Jennie Smith

SAN DIEGO – Psychiatrists may encounter refugee patients from war-torn countries in virtually every part of the United States with complex mental health needs, including high rates of posttraumatic stress disorder, chronic pain, and somatic symptoms, according to two presenters at the annual meeting of the American Psychiatric Association.

Over the past decade, refugees from Middle Eastern counties – particularly Iraq, Syria, and Afghanistan – have increased fourfold as a percentage of all refugees in the United States, while those from Sub-Saharan Africa continue to make up a large share. Despite heated political wrangling, the U.S. Department of State recently increased limits on the number of refugees that can be accepted. California, Texas, New York, Michigan, Ohio, and Washington are the states resettling the most new arrivals.

Refugees with trauma exposure have high rates of posttraumatic stress disorder, chronic pain, and somatic symptoms. In addition, recent research suggests, these refugees may have poorly understood stressors related to migration and adjustment that also may be significant contributors to mental illness risk. Despite this, refugees generally have less access to mental health care than does the general population.

The presenters shared their perspectives on refugee mental health with findings that could inform the timing and nature of interventions in these potentially vulnerable populations.

Cynthia L. Arfken, PhD, of Wayne State University in Detroit, presented results from an ongoing cohort study of Syrian families presenting to a primary care clinic as part of their State Department–mandated health check upon resettlement. Arash Javanbakht, MD, also of the university, led the research.

The investigators recruited families at a primary care clinic in southeastern Michigan, where refugees receive health assessments within the first month of arrival in the United States.

The researchers consecutively enrolled and evaluated 297 individuals, including 59 children aged 6 and older (mean age, 11.3) from Syria. These families represented 95% of refugees seen at the clinic during the study period, from June to December 2016.

The researchers also collected hair and saliva samples from consenting families for a separate study looking at biomarkers and mental health outcomes.

Adults were screened for PTSD using the PTSD checklist for adults, and children for anxiety using the Screen for Child Anxiety Related Emotional Disorders, or SCARED, measure. Psychiatric nurses and bilingual health care workers helped the team obtain consent and conduct assessments.

The researchers found that 61% of the children had a probable anxiety diagnosis, and nearly 85% had probable separation anxiety. Higher child anxiety scores were associated with higher PTSD scores in mothers (P = .05).

Dr. Arfken said in an interview that she and her team were “shocked” at the high prevalence of probable anxiety disorders in the cohort, in part because they’d conducted an earlier study enrolling adult Iraqi refugees and “found hardly any psychiatric symptoms at all.”

The high levels of anxiety seen among the Syrian refugees may be related to the severity of the ongoing conflict, Dr. Arfken said. The children’s results were sufficiently jarring to the team that “we changed our whole plan,” she said, “to concentrate on following up both the children who showed distress and those who did not.” They also attempted some nonmedical interventions, such as dance and mindfulness groups.

Also at the conference, Christopher Morrow, MD, of the University of Maryland in Baltimore, presented findings from a case study that illuminates some of the potential mental health risks for resettled refugees.

Dr. Morrow described a 31-year-old man from Afghanistan who had worked for the U.S. Special Forces in Afghanistan as a translator and subsequently entered the United States as a refugee. About a year later he was admitted to an inpatient psychiatric unit after a violent suicide attempt and was treated for depression.

The researchers noted that the patient had no previous history of depression or other mental illness prior to arriving in the United States. “His symptoms developed over the course of the first year of resettlement,” Dr. Morrow said in an interview.

This patient, Dr. Morrow said, was single and was not religious, leaving him not inclined to join a mosque or other Islamic community group. He was placed in an unskilled work assignment, despite his well-developed skills as a translator. Over the course of a year, he became increasingly isolated and “decompensated to the point where there was a really violent suicide attempt.

“We think that some kind of programmed follow-up – be it a community resource or through primary care – could have helped stabilize him before he got to a point of real hopelessness,” Dr. Morrow said.

Dr. Morrow and his colleagues proposed two interventions as adjustments to current health policy for refugees: adding universal mental health screening to each refugee’s health check in the first month after arrival, and scheduling follow-up later in the resettlement process.

“If there is active follow-up, a way that you could check in with these individuals as they’re acclimating, that’s probably the point where you could intervene best,” he said.

Dr. Morrow and Dr. Arfken disclosed no conflicts of interest related to their research.
 

cpnews@frontlinemedcom.com

SAN DIEGO – Psychiatrists may encounter refugee patients from war-torn countries in virtually every part of the United States with complex mental health needs, including high rates of posttraumatic stress disorder, chronic pain, and somatic symptoms, according to two presenters at the annual meeting of the American Psychiatric Association.

Over the past decade, refugees from Middle Eastern counties – particularly Iraq, Syria, and Afghanistan – have increased fourfold as a percentage of all refugees in the United States, while those from Sub-Saharan Africa continue to make up a large share. Despite heated political wrangling, the U.S. Department of State recently increased limits on the number of refugees that can be accepted. California, Texas, New York, Michigan, Ohio, and Washington are the states resettling the most new arrivals.

Refugees with trauma exposure have high rates of posttraumatic stress disorder, chronic pain, and somatic symptoms. In addition, recent research suggests, these refugees may have poorly understood stressors related to migration and adjustment that also may be significant contributors to mental illness risk. Despite this, refugees generally have less access to mental health care than does the general population.

The presenters shared their perspectives on refugee mental health with findings that could inform the timing and nature of interventions in these potentially vulnerable populations.

Cynthia L. Arfken, PhD, of Wayne State University in Detroit, presented results from an ongoing cohort study of Syrian families presenting to a primary care clinic as part of their State Department–mandated health check upon resettlement. Arash Javanbakht, MD, also of the university, led the research.

The investigators recruited families at a primary care clinic in southeastern Michigan, where refugees receive health assessments within the first month of arrival in the United States.

The researchers consecutively enrolled and evaluated 297 individuals, including 59 children aged 6 and older (mean age, 11.3) from Syria. These families represented 95% of refugees seen at the clinic during the study period, from June to December 2016.

The researchers also collected hair and saliva samples from consenting families for a separate study looking at biomarkers and mental health outcomes.

Adults were screened for PTSD using the PTSD checklist for adults, and children for anxiety using the Screen for Child Anxiety Related Emotional Disorders, or SCARED, measure. Psychiatric nurses and bilingual health care workers helped the team obtain consent and conduct assessments.

The researchers found that 61% of the children had a probable anxiety diagnosis, and nearly 85% had probable separation anxiety. Higher child anxiety scores were associated with higher PTSD scores in mothers (P = .05).

Dr. Arfken said in an interview that she and her team were “shocked” at the high prevalence of probable anxiety disorders in the cohort, in part because they’d conducted an earlier study enrolling adult Iraqi refugees and “found hardly any psychiatric symptoms at all.”

The high levels of anxiety seen among the Syrian refugees may be related to the severity of the ongoing conflict, Dr. Arfken said. The children’s results were sufficiently jarring to the team that “we changed our whole plan,” she said, “to concentrate on following up both the children who showed distress and those who did not.” They also attempted some nonmedical interventions, such as dance and mindfulness groups.

Also at the conference, Christopher Morrow, MD, of the University of Maryland in Baltimore, presented findings from a case study that illuminates some of the potential mental health risks for resettled refugees.

Dr. Morrow described a 31-year-old man from Afghanistan who had worked for the U.S. Special Forces in Afghanistan as a translator and subsequently entered the United States as a refugee. About a year later he was admitted to an inpatient psychiatric unit after a violent suicide attempt and was treated for depression.

The researchers noted that the patient had no previous history of depression or other mental illness prior to arriving in the United States. “His symptoms developed over the course of the first year of resettlement,” Dr. Morrow said in an interview.

This patient, Dr. Morrow said, was single and was not religious, leaving him not inclined to join a mosque or other Islamic community group. He was placed in an unskilled work assignment, despite his well-developed skills as a translator. Over the course of a year, he became increasingly isolated and “decompensated to the point where there was a really violent suicide attempt.

“We think that some kind of programmed follow-up – be it a community resource or through primary care – could have helped stabilize him before he got to a point of real hopelessness,” Dr. Morrow said.

Dr. Morrow and his colleagues proposed two interventions as adjustments to current health policy for refugees: adding universal mental health screening to each refugee’s health check in the first month after arrival, and scheduling follow-up later in the resettlement process.

“If there is active follow-up, a way that you could check in with these individuals as they’re acclimating, that’s probably the point where you could intervene best,” he said.

Dr. Morrow and Dr. Arfken disclosed no conflicts of interest related to their research.
 

cpnews@frontlinemedcom.com

SAN DIEGO – Psychiatrists may encounter refugee patients from war-torn countries in virtually every part of the United States with complex mental health needs, including high rates of posttraumatic stress disorder, chronic pain, and somatic symptoms, according to two presenters at the annual meeting of the American Psychiatric Association.

Over the past decade, refugees from Middle Eastern counties – particularly Iraq, Syria, and Afghanistan – have increased fourfold as a percentage of all refugees in the United States, while those from Sub-Saharan Africa continue to make up a large share. Despite heated political wrangling, the U.S. Department of State recently increased limits on the number of refugees that can be accepted. California, Texas, New York, Michigan, Ohio, and Washington are the states resettling the most new arrivals.

Refugees with trauma exposure have high rates of posttraumatic stress disorder, chronic pain, and somatic symptoms. In addition, recent research suggests, these refugees may have poorly understood stressors related to migration and adjustment that also may be significant contributors to mental illness risk. Despite this, refugees generally have less access to mental health care than does the general population.

The presenters shared their perspectives on refugee mental health with findings that could inform the timing and nature of interventions in these potentially vulnerable populations.

Cynthia L. Arfken, PhD, of Wayne State University in Detroit, presented results from an ongoing cohort study of Syrian families presenting to a primary care clinic as part of their State Department–mandated health check upon resettlement. Arash Javanbakht, MD, also of the university, led the research.

The investigators recruited families at a primary care clinic in southeastern Michigan, where refugees receive health assessments within the first month of arrival in the United States.

The researchers consecutively enrolled and evaluated 297 individuals, including 59 children aged 6 and older (mean age, 11.3) from Syria. These families represented 95% of refugees seen at the clinic during the study period, from June to December 2016.

The researchers also collected hair and saliva samples from consenting families for a separate study looking at biomarkers and mental health outcomes.

Adults were screened for PTSD using the PTSD checklist for adults, and children for anxiety using the Screen for Child Anxiety Related Emotional Disorders, or SCARED, measure. Psychiatric nurses and bilingual health care workers helped the team obtain consent and conduct assessments.

The researchers found that 61% of the children had a probable anxiety diagnosis, and nearly 85% had probable separation anxiety. Higher child anxiety scores were associated with higher PTSD scores in mothers (P = .05).

Dr. Arfken said in an interview that she and her team were “shocked” at the high prevalence of probable anxiety disorders in the cohort, in part because they’d conducted an earlier study enrolling adult Iraqi refugees and “found hardly any psychiatric symptoms at all.”

The high levels of anxiety seen among the Syrian refugees may be related to the severity of the ongoing conflict, Dr. Arfken said. The children’s results were sufficiently jarring to the team that “we changed our whole plan,” she said, “to concentrate on following up both the children who showed distress and those who did not.” They also attempted some nonmedical interventions, such as dance and mindfulness groups.

Also at the conference, Christopher Morrow, MD, of the University of Maryland in Baltimore, presented findings from a case study that illuminates some of the potential mental health risks for resettled refugees.

Dr. Morrow described a 31-year-old man from Afghanistan who had worked for the U.S. Special Forces in Afghanistan as a translator and subsequently entered the United States as a refugee. About a year later he was admitted to an inpatient psychiatric unit after a violent suicide attempt and was treated for depression.

The researchers noted that the patient had no previous history of depression or other mental illness prior to arriving in the United States. “His symptoms developed over the course of the first year of resettlement,” Dr. Morrow said in an interview.

This patient, Dr. Morrow said, was single and was not religious, leaving him not inclined to join a mosque or other Islamic community group. He was placed in an unskilled work assignment, despite his well-developed skills as a translator. Over the course of a year, he became increasingly isolated and “decompensated to the point where there was a really violent suicide attempt.

“We think that some kind of programmed follow-up – be it a community resource or through primary care – could have helped stabilize him before he got to a point of real hopelessness,” Dr. Morrow said.

Dr. Morrow and his colleagues proposed two interventions as adjustments to current health policy for refugees: adding universal mental health screening to each refugee’s health check in the first month after arrival, and scheduling follow-up later in the resettlement process.

“If there is active follow-up, a way that you could check in with these individuals as they’re acclimating, that’s probably the point where you could intervene best,” he said.

Dr. Morrow and Dr. Arfken disclosed no conflicts of interest related to their research.
 

cpnews@frontlinemedcom.com

SAN DIEGO – Readmission rates after discharge for patients with schizophrenia are notoriously high, with approximately a quarter of U.S. schizophrenia patients readmitted within 3 months, according to Paul A. Kurdyak, MD, PhD.

In Ontario, Canada, readmission rates for people with schizophrenia are 12.5% within 30 days of discharge. Paradoxically, however, these same patients receive less follow-up than people hospitalized for other psychiatric disorders, Dr. Kurdyak of the Institute for Clinical Evaluative Sciences in Toronto reported at the annual meeting of the American Psychiatric Association.

To explore the relationship between discharge, follow-up, and subsequent readmission in this population, he assessed the impact of physician follow-up in the month after discharge on readmission rates for schizophrenia patients, noting a lack of published evidence on whether or how it helps. “We try and use readmission as a general performance indicator, and we try and use postdischarge follow-up as a general indicator, but there was no evidence to determine whether seeing a physician following discharge has an impact on anything,” Dr. Kurdyak said.

He and his colleagues tracked primary care and outpatient psychiatric visits in the first 30 days after discharge for about 20,000 people who had been hospitalized with schizophrenia in Ontario. “We chose 30 days because we knew the rate of follow-up within 7 days was just so low,” he said.

He said more than one in three of these patients went more than 30 days without seeing any physician at all.

Schizophrenia patients “are individuals with really high needs, whose average length of stay is about 2 weeks,” he said. “It’s hard to stabilize somebody in 2 weeks, so to have so many of them drop off a cliff [after discharge] is not great.”

Another finding was that the patients who saw any doctor – whether their primary care physician or psychiatrist – saw reduced rates of readmission at 30-210 days after discharge.

Where the benefit of seeing a physician was seen in sharpest relief was among the patients deemed, by use of a validated scoring system, to be at highest risk for readmission. These patients, who made up two-thirds of the cohort, saw a 15% reduction in readmission if they’d had a visit with either a primary care physician or psychiatrist and a 19% reduction if they’d seen both types of physician relative to patients who had no physician follow-up post discharge.

“In the high-risk group, you see a very clear separation between those who saw no physician and those who saw any physician,” Dr. Kurdyak said.

Some of the limitations of the study included the fact that little was known about the quality of the follow-up physician visits or about clinical collaboration, the causes for lack of follow-up were not clear, and follow-up by nonphysician health personnel was not captured.

Nonetheless, Dr. Kurdyak said, “the moral of the story is [that] seeing a physician really differentiates from seeing no physician statistically and clinically.”

In Canada, he noted, “we like to feel comfortable with the idea of universal health care, but, when we take a closer look, we often see real inequities and disparities despite universal health care. I think this is one of these situations where, if readmission is an indicator of need, our ability to provide services to those in the greatest need falls short of the ideal.”

Dr. Kurdyak disclosed no conflicts of interest relevant to his research. 

SAN DIEGO – Readmission rates after discharge for patients with schizophrenia are notoriously high, with approximately a quarter of U.S. schizophrenia patients readmitted within 3 months, according to Paul A. Kurdyak, MD, PhD.

In Ontario, Canada, readmission rates for people with schizophrenia are 12.5% within 30 days of discharge. Paradoxically, however, these same patients receive less follow-up than people hospitalized for other psychiatric disorders, Dr. Kurdyak of the Institute for Clinical Evaluative Sciences in Toronto reported at the annual meeting of the American Psychiatric Association.

To explore the relationship between discharge, follow-up, and subsequent readmission in this population, he assessed the impact of physician follow-up in the month after discharge on readmission rates for schizophrenia patients, noting a lack of published evidence on whether or how it helps. “We try and use readmission as a general performance indicator, and we try and use postdischarge follow-up as a general indicator, but there was no evidence to determine whether seeing a physician following discharge has an impact on anything,” Dr. Kurdyak said.

He and his colleagues tracked primary care and outpatient psychiatric visits in the first 30 days after discharge for about 20,000 people who had been hospitalized with schizophrenia in Ontario. “We chose 30 days because we knew the rate of follow-up within 7 days was just so low,” he said.

He said more than one in three of these patients went more than 30 days without seeing any physician at all.

Schizophrenia patients “are individuals with really high needs, whose average length of stay is about 2 weeks,” he said. “It’s hard to stabilize somebody in 2 weeks, so to have so many of them drop off a cliff [after discharge] is not great.”

Another finding was that the patients who saw any doctor – whether their primary care physician or psychiatrist – saw reduced rates of readmission at 30-210 days after discharge.

Where the benefit of seeing a physician was seen in sharpest relief was among the patients deemed, by use of a validated scoring system, to be at highest risk for readmission. These patients, who made up two-thirds of the cohort, saw a 15% reduction in readmission if they’d had a visit with either a primary care physician or psychiatrist and a 19% reduction if they’d seen both types of physician relative to patients who had no physician follow-up post discharge.

“In the high-risk group, you see a very clear separation between those who saw no physician and those who saw any physician,” Dr. Kurdyak said.

Some of the limitations of the study included the fact that little was known about the quality of the follow-up physician visits or about clinical collaboration, the causes for lack of follow-up were not clear, and follow-up by nonphysician health personnel was not captured.

Nonetheless, Dr. Kurdyak said, “the moral of the story is [that] seeing a physician really differentiates from seeing no physician statistically and clinically.”

In Canada, he noted, “we like to feel comfortable with the idea of universal health care, but, when we take a closer look, we often see real inequities and disparities despite universal health care. I think this is one of these situations where, if readmission is an indicator of need, our ability to provide services to those in the greatest need falls short of the ideal.”

Dr. Kurdyak disclosed no conflicts of interest relevant to his research. 

SAN DIEGO – Readmission rates after discharge for patients with schizophrenia are notoriously high, with approximately a quarter of U.S. schizophrenia patients readmitted within 3 months, according to Paul A. Kurdyak, MD, PhD.

In Ontario, Canada, readmission rates for people with schizophrenia are 12.5% within 30 days of discharge. Paradoxically, however, these same patients receive less follow-up than people hospitalized for other psychiatric disorders, Dr. Kurdyak of the Institute for Clinical Evaluative Sciences in Toronto reported at the annual meeting of the American Psychiatric Association.

To explore the relationship between discharge, follow-up, and subsequent readmission in this population, he assessed the impact of physician follow-up in the month after discharge on readmission rates for schizophrenia patients, noting a lack of published evidence on whether or how it helps. “We try and use readmission as a general performance indicator, and we try and use postdischarge follow-up as a general indicator, but there was no evidence to determine whether seeing a physician following discharge has an impact on anything,” Dr. Kurdyak said.

He and his colleagues tracked primary care and outpatient psychiatric visits in the first 30 days after discharge for about 20,000 people who had been hospitalized with schizophrenia in Ontario. “We chose 30 days because we knew the rate of follow-up within 7 days was just so low,” he said.

He said more than one in three of these patients went more than 30 days without seeing any physician at all.

Schizophrenia patients “are individuals with really high needs, whose average length of stay is about 2 weeks,” he said. “It’s hard to stabilize somebody in 2 weeks, so to have so many of them drop off a cliff [after discharge] is not great.”

Another finding was that the patients who saw any doctor – whether their primary care physician or psychiatrist – saw reduced rates of readmission at 30-210 days after discharge.

Where the benefit of seeing a physician was seen in sharpest relief was among the patients deemed, by use of a validated scoring system, to be at highest risk for readmission. These patients, who made up two-thirds of the cohort, saw a 15% reduction in readmission if they’d had a visit with either a primary care physician or psychiatrist and a 19% reduction if they’d seen both types of physician relative to patients who had no physician follow-up post discharge.

“In the high-risk group, you see a very clear separation between those who saw no physician and those who saw any physician,” Dr. Kurdyak said.

Some of the limitations of the study included the fact that little was known about the quality of the follow-up physician visits or about clinical collaboration, the causes for lack of follow-up were not clear, and follow-up by nonphysician health personnel was not captured.

Nonetheless, Dr. Kurdyak said, “the moral of the story is [that] seeing a physician really differentiates from seeing no physician statistically and clinically.”

In Canada, he noted, “we like to feel comfortable with the idea of universal health care, but, when we take a closer look, we often see real inequities and disparities despite universal health care. I think this is one of these situations where, if readmission is an indicator of need, our ability to provide services to those in the greatest need falls short of the ideal.”

Dr. Kurdyak disclosed no conflicts of interest relevant to his research. 

SAN DIEGO – Cognitive-behavioral therapy (CPT) interventions delivered online are effective in reducing symptoms of mild to moderate depression in adults, according to results presented at the annual meeting of the American Psychiatric Association.

The findings, presented by Charles Koransky, MD, of the University of Maryland, Baltimore, derive from a meta-analysis of 14 randomized studies, conducted between 2005 and 2015, that enrolled more than 1,600 patients aged 18 years and older in Europe and Australia.

Patients in the studies were not receiving any other form of therapy, though some studies allowed concurrent use of antidepressant medications.

Results from patients assigned to the web-based interventions, which lasted 1 month or more, were compared with those who remained on waiting lists for treatment. Most of the interventions included brief clinician contact as part of their designs. Others were entirely self-guided.

Dr. Koransky and his colleagues found that completion rates were high, with between 55% and 93% of patients finishing the assigned interventions. The intervention groups saw significant improvement in symptoms after the online CBT interventions, with a standard mean difference of 0.74 (95% confidence interval, 0.63-0.86; P less than 0.001), compared with patients randomized to wait lists.

For the 11 studies that included between 3- and 6-months’ follow-up, improvement in depressive symptoms was seen to be durable, with a large SMD of 0.85 (95% CI, 0.79-0.90; P less than 0.001). “This shows that the effects last,” Dr. Koransky told conference attendees.

Dr. Koransky noted that statistically significant difference was seen between the studies with interventions that included clinician contact and those that did not. “This is probably because the clinician contact in the studies was brief, 10-minute chats or emails,” he said.

“Internet-based CBT leads to immediate and sustained reduction of depressive symptoms, which is consistent with analyses in the past,” Dr. Koransky said. “We also found that iCBT may be a good option for patients not able to access traditional face-to-face therapy,” he said, noting that several of the interventions in the study were designed to help address access issues in rural Australia.

Dr. Koransky noted that the results might not be generalizable because of the large portion of female patients across studies – more than 75% – and the fact that all patients were recruited through advertisements, suggesting that these were “highly motivated participants seeking some alleviation of their symptoms.” Another limitation of the study was a lack of uniformity across iCBT interfaces.

Nonetheless, he said, the findings have implications for U.S. practitioners, particularly primary care doctors in regions with poor access to mental health specialists.

Internet-delivered CBT may be “great for people in rural settings, especially if prescribed by primary care providers who don’t have the training to provide CBT,” he said.

Dr. Koransky said his group aimed to study these interventions in a U.S. population and among patients referred to iCBT by their primary care doctors. The researchers disclosed no conflicts of interest related to their findings.

SAN DIEGO – Cognitive-behavioral therapy (CPT) interventions delivered online are effective in reducing symptoms of mild to moderate depression in adults, according to results presented at the annual meeting of the American Psychiatric Association.

The findings, presented by Charles Koransky, MD, of the University of Maryland, Baltimore, derive from a meta-analysis of 14 randomized studies, conducted between 2005 and 2015, that enrolled more than 1,600 patients aged 18 years and older in Europe and Australia.

Patients in the studies were not receiving any other form of therapy, though some studies allowed concurrent use of antidepressant medications.

Results from patients assigned to the web-based interventions, which lasted 1 month or more, were compared with those who remained on waiting lists for treatment. Most of the interventions included brief clinician contact as part of their designs. Others were entirely self-guided.

Dr. Koransky and his colleagues found that completion rates were high, with between 55% and 93% of patients finishing the assigned interventions. The intervention groups saw significant improvement in symptoms after the online CBT interventions, with a standard mean difference of 0.74 (95% confidence interval, 0.63-0.86; P less than 0.001), compared with patients randomized to wait lists.

For the 11 studies that included between 3- and 6-months’ follow-up, improvement in depressive symptoms was seen to be durable, with a large SMD of 0.85 (95% CI, 0.79-0.90; P less than 0.001). “This shows that the effects last,” Dr. Koransky told conference attendees.

Dr. Koransky noted that statistically significant difference was seen between the studies with interventions that included clinician contact and those that did not. “This is probably because the clinician contact in the studies was brief, 10-minute chats or emails,” he said.

“Internet-based CBT leads to immediate and sustained reduction of depressive symptoms, which is consistent with analyses in the past,” Dr. Koransky said. “We also found that iCBT may be a good option for patients not able to access traditional face-to-face therapy,” he said, noting that several of the interventions in the study were designed to help address access issues in rural Australia.

Dr. Koransky noted that the results might not be generalizable because of the large portion of female patients across studies – more than 75% – and the fact that all patients were recruited through advertisements, suggesting that these were “highly motivated participants seeking some alleviation of their symptoms.” Another limitation of the study was a lack of uniformity across iCBT interfaces.

Nonetheless, he said, the findings have implications for U.S. practitioners, particularly primary care doctors in regions with poor access to mental health specialists.

Internet-delivered CBT may be “great for people in rural settings, especially if prescribed by primary care providers who don’t have the training to provide CBT,” he said.

Dr. Koransky said his group aimed to study these interventions in a U.S. population and among patients referred to iCBT by their primary care doctors. The researchers disclosed no conflicts of interest related to their findings.

SAN DIEGO – Cognitive-behavioral therapy (CPT) interventions delivered online are effective in reducing symptoms of mild to moderate depression in adults, according to results presented at the annual meeting of the American Psychiatric Association.

The findings, presented by Charles Koransky, MD, of the University of Maryland, Baltimore, derive from a meta-analysis of 14 randomized studies, conducted between 2005 and 2015, that enrolled more than 1,600 patients aged 18 years and older in Europe and Australia.

Patients in the studies were not receiving any other form of therapy, though some studies allowed concurrent use of antidepressant medications.

Results from patients assigned to the web-based interventions, which lasted 1 month or more, were compared with those who remained on waiting lists for treatment. Most of the interventions included brief clinician contact as part of their designs. Others were entirely self-guided.

Dr. Koransky and his colleagues found that completion rates were high, with between 55% and 93% of patients finishing the assigned interventions. The intervention groups saw significant improvement in symptoms after the online CBT interventions, with a standard mean difference of 0.74 (95% confidence interval, 0.63-0.86; P less than 0.001), compared with patients randomized to wait lists.

For the 11 studies that included between 3- and 6-months’ follow-up, improvement in depressive symptoms was seen to be durable, with a large SMD of 0.85 (95% CI, 0.79-0.90; P less than 0.001). “This shows that the effects last,” Dr. Koransky told conference attendees.

Dr. Koransky noted that statistically significant difference was seen between the studies with interventions that included clinician contact and those that did not. “This is probably because the clinician contact in the studies was brief, 10-minute chats or emails,” he said.

“Internet-based CBT leads to immediate and sustained reduction of depressive symptoms, which is consistent with analyses in the past,” Dr. Koransky said. “We also found that iCBT may be a good option for patients not able to access traditional face-to-face therapy,” he said, noting that several of the interventions in the study were designed to help address access issues in rural Australia.

Dr. Koransky noted that the results might not be generalizable because of the large portion of female patients across studies – more than 75% – and the fact that all patients were recruited through advertisements, suggesting that these were “highly motivated participants seeking some alleviation of their symptoms.” Another limitation of the study was a lack of uniformity across iCBT interfaces.

Nonetheless, he said, the findings have implications for U.S. practitioners, particularly primary care doctors in regions with poor access to mental health specialists.

Internet-delivered CBT may be “great for people in rural settings, especially if prescribed by primary care providers who don’t have the training to provide CBT,” he said.

Dr. Koransky said his group aimed to study these interventions in a U.S. population and among patients referred to iCBT by their primary care doctors. The researchers disclosed no conflicts of interest related to their findings.

As new rules about drug compounding get shaped, rheumatologists seek to protect their ability to combine injectable drugs – most commonly a steroid and a local anesthetic – in their own offices.

In a position statement sent to government agencies and members of Congress in February, the American College of Rheumatology voiced concerns that the practice, which it called “critical,” could become a casualty of drug-compounding regulations under revision by the United States Pharmacopeial Convention (USP), a nonprofit group whose standards are enforceable by state and federal regulators.

Carol Renner/NDSU

Steroid fiasco sparked rule revisions

The ACR’s concerns follow a tighter focus by state and federal agencies on drug compounding after a fungal meningitis outbreak in 2012 was traced to contaminated steroids produced in bulk by a compounding pharmacy.

More than 800 infections, 64 of them fatal, occurred after the New England Compounding Center in Framingham, Mass., sold contaminated methylprednisolone acetate that was used in epidural and intra-articular joint injections.

The following year Congress passed the Drug Quality and Security Act, which aims, in part, to prevent compounding pharmacies from engaging in what amounts to unregulated manufacturing.

As part of the law, the FDA created a list of drugs appropriate for compounding and a process by which larger compounding pharmacies must register with the FDA, and agree to inspections. The USP standards, meanwhile, address detailed technical and safety aspects of compounding and are enforceable by the FDA and state agencies.

“USP and FDA have had the ability to regulate compounding for over a decade, but only recently have the rules become actively enforced,” said Donald Miller, PharmD, of North Dakota State University, Fargo, who helped shape the ACR’s position statement on compounding with the help of rheumatologists in private practice.

“When you make guidelines for safety, they make sense, but then you can’t anticipate the way it’s going to affect individuals’ practice. And that’s where rheumatology got caught up,” said Dr. Miller, who was a member of the FDA Arthritis Advisory Committee in 2014-2016.

In-office mixing a top concern

Other specialties, including dermatology and immunology, also stand to be affected by various changes to compounding law and practice – and their societies have been active in voicing concerns.

Though the latest revisions of USP chapter 797, which impacts in-office mixing, are still being sorted out, it’s the No. 1 compounding-related concern for rheumatologists, Dr. Miller said.

Rheumatologists routinely mix an analgesic and a steroid for injection. The analgesic makes the steroids less viscous, and offers patients hours of immediate relief. They also add analgesics to hyaluronic acid injected for viscosupplementation. The mixing is usually conducted bedside, and the injections are administered right away.

Technically, combining these products amounts to sterile compounding, Dr. Miller explained. “And theoretically, under these rules, a physician could still do this, but they’d have to do it under a sterile hood like you find in a pharmacy, and that’s just not practical. It also becomes a matter of interpretation.”

USP chapter 797 sanctions in-office mixing for “immediate use” with individual patients – which is nearly always the case for the steroid injections used in rheumatology. But it’s unclear whether “immediate use” means emergency use only, or allows for routine use, as rheumatologists hope.

“One reason this came to rheumatology’s attention is that some state boards of medicine were inspecting and saying ‘Hey, you can’t do that,’ ” Dr. Miller said.

Pediatric issues

Pediatric rheumatologists, and adult rheumatologists who see children occasionally, use compounding pharmacies to create palatable oral medicines and adjusted doses of adult treatments.

They also use injections combining steroids with analgesics, and consider the addition of the analgesic a key aid to compliance.

“The biggest barrier we have is patient and parent anxiety about doing the procedure and the associated pain. We always administer our steroids mixed with lidocaine to help with the postprocedural discomfort,” said Adam Reinhardt, MD, chief of pediatric rheumatology at the University of Nebraska and Children’s Hospital and Medical Center in Omaha.

Relevance of rules

None of the rheumatologists interviewed questioned the need for tightened state and federal oversight of compounding practices overall – just the applicability of certain rules to their own practice.

Dr. Snow and Dr. Huffstutter noted that reports of infected joints – a potential result of a contaminated injection – are sporadic and rare. “There’s very little research in this, but [these types of injections] have been standard practice for decades,” Dr. Snow said.

Srikanth Mukkera, MD, a rheumatologist in Tupelo, Miss., agreed that “sporadic cases of joint infection do happen following injection, but it can be hard to show if an injection was the cause.”

Assuring that medicines are mixed only immediately prior to injection, and not stored, reduces the likelihood of contamination, Dr. Mukkera said. Moreover, he noted, epidural injections such as those that resulted in the 2012 meningitis outbreak carry different risks than those seen in intra-articular injections.

Dr. Miller, the lead author of the ACR statement, said that the rheumatologists on our committee “don’t know of anyone that’s had a knee or other joint infection from a contaminated injection. They feel that unless somebody finds some evidence of that, they should be allowed to continue” with their usual practice.

He said that he feels that the USP will ultimately heed the concerns of rheumatologists and hopefully provide a more relaxed interpretation of in-office compounding. “We’re hoping they’ll make some exceptions when they revise 797 standards or at least maybe leave room for organizations to create a best practice statement. We’ll see,” Dr. Miller said.

But this is in no way guaranteed. Dr. Huffstutter said he fears that, if the rules come to be interpreted more narrowly, even standard practices like reconstituting biologic drugs for infusion – something that’s also a routine part of in-office practice – could fall under the rubric of sterile compounding and come into question.

The quinacrine problem

A separate compounding-related issue in rheumatology is clinicians’ access to quinacrine, an antimalarial rheumatology drug that, while infrequently used, represents the only alternative to hydroxychloroquine for some lupus patients.

“There are no alternatives out there for hydroxychloroquine, so we need it as a backup,” Dr. Snow said. “If hydroxychloroquine isn’t an option, there’s nothing out there that we can use. There’s no easy replacement.”

Dr. Huffstutter said he currently had no patients on quinacrine. “It’s not very often that we use it, but in those patients that really need it, it can make a huge difference in how they do.”

Quinacrine is no longer manufactured commercially as a finished drug product but is available in a powder that compounding physicians put into 100-mg capsules. It is not on the FDA’s current list of drugs available for compounding except with special permission.

While the ACR has requested that the FDA add it the list of bulk drug substances that can be used in compounding, quinacrine remains off the list for now – and, providers say, hard to find.

Moreover, while rheumatologists may have previously been able to order and store quantities of quinacrine and other compounded nonsterile medications to dispense to their patients, they can no longer easily do so, as only the FDA-approved compounding “outsourcing facilities” are allowed to process larger orders; the rest can only respond to prescriptions for individual patients.

Dr. Miller said it’s likely that quinacrine will make it onto the FDA’s next list of bulk drugs available for compounding. “The FDA has kind of said, ‘Don’t worry about it,’ ” he said.

rhnews@frontlinemedcom.com

As new rules about drug compounding get shaped, rheumatologists seek to protect their ability to combine injectable drugs – most commonly a steroid and a local anesthetic – in their own offices.

In a position statement sent to government agencies and members of Congress in February, the American College of Rheumatology voiced concerns that the practice, which it called “critical,” could become a casualty of drug-compounding regulations under revision by the United States Pharmacopeial Convention (USP), a nonprofit group whose standards are enforceable by state and federal regulators.

Carol Renner/NDSU

Steroid fiasco sparked rule revisions

The ACR’s concerns follow a tighter focus by state and federal agencies on drug compounding after a fungal meningitis outbreak in 2012 was traced to contaminated steroids produced in bulk by a compounding pharmacy.

More than 800 infections, 64 of them fatal, occurred after the New England Compounding Center in Framingham, Mass., sold contaminated methylprednisolone acetate that was used in epidural and intra-articular joint injections.

The following year Congress passed the Drug Quality and Security Act, which aims, in part, to prevent compounding pharmacies from engaging in what amounts to unregulated manufacturing.

As part of the law, the FDA created a list of drugs appropriate for compounding and a process by which larger compounding pharmacies must register with the FDA, and agree to inspections. The USP standards, meanwhile, address detailed technical and safety aspects of compounding and are enforceable by the FDA and state agencies.

“USP and FDA have had the ability to regulate compounding for over a decade, but only recently have the rules become actively enforced,” said Donald Miller, PharmD, of North Dakota State University, Fargo, who helped shape the ACR’s position statement on compounding with the help of rheumatologists in private practice.

“When you make guidelines for safety, they make sense, but then you can’t anticipate the way it’s going to affect individuals’ practice. And that’s where rheumatology got caught up,” said Dr. Miller, who was a member of the FDA Arthritis Advisory Committee in 2014-2016.

In-office mixing a top concern

Other specialties, including dermatology and immunology, also stand to be affected by various changes to compounding law and practice – and their societies have been active in voicing concerns.

Though the latest revisions of USP chapter 797, which impacts in-office mixing, are still being sorted out, it’s the No. 1 compounding-related concern for rheumatologists, Dr. Miller said.

Rheumatologists routinely mix an analgesic and a steroid for injection. The analgesic makes the steroids less viscous, and offers patients hours of immediate relief. They also add analgesics to hyaluronic acid injected for viscosupplementation. The mixing is usually conducted bedside, and the injections are administered right away.

Technically, combining these products amounts to sterile compounding, Dr. Miller explained. “And theoretically, under these rules, a physician could still do this, but they’d have to do it under a sterile hood like you find in a pharmacy, and that’s just not practical. It also becomes a matter of interpretation.”

USP chapter 797 sanctions in-office mixing for “immediate use” with individual patients – which is nearly always the case for the steroid injections used in rheumatology. But it’s unclear whether “immediate use” means emergency use only, or allows for routine use, as rheumatologists hope.

“One reason this came to rheumatology’s attention is that some state boards of medicine were inspecting and saying ‘Hey, you can’t do that,’ ” Dr. Miller said.

Pediatric issues

Pediatric rheumatologists, and adult rheumatologists who see children occasionally, use compounding pharmacies to create palatable oral medicines and adjusted doses of adult treatments.

They also use injections combining steroids with analgesics, and consider the addition of the analgesic a key aid to compliance.

“The biggest barrier we have is patient and parent anxiety about doing the procedure and the associated pain. We always administer our steroids mixed with lidocaine to help with the postprocedural discomfort,” said Adam Reinhardt, MD, chief of pediatric rheumatology at the University of Nebraska and Children’s Hospital and Medical Center in Omaha.

Relevance of rules

None of the rheumatologists interviewed questioned the need for tightened state and federal oversight of compounding practices overall – just the applicability of certain rules to their own practice.

Dr. Snow and Dr. Huffstutter noted that reports of infected joints – a potential result of a contaminated injection – are sporadic and rare. “There’s very little research in this, but [these types of injections] have been standard practice for decades,” Dr. Snow said.

Srikanth Mukkera, MD, a rheumatologist in Tupelo, Miss., agreed that “sporadic cases of joint infection do happen following injection, but it can be hard to show if an injection was the cause.”

Assuring that medicines are mixed only immediately prior to injection, and not stored, reduces the likelihood of contamination, Dr. Mukkera said. Moreover, he noted, epidural injections such as those that resulted in the 2012 meningitis outbreak carry different risks than those seen in intra-articular injections.

Dr. Miller, the lead author of the ACR statement, said that the rheumatologists on our committee “don’t know of anyone that’s had a knee or other joint infection from a contaminated injection. They feel that unless somebody finds some evidence of that, they should be allowed to continue” with their usual practice.

He said that he feels that the USP will ultimately heed the concerns of rheumatologists and hopefully provide a more relaxed interpretation of in-office compounding. “We’re hoping they’ll make some exceptions when they revise 797 standards or at least maybe leave room for organizations to create a best practice statement. We’ll see,” Dr. Miller said.

But this is in no way guaranteed. Dr. Huffstutter said he fears that, if the rules come to be interpreted more narrowly, even standard practices like reconstituting biologic drugs for infusion – something that’s also a routine part of in-office practice – could fall under the rubric of sterile compounding and come into question.

The quinacrine problem

A separate compounding-related issue in rheumatology is clinicians’ access to quinacrine, an antimalarial rheumatology drug that, while infrequently used, represents the only alternative to hydroxychloroquine for some lupus patients.

“There are no alternatives out there for hydroxychloroquine, so we need it as a backup,” Dr. Snow said. “If hydroxychloroquine isn’t an option, there’s nothing out there that we can use. There’s no easy replacement.”

Dr. Huffstutter said he currently had no patients on quinacrine. “It’s not very often that we use it, but in those patients that really need it, it can make a huge difference in how they do.”

Quinacrine is no longer manufactured commercially as a finished drug product but is available in a powder that compounding physicians put into 100-mg capsules. It is not on the FDA’s current list of drugs available for compounding except with special permission.

While the ACR has requested that the FDA add it the list of bulk drug substances that can be used in compounding, quinacrine remains off the list for now – and, providers say, hard to find.

Moreover, while rheumatologists may have previously been able to order and store quantities of quinacrine and other compounded nonsterile medications to dispense to their patients, they can no longer easily do so, as only the FDA-approved compounding “outsourcing facilities” are allowed to process larger orders; the rest can only respond to prescriptions for individual patients.

Dr. Miller said it’s likely that quinacrine will make it onto the FDA’s next list of bulk drugs available for compounding. “The FDA has kind of said, ‘Don’t worry about it,’ ” he said.

rhnews@frontlinemedcom.com

As new rules about drug compounding get shaped, rheumatologists seek to protect their ability to combine injectable drugs – most commonly a steroid and a local anesthetic – in their own offices.

In a position statement sent to government agencies and members of Congress in February, the American College of Rheumatology voiced concerns that the practice, which it called “critical,” could become a casualty of drug-compounding regulations under revision by the United States Pharmacopeial Convention (USP), a nonprofit group whose standards are enforceable by state and federal regulators.

Carol Renner/NDSU

Steroid fiasco sparked rule revisions

The ACR’s concerns follow a tighter focus by state and federal agencies on drug compounding after a fungal meningitis outbreak in 2012 was traced to contaminated steroids produced in bulk by a compounding pharmacy.

More than 800 infections, 64 of them fatal, occurred after the New England Compounding Center in Framingham, Mass., sold contaminated methylprednisolone acetate that was used in epidural and intra-articular joint injections.

The following year Congress passed the Drug Quality and Security Act, which aims, in part, to prevent compounding pharmacies from engaging in what amounts to unregulated manufacturing.

As part of the law, the FDA created a list of drugs appropriate for compounding and a process by which larger compounding pharmacies must register with the FDA, and agree to inspections. The USP standards, meanwhile, address detailed technical and safety aspects of compounding and are enforceable by the FDA and state agencies.

“USP and FDA have had the ability to regulate compounding for over a decade, but only recently have the rules become actively enforced,” said Donald Miller, PharmD, of North Dakota State University, Fargo, who helped shape the ACR’s position statement on compounding with the help of rheumatologists in private practice.

“When you make guidelines for safety, they make sense, but then you can’t anticipate the way it’s going to affect individuals’ practice. And that’s where rheumatology got caught up,” said Dr. Miller, who was a member of the FDA Arthritis Advisory Committee in 2014-2016.

In-office mixing a top concern

Other specialties, including dermatology and immunology, also stand to be affected by various changes to compounding law and practice – and their societies have been active in voicing concerns.

Though the latest revisions of USP chapter 797, which impacts in-office mixing, are still being sorted out, it’s the No. 1 compounding-related concern for rheumatologists, Dr. Miller said.

Rheumatologists routinely mix an analgesic and a steroid for injection. The analgesic makes the steroids less viscous, and offers patients hours of immediate relief. They also add analgesics to hyaluronic acid injected for viscosupplementation. The mixing is usually conducted bedside, and the injections are administered right away.

Technically, combining these products amounts to sterile compounding, Dr. Miller explained. “And theoretically, under these rules, a physician could still do this, but they’d have to do it under a sterile hood like you find in a pharmacy, and that’s just not practical. It also becomes a matter of interpretation.”

USP chapter 797 sanctions in-office mixing for “immediate use” with individual patients – which is nearly always the case for the steroid injections used in rheumatology. But it’s unclear whether “immediate use” means emergency use only, or allows for routine use, as rheumatologists hope.

“One reason this came to rheumatology’s attention is that some state boards of medicine were inspecting and saying ‘Hey, you can’t do that,’ ” Dr. Miller said.

Pediatric issues

Pediatric rheumatologists, and adult rheumatologists who see children occasionally, use compounding pharmacies to create palatable oral medicines and adjusted doses of adult treatments.

They also use injections combining steroids with analgesics, and consider the addition of the analgesic a key aid to compliance.

“The biggest barrier we have is patient and parent anxiety about doing the procedure and the associated pain. We always administer our steroids mixed with lidocaine to help with the postprocedural discomfort,” said Adam Reinhardt, MD, chief of pediatric rheumatology at the University of Nebraska and Children’s Hospital and Medical Center in Omaha.

Relevance of rules

None of the rheumatologists interviewed questioned the need for tightened state and federal oversight of compounding practices overall – just the applicability of certain rules to their own practice.

Dr. Snow and Dr. Huffstutter noted that reports of infected joints – a potential result of a contaminated injection – are sporadic and rare. “There’s very little research in this, but [these types of injections] have been standard practice for decades,” Dr. Snow said.

Srikanth Mukkera, MD, a rheumatologist in Tupelo, Miss., agreed that “sporadic cases of joint infection do happen following injection, but it can be hard to show if an injection was the cause.”

Assuring that medicines are mixed only immediately prior to injection, and not stored, reduces the likelihood of contamination, Dr. Mukkera said. Moreover, he noted, epidural injections such as those that resulted in the 2012 meningitis outbreak carry different risks than those seen in intra-articular injections.

Dr. Miller, the lead author of the ACR statement, said that the rheumatologists on our committee “don’t know of anyone that’s had a knee or other joint infection from a contaminated injection. They feel that unless somebody finds some evidence of that, they should be allowed to continue” with their usual practice.

He said that he feels that the USP will ultimately heed the concerns of rheumatologists and hopefully provide a more relaxed interpretation of in-office compounding. “We’re hoping they’ll make some exceptions when they revise 797 standards or at least maybe leave room for organizations to create a best practice statement. We’ll see,” Dr. Miller said.

But this is in no way guaranteed. Dr. Huffstutter said he fears that, if the rules come to be interpreted more narrowly, even standard practices like reconstituting biologic drugs for infusion – something that’s also a routine part of in-office practice – could fall under the rubric of sterile compounding and come into question.

The quinacrine problem

A separate compounding-related issue in rheumatology is clinicians’ access to quinacrine, an antimalarial rheumatology drug that, while infrequently used, represents the only alternative to hydroxychloroquine for some lupus patients.

“There are no alternatives out there for hydroxychloroquine, so we need it as a backup,” Dr. Snow said. “If hydroxychloroquine isn’t an option, there’s nothing out there that we can use. There’s no easy replacement.”

Dr. Huffstutter said he currently had no patients on quinacrine. “It’s not very often that we use it, but in those patients that really need it, it can make a huge difference in how they do.”

Quinacrine is no longer manufactured commercially as a finished drug product but is available in a powder that compounding physicians put into 100-mg capsules. It is not on the FDA’s current list of drugs available for compounding except with special permission.

While the ACR has requested that the FDA add it the list of bulk drug substances that can be used in compounding, quinacrine remains off the list for now – and, providers say, hard to find.

Moreover, while rheumatologists may have previously been able to order and store quantities of quinacrine and other compounded nonsterile medications to dispense to their patients, they can no longer easily do so, as only the FDA-approved compounding “outsourcing facilities” are allowed to process larger orders; the rest can only respond to prescriptions for individual patients.

Dr. Miller said it’s likely that quinacrine will make it onto the FDA’s next list of bulk drugs available for compounding. “The FDA has kind of said, ‘Don’t worry about it,’ ” he said.

rhnews@frontlinemedcom.com

An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

The National Academies, a group of nongovernmental advisory bodies that includes the former Institute of Medicine, said that “the tools to prevent these deaths” exist – namely vaccination to prevent new hepatitis B infections and antiviral drugs, including new oral medications that can cure chronic hepatitis C infections within months.

The authors of the 200-plus-page report, led by Brian Strom, MD, MPH, of Rutgers University in Newark, NJ, calculate that deaths from hepatitis B infection could be halved by 2030 if 90% of patients are diagnosed, if 90% of those diagnosed are connected to care, and if 80% of those for whom treatment is indicated receive it. Treating everyone with chronic hepatitis C would reduce new infections by 90% by 2030, while reducing related deaths by 65%, Dr. Strom and his colleagues estimate.

But the authors also concede that drastic changes to current health policy would be required to reach these goals. These include the adoption of “aggressive testing, diagnosis, treatment, and prevention methods, such as needle exchange.”

They propose that the federal government seek a unique licensing arrangement with one or more manufacturers to bring down the notoriously high cost of direct-acting drugs used in hepatitis C, as a way of raising treatment rates. Currently, fewer than half the patients on Medicaid who are eligible for hepatitis C treatment receive it, and fewer than 1% of prisoners, who have high rates of infection.

Dr. Joseph Lim, director of the viral hepatitis program at Yale University in New Haven. Conn., who was not involved in the National Academies report, called it helpful in the sense that “it casts a spotlight on something that those of us involved in the care of people with viral hepatitis have long known – which is that this is a national and global public health burden that has been under the radar and in the shadow of other important health priorities.”

Both hepatitis B and C increase the risk of liver cancer and are associated with significant morbidity and mortality. Though approximately 4 million people in the United States are estimated to be infected with chronic hepatitis B (1.3 million) or C (2.7 million), these diseases account for less than 1% of the research budget at the National Institutes of Health, the report said. This compares unfavorably to funding for HIV, which affects about 1 million Americans.

As the report states, the tools to radically reduce hepatitis B and C deaths already exist. However, Dr. Lim cautioned in an interview, “the public health infrastructure to address viral hepatitis has been woefully inadequate.” In the United States, he noted, most states receive federal funding for at most a single person in charge of viral hepatitis epidemiology. “The resources currently available are in no way adequate to achieve the very aggressive goals described in the report,” he said.

Even among people with a known diagnosis of hepatitis B or C, only some receive confirmatory testing, Dr. Lim said. And of those with confirmed infections, “only a fraction are linked to care from the diagnosing clinician to a provider with the capacity to assess the state of liver disease and determine whether antiviral therapy is warranted.” Finally, he said, “many patients continue to face barriers to curative therapy due to cost and restrictions by public and private payers.”

Among the recommendations contained in the report is that unrestricted, mass treatment of hepatitis C infections be undertaken – regardless of disease stage. Currently, direct-acting antiviral agents remain costly and are poorly covered, notably by Medicaid. The National Academies advise that the government rectify this by purchasing “a license or assignment to the patent on a direct-acting antiviral drug, and use it only in those market segments where the government pays for treatment and access is now limited, such as Medicaid and prisons.” 

Dr. Lim called the licensing proposal “very novel and bold,” but noted that there is no precedent in the United States for diseases such as hepatitis C. “If it could be done it would be an incredible model of government-pharma partnership for the public health good, and have a very significant impact.”

Steven Flamm, MD, chief of the liver transplantation program at Northwestern University in Chicago, who like Dr. Lim was not involved in the creation of the report, said in an interview that it contained innovative ideas and helped underscore the fact that “hepatitis has been given short shrift. The NIH and other agencies do not devote time and energy to this particular medical issue for reasons that are not completely clear.”

But “the problem with these kinds of analyses,” he said, “is that carrying them out is harder than making the recommendations.”

Dr. Flamm echoed Dr. Lim’s concerns about the practicability of implementing some of the recommendations in what he considers a resource-deprived health care environment for viral hepatitis.

“Is elimination possible or can you take a big bite out of it? The answer to that question is yes. We now have agents that can treat chronic viral hepatitis well, which we didn’t have a few years ago.”

Still, he emphasized, having the tools is only one part of the picture. Hepatitis C diagnostic tests have been available since the early 1990s. Yet, Dr. Flamm pointed out, fewer than half of patients have been diagnosed. “If the new CDC screening guidelines gain traction, we will do better than that.”

Dr. Flamm said that he considered the report’s call for a unique government licensing agreement for hepatitis C drugs a tall order. The drugs are already heavily discounted by manufacturers in many cases, he said, yet remain unavailable to those in need of them. In Illinois, Dr. Flamm said, few Medicaid patients with confirmed hepatitis C are given the short-acting antivirals that have revolutionized treatment. “The vast majority have no access to the therapy at all,” he said.

One of the report’s strengths, he said, is in detailing innovative prevention strategies such as delivering and promoting hepatitis B vaccinations to adults through local pharmacies, after the model of influenza vaccinations, and also conducting needle exchanges through pharmacies for intravenous drug users, who are at high risk of contracting both hepatitis B and C.

“Many of these strategies are not very costly,” he said. “The problem is you run into moral platitudes – to eliminate hepatitis, we will have to overcome that,” Dr. Flamm said, something that cannot be taken for granted in the current political environment.

But even if the goals outlined in the report seem ambitious, its authors have done an important service in underscoring the burden of viral hepatitis and laying out how some barriers to prevention, diagnosis, and treatment might be broken, he said.

Viral hepatitis “is a big deal, and it does cost a tremendous amount of money,” he added. “Everybody focuses on the therapeutic cost, but nobody focuses on the costs, direct and indirect, of all the sick people that are out there.”

An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

The National Academies, a group of nongovernmental advisory bodies that includes the former Institute of Medicine, said that “the tools to prevent these deaths” exist – namely vaccination to prevent new hepatitis B infections and antiviral drugs, including new oral medications that can cure chronic hepatitis C infections within months.

The authors of the 200-plus-page report, led by Brian Strom, MD, MPH, of Rutgers University in Newark, NJ, calculate that deaths from hepatitis B infection could be halved by 2030 if 90% of patients are diagnosed, if 90% of those diagnosed are connected to care, and if 80% of those for whom treatment is indicated receive it. Treating everyone with chronic hepatitis C would reduce new infections by 90% by 2030, while reducing related deaths by 65%, Dr. Strom and his colleagues estimate.

But the authors also concede that drastic changes to current health policy would be required to reach these goals. These include the adoption of “aggressive testing, diagnosis, treatment, and prevention methods, such as needle exchange.”

They propose that the federal government seek a unique licensing arrangement with one or more manufacturers to bring down the notoriously high cost of direct-acting drugs used in hepatitis C, as a way of raising treatment rates. Currently, fewer than half the patients on Medicaid who are eligible for hepatitis C treatment receive it, and fewer than 1% of prisoners, who have high rates of infection.

Dr. Joseph Lim, director of the viral hepatitis program at Yale University in New Haven. Conn., who was not involved in the National Academies report, called it helpful in the sense that “it casts a spotlight on something that those of us involved in the care of people with viral hepatitis have long known – which is that this is a national and global public health burden that has been under the radar and in the shadow of other important health priorities.”

Both hepatitis B and C increase the risk of liver cancer and are associated with significant morbidity and mortality. Though approximately 4 million people in the United States are estimated to be infected with chronic hepatitis B (1.3 million) or C (2.7 million), these diseases account for less than 1% of the research budget at the National Institutes of Health, the report said. This compares unfavorably to funding for HIV, which affects about 1 million Americans.

As the report states, the tools to radically reduce hepatitis B and C deaths already exist. However, Dr. Lim cautioned in an interview, “the public health infrastructure to address viral hepatitis has been woefully inadequate.” In the United States, he noted, most states receive federal funding for at most a single person in charge of viral hepatitis epidemiology. “The resources currently available are in no way adequate to achieve the very aggressive goals described in the report,” he said.

Even among people with a known diagnosis of hepatitis B or C, only some receive confirmatory testing, Dr. Lim said. And of those with confirmed infections, “only a fraction are linked to care from the diagnosing clinician to a provider with the capacity to assess the state of liver disease and determine whether antiviral therapy is warranted.” Finally, he said, “many patients continue to face barriers to curative therapy due to cost and restrictions by public and private payers.”

Among the recommendations contained in the report is that unrestricted, mass treatment of hepatitis C infections be undertaken – regardless of disease stage. Currently, direct-acting antiviral agents remain costly and are poorly covered, notably by Medicaid. The National Academies advise that the government rectify this by purchasing “a license or assignment to the patent on a direct-acting antiviral drug, and use it only in those market segments where the government pays for treatment and access is now limited, such as Medicaid and prisons.” 

Dr. Lim called the licensing proposal “very novel and bold,” but noted that there is no precedent in the United States for diseases such as hepatitis C. “If it could be done it would be an incredible model of government-pharma partnership for the public health good, and have a very significant impact.”

Steven Flamm, MD, chief of the liver transplantation program at Northwestern University in Chicago, who like Dr. Lim was not involved in the creation of the report, said in an interview that it contained innovative ideas and helped underscore the fact that “hepatitis has been given short shrift. The NIH and other agencies do not devote time and energy to this particular medical issue for reasons that are not completely clear.”

But “the problem with these kinds of analyses,” he said, “is that carrying them out is harder than making the recommendations.”

Dr. Flamm echoed Dr. Lim’s concerns about the practicability of implementing some of the recommendations in what he considers a resource-deprived health care environment for viral hepatitis.

“Is elimination possible or can you take a big bite out of it? The answer to that question is yes. We now have agents that can treat chronic viral hepatitis well, which we didn’t have a few years ago.”

Still, he emphasized, having the tools is only one part of the picture. Hepatitis C diagnostic tests have been available since the early 1990s. Yet, Dr. Flamm pointed out, fewer than half of patients have been diagnosed. “If the new CDC screening guidelines gain traction, we will do better than that.”

Dr. Flamm said that he considered the report’s call for a unique government licensing agreement for hepatitis C drugs a tall order. The drugs are already heavily discounted by manufacturers in many cases, he said, yet remain unavailable to those in need of them. In Illinois, Dr. Flamm said, few Medicaid patients with confirmed hepatitis C are given the short-acting antivirals that have revolutionized treatment. “The vast majority have no access to the therapy at all,” he said.

One of the report’s strengths, he said, is in detailing innovative prevention strategies such as delivering and promoting hepatitis B vaccinations to adults through local pharmacies, after the model of influenza vaccinations, and also conducting needle exchanges through pharmacies for intravenous drug users, who are at high risk of contracting both hepatitis B and C.

“Many of these strategies are not very costly,” he said. “The problem is you run into moral platitudes – to eliminate hepatitis, we will have to overcome that,” Dr. Flamm said, something that cannot be taken for granted in the current political environment.

But even if the goals outlined in the report seem ambitious, its authors have done an important service in underscoring the burden of viral hepatitis and laying out how some barriers to prevention, diagnosis, and treatment might be broken, he said.

Viral hepatitis “is a big deal, and it does cost a tremendous amount of money,” he added. “Everybody focuses on the therapeutic cost, but nobody focuses on the costs, direct and indirect, of all the sick people that are out there.”

An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

The National Academies, a group of nongovernmental advisory bodies that includes the former Institute of Medicine, said that “the tools to prevent these deaths” exist – namely vaccination to prevent new hepatitis B infections and antiviral drugs, including new oral medications that can cure chronic hepatitis C infections within months.

The authors of the 200-plus-page report, led by Brian Strom, MD, MPH, of Rutgers University in Newark, NJ, calculate that deaths from hepatitis B infection could be halved by 2030 if 90% of patients are diagnosed, if 90% of those diagnosed are connected to care, and if 80% of those for whom treatment is indicated receive it. Treating everyone with chronic hepatitis C would reduce new infections by 90% by 2030, while reducing related deaths by 65%, Dr. Strom and his colleagues estimate.

But the authors also concede that drastic changes to current health policy would be required to reach these goals. These include the adoption of “aggressive testing, diagnosis, treatment, and prevention methods, such as needle exchange.”

They propose that the federal government seek a unique licensing arrangement with one or more manufacturers to bring down the notoriously high cost of direct-acting drugs used in hepatitis C, as a way of raising treatment rates. Currently, fewer than half the patients on Medicaid who are eligible for hepatitis C treatment receive it, and fewer than 1% of prisoners, who have high rates of infection.

Dr. Joseph Lim, director of the viral hepatitis program at Yale University in New Haven. Conn., who was not involved in the National Academies report, called it helpful in the sense that “it casts a spotlight on something that those of us involved in the care of people with viral hepatitis have long known – which is that this is a national and global public health burden that has been under the radar and in the shadow of other important health priorities.”

Both hepatitis B and C increase the risk of liver cancer and are associated with significant morbidity and mortality. Though approximately 4 million people in the United States are estimated to be infected with chronic hepatitis B (1.3 million) or C (2.7 million), these diseases account for less than 1% of the research budget at the National Institutes of Health, the report said. This compares unfavorably to funding for HIV, which affects about 1 million Americans.

As the report states, the tools to radically reduce hepatitis B and C deaths already exist. However, Dr. Lim cautioned in an interview, “the public health infrastructure to address viral hepatitis has been woefully inadequate.” In the United States, he noted, most states receive federal funding for at most a single person in charge of viral hepatitis epidemiology. “The resources currently available are in no way adequate to achieve the very aggressive goals described in the report,” he said.

Even among people with a known diagnosis of hepatitis B or C, only some receive confirmatory testing, Dr. Lim said. And of those with confirmed infections, “only a fraction are linked to care from the diagnosing clinician to a provider with the capacity to assess the state of liver disease and determine whether antiviral therapy is warranted.” Finally, he said, “many patients continue to face barriers to curative therapy due to cost and restrictions by public and private payers.”

Among the recommendations contained in the report is that unrestricted, mass treatment of hepatitis C infections be undertaken – regardless of disease stage. Currently, direct-acting antiviral agents remain costly and are poorly covered, notably by Medicaid. The National Academies advise that the government rectify this by purchasing “a license or assignment to the patent on a direct-acting antiviral drug, and use it only in those market segments where the government pays for treatment and access is now limited, such as Medicaid and prisons.” 

Dr. Lim called the licensing proposal “very novel and bold,” but noted that there is no precedent in the United States for diseases such as hepatitis C. “If it could be done it would be an incredible model of government-pharma partnership for the public health good, and have a very significant impact.”

Steven Flamm, MD, chief of the liver transplantation program at Northwestern University in Chicago, who like Dr. Lim was not involved in the creation of the report, said in an interview that it contained innovative ideas and helped underscore the fact that “hepatitis has been given short shrift. The NIH and other agencies do not devote time and energy to this particular medical issue for reasons that are not completely clear.”

But “the problem with these kinds of analyses,” he said, “is that carrying them out is harder than making the recommendations.”

Dr. Flamm echoed Dr. Lim’s concerns about the practicability of implementing some of the recommendations in what he considers a resource-deprived health care environment for viral hepatitis.

“Is elimination possible or can you take a big bite out of it? The answer to that question is yes. We now have agents that can treat chronic viral hepatitis well, which we didn’t have a few years ago.”

Still, he emphasized, having the tools is only one part of the picture. Hepatitis C diagnostic tests have been available since the early 1990s. Yet, Dr. Flamm pointed out, fewer than half of patients have been diagnosed. “If the new CDC screening guidelines gain traction, we will do better than that.”

Dr. Flamm said that he considered the report’s call for a unique government licensing agreement for hepatitis C drugs a tall order. The drugs are already heavily discounted by manufacturers in many cases, he said, yet remain unavailable to those in need of them. In Illinois, Dr. Flamm said, few Medicaid patients with confirmed hepatitis C are given the short-acting antivirals that have revolutionized treatment. “The vast majority have no access to the therapy at all,” he said.

One of the report’s strengths, he said, is in detailing innovative prevention strategies such as delivering and promoting hepatitis B vaccinations to adults through local pharmacies, after the model of influenza vaccinations, and also conducting needle exchanges through pharmacies for intravenous drug users, who are at high risk of contracting both hepatitis B and C.

“Many of these strategies are not very costly,” he said. “The problem is you run into moral platitudes – to eliminate hepatitis, we will have to overcome that,” Dr. Flamm said, something that cannot be taken for granted in the current political environment.

But even if the goals outlined in the report seem ambitious, its authors have done an important service in underscoring the burden of viral hepatitis and laying out how some barriers to prevention, diagnosis, and treatment might be broken, he said.

Viral hepatitis “is a big deal, and it does cost a tremendous amount of money,” he added. “Everybody focuses on the therapeutic cost, but nobody focuses on the costs, direct and indirect, of all the sick people that are out there.”

A ubiquitous yeast strain may play a role in exacerbating inflammatory bowel disease (IBD), an animal study showed.

While research has shown that the composition of gut microbiota in people with IBD is different from that of healthy people, most of the attention has been focused on bacteria. The roles of other microorganisms, including yeasts, are still poorly understood.

In research published in Science Translational Medicine, Tyson Chiaro, of the University of Utah, Salt Lake City, and his colleagues inoculated sterile mice with either of two fungal species: Rhodotorula aurantiaca – an environmentally acquired yeast found in milk and fruit juices – or Saccharomyces cerevisiae – Baker’s yeast – for which some people with Crohn’s disease have been shown to have elevated antibodies. The mice were inoculated gradually over a period of a week to mimic consumption of food enriched with yeast products. The researchers then treated the mice with drugs to induce colitislike symptoms and analyzed colon tissues for damage. Mr. Chiaro and his colleagues found that colonization with S. cerevisiae, but not with R. aurantiaca, aggravated colitis and resulted in epithelial damage leading to greater gut permeability (Sci Transl Med. 2017;9[380] pii: eaaf9044]).

Mr. Chiaro and his colleagues then investigated whether heat-killed S. cerevisiae also induced aggravated colitis and found that it did not, suggesting that a metabolically active organism was required to aggravate disease. Mr. Chiaro and his colleagues performed screens of fecal metabolites in the mice and found that S. cerevisiae colonization enhanced purine metabolism, resulting in increased uric acid production.

To test whether this purine pathway was aggravating colitis, the researchers blocked it with allopurinol (10 mg/kg). The S. cerevisiae– inoculated mice that were treated with allopurinol had reduced uric acid–levels and ameliorated colitis–symptoms. The results suggest that allopurinol might be of more clinical value in treating IBD than previously thought. The drug has been used in patients with Crohn’s disease to increase the efficacy of other IBD medications, and “many patients who received adjunctive allopurinol therapy were reported to have major clinical improvement,” Mr. Chiaro and his colleagues noted. The results “suggest that some of the improvement might come from preventing yeast-induced–uric acid buildup in the intestine. Thus, allopurinol treatment in some IBD patients with adverse reactions to yeast and high uric acid might be of therapeutic benefit and should be explored.”

Mr. Chiaro’s coauthors reported a variety of individual grant and fellowship awards, including from the National Institute of Allergy and Infectious Disease and the National Institutes of Health. None declared commercial conflicts of interest.
 

ginews@gastro.org

A ubiquitous yeast strain may play a role in exacerbating inflammatory bowel disease (IBD), an animal study showed.

While research has shown that the composition of gut microbiota in people with IBD is different from that of healthy people, most of the attention has been focused on bacteria. The roles of other microorganisms, including yeasts, are still poorly understood.

In research published in Science Translational Medicine, Tyson Chiaro, of the University of Utah, Salt Lake City, and his colleagues inoculated sterile mice with either of two fungal species: Rhodotorula aurantiaca – an environmentally acquired yeast found in milk and fruit juices – or Saccharomyces cerevisiae – Baker’s yeast – for which some people with Crohn’s disease have been shown to have elevated antibodies. The mice were inoculated gradually over a period of a week to mimic consumption of food enriched with yeast products. The researchers then treated the mice with drugs to induce colitislike symptoms and analyzed colon tissues for damage. Mr. Chiaro and his colleagues found that colonization with S. cerevisiae, but not with R. aurantiaca, aggravated colitis and resulted in epithelial damage leading to greater gut permeability (Sci Transl Med. 2017;9[380] pii: eaaf9044]).

Mr. Chiaro and his colleagues then investigated whether heat-killed S. cerevisiae also induced aggravated colitis and found that it did not, suggesting that a metabolically active organism was required to aggravate disease. Mr. Chiaro and his colleagues performed screens of fecal metabolites in the mice and found that S. cerevisiae colonization enhanced purine metabolism, resulting in increased uric acid production.

To test whether this purine pathway was aggravating colitis, the researchers blocked it with allopurinol (10 mg/kg). The S. cerevisiae– inoculated mice that were treated with allopurinol had reduced uric acid–levels and ameliorated colitis–symptoms. The results suggest that allopurinol might be of more clinical value in treating IBD than previously thought. The drug has been used in patients with Crohn’s disease to increase the efficacy of other IBD medications, and “many patients who received adjunctive allopurinol therapy were reported to have major clinical improvement,” Mr. Chiaro and his colleagues noted. The results “suggest that some of the improvement might come from preventing yeast-induced–uric acid buildup in the intestine. Thus, allopurinol treatment in some IBD patients with adverse reactions to yeast and high uric acid might be of therapeutic benefit and should be explored.”

Mr. Chiaro’s coauthors reported a variety of individual grant and fellowship awards, including from the National Institute of Allergy and Infectious Disease and the National Institutes of Health. None declared commercial conflicts of interest.
 

ginews@gastro.org

A ubiquitous yeast strain may play a role in exacerbating inflammatory bowel disease (IBD), an animal study showed.

While research has shown that the composition of gut microbiota in people with IBD is different from that of healthy people, most of the attention has been focused on bacteria. The roles of other microorganisms, including yeasts, are still poorly understood.

In research published in Science Translational Medicine, Tyson Chiaro, of the University of Utah, Salt Lake City, and his colleagues inoculated sterile mice with either of two fungal species: Rhodotorula aurantiaca – an environmentally acquired yeast found in milk and fruit juices – or Saccharomyces cerevisiae – Baker’s yeast – for which some people with Crohn’s disease have been shown to have elevated antibodies. The mice were inoculated gradually over a period of a week to mimic consumption of food enriched with yeast products. The researchers then treated the mice with drugs to induce colitislike symptoms and analyzed colon tissues for damage. Mr. Chiaro and his colleagues found that colonization with S. cerevisiae, but not with R. aurantiaca, aggravated colitis and resulted in epithelial damage leading to greater gut permeability (Sci Transl Med. 2017;9[380] pii: eaaf9044]).

Mr. Chiaro and his colleagues then investigated whether heat-killed S. cerevisiae also induced aggravated colitis and found that it did not, suggesting that a metabolically active organism was required to aggravate disease. Mr. Chiaro and his colleagues performed screens of fecal metabolites in the mice and found that S. cerevisiae colonization enhanced purine metabolism, resulting in increased uric acid production.

To test whether this purine pathway was aggravating colitis, the researchers blocked it with allopurinol (10 mg/kg). The S. cerevisiae– inoculated mice that were treated with allopurinol had reduced uric acid–levels and ameliorated colitis–symptoms. The results suggest that allopurinol might be of more clinical value in treating IBD than previously thought. The drug has been used in patients with Crohn’s disease to increase the efficacy of other IBD medications, and “many patients who received adjunctive allopurinol therapy were reported to have major clinical improvement,” Mr. Chiaro and his colleagues noted. The results “suggest that some of the improvement might come from preventing yeast-induced–uric acid buildup in the intestine. Thus, allopurinol treatment in some IBD patients with adverse reactions to yeast and high uric acid might be of therapeutic benefit and should be explored.”

Mr. Chiaro’s coauthors reported a variety of individual grant and fellowship awards, including from the National Institute of Allergy and Infectious Disease and the National Institutes of Health. None declared commercial conflicts of interest.
 

ginews@gastro.org

A high proportion of children with type 1 diabetes who are hospitalized for diabetic ketoacidosis (DKA) develop acute kidney injury (AKI), according to results from a study.

Researchers reviewing records from a Canadian hospital found that in a cohort of 165 children hospitalized for DKA during a 5-year period (2008-2013), 64% developed the complication. Severe forms of AKI (stage 2 or 3) were common, representing 45% and 20%, respectively, of children with AKI. Two patients in the cohort required dialysis.

Boarding1Now/Thinkstock

A high proportion of children with type 1 diabetes who are hospitalized for diabetic ketoacidosis (DKA) develop acute kidney injury (AKI), according to results from a study.

Researchers reviewing records from a Canadian hospital found that in a cohort of 165 children hospitalized for DKA during a 5-year period (2008-2013), 64% developed the complication. Severe forms of AKI (stage 2 or 3) were common, representing 45% and 20%, respectively, of children with AKI. Two patients in the cohort required dialysis.

Boarding1Now/Thinkstock

A high proportion of children with type 1 diabetes who are hospitalized for diabetic ketoacidosis (DKA) develop acute kidney injury (AKI), according to results from a study.

Researchers reviewing records from a Canadian hospital found that in a cohort of 165 children hospitalized for DKA during a 5-year period (2008-2013), 64% developed the complication. Severe forms of AKI (stage 2 or 3) were common, representing 45% and 20%, respectively, of children with AKI. Two patients in the cohort required dialysis.

Boarding1Now/Thinkstock

Early elective delivery in the United States is at an all-time low of 1.9%, down from 17% in 2010, according to a report by a nonprofit group that monitors safety and care quality in hospitals.

Early elective delivery comprises Cesarean deliveries or inductions performed before 39 weeks without medical necessity, and higher rates are considered a barometer of poor labor management in hospitals. For its annual report on maternity practices, published Feb. 28, the Leapfrog Group, a Washington, D.C.–based nonprofit, collected voluntarily reported data from 1,859 hospitals, or about half of the nation’s hospitals, in 2016.

monkeybusinessimages/Thinkstock

Early elective delivery in the United States is at an all-time low of 1.9%, down from 17% in 2010, according to a report by a nonprofit group that monitors safety and care quality in hospitals.

Early elective delivery comprises Cesarean deliveries or inductions performed before 39 weeks without medical necessity, and higher rates are considered a barometer of poor labor management in hospitals. For its annual report on maternity practices, published Feb. 28, the Leapfrog Group, a Washington, D.C.–based nonprofit, collected voluntarily reported data from 1,859 hospitals, or about half of the nation’s hospitals, in 2016.

monkeybusinessimages/Thinkstock

Early elective delivery in the United States is at an all-time low of 1.9%, down from 17% in 2010, according to a report by a nonprofit group that monitors safety and care quality in hospitals.

Early elective delivery comprises Cesarean deliveries or inductions performed before 39 weeks without medical necessity, and higher rates are considered a barometer of poor labor management in hospitals. For its annual report on maternity practices, published Feb. 28, the Leapfrog Group, a Washington, D.C.–based nonprofit, collected voluntarily reported data from 1,859 hospitals, or about half of the nation’s hospitals, in 2016.

monkeybusinessimages/Thinkstock

A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.

The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.

Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.

In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).

The four cases were:

• A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
• A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
• A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
• A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.

Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.

“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”

We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.

The investigators did not disclose outside funding or conflicts of interest related to their findings.

*This story was updated March 16, 2017, with the correct journal source.

A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.

The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.

Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.

In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).

The four cases were:

• A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
• A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
• A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
• A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.

Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.

“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”

We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.

The investigators did not disclose outside funding or conflicts of interest related to their findings.

*This story was updated March 16, 2017, with the correct journal source.

A reporting system for lung cancer screening with low-dose computed tomography may underemphasize important abnormal findings other than nodules, researchers say, potentially leading to missed malignancies.

The American College of Radiology Lung Imaging Reporting and Data System, or Lung-RADS, was introduced in 2014 to standardize reporting for low-dose CT findings and also to reduce false-positive rates, by applying tighter criteria that was used in the National Lung Screening Trial.

Lung-RADS does not have specific reporting categories for patients with isolated hilar and mediastinal adenopathy or pleural effusion in the absence of lung nodules, even though these can indicate malignancy. It does allow for the inclusion of what is called an “S” code to indicate clinically significant findings other than nodules.

In the March 2017 issue of CHEST, Hiren Mehta, MD, and his colleagues at the University of Florida in Gainesville, report on four cases from their center in which patients with these pathologies had their scans read as Lung-RADS category 1, indicating a less than 1% likelihood of malignancy. No S codes were added to their reports. Subsequent testing in these patients revealed cancers (CHEST. 2017 March;151[3]:525-26).

The four cases were:

• A 56-year-old male with hilar and mediastinal adenopathy who was recommended for repeat screening at 12 months. The patient presented 6 months later with pneumonia; biopsy revealed large cell lung cancer.
• A 76-year-old male with paratracheal lymph nodes and a solitary subcarinal lymph node. A subsequent biopsy revealed adenocarcinoma.
• A 67-year-old male whose scan showed bulky hilar and mediastinal adenopathy. Subsequent testing revealed Hodgkin’s lymphoma.
• A 75-year-old female whose scan showed a small pleural effusion and no nodules. Repeat scanning at 1 year showed enlargement of the effusion and lung adenocarcinoma.

Dr. Mehta and colleagues noted in their analysis that Lung-RADS has not been studied prospectively in real practice settings and that the four cases – two of which involved delayed diagnosis – reveal “a significant limitation” of Lung-RADS.

“Based on our experience, we believe that particular caution should be exercised in reporting Lung-RADS 1 category for patients with adenopathy/pleural effusion with no lung nodules, as a majority of the lung cancer screening scans will be ordered by [primary care providers] ... [As] with any new system, an ongoing evaluation of the performance of Lung-RADS should be conducted so that the sensitivity and mortality benefit seen in the [National Lung Screening Trial] is not compromised.”

We strongly believe, based on our experience with these 4 cases that the new version of Lung-RADS 2.0 should [account for shortcomings of the current Lung-RADS] and have a separate category for findings that are highly suspicious for malignancy but do not have an accompanying lung nodule,” they wrote.

The investigators did not disclose outside funding or conflicts of interest related to their findings.

*This story was updated March 16, 2017, with the correct journal source.

Treatment with pembrolizumab, a humanized antibody used in cancer immunotherapy, may affect the pigmentation of some benign skin lesions, according to a case study in British Journal of Dermatology.

Pembrolizumab works by targeting the programmed cell death-1 (PD-1) receptor and is used in the treatment of metastatic melanoma and some other cancers.

The case report, by Zachary J. Wolner, MD, of Memorial Sloan Kettering Cancer Center in New York, and his colleagues, describes a male patient in his 60s with HRAS mutant metastatic melanoma who was treated with pembrolizumab 2 mg/kg every 3 weeks for 13 months, and had received no previous systematic treatment. At 4 months after starting pembrolizumab, the patient experienced whitening of eyebrows and eyelashes, along with scalp and body hair, followed by lighter overall skin pigmentation and the fading of pigmented skin lesions. Baseline (pre-pembrolizumab) and 1-year follow-up skin photography confirmed lightening or disappearance of solar lentigines, seborrheic keratoses, and melanocytic nevi along with overall lightening of the skin (Br J. Dermatol. 2017 doi: 10.1111/bjd.15354).

Dr. Wolner and his colleagues noted that while changing skin lesions have not been reported in clinical trials of anti-PD-1 therapies, one study in patients treated with an anti-PD-1 therapy for metastatic melanoma found changes to nevi in 6 of 34 (18%) patients. Patients using a melanoma website also have self-reported disappearing nevi after immunotherapy treatment, the authors noted.

Expression of the coinhibitory molecule PD-L1 “is not limited to malignant tumors,” the researchers wrote, adding that previous studies have identified PD-L1 expression in melanocytes of benign melanocytic nevi. “Therefore it is biologically plausible that PD-1 inhibition may affect the natural history of benign melanocytic neoplasms.”

Also, they wrote, “the co-occurrence of vitiligo and poliosis in our patient suggests a role for autoimmunity in the fading/disappearance of his pigmented lesions.” The investigators cited a recent study in 67 patients with metastatic melanoma receiving pembrolizumab, which found that 25% developed vitiligo. Response to treatment also was significantly associated with occurrence of vitiligo (JAMA Dermatol. 2016;152[1]:45-51).

Dr. Wolner and his colleagues cautioned that their findings were limited to a single case report, and also by “lack of histological sampling and molecular characterization of fading/disappearing nevi.” An alternative explanation for the observed changes “includes fading/disappearance not related to PD-1 inhibition or due to chance alone.”

A National Institutes of Health/National Cancer Institute Cancer Center grant was used to help fund the study. Two of Dr. Wolner’s coauthors disclosed consultant or advisory board relationships with Merck and other pharmaceutical manufacturers.

Treatment with pembrolizumab, a humanized antibody used in cancer immunotherapy, may affect the pigmentation of some benign skin lesions, according to a case study in British Journal of Dermatology.

Pembrolizumab works by targeting the programmed cell death-1 (PD-1) receptor and is used in the treatment of metastatic melanoma and some other cancers.

The case report, by Zachary J. Wolner, MD, of Memorial Sloan Kettering Cancer Center in New York, and his colleagues, describes a male patient in his 60s with HRAS mutant metastatic melanoma who was treated with pembrolizumab 2 mg/kg every 3 weeks for 13 months, and had received no previous systematic treatment. At 4 months after starting pembrolizumab, the patient experienced whitening of eyebrows and eyelashes, along with scalp and body hair, followed by lighter overall skin pigmentation and the fading of pigmented skin lesions. Baseline (pre-pembrolizumab) and 1-year follow-up skin photography confirmed lightening or disappearance of solar lentigines, seborrheic keratoses, and melanocytic nevi along with overall lightening of the skin (Br J. Dermatol. 2017 doi: 10.1111/bjd.15354).

Dr. Wolner and his colleagues noted that while changing skin lesions have not been reported in clinical trials of anti-PD-1 therapies, one study in patients treated with an anti-PD-1 therapy for metastatic melanoma found changes to nevi in 6 of 34 (18%) patients. Patients using a melanoma website also have self-reported disappearing nevi after immunotherapy treatment, the authors noted.

Expression of the coinhibitory molecule PD-L1 “is not limited to malignant tumors,” the researchers wrote, adding that previous studies have identified PD-L1 expression in melanocytes of benign melanocytic nevi. “Therefore it is biologically plausible that PD-1 inhibition may affect the natural history of benign melanocytic neoplasms.”

Also, they wrote, “the co-occurrence of vitiligo and poliosis in our patient suggests a role for autoimmunity in the fading/disappearance of his pigmented lesions.” The investigators cited a recent study in 67 patients with metastatic melanoma receiving pembrolizumab, which found that 25% developed vitiligo. Response to treatment also was significantly associated with occurrence of vitiligo (JAMA Dermatol. 2016;152[1]:45-51).

Dr. Wolner and his colleagues cautioned that their findings were limited to a single case report, and also by “lack of histological sampling and molecular characterization of fading/disappearing nevi.” An alternative explanation for the observed changes “includes fading/disappearance not related to PD-1 inhibition or due to chance alone.”

A National Institutes of Health/National Cancer Institute Cancer Center grant was used to help fund the study. Two of Dr. Wolner’s coauthors disclosed consultant or advisory board relationships with Merck and other pharmaceutical manufacturers.

Treatment with pembrolizumab, a humanized antibody used in cancer immunotherapy, may affect the pigmentation of some benign skin lesions, according to a case study in British Journal of Dermatology.

Pembrolizumab works by targeting the programmed cell death-1 (PD-1) receptor and is used in the treatment of metastatic melanoma and some other cancers.

The case report, by Zachary J. Wolner, MD, of Memorial Sloan Kettering Cancer Center in New York, and his colleagues, describes a male patient in his 60s with HRAS mutant metastatic melanoma who was treated with pembrolizumab 2 mg/kg every 3 weeks for 13 months, and had received no previous systematic treatment. At 4 months after starting pembrolizumab, the patient experienced whitening of eyebrows and eyelashes, along with scalp and body hair, followed by lighter overall skin pigmentation and the fading of pigmented skin lesions. Baseline (pre-pembrolizumab) and 1-year follow-up skin photography confirmed lightening or disappearance of solar lentigines, seborrheic keratoses, and melanocytic nevi along with overall lightening of the skin (Br J. Dermatol. 2017 doi: 10.1111/bjd.15354).

Dr. Wolner and his colleagues noted that while changing skin lesions have not been reported in clinical trials of anti-PD-1 therapies, one study in patients treated with an anti-PD-1 therapy for metastatic melanoma found changes to nevi in 6 of 34 (18%) patients. Patients using a melanoma website also have self-reported disappearing nevi after immunotherapy treatment, the authors noted.

Expression of the coinhibitory molecule PD-L1 “is not limited to malignant tumors,” the researchers wrote, adding that previous studies have identified PD-L1 expression in melanocytes of benign melanocytic nevi. “Therefore it is biologically plausible that PD-1 inhibition may affect the natural history of benign melanocytic neoplasms.”

Also, they wrote, “the co-occurrence of vitiligo and poliosis in our patient suggests a role for autoimmunity in the fading/disappearance of his pigmented lesions.” The investigators cited a recent study in 67 patients with metastatic melanoma receiving pembrolizumab, which found that 25% developed vitiligo. Response to treatment also was significantly associated with occurrence of vitiligo (JAMA Dermatol. 2016;152[1]:45-51).

Dr. Wolner and his colleagues cautioned that their findings were limited to a single case report, and also by “lack of histological sampling and molecular characterization of fading/disappearing nevi.” An alternative explanation for the observed changes “includes fading/disappearance not related to PD-1 inhibition or due to chance alone.”

A National Institutes of Health/National Cancer Institute Cancer Center grant was used to help fund the study. Two of Dr. Wolner’s coauthors disclosed consultant or advisory board relationships with Merck and other pharmaceutical manufacturers.