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MHPAEA lowers out-of-pocket spending for families of children with mental illnesses
Families of children with mental health conditions had lower spending when enrolled in insurance plans under the Mental Health Parity and Addiction Equity Act, but these cost savings did not represent a “substantial improvement” for families at the higher end of mental health spending, according to results of a study published in Pediatrics.
They found children in plans subject to MHPAEA spent an average of $140 less on mental health care (95% confidence interval, −$196 to −$84), compared with expected “changes in the comparison group.” In families with a high level of spending for mental health, those who were insured with plans subject to parity had an average annual OOP mental health spending of $234 less (95% confidence interval, −$391 to −$76) than the comparison group.
In the first year after MHPAEA, all children subject to parity had $112 average lower spending (95% CI, −$167 to −$57), with $171 average lower spending (95% CI, −$241 to −$101) in the second year than the comparison group. Among high spenders, OOP spending was $210 lower (95% CI, −$414 to −$5) in the first year and $258 lower (95% CI, −$401 to −$114) in the second year than the comparison group.
Among patients with high mental health spending, there was a 0.5 increase in number of inpatient mental health days per year (95% CI, 0.1-0.9), according to the researchers. In addition, total mental health spending increased overall for high-spending families: Those who were self-insured paid an average of $5,302 preparity, compared with $8,708 postparity, whereas a comparison group of fully insured patients paid an average of $5,460 preparity, compared with $9,177 postparity.
“Our finding of a reduction in OOP mental health spending attributable to parity among all children with mental health conditions is consistent with the limited body of literature focused on children,” Dr. Kennedy-Hendricks and her colleagues wrote. “Although the estimated reduction in OOP spending was larger for children with high spending than among children with mental health conditions more broadly, given the much higher average annual OOP spending preparity among the high-spending group, this constitutes a relatively small reduction in OOP spending attributable to the law.”
The researchers noted as potential limitations that there may be differences in the children in the exposed and comparison group; selection of the high-spending group was based on both preparity and postparity; and there may be potential differences in other states not studied.
This study was funded by the National Institutes of Health and supported by a grant from the National Institute of Mental Health. The authors reported no relevant financial disclosures.
SOURCE: Kennedy-Hendricks A et al. Pediatrics. 2018 Jul 23. doi: 10.1542/peds.2017-2618.
While “we all hoped” mental health parity would achieve cost savings and improve payment of mental and physical health services, as well as workforce and access issues, there are limited savings seen when applying parity to these services for children. In addition, the study by Dr. Kennedy-Hendricks and associates revealed overall mental health spending and use more than doubled, which remains unexplained by parity, James M. Perrin, MD, said in an editorial.
He said, “the bottom line is that parity has some (but only limited) impact on the access to and costs of mental health services.” Other efforts, such as those to help prevent mental health conditions and integrate treatment of mental and behavioral health with the rest of pediatric health care, should be considered.
Can mental health parity still play a role? “The current study offers some hope, although it also suggests the need to monitor and enforce parity better than what seems to have occurred at least in its early years,” Dr. Perrin said. “Parity seems less likely to improve preventive efforts unless mental health benefits clearly support the many effective preventive interventions.”
“With a growing emphasis on the importance of mental and behavioral health and their influences on many other aspects of the health of children and adults, it may be time to think more imaginatively about health care financing that can better ensure attention to mental health concerns broadly,” he said. While new alternative payment models may help bridge the gap, this study emphasizes the need to improve the way in which mental and behavioral health care is paid.
Dr. Perrin is at the MassGeneral Hospital for Children and Harvard Medical School, both in Boston. He reported no relevant conflicts of interest. These comments summarize his editorial accompanying the article by Dr. Kennedy-Hendricks and associates. (Pediatrics. 2018 Jul 23. doi: 10.1542/peds.2018-1572 ).
While “we all hoped” mental health parity would achieve cost savings and improve payment of mental and physical health services, as well as workforce and access issues, there are limited savings seen when applying parity to these services for children. In addition, the study by Dr. Kennedy-Hendricks and associates revealed overall mental health spending and use more than doubled, which remains unexplained by parity, James M. Perrin, MD, said in an editorial.
He said, “the bottom line is that parity has some (but only limited) impact on the access to and costs of mental health services.” Other efforts, such as those to help prevent mental health conditions and integrate treatment of mental and behavioral health with the rest of pediatric health care, should be considered.
Can mental health parity still play a role? “The current study offers some hope, although it also suggests the need to monitor and enforce parity better than what seems to have occurred at least in its early years,” Dr. Perrin said. “Parity seems less likely to improve preventive efforts unless mental health benefits clearly support the many effective preventive interventions.”
“With a growing emphasis on the importance of mental and behavioral health and their influences on many other aspects of the health of children and adults, it may be time to think more imaginatively about health care financing that can better ensure attention to mental health concerns broadly,” he said. While new alternative payment models may help bridge the gap, this study emphasizes the need to improve the way in which mental and behavioral health care is paid.
Dr. Perrin is at the MassGeneral Hospital for Children and Harvard Medical School, both in Boston. He reported no relevant conflicts of interest. These comments summarize his editorial accompanying the article by Dr. Kennedy-Hendricks and associates. (Pediatrics. 2018 Jul 23. doi: 10.1542/peds.2018-1572 ).
While “we all hoped” mental health parity would achieve cost savings and improve payment of mental and physical health services, as well as workforce and access issues, there are limited savings seen when applying parity to these services for children. In addition, the study by Dr. Kennedy-Hendricks and associates revealed overall mental health spending and use more than doubled, which remains unexplained by parity, James M. Perrin, MD, said in an editorial.
He said, “the bottom line is that parity has some (but only limited) impact on the access to and costs of mental health services.” Other efforts, such as those to help prevent mental health conditions and integrate treatment of mental and behavioral health with the rest of pediatric health care, should be considered.
Can mental health parity still play a role? “The current study offers some hope, although it also suggests the need to monitor and enforce parity better than what seems to have occurred at least in its early years,” Dr. Perrin said. “Parity seems less likely to improve preventive efforts unless mental health benefits clearly support the many effective preventive interventions.”
“With a growing emphasis on the importance of mental and behavioral health and their influences on many other aspects of the health of children and adults, it may be time to think more imaginatively about health care financing that can better ensure attention to mental health concerns broadly,” he said. While new alternative payment models may help bridge the gap, this study emphasizes the need to improve the way in which mental and behavioral health care is paid.
Dr. Perrin is at the MassGeneral Hospital for Children and Harvard Medical School, both in Boston. He reported no relevant conflicts of interest. These comments summarize his editorial accompanying the article by Dr. Kennedy-Hendricks and associates. (Pediatrics. 2018 Jul 23. doi: 10.1542/peds.2018-1572 ).
Families of children with mental health conditions had lower spending when enrolled in insurance plans under the Mental Health Parity and Addiction Equity Act, but these cost savings did not represent a “substantial improvement” for families at the higher end of mental health spending, according to results of a study published in Pediatrics.
They found children in plans subject to MHPAEA spent an average of $140 less on mental health care (95% confidence interval, −$196 to −$84), compared with expected “changes in the comparison group.” In families with a high level of spending for mental health, those who were insured with plans subject to parity had an average annual OOP mental health spending of $234 less (95% confidence interval, −$391 to −$76) than the comparison group.
In the first year after MHPAEA, all children subject to parity had $112 average lower spending (95% CI, −$167 to −$57), with $171 average lower spending (95% CI, −$241 to −$101) in the second year than the comparison group. Among high spenders, OOP spending was $210 lower (95% CI, −$414 to −$5) in the first year and $258 lower (95% CI, −$401 to −$114) in the second year than the comparison group.
Among patients with high mental health spending, there was a 0.5 increase in number of inpatient mental health days per year (95% CI, 0.1-0.9), according to the researchers. In addition, total mental health spending increased overall for high-spending families: Those who were self-insured paid an average of $5,302 preparity, compared with $8,708 postparity, whereas a comparison group of fully insured patients paid an average of $5,460 preparity, compared with $9,177 postparity.
“Our finding of a reduction in OOP mental health spending attributable to parity among all children with mental health conditions is consistent with the limited body of literature focused on children,” Dr. Kennedy-Hendricks and her colleagues wrote. “Although the estimated reduction in OOP spending was larger for children with high spending than among children with mental health conditions more broadly, given the much higher average annual OOP spending preparity among the high-spending group, this constitutes a relatively small reduction in OOP spending attributable to the law.”
The researchers noted as potential limitations that there may be differences in the children in the exposed and comparison group; selection of the high-spending group was based on both preparity and postparity; and there may be potential differences in other states not studied.
This study was funded by the National Institutes of Health and supported by a grant from the National Institute of Mental Health. The authors reported no relevant financial disclosures.
SOURCE: Kennedy-Hendricks A et al. Pediatrics. 2018 Jul 23. doi: 10.1542/peds.2017-2618.
Families of children with mental health conditions had lower spending when enrolled in insurance plans under the Mental Health Parity and Addiction Equity Act, but these cost savings did not represent a “substantial improvement” for families at the higher end of mental health spending, according to results of a study published in Pediatrics.
They found children in plans subject to MHPAEA spent an average of $140 less on mental health care (95% confidence interval, −$196 to −$84), compared with expected “changes in the comparison group.” In families with a high level of spending for mental health, those who were insured with plans subject to parity had an average annual OOP mental health spending of $234 less (95% confidence interval, −$391 to −$76) than the comparison group.
In the first year after MHPAEA, all children subject to parity had $112 average lower spending (95% CI, −$167 to −$57), with $171 average lower spending (95% CI, −$241 to −$101) in the second year than the comparison group. Among high spenders, OOP spending was $210 lower (95% CI, −$414 to −$5) in the first year and $258 lower (95% CI, −$401 to −$114) in the second year than the comparison group.
Among patients with high mental health spending, there was a 0.5 increase in number of inpatient mental health days per year (95% CI, 0.1-0.9), according to the researchers. In addition, total mental health spending increased overall for high-spending families: Those who were self-insured paid an average of $5,302 preparity, compared with $8,708 postparity, whereas a comparison group of fully insured patients paid an average of $5,460 preparity, compared with $9,177 postparity.
“Our finding of a reduction in OOP mental health spending attributable to parity among all children with mental health conditions is consistent with the limited body of literature focused on children,” Dr. Kennedy-Hendricks and her colleagues wrote. “Although the estimated reduction in OOP spending was larger for children with high spending than among children with mental health conditions more broadly, given the much higher average annual OOP spending preparity among the high-spending group, this constitutes a relatively small reduction in OOP spending attributable to the law.”
The researchers noted as potential limitations that there may be differences in the children in the exposed and comparison group; selection of the high-spending group was based on both preparity and postparity; and there may be potential differences in other states not studied.
This study was funded by the National Institutes of Health and supported by a grant from the National Institute of Mental Health. The authors reported no relevant financial disclosures.
SOURCE: Kennedy-Hendricks A et al. Pediatrics. 2018 Jul 23. doi: 10.1542/peds.2017-2618.
FROM PEDIATRICS
Key clinical point:
Major finding: Parity yielded $140 less spending on mental health care–associated costs, compared with expected changes in the comparison group.
Study details: An analysis of inpatient, outpatient, and pharmaceutical claims data of children with mental health conditions from the Health Care Cost Institute between 2008 and 2012.
Disclosures: This study was funded by the National Institutes of Health and supported by a grant from the National Institute of Mental Health. The authors reported no relevant financial disclosures.
Source: Kennedy-Hendricks A et al. Pediatrics. 2018 Jul 23. doi: 10.1542/peds.2017-2618.
Trauma surgeons up for emergency pediatric appendectomy
But a study of 220 children who had emergency appendectomies found only minor differences in outcomes between those operated on by a trauma surgeon and those by a pediatric surgeon.
“These results may be useful in optimizing the surgical workforce to care for a community,” said Derek B. Wall, MD, FACS, and Carlos Ortega, MD, FACS, of NorthShore University HealthSystem in Skokie, Ill. They noted that trauma surgeons in their group were asked to cover appendicitis in children aged 5-10 years because of the surgeons’ in-house availability and because of the difficulty pediatric surgeons often had in getting to the hospital in a timely fashion.
The study was done at Evanston (Ill.) Hospital, a Level 1 trauma center in the northern suburbs of Chicago. This trauma group were all board certified in general surgery, but none had received formal pediatric surgery fellowship training.
The study, published in the Journal of Trauma and Acute Surgery, evaluated appendectomies in children aged 5-10 years from January 2007 to December 2016. A total of 138 were performed by trauma surgeons, while 82 were done by pediatric surgeons. The patients operated on by trauma surgeons were more likely to be female (47% vs. 32%; P = .03), get to surgery more quickly (214 minutes from diagnosis vs. 318 minutes; P = .01), have a laparoscopic operation (70% vs. 55%; P = .04), have a shorter operation (40 minutes vs. 49 minutes; P less than .0001), and leave the hospital sooner (32 hours vs. 41 hours; P less than .0001). They were also more likely to be transferred from an outside hospital (60% vs. 37%; P less than .001) and less likely to be diagnosed without imaging (2% vs. 26%; P less than .0001). The study found no significant differences in complications.
Among the 31 patients who had perforated appendix, the difference in length of stay was even more pronounced: 4 days in the trauma surgery group (n = 21) versus 7.2 days in the pediatric surgery patients.
The investigators explained the rationale for focusing on the population aged 5-10 years: “We focused on a younger, narrower age range than that in previous studies, allowing comparison of outcomes in children of the same age and with equal rates of perforated appendicitis.” They noted that patients younger than age 5 are “well accepted as the domain of the pediatric surgeon,” while children over than 10 are more frequently managed by general surgeons.
At Evanston Hospital, pediatric surgeons had typically performed appendectomy in the targeted age group. But, “they cannot always quickly get to our hospital because of distance and city traffic,” the study authors noted. Therefore, the trauma surgeons were asked to cover for this population group.
They acknowledged the population size of the study was probably too small to identify any significant difference in complication rates between the two surgery groups, especially for patients who had had perforated appendicitis. Also, because of the study’s retrospective nature, most of the pediatric surgery cases were from an earlier period; therefore, later cases may have reflected advances in minimally invasive technology. “Perhaps surgical practice in a more recent time period contributes more to outcomes than specialty,” investigators wrote.
Dr. Wall and Dr. Ortega reported having no financial relationships.
SOURCE: Wall DB, Ortega C. J Trauma Acute Care Surg. 2018:85;118-21.
But a study of 220 children who had emergency appendectomies found only minor differences in outcomes between those operated on by a trauma surgeon and those by a pediatric surgeon.
“These results may be useful in optimizing the surgical workforce to care for a community,” said Derek B. Wall, MD, FACS, and Carlos Ortega, MD, FACS, of NorthShore University HealthSystem in Skokie, Ill. They noted that trauma surgeons in their group were asked to cover appendicitis in children aged 5-10 years because of the surgeons’ in-house availability and because of the difficulty pediatric surgeons often had in getting to the hospital in a timely fashion.
The study was done at Evanston (Ill.) Hospital, a Level 1 trauma center in the northern suburbs of Chicago. This trauma group were all board certified in general surgery, but none had received formal pediatric surgery fellowship training.
The study, published in the Journal of Trauma and Acute Surgery, evaluated appendectomies in children aged 5-10 years from January 2007 to December 2016. A total of 138 were performed by trauma surgeons, while 82 were done by pediatric surgeons. The patients operated on by trauma surgeons were more likely to be female (47% vs. 32%; P = .03), get to surgery more quickly (214 minutes from diagnosis vs. 318 minutes; P = .01), have a laparoscopic operation (70% vs. 55%; P = .04), have a shorter operation (40 minutes vs. 49 minutes; P less than .0001), and leave the hospital sooner (32 hours vs. 41 hours; P less than .0001). They were also more likely to be transferred from an outside hospital (60% vs. 37%; P less than .001) and less likely to be diagnosed without imaging (2% vs. 26%; P less than .0001). The study found no significant differences in complications.
Among the 31 patients who had perforated appendix, the difference in length of stay was even more pronounced: 4 days in the trauma surgery group (n = 21) versus 7.2 days in the pediatric surgery patients.
The investigators explained the rationale for focusing on the population aged 5-10 years: “We focused on a younger, narrower age range than that in previous studies, allowing comparison of outcomes in children of the same age and with equal rates of perforated appendicitis.” They noted that patients younger than age 5 are “well accepted as the domain of the pediatric surgeon,” while children over than 10 are more frequently managed by general surgeons.
At Evanston Hospital, pediatric surgeons had typically performed appendectomy in the targeted age group. But, “they cannot always quickly get to our hospital because of distance and city traffic,” the study authors noted. Therefore, the trauma surgeons were asked to cover for this population group.
They acknowledged the population size of the study was probably too small to identify any significant difference in complication rates between the two surgery groups, especially for patients who had had perforated appendicitis. Also, because of the study’s retrospective nature, most of the pediatric surgery cases were from an earlier period; therefore, later cases may have reflected advances in minimally invasive technology. “Perhaps surgical practice in a more recent time period contributes more to outcomes than specialty,” investigators wrote.
Dr. Wall and Dr. Ortega reported having no financial relationships.
SOURCE: Wall DB, Ortega C. J Trauma Acute Care Surg. 2018:85;118-21.
But a study of 220 children who had emergency appendectomies found only minor differences in outcomes between those operated on by a trauma surgeon and those by a pediatric surgeon.
“These results may be useful in optimizing the surgical workforce to care for a community,” said Derek B. Wall, MD, FACS, and Carlos Ortega, MD, FACS, of NorthShore University HealthSystem in Skokie, Ill. They noted that trauma surgeons in their group were asked to cover appendicitis in children aged 5-10 years because of the surgeons’ in-house availability and because of the difficulty pediatric surgeons often had in getting to the hospital in a timely fashion.
The study was done at Evanston (Ill.) Hospital, a Level 1 trauma center in the northern suburbs of Chicago. This trauma group were all board certified in general surgery, but none had received formal pediatric surgery fellowship training.
The study, published in the Journal of Trauma and Acute Surgery, evaluated appendectomies in children aged 5-10 years from January 2007 to December 2016. A total of 138 were performed by trauma surgeons, while 82 were done by pediatric surgeons. The patients operated on by trauma surgeons were more likely to be female (47% vs. 32%; P = .03), get to surgery more quickly (214 minutes from diagnosis vs. 318 minutes; P = .01), have a laparoscopic operation (70% vs. 55%; P = .04), have a shorter operation (40 minutes vs. 49 minutes; P less than .0001), and leave the hospital sooner (32 hours vs. 41 hours; P less than .0001). They were also more likely to be transferred from an outside hospital (60% vs. 37%; P less than .001) and less likely to be diagnosed without imaging (2% vs. 26%; P less than .0001). The study found no significant differences in complications.
Among the 31 patients who had perforated appendix, the difference in length of stay was even more pronounced: 4 days in the trauma surgery group (n = 21) versus 7.2 days in the pediatric surgery patients.
The investigators explained the rationale for focusing on the population aged 5-10 years: “We focused on a younger, narrower age range than that in previous studies, allowing comparison of outcomes in children of the same age and with equal rates of perforated appendicitis.” They noted that patients younger than age 5 are “well accepted as the domain of the pediatric surgeon,” while children over than 10 are more frequently managed by general surgeons.
At Evanston Hospital, pediatric surgeons had typically performed appendectomy in the targeted age group. But, “they cannot always quickly get to our hospital because of distance and city traffic,” the study authors noted. Therefore, the trauma surgeons were asked to cover for this population group.
They acknowledged the population size of the study was probably too small to identify any significant difference in complication rates between the two surgery groups, especially for patients who had had perforated appendicitis. Also, because of the study’s retrospective nature, most of the pediatric surgery cases were from an earlier period; therefore, later cases may have reflected advances in minimally invasive technology. “Perhaps surgical practice in a more recent time period contributes more to outcomes than specialty,” investigators wrote.
Dr. Wall and Dr. Ortega reported having no financial relationships.
SOURCE: Wall DB, Ortega C. J Trauma Acute Care Surg. 2018:85;118-21.
FROM THE JOURNAL OF TRAUMA AND ACUTE CARE SURGERY
Key clinical point: Trauma surgeons performed emergency pediatric appendectomy as well as pediatric surgeons did.
Major finding: Hospital stays averaged 32 and 41 hours for patients treated by trauma surgeons and pediatric surgeons, respectively.
Study details: Retrospective chart review of 220 children aged 5-10 years who had emergency appendectomy at a suburban Level 1 trauma center during 2007-2016.
Disclosures: The investigators reported having no financial relationships.
Source: Wall DB et al. J Trauma Acute Care Surg. 2018:85;118-21.
Study quantifies occupational exposure risks of EDT
For trauma patients who are in extremis, but with the high rates of HIV/hepatitis among trauma patients, one that also carries what had been an unknown exposure risk for emergency staff.
“The most important findings of this prospective, multicenter study are that occupational exposures were reported in 7.2% of EDT resuscitations and 1.6% of EDT resuscitation participants and that occupational exposure risk appears to be further mitigated with strict PPE [personal protective equipment] compliance to universal precautions,” lead author Andrew Nunn, MD, and his colleagues wrote. Dr. Nunn is a trauma surgeon with Wake Forest Baptist Health in Winston-Salem, N.C.
The researchers surveyed 1,360 emergency department (ED) personnel after they performed 305 EDTs at 16 academic and community trauma centers nationwide in 2015 and 2016. The patients who had an EDT were mostly men ranging in age from 24 to 41 years (90.5%) with penetrating injuries (77.4%) and arrived at the ED after prehospital CPR (56.7%). Twenty-two occupational exposures occurred during 22 of the EDT resuscitations, with trainees sustaining most of them (68.2%). The most common source of injury was sharps, accounting for 86.4% (scalpels, 38.9%; fractured bone, 27.8%; needles, 16.7%; and scissors, 3%).
“Occupational exposures correlated with PPE utilization, as universal precautions during EDT were more often observed in providers who did not sustain occupational exposures, compared with those sustaining exposures,” Dr. Nunn and his coauthors wrote. For example, 98% of those reporting no exposure were gloved versus 91% of those who were exposed (P greater than .05).
Dr. Nunn and his coauthors called the risk of HIV or hepatitis C virus (HCV) transmission during EDT “extraordinarily low.” Based on data from their study, they determined the risk of blood-borne pathogen transmission during an EDT resuscitation is 6 in 1 million for HIV and 1 in 10,000 for HCV, and the individual risk is 1 in 1 million and 3 in 100,000, respectively. Compliance with PPE precautions further limited exposure risk, but the study found that more than 10% of surveyed personnel did not utilize one of the four components of PPE besides gloves – eyewear, mask, gown or hat.
Most – but not all – survey responders followed up after the incidence of exposure. “[A total of] 91.7% of providers reporting their exposures also reported following up with their institution specific occupational exposure protocol,” the investigators wrote.
“Our findings have particular implications for trainees,” the study authors noted, citing the high percentage of injuries in this group. The findings emphasized the need for universal PPE compliance and enforcement by resuscitation team leaders. Nonetheless, the study found that the exposure rates during EDT are no greater than other surgical procedures.
“Regardless of the lifesaving nature of the procedure, improved universal precaution compliance with PPE is paramount and would further minimize occupational exposure risks to providers during EDT,” Dr. Nunn and his coauthors said.
Dr. Nunn and his coauthors reported having no financial relationships.
SOURCE: Nunn A et al. J Trauma Acute Care Surg. 2018:85;78-84.
For trauma patients who are in extremis, but with the high rates of HIV/hepatitis among trauma patients, one that also carries what had been an unknown exposure risk for emergency staff.
“The most important findings of this prospective, multicenter study are that occupational exposures were reported in 7.2% of EDT resuscitations and 1.6% of EDT resuscitation participants and that occupational exposure risk appears to be further mitigated with strict PPE [personal protective equipment] compliance to universal precautions,” lead author Andrew Nunn, MD, and his colleagues wrote. Dr. Nunn is a trauma surgeon with Wake Forest Baptist Health in Winston-Salem, N.C.
The researchers surveyed 1,360 emergency department (ED) personnel after they performed 305 EDTs at 16 academic and community trauma centers nationwide in 2015 and 2016. The patients who had an EDT were mostly men ranging in age from 24 to 41 years (90.5%) with penetrating injuries (77.4%) and arrived at the ED after prehospital CPR (56.7%). Twenty-two occupational exposures occurred during 22 of the EDT resuscitations, with trainees sustaining most of them (68.2%). The most common source of injury was sharps, accounting for 86.4% (scalpels, 38.9%; fractured bone, 27.8%; needles, 16.7%; and scissors, 3%).
“Occupational exposures correlated with PPE utilization, as universal precautions during EDT were more often observed in providers who did not sustain occupational exposures, compared with those sustaining exposures,” Dr. Nunn and his coauthors wrote. For example, 98% of those reporting no exposure were gloved versus 91% of those who were exposed (P greater than .05).
Dr. Nunn and his coauthors called the risk of HIV or hepatitis C virus (HCV) transmission during EDT “extraordinarily low.” Based on data from their study, they determined the risk of blood-borne pathogen transmission during an EDT resuscitation is 6 in 1 million for HIV and 1 in 10,000 for HCV, and the individual risk is 1 in 1 million and 3 in 100,000, respectively. Compliance with PPE precautions further limited exposure risk, but the study found that more than 10% of surveyed personnel did not utilize one of the four components of PPE besides gloves – eyewear, mask, gown or hat.
Most – but not all – survey responders followed up after the incidence of exposure. “[A total of] 91.7% of providers reporting their exposures also reported following up with their institution specific occupational exposure protocol,” the investigators wrote.
“Our findings have particular implications for trainees,” the study authors noted, citing the high percentage of injuries in this group. The findings emphasized the need for universal PPE compliance and enforcement by resuscitation team leaders. Nonetheless, the study found that the exposure rates during EDT are no greater than other surgical procedures.
“Regardless of the lifesaving nature of the procedure, improved universal precaution compliance with PPE is paramount and would further minimize occupational exposure risks to providers during EDT,” Dr. Nunn and his coauthors said.
Dr. Nunn and his coauthors reported having no financial relationships.
SOURCE: Nunn A et al. J Trauma Acute Care Surg. 2018:85;78-84.
For trauma patients who are in extremis, but with the high rates of HIV/hepatitis among trauma patients, one that also carries what had been an unknown exposure risk for emergency staff.
“The most important findings of this prospective, multicenter study are that occupational exposures were reported in 7.2% of EDT resuscitations and 1.6% of EDT resuscitation participants and that occupational exposure risk appears to be further mitigated with strict PPE [personal protective equipment] compliance to universal precautions,” lead author Andrew Nunn, MD, and his colleagues wrote. Dr. Nunn is a trauma surgeon with Wake Forest Baptist Health in Winston-Salem, N.C.
The researchers surveyed 1,360 emergency department (ED) personnel after they performed 305 EDTs at 16 academic and community trauma centers nationwide in 2015 and 2016. The patients who had an EDT were mostly men ranging in age from 24 to 41 years (90.5%) with penetrating injuries (77.4%) and arrived at the ED after prehospital CPR (56.7%). Twenty-two occupational exposures occurred during 22 of the EDT resuscitations, with trainees sustaining most of them (68.2%). The most common source of injury was sharps, accounting for 86.4% (scalpels, 38.9%; fractured bone, 27.8%; needles, 16.7%; and scissors, 3%).
“Occupational exposures correlated with PPE utilization, as universal precautions during EDT were more often observed in providers who did not sustain occupational exposures, compared with those sustaining exposures,” Dr. Nunn and his coauthors wrote. For example, 98% of those reporting no exposure were gloved versus 91% of those who were exposed (P greater than .05).
Dr. Nunn and his coauthors called the risk of HIV or hepatitis C virus (HCV) transmission during EDT “extraordinarily low.” Based on data from their study, they determined the risk of blood-borne pathogen transmission during an EDT resuscitation is 6 in 1 million for HIV and 1 in 10,000 for HCV, and the individual risk is 1 in 1 million and 3 in 100,000, respectively. Compliance with PPE precautions further limited exposure risk, but the study found that more than 10% of surveyed personnel did not utilize one of the four components of PPE besides gloves – eyewear, mask, gown or hat.
Most – but not all – survey responders followed up after the incidence of exposure. “[A total of] 91.7% of providers reporting their exposures also reported following up with their institution specific occupational exposure protocol,” the investigators wrote.
“Our findings have particular implications for trainees,” the study authors noted, citing the high percentage of injuries in this group. The findings emphasized the need for universal PPE compliance and enforcement by resuscitation team leaders. Nonetheless, the study found that the exposure rates during EDT are no greater than other surgical procedures.
“Regardless of the lifesaving nature of the procedure, improved universal precaution compliance with PPE is paramount and would further minimize occupational exposure risks to providers during EDT,” Dr. Nunn and his coauthors said.
Dr. Nunn and his coauthors reported having no financial relationships.
SOURCE: Nunn A et al. J Trauma Acute Care Surg. 2018:85;78-84.
FROM THE JOURNAL OF TRAUMA AND ACUTE CARE SURGERY
Key clinical point: Occupational exposure risk of emergency department thoracotomy (EDT) is low for personnel.
Major finding: Occupational exposure rate to HIV/hepatitis in trauma undergoing EDT is 7.2% for personnel.
Study details: Prospective, observational study that included 1,360 personnel surveyed after they performed 305 EDTs in 2015 and 2016.
Disclosures: Dr. Nunn and his coauthors reported having no financial relationships.
Source: Nunn A et al. J Trauma Acute Care Surg. 2018:85;78-84.
Children’s ‘gluten-free’ foods are no healthier than others
Children’s foods labeled as gluten-free (GF) generally had less sodium and fat than other foods marketed for children, but they also had a higher percentage of calories from sugar, a study in Pediatrics found. Further,
Parents and caregivers who are purchasing gluten-free products should carefully assess product labels. Another positive step would be to serve whole, unprocessed food, she wrote in Pediatrics.
Dr. Elliott purchased all child-targeted packaged foods available at two major supermarket chains in Alberta from February 2017 to March 2017, excluding candy, chocolate, potato chips, cheese-flavored snacks, sugary sodas, and similar “junk food” products. Of the 374 foods purchased, 18% had gluten-free claims.
“The intent was to examine the regular foods that have been repackaged to attract children,” she wrote, which she defined as meeting any of the following criteria qualified:
- Contains the word “child” or “kids’” in the product or brand name.
- Has the word “fun” or “play” on the package.
- The foods are linked to children’s TV programs, toys, or movies.
- The foods are promoted for lunch boxes.
- Contains graphics or activities, or promotional offers, intended for children.
- “Presents unusual or child-oriented shapes, unusual colors, or playful product names or tastes.”
Dr. Elliott compared the nutritional content of products labeled as gluten-free with that of products without a gluten-free label based on 100-g servings. She then compared the same GF-labeled products to their equivalent products without a GF label, when possible.
She used the Pan American Health Organization (PAHO) Nutrient Profile Model to evaluate the foods. PAHO criteria for nutritionally poor qualities include the following when applied to “processed” and “ultraprocessed” foods:
- A ratio between sodium and calories greater than or equal to 1.
- Total calories from sugar (glucose, fructose, and disaccharides) at least 10% or more of total calories.
- Contains other nonsugar sweeteners.
- Total calories from fat are at least 30% or more of total calories.
- Total saturated fat is at least at least 10% or more of total calories.
Nearly all the non-gluten free children’s foods (97%) and 88% of the children’s gluten-free foods were considered to have poor nutritional quality (P less than .001). High sugar content was present in 79% of gluten-free products and 81% of their gluten-containing equivalent products (P less than .001).
These foods can be classified as unhealthy because of “their high levels of sugar, sodium, and/or fat, which means that the options for purchasing healthy packaged foods are limited,” Dr. Elliott wrote.
Gluten free–labeled products did have less sodium, total fat, and saturated fat than did those without gluten-free claims, but sugar levels were higher and protein levels lower (nonstatistically significant) in gluten-free products.
“Such findings echo those in other studies of child-targeted supermarket foods and reveal that products marketed as ‘better for you’ for children are as much about marketing as they are about nutrition,” Dr. Elliott wrote. “Given children’s lower daily caloric intake and the challenges associated with consuming a nutrient-rich, gluten-free diet for children with celiac disease in particular, it is important that the products designed for children are held to a higher nutritional standard.”
The study’s biggest limitations are its inability to represent all child-marketed packaged foods available in stores and the fact that many foods labeled as “gluten-free” would not have gluten in them anyway, such as apple sauce and fruit snacks.
“In this case, the use of a gluten-free claim on products that are inherently free of gluten might be understood as a marketing tool directed at consumers who view gluten-free products as healthier than their regular counterparts,” Dr. Elliott noted
The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
SOURCE: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
Children’s foods labeled as gluten-free (GF) generally had less sodium and fat than other foods marketed for children, but they also had a higher percentage of calories from sugar, a study in Pediatrics found. Further,
Parents and caregivers who are purchasing gluten-free products should carefully assess product labels. Another positive step would be to serve whole, unprocessed food, she wrote in Pediatrics.
Dr. Elliott purchased all child-targeted packaged foods available at two major supermarket chains in Alberta from February 2017 to March 2017, excluding candy, chocolate, potato chips, cheese-flavored snacks, sugary sodas, and similar “junk food” products. Of the 374 foods purchased, 18% had gluten-free claims.
“The intent was to examine the regular foods that have been repackaged to attract children,” she wrote, which she defined as meeting any of the following criteria qualified:
- Contains the word “child” or “kids’” in the product or brand name.
- Has the word “fun” or “play” on the package.
- The foods are linked to children’s TV programs, toys, or movies.
- The foods are promoted for lunch boxes.
- Contains graphics or activities, or promotional offers, intended for children.
- “Presents unusual or child-oriented shapes, unusual colors, or playful product names or tastes.”
Dr. Elliott compared the nutritional content of products labeled as gluten-free with that of products without a gluten-free label based on 100-g servings. She then compared the same GF-labeled products to their equivalent products without a GF label, when possible.
She used the Pan American Health Organization (PAHO) Nutrient Profile Model to evaluate the foods. PAHO criteria for nutritionally poor qualities include the following when applied to “processed” and “ultraprocessed” foods:
- A ratio between sodium and calories greater than or equal to 1.
- Total calories from sugar (glucose, fructose, and disaccharides) at least 10% or more of total calories.
- Contains other nonsugar sweeteners.
- Total calories from fat are at least 30% or more of total calories.
- Total saturated fat is at least at least 10% or more of total calories.
Nearly all the non-gluten free children’s foods (97%) and 88% of the children’s gluten-free foods were considered to have poor nutritional quality (P less than .001). High sugar content was present in 79% of gluten-free products and 81% of their gluten-containing equivalent products (P less than .001).
These foods can be classified as unhealthy because of “their high levels of sugar, sodium, and/or fat, which means that the options for purchasing healthy packaged foods are limited,” Dr. Elliott wrote.
Gluten free–labeled products did have less sodium, total fat, and saturated fat than did those without gluten-free claims, but sugar levels were higher and protein levels lower (nonstatistically significant) in gluten-free products.
“Such findings echo those in other studies of child-targeted supermarket foods and reveal that products marketed as ‘better for you’ for children are as much about marketing as they are about nutrition,” Dr. Elliott wrote. “Given children’s lower daily caloric intake and the challenges associated with consuming a nutrient-rich, gluten-free diet for children with celiac disease in particular, it is important that the products designed for children are held to a higher nutritional standard.”
The study’s biggest limitations are its inability to represent all child-marketed packaged foods available in stores and the fact that many foods labeled as “gluten-free” would not have gluten in them anyway, such as apple sauce and fruit snacks.
“In this case, the use of a gluten-free claim on products that are inherently free of gluten might be understood as a marketing tool directed at consumers who view gluten-free products as healthier than their regular counterparts,” Dr. Elliott noted
The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
SOURCE: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
Children’s foods labeled as gluten-free (GF) generally had less sodium and fat than other foods marketed for children, but they also had a higher percentage of calories from sugar, a study in Pediatrics found. Further,
Parents and caregivers who are purchasing gluten-free products should carefully assess product labels. Another positive step would be to serve whole, unprocessed food, she wrote in Pediatrics.
Dr. Elliott purchased all child-targeted packaged foods available at two major supermarket chains in Alberta from February 2017 to March 2017, excluding candy, chocolate, potato chips, cheese-flavored snacks, sugary sodas, and similar “junk food” products. Of the 374 foods purchased, 18% had gluten-free claims.
“The intent was to examine the regular foods that have been repackaged to attract children,” she wrote, which she defined as meeting any of the following criteria qualified:
- Contains the word “child” or “kids’” in the product or brand name.
- Has the word “fun” or “play” on the package.
- The foods are linked to children’s TV programs, toys, or movies.
- The foods are promoted for lunch boxes.
- Contains graphics or activities, or promotional offers, intended for children.
- “Presents unusual or child-oriented shapes, unusual colors, or playful product names or tastes.”
Dr. Elliott compared the nutritional content of products labeled as gluten-free with that of products without a gluten-free label based on 100-g servings. She then compared the same GF-labeled products to their equivalent products without a GF label, when possible.
She used the Pan American Health Organization (PAHO) Nutrient Profile Model to evaluate the foods. PAHO criteria for nutritionally poor qualities include the following when applied to “processed” and “ultraprocessed” foods:
- A ratio between sodium and calories greater than or equal to 1.
- Total calories from sugar (glucose, fructose, and disaccharides) at least 10% or more of total calories.
- Contains other nonsugar sweeteners.
- Total calories from fat are at least 30% or more of total calories.
- Total saturated fat is at least at least 10% or more of total calories.
Nearly all the non-gluten free children’s foods (97%) and 88% of the children’s gluten-free foods were considered to have poor nutritional quality (P less than .001). High sugar content was present in 79% of gluten-free products and 81% of their gluten-containing equivalent products (P less than .001).
These foods can be classified as unhealthy because of “their high levels of sugar, sodium, and/or fat, which means that the options for purchasing healthy packaged foods are limited,” Dr. Elliott wrote.
Gluten free–labeled products did have less sodium, total fat, and saturated fat than did those without gluten-free claims, but sugar levels were higher and protein levels lower (nonstatistically significant) in gluten-free products.
“Such findings echo those in other studies of child-targeted supermarket foods and reveal that products marketed as ‘better for you’ for children are as much about marketing as they are about nutrition,” Dr. Elliott wrote. “Given children’s lower daily caloric intake and the challenges associated with consuming a nutrient-rich, gluten-free diet for children with celiac disease in particular, it is important that the products designed for children are held to a higher nutritional standard.”
The study’s biggest limitations are its inability to represent all child-marketed packaged foods available in stores and the fact that many foods labeled as “gluten-free” would not have gluten in them anyway, such as apple sauce and fruit snacks.
“In this case, the use of a gluten-free claim on products that are inherently free of gluten might be understood as a marketing tool directed at consumers who view gluten-free products as healthier than their regular counterparts,” Dr. Elliott noted
The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
SOURCE: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
FROM PEDIATRICS
Key clinical point: Most prepackaged gluten-free foods marketed for children are unhealthy.
Major finding: Of gluten-free packaged children’s foods, 88% had poor nutritional quality, as did 97% of children’s food not labeled as gluten-free.
Study details: The findings are based on a comparison of 374 child-marketed packaged foods, including 66 gluten free–labeled foods and their non-gluten free equivalents and other non-gluten free foods.
Disclosures: The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
Source: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
Breast cancer patients don’t get the financial counseling they want from their clinicians
About half of medical oncologists – and even fewer surgeons and radiation oncologists – have someone in their practice to discuss the financial implications of treating breast cancer, a physician-patient survey has found.
Patients are feeling that lack of service, too; 73% of women in the survey said their providers didn’t offer much, or even any, help in tackling the potentially devastating financial impact of their cancer. Women reported a variety of these issues, including increased debt, lost time at work, skimping on their food budget, and even losing their homes as the medical bills added up.
“The privations observed in the current study are sobering and consistent with studies published before the widespread awareness of the potential for financial toxicity after the diagnosis and treatment of cancer,” wrote Reshma Jagsi, MD, and coauthors. The report was published in Cancer. 
“… Unfortunately, unmet needs for discussion persist, as does unresolved worry. The percentage of patients who perceive meaningful clinician engagement is low, with far fewer than one-quarter of respondents reporting more than a little discussion of these issues, which is strikingly lower than the percentage of providers who perceive routinely making services available,” they wrote.
Dr. Jagsi, of the University of Michigan, Ann Arbor, and her colleagues used the Surveillance, Epidemiology, and End Results (SEER) database to identify 2,502 women in Georgia and Los Angeles County who were diagnosed with early-stage breast cancer from 2013 to 2015. They contacted these women, who were at least 1 year out from diagnosis, and their oncology providers with a survey designed to determine how both groups communicated about financial issues, and how those issues affected patients’ day-to-day lives.
Most of the clinicians were surgeons (370); the rest were medical oncologists (306) or radiation oncologists (169). About a quarter of each group was in a teaching practice.
Among the medical oncologists, 50.9% reported that someone in their practice often or always discussed financial burden with patients, as did 15.6% of surgeons and 43.2% of radiation oncologists. Medical oncologists were also more likely to respond that they were very aware of out-of-pocket costs for patients, as did 27.3% of surgeons and 34.3% of radiation oncologists.
About 57% of medical oncologists thought it was quite or extremely important to save their patients money; 35.3% of surgeons and 55.8% of radiation oncologists also responded so.
Many women reported at least some measure of financial toxicity related to their cancer and its treatment, and this varied widely by ethnicity and race. Debt was common, noted by 58.9% of black patients, 33.5% of Latina patients, and about 28% of both white and Asian patients.
“Many patients also had substantial lost income and out-of-pocket expenses that they attributed to breast cancer,” the authors wrote. “Overall, 14% of patients reported lost income that was [at least] 10% of their household income, 17% of patients reported spending [at least] 10% of household income on out-of-pocket medical expenses, and 7% of patients reported spending [at least] 10% of household income on out-of-pocket nonmedical expenses.
Housing loss attributed to breast cancer was most common among blacks (6%) and Latinas (4.7%), and less so among whites and Asians (about 1% each).
Blacks and Latinas also were more likely to report a utility disconnection due to unpaid bills (5.9% and 3.2%, respectively) compared with whites and Asians (1.7% and 0.5%).
One way women financially coped, the survey found, was to cut the food budget. “One in five whites [21.5%] and Asians [22.5%] cut down spending on food, as did nearly one-half of black individuals [45.2%] and greater than one-third of Latinas [35.8%].”
Worry about finances was most common among blacks and Latinas (about 50%), but about a third of white and Asian women also reported worry. Survey results suggested that clinicians were not addressing these issues.
Women – especially nonwhite women – wanted to have these talks, with 15.2% of whites, 31.1% of blacks, 30.3% of Latinas, and 25.4% of Asians reporting this desire.
“Unmet patient needs for engagement with physicians regarding financial concerns were common. Of the 945 women who expressed worrying at least somewhat, 679 (72.8%) indicated that cancer physicians and their staff did not help at least somewhat,” the authors said.
More than half of the 523 women who expressed a desire to talk to health care providers regarding the impact of breast cancer on employment or finances (55.4%) reported that this discussion never took place, either with the oncologist, primary care provider, social worker, or any other professional involved in their care.
A multivariate analysis examined patient characteristics associated with the desire to discuss financial toxicity with a health care provider. Younger age, nonwhite race, lower income, being employed, receiving chemotherapy, and living in Georgia all showed significant, independent interaction.
“Given these findings, it is clear that thoughtfully designed, prospective interventions are necessary to address the remarkably common experiences of financial burden that patients report even in the modern era,” the investigators wrote. “These interventions might include training for physicians and their staff regarding how to have effective conversations in this context, in ways that are sensitive to cultural differences and needs. Other promising approaches might include the use of advanced technology to engage patients in interactive exercises that elicit their financial concerns and experiences and alert providers to their needs.”
The study was largely funded by a grant from the National Cancer Institute and the University of Michigan. Dr. Jagsi disclosed that she has been a consultant for Amgen but not relative to this study.
SOURCE: Jagsi R et al. Cancer 2018 Jul 23. doi: 10.1002/cncr.31532.
About half of medical oncologists – and even fewer surgeons and radiation oncologists – have someone in their practice to discuss the financial implications of treating breast cancer, a physician-patient survey has found.
Patients are feeling that lack of service, too; 73% of women in the survey said their providers didn’t offer much, or even any, help in tackling the potentially devastating financial impact of their cancer. Women reported a variety of these issues, including increased debt, lost time at work, skimping on their food budget, and even losing their homes as the medical bills added up.
“The privations observed in the current study are sobering and consistent with studies published before the widespread awareness of the potential for financial toxicity after the diagnosis and treatment of cancer,” wrote Reshma Jagsi, MD, and coauthors. The report was published in Cancer.
“… Unfortunately, unmet needs for discussion persist, as does unresolved worry. The percentage of patients who perceive meaningful clinician engagement is low, with far fewer than one-quarter of respondents reporting more than a little discussion of these issues, which is strikingly lower than the percentage of providers who perceive routinely making services available,” they wrote.
Dr. Jagsi, of the University of Michigan, Ann Arbor, and her colleagues used the Surveillance, Epidemiology, and End Results (SEER) database to identify 2,502 women in Georgia and Los Angeles County who were diagnosed with early-stage breast cancer from 2013 to 2015. They contacted these women, who were at least 1 year out from diagnosis, and their oncology providers with a survey designed to determine how both groups communicated about financial issues, and how those issues affected patients’ day-to-day lives.
Most of the clinicians were surgeons (370); the rest were medical oncologists (306) or radiation oncologists (169). About a quarter of each group was in a teaching practice.
Among the medical oncologists, 50.9% reported that someone in their practice often or always discussed financial burden with patients, as did 15.6% of surgeons and 43.2% of radiation oncologists. Medical oncologists were also more likely to respond that they were very aware of out-of-pocket costs for patients, as did 27.3% of surgeons and 34.3% of radiation oncologists.
About 57% of medical oncologists thought it was quite or extremely important to save their patients money; 35.3% of surgeons and 55.8% of radiation oncologists also responded so.
Many women reported at least some measure of financial toxicity related to their cancer and its treatment, and this varied widely by ethnicity and race. Debt was common, noted by 58.9% of black patients, 33.5% of Latina patients, and about 28% of both white and Asian patients.
“Many patients also had substantial lost income and out-of-pocket expenses that they attributed to breast cancer,” the authors wrote. “Overall, 14% of patients reported lost income that was [at least] 10% of their household income, 17% of patients reported spending [at least] 10% of household income on out-of-pocket medical expenses, and 7% of patients reported spending [at least] 10% of household income on out-of-pocket nonmedical expenses.
Housing loss attributed to breast cancer was most common among blacks (6%) and Latinas (4.7%), and less so among whites and Asians (about 1% each).
Blacks and Latinas also were more likely to report a utility disconnection due to unpaid bills (5.9% and 3.2%, respectively) compared with whites and Asians (1.7% and 0.5%).
One way women financially coped, the survey found, was to cut the food budget. “One in five whites [21.5%] and Asians [22.5%] cut down spending on food, as did nearly one-half of black individuals [45.2%] and greater than one-third of Latinas [35.8%].”
Worry about finances was most common among blacks and Latinas (about 50%), but about a third of white and Asian women also reported worry. Survey results suggested that clinicians were not addressing these issues.
Women – especially nonwhite women – wanted to have these talks, with 15.2% of whites, 31.1% of blacks, 30.3% of Latinas, and 25.4% of Asians reporting this desire.
“Unmet patient needs for engagement with physicians regarding financial concerns were common. Of the 945 women who expressed worrying at least somewhat, 679 (72.8%) indicated that cancer physicians and their staff did not help at least somewhat,” the authors said.
More than half of the 523 women who expressed a desire to talk to health care providers regarding the impact of breast cancer on employment or finances (55.4%) reported that this discussion never took place, either with the oncologist, primary care provider, social worker, or any other professional involved in their care.
A multivariate analysis examined patient characteristics associated with the desire to discuss financial toxicity with a health care provider. Younger age, nonwhite race, lower income, being employed, receiving chemotherapy, and living in Georgia all showed significant, independent interaction.
“Given these findings, it is clear that thoughtfully designed, prospective interventions are necessary to address the remarkably common experiences of financial burden that patients report even in the modern era,” the investigators wrote. “These interventions might include training for physicians and their staff regarding how to have effective conversations in this context, in ways that are sensitive to cultural differences and needs. Other promising approaches might include the use of advanced technology to engage patients in interactive exercises that elicit their financial concerns and experiences and alert providers to their needs.”
The study was largely funded by a grant from the National Cancer Institute and the University of Michigan. Dr. Jagsi disclosed that she has been a consultant for Amgen but not relative to this study.
SOURCE: Jagsi R et al. Cancer 2018 Jul 23. doi: 10.1002/cncr.31532.
About half of medical oncologists – and even fewer surgeons and radiation oncologists – have someone in their practice to discuss the financial implications of treating breast cancer, a physician-patient survey has found.
Patients are feeling that lack of service, too; 73% of women in the survey said their providers didn’t offer much, or even any, help in tackling the potentially devastating financial impact of their cancer. Women reported a variety of these issues, including increased debt, lost time at work, skimping on their food budget, and even losing their homes as the medical bills added up.
“The privations observed in the current study are sobering and consistent with studies published before the widespread awareness of the potential for financial toxicity after the diagnosis and treatment of cancer,” wrote Reshma Jagsi, MD, and coauthors. The report was published in Cancer.
“… Unfortunately, unmet needs for discussion persist, as does unresolved worry. The percentage of patients who perceive meaningful clinician engagement is low, with far fewer than one-quarter of respondents reporting more than a little discussion of these issues, which is strikingly lower than the percentage of providers who perceive routinely making services available,” they wrote.
Dr. Jagsi, of the University of Michigan, Ann Arbor, and her colleagues used the Surveillance, Epidemiology, and End Results (SEER) database to identify 2,502 women in Georgia and Los Angeles County who were diagnosed with early-stage breast cancer from 2013 to 2015. They contacted these women, who were at least 1 year out from diagnosis, and their oncology providers with a survey designed to determine how both groups communicated about financial issues, and how those issues affected patients’ day-to-day lives.
Most of the clinicians were surgeons (370); the rest were medical oncologists (306) or radiation oncologists (169). About a quarter of each group was in a teaching practice.
Among the medical oncologists, 50.9% reported that someone in their practice often or always discussed financial burden with patients, as did 15.6% of surgeons and 43.2% of radiation oncologists. Medical oncologists were also more likely to respond that they were very aware of out-of-pocket costs for patients, as did 27.3% of surgeons and 34.3% of radiation oncologists.
About 57% of medical oncologists thought it was quite or extremely important to save their patients money; 35.3% of surgeons and 55.8% of radiation oncologists also responded so.
Many women reported at least some measure of financial toxicity related to their cancer and its treatment, and this varied widely by ethnicity and race. Debt was common, noted by 58.9% of black patients, 33.5% of Latina patients, and about 28% of both white and Asian patients.
“Many patients also had substantial lost income and out-of-pocket expenses that they attributed to breast cancer,” the authors wrote. “Overall, 14% of patients reported lost income that was [at least] 10% of their household income, 17% of patients reported spending [at least] 10% of household income on out-of-pocket medical expenses, and 7% of patients reported spending [at least] 10% of household income on out-of-pocket nonmedical expenses.
Housing loss attributed to breast cancer was most common among blacks (6%) and Latinas (4.7%), and less so among whites and Asians (about 1% each).
Blacks and Latinas also were more likely to report a utility disconnection due to unpaid bills (5.9% and 3.2%, respectively) compared with whites and Asians (1.7% and 0.5%).
One way women financially coped, the survey found, was to cut the food budget. “One in five whites [21.5%] and Asians [22.5%] cut down spending on food, as did nearly one-half of black individuals [45.2%] and greater than one-third of Latinas [35.8%].”
Worry about finances was most common among blacks and Latinas (about 50%), but about a third of white and Asian women also reported worry. Survey results suggested that clinicians were not addressing these issues.
Women – especially nonwhite women – wanted to have these talks, with 15.2% of whites, 31.1% of blacks, 30.3% of Latinas, and 25.4% of Asians reporting this desire.
“Unmet patient needs for engagement with physicians regarding financial concerns were common. Of the 945 women who expressed worrying at least somewhat, 679 (72.8%) indicated that cancer physicians and their staff did not help at least somewhat,” the authors said.
More than half of the 523 women who expressed a desire to talk to health care providers regarding the impact of breast cancer on employment or finances (55.4%) reported that this discussion never took place, either with the oncologist, primary care provider, social worker, or any other professional involved in their care.
A multivariate analysis examined patient characteristics associated with the desire to discuss financial toxicity with a health care provider. Younger age, nonwhite race, lower income, being employed, receiving chemotherapy, and living in Georgia all showed significant, independent interaction.
“Given these findings, it is clear that thoughtfully designed, prospective interventions are necessary to address the remarkably common experiences of financial burden that patients report even in the modern era,” the investigators wrote. “These interventions might include training for physicians and their staff regarding how to have effective conversations in this context, in ways that are sensitive to cultural differences and needs. Other promising approaches might include the use of advanced technology to engage patients in interactive exercises that elicit their financial concerns and experiences and alert providers to their needs.”
The study was largely funded by a grant from the National Cancer Institute and the University of Michigan. Dr. Jagsi disclosed that she has been a consultant for Amgen but not relative to this study.
SOURCE: Jagsi R et al. Cancer 2018 Jul 23. doi: 10.1002/cncr.31532.
FROM CANCER
Key clinical point: Oncology care providers aren’t providing adequate financial counseling for patients with breast cancer.
Major finding: Half of medical oncologists say they don’t have a staff member routinely discuss the financial impact of breast cancer, and 73% of patients say they’ve never had this discussion with their doctor.
Study details: The survey comprised 2,502 patients and 845 physicians.
Disclosures: The study was largely funded by a grant from the National Cancer Institute and the University of Michigan. Dr. Jagsi disclosed that she has been a consultant for Amgen but not relative to this study.
Source: Jagsi R et al. Cancer 2018 Jul 23. doi: 10.1002/cncr.31532.
FDA approves biosimilar filgrastim
The US Food and Drug Administration (FDA) has approved the leukocyte growth factor Nivestym™ (filgrastim-aafi), a biosimilar to Neupogen (filgrastim).
Nivestym is approved to treat patients with nonmyeloid malignancies who are receiving myelosuppressive chemotherapy or undergoing bone marrow transplant, acute myeloid leukemia patients receiving induction or consolidation chemotherapy, patients undergoing autologous peripheral blood progenitor cell collection, and patients with severe chronic neutropenia.
The FDA’s approval of Nivestym was based on a review of evidence suggesting the drug is highly similar to Neupogen, according to Pfizer, the company developing Nivestym.
The full approved indication for Nivestym is as follows:
- To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever
- To reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy in patients with acute myeloid leukemia
- To reduce the duration of neutropenia and neutropenia-related clinical sequelae (eg, febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplant
- For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
- For chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (eg, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
For more details on Nivestym, see the full prescribing information.
The US Food and Drug Administration (FDA) has approved the leukocyte growth factor Nivestym™ (filgrastim-aafi), a biosimilar to Neupogen (filgrastim).
Nivestym is approved to treat patients with nonmyeloid malignancies who are receiving myelosuppressive chemotherapy or undergoing bone marrow transplant, acute myeloid leukemia patients receiving induction or consolidation chemotherapy, patients undergoing autologous peripheral blood progenitor cell collection, and patients with severe chronic neutropenia.
The FDA’s approval of Nivestym was based on a review of evidence suggesting the drug is highly similar to Neupogen, according to Pfizer, the company developing Nivestym.
The full approved indication for Nivestym is as follows:
- To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever
- To reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy in patients with acute myeloid leukemia
- To reduce the duration of neutropenia and neutropenia-related clinical sequelae (eg, febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplant
- For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
- For chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (eg, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
For more details on Nivestym, see the full prescribing information.
The US Food and Drug Administration (FDA) has approved the leukocyte growth factor Nivestym™ (filgrastim-aafi), a biosimilar to Neupogen (filgrastim).
Nivestym is approved to treat patients with nonmyeloid malignancies who are receiving myelosuppressive chemotherapy or undergoing bone marrow transplant, acute myeloid leukemia patients receiving induction or consolidation chemotherapy, patients undergoing autologous peripheral blood progenitor cell collection, and patients with severe chronic neutropenia.
The FDA’s approval of Nivestym was based on a review of evidence suggesting the drug is highly similar to Neupogen, according to Pfizer, the company developing Nivestym.
The full approved indication for Nivestym is as follows:
- To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever
- To reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy in patients with acute myeloid leukemia
- To reduce the duration of neutropenia and neutropenia-related clinical sequelae (eg, febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplant
- For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
- For chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (eg, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
For more details on Nivestym, see the full prescribing information.
Tool may reveal optimal time for SCT in MF
A new tool can help patients with myelofibrosis (MF) decide when to pursue stem cell transplant (SCT), according to the MPN Research Foundation.
The SCT Spectrum Transplant Timing tool (SSTT) is an online MF risk calculator.
It is designed to inform patients of their risk status in a timely manner so they can be proactive in speaking to their doctors about SCT.
“There is an optimal time to start SCT, simply because the odds of success soar in our favor when we start early rather than late in the game,” said Zhenya Senyak, editor of MPN Forum, an MF patient, and creator of the SSTT.
“The SCT Spectrum Timing Tool can help inform the timing of that decision.”
The SSTT incorporates the Dynamic International Prognostic Scoring System (DIPSS), asking patients about their age, white blood cell count, hemoglobin level, peripheral blood blast percentage, and constitutional symptoms.
Patients’ answers are used to create a color signal that indicates their current MF risk level. Accompanying information explains what the risk level means, provides median survival times for that level, and alerts patients of the relative urgency of SCT.
Patients can review these results with their hematologist to ensure accuracy and incorporate risk factors not measured by the SSTT.
The SSTT also includes resources to support SCT discussions between patients and hematologists.
Senyak created SSTT with help from the MPN SCT Transplantation Timing Taskforce, a group of 18 MPN and transplant specialists, patient advocates, and SCT survivors. The work was sponsored by the MPN Research Foundation.
“The decision of whether or not to pursue a stem cell transplant is incredibly fraught for any person,” said Ruben Mesa, MD, a member of the MPN SCT Transplantation Timing Taskforce.
“Our hope in assisting with this effort is to lend our knowledge and experience to create a guide to assist with patient-doctor communication around this very complicated issue.”
A new tool can help patients with myelofibrosis (MF) decide when to pursue stem cell transplant (SCT), according to the MPN Research Foundation.
The SCT Spectrum Transplant Timing tool (SSTT) is an online MF risk calculator.
It is designed to inform patients of their risk status in a timely manner so they can be proactive in speaking to their doctors about SCT.
“There is an optimal time to start SCT, simply because the odds of success soar in our favor when we start early rather than late in the game,” said Zhenya Senyak, editor of MPN Forum, an MF patient, and creator of the SSTT.
“The SCT Spectrum Timing Tool can help inform the timing of that decision.”
The SSTT incorporates the Dynamic International Prognostic Scoring System (DIPSS), asking patients about their age, white blood cell count, hemoglobin level, peripheral blood blast percentage, and constitutional symptoms.
Patients’ answers are used to create a color signal that indicates their current MF risk level. Accompanying information explains what the risk level means, provides median survival times for that level, and alerts patients of the relative urgency of SCT.
Patients can review these results with their hematologist to ensure accuracy and incorporate risk factors not measured by the SSTT.
The SSTT also includes resources to support SCT discussions between patients and hematologists.
Senyak created SSTT with help from the MPN SCT Transplantation Timing Taskforce, a group of 18 MPN and transplant specialists, patient advocates, and SCT survivors. The work was sponsored by the MPN Research Foundation.
“The decision of whether or not to pursue a stem cell transplant is incredibly fraught for any person,” said Ruben Mesa, MD, a member of the MPN SCT Transplantation Timing Taskforce.
“Our hope in assisting with this effort is to lend our knowledge and experience to create a guide to assist with patient-doctor communication around this very complicated issue.”
A new tool can help patients with myelofibrosis (MF) decide when to pursue stem cell transplant (SCT), according to the MPN Research Foundation.
The SCT Spectrum Transplant Timing tool (SSTT) is an online MF risk calculator.
It is designed to inform patients of their risk status in a timely manner so they can be proactive in speaking to their doctors about SCT.
“There is an optimal time to start SCT, simply because the odds of success soar in our favor when we start early rather than late in the game,” said Zhenya Senyak, editor of MPN Forum, an MF patient, and creator of the SSTT.
“The SCT Spectrum Timing Tool can help inform the timing of that decision.”
The SSTT incorporates the Dynamic International Prognostic Scoring System (DIPSS), asking patients about their age, white blood cell count, hemoglobin level, peripheral blood blast percentage, and constitutional symptoms.
Patients’ answers are used to create a color signal that indicates their current MF risk level. Accompanying information explains what the risk level means, provides median survival times for that level, and alerts patients of the relative urgency of SCT.
Patients can review these results with their hematologist to ensure accuracy and incorporate risk factors not measured by the SSTT.
The SSTT also includes resources to support SCT discussions between patients and hematologists.
Senyak created SSTT with help from the MPN SCT Transplantation Timing Taskforce, a group of 18 MPN and transplant specialists, patient advocates, and SCT survivors. The work was sponsored by the MPN Research Foundation.
“The decision of whether or not to pursue a stem cell transplant is incredibly fraught for any person,” said Ruben Mesa, MD, a member of the MPN SCT Transplantation Timing Taskforce.
“Our hope in assisting with this effort is to lend our knowledge and experience to create a guide to assist with patient-doctor communication around this very complicated issue.”
Greening intervention tied to self-reported improved mental health
Living close to an urban greening program improved mental health in low-income city dwellers, according to results from a randomized trial, in which the greening intervention consisted of removing trash from vacant lots, grading the land, planting new grass and trees, installing wooden fences, and performing maintenance.
Options for depression treatment are limited, and this has led researchers to consider environmental factors that might contribute to the condition. Vacant or dilapidated neighborhood spaces are a known factor for depression.
The researchers performed a citywide cluster randomized trial in Philadelphia, which included 541 vacant lots in 110 clusters. A total of 37 clusters were assigned to the greening intervention, 36 to the trash cleanup intervention, and 37 clusters were left alone. The researchers interviewed local residents near each cluster, using the short-form Kessler-6 Psychological Distress Scale to assess mental health outcomes, wrote Dr. South, of the University of Pennsylvania, Philadelphia.
The researchers interviewed 442 participants (mean age 44.6 years, 59.7% female) in the preintervention period, and 342 (77.4%) during the postintervention period. The researchers conducted a neighborhood poverty subset analysis that included 139 participants.
Intention-to-treat analyses showed that, compared with no intervention, those in the greening intervention experienced a significant decrease in reporting feeling depressed (–41.5%; 95% confidence interval, –63.6 to –5.9; P = .03) and feeling worthless (–50.9%; 95% CI, –74.7 to –4.7; P = .04). The investigators also found a trend toward a reduction in participants who self-reported being in poor mental health (–62.8%; 95% CI, –86.5 to –27.5; P = .051).
When the analysis was restricted to neighborhoods below the poverty line, the greening intervention led to a significant decrease in participants feeling depressed (–68.7%; 95% CI, –86.5 to –27.5; P =.007), but no statistically significant difference was found in participants with self-reported poor mental health.
The trash cleanup intervention had no significant associations with changes in mental health outcomes, compared with no intervention.
Dr. South reported having no disclosures. The study was funded by the National Institutes of Health, and the Centers for Disease Control and Prevention.
SOURCE: South EC et al. JAMA Network Open. 2018 Jul 20. doi: 10.1001/jamanetworkopen.2018.0298.
Living close to an urban greening program improved mental health in low-income city dwellers, according to results from a randomized trial, in which the greening intervention consisted of removing trash from vacant lots, grading the land, planting new grass and trees, installing wooden fences, and performing maintenance.
Options for depression treatment are limited, and this has led researchers to consider environmental factors that might contribute to the condition. Vacant or dilapidated neighborhood spaces are a known factor for depression.
The researchers performed a citywide cluster randomized trial in Philadelphia, which included 541 vacant lots in 110 clusters. A total of 37 clusters were assigned to the greening intervention, 36 to the trash cleanup intervention, and 37 clusters were left alone. The researchers interviewed local residents near each cluster, using the short-form Kessler-6 Psychological Distress Scale to assess mental health outcomes, wrote Dr. South, of the University of Pennsylvania, Philadelphia.
The researchers interviewed 442 participants (mean age 44.6 years, 59.7% female) in the preintervention period, and 342 (77.4%) during the postintervention period. The researchers conducted a neighborhood poverty subset analysis that included 139 participants.
Intention-to-treat analyses showed that, compared with no intervention, those in the greening intervention experienced a significant decrease in reporting feeling depressed (–41.5%; 95% confidence interval, –63.6 to –5.9; P = .03) and feeling worthless (–50.9%; 95% CI, –74.7 to –4.7; P = .04). The investigators also found a trend toward a reduction in participants who self-reported being in poor mental health (–62.8%; 95% CI, –86.5 to –27.5; P = .051).
When the analysis was restricted to neighborhoods below the poverty line, the greening intervention led to a significant decrease in participants feeling depressed (–68.7%; 95% CI, –86.5 to –27.5; P =.007), but no statistically significant difference was found in participants with self-reported poor mental health.
The trash cleanup intervention had no significant associations with changes in mental health outcomes, compared with no intervention.
Dr. South reported having no disclosures. The study was funded by the National Institutes of Health, and the Centers for Disease Control and Prevention.
SOURCE: South EC et al. JAMA Network Open. 2018 Jul 20. doi: 10.1001/jamanetworkopen.2018.0298.
Living close to an urban greening program improved mental health in low-income city dwellers, according to results from a randomized trial, in which the greening intervention consisted of removing trash from vacant lots, grading the land, planting new grass and trees, installing wooden fences, and performing maintenance.
Options for depression treatment are limited, and this has led researchers to consider environmental factors that might contribute to the condition. Vacant or dilapidated neighborhood spaces are a known factor for depression.
The researchers performed a citywide cluster randomized trial in Philadelphia, which included 541 vacant lots in 110 clusters. A total of 37 clusters were assigned to the greening intervention, 36 to the trash cleanup intervention, and 37 clusters were left alone. The researchers interviewed local residents near each cluster, using the short-form Kessler-6 Psychological Distress Scale to assess mental health outcomes, wrote Dr. South, of the University of Pennsylvania, Philadelphia.
The researchers interviewed 442 participants (mean age 44.6 years, 59.7% female) in the preintervention period, and 342 (77.4%) during the postintervention period. The researchers conducted a neighborhood poverty subset analysis that included 139 participants.
Intention-to-treat analyses showed that, compared with no intervention, those in the greening intervention experienced a significant decrease in reporting feeling depressed (–41.5%; 95% confidence interval, –63.6 to –5.9; P = .03) and feeling worthless (–50.9%; 95% CI, –74.7 to –4.7; P = .04). The investigators also found a trend toward a reduction in participants who self-reported being in poor mental health (–62.8%; 95% CI, –86.5 to –27.5; P = .051).
When the analysis was restricted to neighborhoods below the poverty line, the greening intervention led to a significant decrease in participants feeling depressed (–68.7%; 95% CI, –86.5 to –27.5; P =.007), but no statistically significant difference was found in participants with self-reported poor mental health.
The trash cleanup intervention had no significant associations with changes in mental health outcomes, compared with no intervention.
Dr. South reported having no disclosures. The study was funded by the National Institutes of Health, and the Centers for Disease Control and Prevention.
SOURCE: South EC et al. JAMA Network Open. 2018 Jul 20. doi: 10.1001/jamanetworkopen.2018.0298.
FROM JAMA NETWORK OPEN
Key clinical point: Treating blighted physical environments in addition to traditional patient treatments may help lift self-reported depression.
Major finding: Low-income residents reported a 68% reduction in feeling depressed.
Study details: Randomized, controlled trial of 442 individuals living near vacant lots.
Disclosures: Dr. South reported having no disclosures. The study was funded by the National Institutes of Health, and the Centers for Disease Control and Prevention.
Source: South EC et al. JAMA Network Open. 2018 Jul 20. doi: 10.1001/jamanetworkopen.2018.0298.
FDA approves Nivestym, second biosimilar to Neupogen
Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim) was approved July 20 by the Food and Drug Administration, according to a statement provided by the agency. Nivestym is the second biosimilar to Neupogen to be approved in the United States.
- Patients with cancer receiving myelosuppressive chemotherapy.
- Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.
- Patients with cancer undergoing bone marrow transplantation.
- Patients undergoing autologous peripheral blood progenitor cell collection and therapy.
- Patients with severe chronic neutropenia.
According to a press release from Pfizer, the manufacturer of the biosimilar, Nivestym is expected to be available in the United States at a significant discount to the current wholesale acquisition cost of Neupogen, which is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations.
The FDA statement notes that a biosimilar is approved based on a showing that it is highly similar to an already approved biologic product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Prescribing information is available here.
Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim) was approved July 20 by the Food and Drug Administration, according to a statement provided by the agency. Nivestym is the second biosimilar to Neupogen to be approved in the United States.
- Patients with cancer receiving myelosuppressive chemotherapy.
- Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.
- Patients with cancer undergoing bone marrow transplantation.
- Patients undergoing autologous peripheral blood progenitor cell collection and therapy.
- Patients with severe chronic neutropenia.
According to a press release from Pfizer, the manufacturer of the biosimilar, Nivestym is expected to be available in the United States at a significant discount to the current wholesale acquisition cost of Neupogen, which is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations.
The FDA statement notes that a biosimilar is approved based on a showing that it is highly similar to an already approved biologic product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Prescribing information is available here.
Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim) was approved July 20 by the Food and Drug Administration, according to a statement provided by the agency. Nivestym is the second biosimilar to Neupogen to be approved in the United States.
- Patients with cancer receiving myelosuppressive chemotherapy.
- Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.
- Patients with cancer undergoing bone marrow transplantation.
- Patients undergoing autologous peripheral blood progenitor cell collection and therapy.
- Patients with severe chronic neutropenia.
According to a press release from Pfizer, the manufacturer of the biosimilar, Nivestym is expected to be available in the United States at a significant discount to the current wholesale acquisition cost of Neupogen, which is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations.
The FDA statement notes that a biosimilar is approved based on a showing that it is highly similar to an already approved biologic product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Prescribing information is available here.
Researchers identify potential sickle cell disease target
Researchers have identified a repressor of fetal hemoglobin (HbF), which they assert could offer a therapeutic target for patients with sickle cell disease (SCD) and some forms of beta thalassemia, according to a new paper published in Science.
Strategies to boost HbF have so far been limited to gene therapy and hydroxyurea, which has been shown to have limited efficacy.
The finding was made using a tailored CRISPR screen of adult human erythroid cells; the CRISPR screen targeted protein kinases, which are controllable by small molecules, which makes them more feasible for treatment therapeutically, researchers wrote.
“Using an improved CRISPR-Cas9 domain-focused screening approach, we identified the erythroid-specific kinase HRI [heme-regulated inhibitor] as a potentially druggable target that is involved in HbF silencing,” wrote Gerd A. Blobel, MD, PhD, of Children’s Hospital of Philadelphia and his colleagues.
HRI is an erythroid-specific kinase that controls protein translation. Once identified, depleting HRI resulted in an increase of HbF production and reduced sickling in cultured erythroid cells. Researchers said that diminished expression of the transcription factor BCL11A, an HbF repressor, accounted for the effects of HRI depletion.
The results with erythroid cell cultures suggest that HRI loss is well tolerated, but the mechanism of inducing fetal hemoglobin is still not fully understood, the researchers noted. Also, while HRI may be targetable, the extent of the benefits of this targeting are not yet known.
“It remains to be seen whether HRI inhibition in SCD patients would elevate HbF levels sufficiently to improve outcomes,” the researchers wrote. “HRI inhibition elevated HbF levels to a point at which it reduced cell sickling in culture, suggesting that pharmacologic HRI inhibitors may provide clinical benefit in SCD patients. Moreover, in light of our results, combining HRI inhibition with an additional pharmacologic HbF inducer may improve the therapeutic index. "Funding was provided by NIH training grants and Cold Spring Harbor Laboratory. Three of the authors reported that they are inventors on a patent submitted by the Children’s Hospital of Philadelphia that covers the therapeutic targeting of HRI for hemoglobinopathies.
SOURCE: Grevet J et al. Science. 2018 Jul 20. doi: 10.1126/science.aao0932.
Researchers have identified a repressor of fetal hemoglobin (HbF), which they assert could offer a therapeutic target for patients with sickle cell disease (SCD) and some forms of beta thalassemia, according to a new paper published in Science.
Strategies to boost HbF have so far been limited to gene therapy and hydroxyurea, which has been shown to have limited efficacy.
The finding was made using a tailored CRISPR screen of adult human erythroid cells; the CRISPR screen targeted protein kinases, which are controllable by small molecules, which makes them more feasible for treatment therapeutically, researchers wrote.
“Using an improved CRISPR-Cas9 domain-focused screening approach, we identified the erythroid-specific kinase HRI [heme-regulated inhibitor] as a potentially druggable target that is involved in HbF silencing,” wrote Gerd A. Blobel, MD, PhD, of Children’s Hospital of Philadelphia and his colleagues.
HRI is an erythroid-specific kinase that controls protein translation. Once identified, depleting HRI resulted in an increase of HbF production and reduced sickling in cultured erythroid cells. Researchers said that diminished expression of the transcription factor BCL11A, an HbF repressor, accounted for the effects of HRI depletion.
The results with erythroid cell cultures suggest that HRI loss is well tolerated, but the mechanism of inducing fetal hemoglobin is still not fully understood, the researchers noted. Also, while HRI may be targetable, the extent of the benefits of this targeting are not yet known.
“It remains to be seen whether HRI inhibition in SCD patients would elevate HbF levels sufficiently to improve outcomes,” the researchers wrote. “HRI inhibition elevated HbF levels to a point at which it reduced cell sickling in culture, suggesting that pharmacologic HRI inhibitors may provide clinical benefit in SCD patients. Moreover, in light of our results, combining HRI inhibition with an additional pharmacologic HbF inducer may improve the therapeutic index. "Funding was provided by NIH training grants and Cold Spring Harbor Laboratory. Three of the authors reported that they are inventors on a patent submitted by the Children’s Hospital of Philadelphia that covers the therapeutic targeting of HRI for hemoglobinopathies.
SOURCE: Grevet J et al. Science. 2018 Jul 20. doi: 10.1126/science.aao0932.
Researchers have identified a repressor of fetal hemoglobin (HbF), which they assert could offer a therapeutic target for patients with sickle cell disease (SCD) and some forms of beta thalassemia, according to a new paper published in Science.
Strategies to boost HbF have so far been limited to gene therapy and hydroxyurea, which has been shown to have limited efficacy.
The finding was made using a tailored CRISPR screen of adult human erythroid cells; the CRISPR screen targeted protein kinases, which are controllable by small molecules, which makes them more feasible for treatment therapeutically, researchers wrote.
“Using an improved CRISPR-Cas9 domain-focused screening approach, we identified the erythroid-specific kinase HRI [heme-regulated inhibitor] as a potentially druggable target that is involved in HbF silencing,” wrote Gerd A. Blobel, MD, PhD, of Children’s Hospital of Philadelphia and his colleagues.
HRI is an erythroid-specific kinase that controls protein translation. Once identified, depleting HRI resulted in an increase of HbF production and reduced sickling in cultured erythroid cells. Researchers said that diminished expression of the transcription factor BCL11A, an HbF repressor, accounted for the effects of HRI depletion.
The results with erythroid cell cultures suggest that HRI loss is well tolerated, but the mechanism of inducing fetal hemoglobin is still not fully understood, the researchers noted. Also, while HRI may be targetable, the extent of the benefits of this targeting are not yet known.
“It remains to be seen whether HRI inhibition in SCD patients would elevate HbF levels sufficiently to improve outcomes,” the researchers wrote. “HRI inhibition elevated HbF levels to a point at which it reduced cell sickling in culture, suggesting that pharmacologic HRI inhibitors may provide clinical benefit in SCD patients. Moreover, in light of our results, combining HRI inhibition with an additional pharmacologic HbF inducer may improve the therapeutic index. "Funding was provided by NIH training grants and Cold Spring Harbor Laboratory. Three of the authors reported that they are inventors on a patent submitted by the Children’s Hospital of Philadelphia that covers the therapeutic targeting of HRI for hemoglobinopathies.
SOURCE: Grevet J et al. Science. 2018 Jul 20. doi: 10.1126/science.aao0932.
REPORTING FROM SCIENCE