, and many hospitalists have expressed interest in learning best practices in the use of the technology.
To that end, the Society of Hospital Medicine (SHM) is offering a half-day POCUS pre-course at Hospital Medicine 2018 this April in Orlando, with the intent of helping hospitalists learn how best to use POCUS in clinical settings.
“The agenda is really designed to teach people the basics of point-of-care ultrasound,” said Nilam J. Soni, MD, MSc, of the University of Texas at San Antonio and South Texas Veterans Health Care System, also in San Antonio, and a coinstructor of the POCUS pre-course. “It’s designed for the novice learner who has no prior experience in using ultrasound.”
Dr. Soni and his coinstructor, Ricardo Antonio Franco-Sadud, MD, of the Medical College of Wisconsin, Milwaukee, will lead attendees through the basics of “Point-of-Care Ultrasound for the Hospitalist” at HM18. Dr. Soni has taught a version of this course for almost a decade and is the assistant director of POCUS training programs with Veterans Affairs’ Simulation Learning Education and Research Network (SimLEARN). The pre-course is a 4.5-hour, multimodal class that involves hands-on training to teach the fundamentals of how to evaluate patients using POCUS.
With this course, Dr. Soni said, SHM is addressing training needs from “above and below.”
“Medical students, residents, fellows – basically doctors in training, whether they are student residents or getting ultrasound instruction in their basic training – when these kids graduate, they are pretty good,” he said. “But what about all the doctors who graduated long ago? They didn’t get any POCUS training. That’s where SHM, CHEST, and some of the other societies come in to play. We can offer these courses for training.”
Ultrasound training and credentialing has become a focus for SHM as interest has grown among clinicians. The Journal of Hospital Medicine recently released a consensus statement, “Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures,” which offers recommendations for credentialing hospitalists in ultrasound guidance and proposes initial and ongoing pathways to improve how hospitalists perform these procedures. The statement emphasizes how ultrasound guidance is increasingly essential to six bedside procedures that are core competencies of hospitalists: abdominal paracentesis, arterial catheter placement, arthrocentesis, central venous catheter placement, lumbar puncture, and thoracentesis.
According to Brian P. Lucas, MD, of Rush Medical College, Chicago, and lead author of the position statement, SHM’s Education Committee convened a POCUS Task Force to take on the project as American Board of Internal Medicine (ABIM) diplomates are no longer expected as part of their residency training to manually perform certain bedside procedures, with or without ultrasound guidance. SHM’s Board of Directors gave final approval on the statement in September 2017.
“There is much variation in the training and experience of both bedside procedures and point-of-care ultrasound. Many practicing hospitalists, for example, have no experience using ultrasound guidance for central lines,” Dr. Lucas said. “How then should hospitals initially, and then biennially, vet hospitalists’ competence in the performance of ultrasound-guided bedside procedures? This nationwide collaborative of experts, educators and front-line providers puts forth some recommendations to this very thorny problem.”
SHM also offers, in collaboration with the American College of Chest Physicians, a Point-of-Care Ultrasound Certificate of Completion for clinicians. The program is designed primarily to educate hospitalists and other providers caring for acutely ill patients, and requires attendance at a series of training programs within the course of 3 years, at the end of which a clinician must complete a comprehensive skills and knowledge assessment to obtain the certificate.
Focus on POCUS
Although medical societies recognize the growing demand, and are offering more ultrasound training, many hospitalists may not be familiar with POCUS specifically and the benefits of utilizing a bedside ultrasound exam, Dr. Soni noted.
“When we talk about point-of-care ultrasound, how is it different from what everyone else thinks about ultrasound? Specifically, it’s a point-of-care bedside exam” Dr. Soni explained. “So, the same provider – whether it’s a physician, nurse practitioner, or PA – who is taking care of a patient, can use ultrasound at the bedside to evaluate specific things in the patient’s body and answer very focused questions.”
The ability to have a hospitalist immediately use an imaging technique at a patient’s bedside can be invaluable, because it allows the clinician to provide a fairly accurate diagnosis in conjunction with patient input. This is much more effective than the traditional process of ultrasound imaging, Dr. Soni said.
“If you go to your primary care doctor [who orders] an ultrasound, you go to the radiology department and the technician captures the images,” he said. “Then the radiologist, who never even sees the patient, reads the ultrasound images with little to no clinical data.” The compartmentalization of the treating clinician, patient, and radiologist leaves the latter without critical information when reading an ultrasound. POCUS can potentially overcome this problematic situation, Dr. Soni suggested.
The HM18 POCUS pre-course has four objectives:
1. Recognize the fundamentals of ultrasound and the basic operation of an ultrasound machine (“knobology”).
2. Differentiate between the different types of ultrasound transducers and determine which is most appropriate for different POCUS applications.
3. Exhibit proper techniques on focused cardiac and lung ultrasound exams and be able to recognize thoracic pathologies from abnormal ultrasound results.
4. Identify and understand normal sonographic appearance of solid abdominal organs and vasculature of the neck and lower extremities and the ability to interpret abnormal ultrasounds to identify pathologies.
While all attendees can expect to learn a new skill that will improve their practice, POCUS training will specifically benefit hospitalists and the institutions in which they work, Dr. Soni said.
“Hospitalists, by nature, work for the hospital. In most cases, hospitalists are subsidized by the hospital. Because of that, the bigger gain from using ultrasound is not in the billing,” he said. “You can bill for focused ultrasound exams of the lungs, heart, abdomen, etc., and you might get a professional fee of $30-$40. But the bigger win in all of this, financially, is giving people more efficient health care. If we can prevent one complication from a bedside procedure or expedite a patient’s care and get them better sooner, we can save the hospital and the system money.”
The SHM is accredited to provide continuing medical education for physicians by the Accreditation Council for Continuing Medical Education. This live activity course will count for a maximum of 4.75 AMA PRA Category 1 Credits.
Point-of-Care Ultrasound for the Hospitalist
Sunday, April 8, 7:30 a.m.–12:15 p.m.
