Some policy responses to the opioid epidemic have immediate, beneficial effects, while others lead to short-term harms that might be offset by long-term health benefits, according to researchers who have mathematically modeled the impact of 11 interventions.

Policies that expand addiction treatment or curb harmful effects of addiction such as overdose and infection were immediately beneficial in the model, with no negative effects on life years (LYs), quality-adjusted life years (QALYs), or addiction deaths, the researchers reported.

In contrast, policies that constrain prescription opioid supply resulted in some benefits, but also short-term harms because of inadequate pain control and users switching to heroin.

However, the modeling study also suggests those harms might be mitigated over the long term as new addictions are averted, according to Allison L. Pitt, a PhD candidate in the department of management science and engineering at Stanford (Calif.) University, and her coauthors.

Combining different interventions had additive benefits in the model, prompting Ms. Pitt and her coauthors to recommend a multifaceted policy approach to curb opioid abuse and reduce addiction deaths.

“No epidemic has ever been averted solely by treating single affected cases,” they wrote in the American Journal of Public Health. “Instead, portfolios of policies will likely be required, including those that prevent addiction, treat addiction, and mitigate its effects.”

In their study, Ms. Pitt and her colleagues projected the impact of 11 policies aimed at curbing opioid addiction and reducing addiction deaths. They used dynamic compartmental modeling, a technique commonly used for evaluating the spread of contagious disease.

This technique is appropriate for studying the opioid epidemic, because it allows for dynamic modeling of addiction incidence that reflects a changing number of prescription holders, the authors said in their report, which focused on projected outcomes of various interventions at 5 and 10 years.

None of the policies substantially reduced opioid-related deaths in 5-year outcomes projections, they found. Increasing availability of naloxone averted 4% of addiction deaths, the highest reduction of any intervention over that time period.

However, interventions focused on providing services for people with addictions did generally provide uniform benefits over the 5-year horizon: “Naloxone availability, needle exchange, medication-assisted treatment, and psychosocial treatment policies generate gains in LYs and QALYs and reduce deaths, without harming any group,” Ms. Pitt and her coauthors said.

Interventions that reduced opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, increased LYs and QALYs while decreasing total addiction deaths over 5 years. However, the investigators said, those benefits were partly offset by increases in heroin-related deaths.

Drug rescheduling was associated with a 45.6% increase in heroin-related deaths over 5 years in the model, the highest percentage increase of any intervention in the published data.

Over the 10-year horizon, addiction deaths continued to decrease proportionally for naloxone availability and needle-exchange policies, authors said. By comparison, policies focused on opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, averted substantially more deaths over 10 years than would be expected, compared with the 5-year results, investigators said.

Acute pain prescribing, which increased opioid-related deaths over 5 years in the model, was associated with a decrease in opioid-related deaths over 10 years, they added.

The report coauthors were Keith Humphreys, PhD, of Stanford’s department of psychiatry and behavioral sciences, and Margaret L. Brandeau, PhD, of the university’s department of management science and engineering.

The coauthors cited several limitations. One is that the opioid epidemic is changing in unpredictable ways. Therefore, numerous assumptions about the epidemic were made based on the opinions of clinicians and scientists.

The study was supported by a grant from the National Institute on Drug Abuse. Dr. Humphreys reported support through a Senior Career Research Scientist award from the VA Health Services Research and Development Service.

SOURCE: Pitt AL et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304590.

Some policy responses to the opioid epidemic have immediate, beneficial effects, while others lead to short-term harms that might be offset by long-term health benefits, according to researchers who have mathematically modeled the impact of 11 interventions.

Policies that expand addiction treatment or curb harmful effects of addiction such as overdose and infection were immediately beneficial in the model, with no negative effects on life years (LYs), quality-adjusted life years (QALYs), or addiction deaths, the researchers reported.

In contrast, policies that constrain prescription opioid supply resulted in some benefits, but also short-term harms because of inadequate pain control and users switching to heroin.

However, the modeling study also suggests those harms might be mitigated over the long term as new addictions are averted, according to Allison L. Pitt, a PhD candidate in the department of management science and engineering at Stanford (Calif.) University, and her coauthors.

Combining different interventions had additive benefits in the model, prompting Ms. Pitt and her coauthors to recommend a multifaceted policy approach to curb opioid abuse and reduce addiction deaths.

“No epidemic has ever been averted solely by treating single affected cases,” they wrote in the American Journal of Public Health. “Instead, portfolios of policies will likely be required, including those that prevent addiction, treat addiction, and mitigate its effects.”

In their study, Ms. Pitt and her colleagues projected the impact of 11 policies aimed at curbing opioid addiction and reducing addiction deaths. They used dynamic compartmental modeling, a technique commonly used for evaluating the spread of contagious disease.

This technique is appropriate for studying the opioid epidemic, because it allows for dynamic modeling of addiction incidence that reflects a changing number of prescription holders, the authors said in their report, which focused on projected outcomes of various interventions at 5 and 10 years.

None of the policies substantially reduced opioid-related deaths in 5-year outcomes projections, they found. Increasing availability of naloxone averted 4% of addiction deaths, the highest reduction of any intervention over that time period.

However, interventions focused on providing services for people with addictions did generally provide uniform benefits over the 5-year horizon: “Naloxone availability, needle exchange, medication-assisted treatment, and psychosocial treatment policies generate gains in LYs and QALYs and reduce deaths, without harming any group,” Ms. Pitt and her coauthors said.

Interventions that reduced opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, increased LYs and QALYs while decreasing total addiction deaths over 5 years. However, the investigators said, those benefits were partly offset by increases in heroin-related deaths.

Drug rescheduling was associated with a 45.6% increase in heroin-related deaths over 5 years in the model, the highest percentage increase of any intervention in the published data.

Over the 10-year horizon, addiction deaths continued to decrease proportionally for naloxone availability and needle-exchange policies, authors said. By comparison, policies focused on opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, averted substantially more deaths over 10 years than would be expected, compared with the 5-year results, investigators said.

Acute pain prescribing, which increased opioid-related deaths over 5 years in the model, was associated with a decrease in opioid-related deaths over 10 years, they added.

The report coauthors were Keith Humphreys, PhD, of Stanford’s department of psychiatry and behavioral sciences, and Margaret L. Brandeau, PhD, of the university’s department of management science and engineering.

The coauthors cited several limitations. One is that the opioid epidemic is changing in unpredictable ways. Therefore, numerous assumptions about the epidemic were made based on the opinions of clinicians and scientists.

The study was supported by a grant from the National Institute on Drug Abuse. Dr. Humphreys reported support through a Senior Career Research Scientist award from the VA Health Services Research and Development Service.

SOURCE: Pitt AL et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304590.

Some policy responses to the opioid epidemic have immediate, beneficial effects, while others lead to short-term harms that might be offset by long-term health benefits, according to researchers who have mathematically modeled the impact of 11 interventions.

Policies that expand addiction treatment or curb harmful effects of addiction such as overdose and infection were immediately beneficial in the model, with no negative effects on life years (LYs), quality-adjusted life years (QALYs), or addiction deaths, the researchers reported.

In contrast, policies that constrain prescription opioid supply resulted in some benefits, but also short-term harms because of inadequate pain control and users switching to heroin.

However, the modeling study also suggests those harms might be mitigated over the long term as new addictions are averted, according to Allison L. Pitt, a PhD candidate in the department of management science and engineering at Stanford (Calif.) University, and her coauthors.

Combining different interventions had additive benefits in the model, prompting Ms. Pitt and her coauthors to recommend a multifaceted policy approach to curb opioid abuse and reduce addiction deaths.

“No epidemic has ever been averted solely by treating single affected cases,” they wrote in the American Journal of Public Health. “Instead, portfolios of policies will likely be required, including those that prevent addiction, treat addiction, and mitigate its effects.”

In their study, Ms. Pitt and her colleagues projected the impact of 11 policies aimed at curbing opioid addiction and reducing addiction deaths. They used dynamic compartmental modeling, a technique commonly used for evaluating the spread of contagious disease.

This technique is appropriate for studying the opioid epidemic, because it allows for dynamic modeling of addiction incidence that reflects a changing number of prescription holders, the authors said in their report, which focused on projected outcomes of various interventions at 5 and 10 years.

None of the policies substantially reduced opioid-related deaths in 5-year outcomes projections, they found. Increasing availability of naloxone averted 4% of addiction deaths, the highest reduction of any intervention over that time period.

However, interventions focused on providing services for people with addictions did generally provide uniform benefits over the 5-year horizon: “Naloxone availability, needle exchange, medication-assisted treatment, and psychosocial treatment policies generate gains in LYs and QALYs and reduce deaths, without harming any group,” Ms. Pitt and her coauthors said.

Interventions that reduced opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, increased LYs and QALYs while decreasing total addiction deaths over 5 years. However, the investigators said, those benefits were partly offset by increases in heroin-related deaths.

Drug rescheduling was associated with a 45.6% increase in heroin-related deaths over 5 years in the model, the highest percentage increase of any intervention in the published data.

Over the 10-year horizon, addiction deaths continued to decrease proportionally for naloxone availability and needle-exchange policies, authors said. By comparison, policies focused on opioid supply, such as excess opioid disposal and reduced prescribing for transitioning pain, averted substantially more deaths over 10 years than would be expected, compared with the 5-year results, investigators said.

Acute pain prescribing, which increased opioid-related deaths over 5 years in the model, was associated with a decrease in opioid-related deaths over 10 years, they added.

The report coauthors were Keith Humphreys, PhD, of Stanford’s department of psychiatry and behavioral sciences, and Margaret L. Brandeau, PhD, of the university’s department of management science and engineering.

The coauthors cited several limitations. One is that the opioid epidemic is changing in unpredictable ways. Therefore, numerous assumptions about the epidemic were made based on the opinions of clinicians and scientists.

The study was supported by a grant from the National Institute on Drug Abuse. Dr. Humphreys reported support through a Senior Career Research Scientist award from the VA Health Services Research and Development Service.

SOURCE: Pitt AL et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304590.

The Roman Catholic Church continues to be rocked by the burgeoning reality of priests as sexual predators. Some Catholics, including the Pope, have stepped up and acknowledged the blame for the decades of abuse, but others have been less inclined to do so. The latter attitude was and still is crushing to some the victims.

“Being raised Catholic, I remember – you don’t speak out against your own church,” Jim VanSickle says in an interview with National Catholic Reporter. “Nobody’s going to listen to you.”

Many of the survivors, Mr. VanSickle included, belonged to very conservative parishes. Parishioners often showed no compassion. After being sexually assaulted at age 16, he suffered in silence for almost 4 decades before speaking out during the recent release of Grand Jury report on the church abuses by the Pennsylvania attorney general.

“I’ve known others [who] came forward. They were ridiculed and ostracized – even by their own family members,” Mr. VanSickle says.

“We lived in a neighborhood where most of the people in the subdivision were Catholic. Everything in our lives revolved around the church,” said another victim, Utah resident Judy Larson. To be in that kind of environment and try to say something horrible happened to you, by a person everybody thinks is a god on earth, you’re all alone.”

As reported by Zita Ballinger Fletcher of the Catholic News Service, “survivors also faced a stigma caused by sexual assault. The victims were molested at an age when they did not know about sex. Confused, they realized what happened when they grew up. Feeling disgust, anger, and shame, they feared hostile reactions from their traditional communities.”

The childhood horror has left many of the victims angry and disillusioned with the Catholic Church.

“People say, ‘You’re a bad person,’ ” Mr. VanSickle says. “It’s amazing that they attack their own people. They attack their own faithful.”

Click here to read about the challenges faced by these survivors.

The Roman Catholic Church continues to be rocked by the burgeoning reality of priests as sexual predators. Some Catholics, including the Pope, have stepped up and acknowledged the blame for the decades of abuse, but others have been less inclined to do so. The latter attitude was and still is crushing to some the victims.

“Being raised Catholic, I remember – you don’t speak out against your own church,” Jim VanSickle says in an interview with National Catholic Reporter. “Nobody’s going to listen to you.”

Many of the survivors, Mr. VanSickle included, belonged to very conservative parishes. Parishioners often showed no compassion. After being sexually assaulted at age 16, he suffered in silence for almost 4 decades before speaking out during the recent release of Grand Jury report on the church abuses by the Pennsylvania attorney general.

“I’ve known others [who] came forward. They were ridiculed and ostracized – even by their own family members,” Mr. VanSickle says.

“We lived in a neighborhood where most of the people in the subdivision were Catholic. Everything in our lives revolved around the church,” said another victim, Utah resident Judy Larson. To be in that kind of environment and try to say something horrible happened to you, by a person everybody thinks is a god on earth, you’re all alone.”

As reported by Zita Ballinger Fletcher of the Catholic News Service, “survivors also faced a stigma caused by sexual assault. The victims were molested at an age when they did not know about sex. Confused, they realized what happened when they grew up. Feeling disgust, anger, and shame, they feared hostile reactions from their traditional communities.”

The childhood horror has left many of the victims angry and disillusioned with the Catholic Church.

“People say, ‘You’re a bad person,’ ” Mr. VanSickle says. “It’s amazing that they attack their own people. They attack their own faithful.”

Click here to read about the challenges faced by these survivors.

The Roman Catholic Church continues to be rocked by the burgeoning reality of priests as sexual predators. Some Catholics, including the Pope, have stepped up and acknowledged the blame for the decades of abuse, but others have been less inclined to do so. The latter attitude was and still is crushing to some the victims.

“Being raised Catholic, I remember – you don’t speak out against your own church,” Jim VanSickle says in an interview with National Catholic Reporter. “Nobody’s going to listen to you.”

Many of the survivors, Mr. VanSickle included, belonged to very conservative parishes. Parishioners often showed no compassion. After being sexually assaulted at age 16, he suffered in silence for almost 4 decades before speaking out during the recent release of Grand Jury report on the church abuses by the Pennsylvania attorney general.

“I’ve known others [who] came forward. They were ridiculed and ostracized – even by their own family members,” Mr. VanSickle says.

“We lived in a neighborhood where most of the people in the subdivision were Catholic. Everything in our lives revolved around the church,” said another victim, Utah resident Judy Larson. To be in that kind of environment and try to say something horrible happened to you, by a person everybody thinks is a god on earth, you’re all alone.”

As reported by Zita Ballinger Fletcher of the Catholic News Service, “survivors also faced a stigma caused by sexual assault. The victims were molested at an age when they did not know about sex. Confused, they realized what happened when they grew up. Feeling disgust, anger, and shame, they feared hostile reactions from their traditional communities.”

The childhood horror has left many of the victims angry and disillusioned with the Catholic Church.

“People say, ‘You’re a bad person,’ ” Mr. VanSickle says. “It’s amazing that they attack their own people. They attack their own faithful.”

Click here to read about the challenges faced by these survivors.

MUNICH – The big news in the field of heart failure at the annual congress of the European Society of Cardiology concerned an obscure form of the disease traditionally considered rare: transthyretin amyloid cardiomyopathy (TAC).

Bruce Jancin/MDedge News

It turns out that TAC is far more common than previously recognized; it can now be diagnosed and staged noninvasively; and – most important of all – there is for the first time an effective disease-modifying treatment in the form of a novel oral drug called tafamidis, as demonstrated in the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) presented at the meeting.

“This is the first phase 3 trial that can offer a chance for people with a terrible, severe disease. And within the last year, while the trial was being conducted, it became clear that this disease is much more underdiagnosed than rare,” said Claudio Rapezzi, MD, ATTR-ACT principal investigator and director of the school of cardiovascular diseases at the University of Bologna, Italy.

ATTR-ACT participants randomized to tafamidis showed significant reductions in all-cause mortality and cardiovascular hospitalizations, compared with placebo-treated controls at 30 months follow-up. They also experienced significantly lesser declines in both quality of life as reflected in Kansas City Cardiomyopathy Questionnaire scores and in physical function as captured in 6-minute walk distance.

Bruce Jancin/MDedge News

Designated discussant Jacob George, MD, was over the moon regarding the results.

“This is a pioneering, game-changing trial that is likely to transform the way we diagnose and treat patients with cardiac amyloidosis,” said Dr. George of Kaplan Medical Center in Rehovot, Israel.

“We’re now in an era that, to my opinion, any patient with nonischemic unexplained heart failure should be screened for the presence of amyloidosis because, first, we now know how to prognosticate these patients, and second, we can offer them a real disease-modifying agent,” he added.
 

An underdiagnosed disease

Transthyretin amyloid cardiomyopathy occurs when transthyretin, a transport protein, becomes destabilized and misfolds, promoting deposition of amyloid fibrils in the myocardium. This results in progressive ventricular wall thickening and stiffness, manifest as restrictive cardiomyopathy and progressive heart failure. The cause of transthyretin destabilization can be either autosomal dominant inheritance of any of more than 100 pathogenic mutations in the transthyretin gene identified to date or a spontaneous wild type protein.

Think of TAC as a sort of dementia of the heart. As Dr. George noted, the cardiac disease bears “remarkable similarities” to Alzheimer’s disease, with both conditions entailing extracellular deposition of amyloid.

In the heritable form of TAC, patients typically present with heart failure symptoms at about age 50-55, while the wild type form becomes symptomatic much later at a mean age of about 75. Average survival from time of diagnosis is only about 3 years.

Recent studies from multiple centers have reported that the prevalence of TAC was 16% in patients undergoing transcatheter aortic valve replacement for severe aortic stenosis, 13% among patients with heart failure with preserved ejection fraction, and 5% in patients who had been presumed to have hypertrophic cardiomyopathy: So, not a rare condition.

“In our clinic, vast and surprising numbers of patients with unexplained nonischemic heart failure are scan positive [for TAC],” according to Dr. George.
 

Breakthroughs in diagnosis and staging

The echocardiographic red flag for TAC in a patient with heart failure symptoms is symmetric hypertrophy with a normal end-diastolic volume and thickened ventricles. The end-diastolic interventricular septal wall thickness is typically about 15 mm. The left ventricular ejection fraction is typically in the normal range, “but the clue is not the preservation of the ejection fraction, it’s the [normal] quality of the volume,” Dr. Rapezzi said.

A clinical clue suggestive of TAC upon physical examination, even in the absence of heart failure symptoms, is development of bilateral carpal tunnel syndrome in an older man. That’s because the same disease process that results in TAC can involve deposition of amyloid fibrils in peripheral nerves. Indeed, tafamidis is already approved in Europe and Japan under the trade name Vyndaqel as a treatment for familial amyloid polyneuropathy. For TAC, however, tafamidis remains investigational with fast-track status provided by both the Food and Drug Administration and the European Medicines Agency.

When TAC is suspected, it’s no longer necessary to subject patients to an onerous myocardial biopsy. Total body scintigraphy with bone tracers has been shown to be nearly as sensitive and specific as biopsy for the diagnosis.

Staging can now be done noninvasively as well. Investigators at the U.K. National Amyloidosis Centre recently reported that patients with TAC can be accurately staged using two biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP) and estimated glomerular filtration rate (eGFR). In their series of 869 patients with TAC, median survival for those with stage I disease as defined by their protocol was 69 months, compared with 47 months for stage II disease and 24 months for those with stage III disease. This simple U.K. staging system was then validated in a separate French cohort of TAC patients (Eur Heart J. 2018 Aug 7;39[30]:2799-806).
 

The ATTR-ACT trial

Dr. Rapezzi reported on 441 patients with TAC who were randomized to oral tafamidis at either 20 mg or 80 mg per day or placebo and followed prospectively for 30 months in the 13-country, double-blind, phase 3 trial. At 30 months, all-cause mortality was 29.5% in patients who received tafamidis, compared with 42.9% in controls, for a 30% relative risk reduction. The rate of cardiovascular hospitalizations was 0.48 per year with tafamidis, compared with 0.70 per year with placebo, for a 38% relative risk reduction. The mortality benefit didn’t achieve significance until 15-18 months into the trial, as to be expected given tafamidis’ mechanism of action, which involves binding to transthyretin, gradually stabilizing it, and curbing amyloid fibril deposition.

Of note, the benefit was similar regardless of the dose used and whether patients had hereditary or wild type TAC.

Tafamidis proved safe and well tolerated, with a side-effect profile similar to placebo. While diarrhea and urinary tract infections have been an issue in tafamidis-treated patients with familial amyloid polyneuropathy, these adverse events were actually less common in TAC patients who received tafamidis than with placebo, according to Dr. Rapezzi.

A key point, the cardiologist emphasized, is that the benefits of active treatment were greatest in patients with earlier-stage disease. Therefore it’s vital that the diagnosis of TAC be made early, with prompt initiation of treatment to follow, in order to catch the disease at a more reversible stage. That could mean there will be a whole lot more bone scintigraphy being done in patients with unexplained nonischemic heart failure.

Dr. Rapezzi reported receiving research grants, speaker honoraria, and consulting fees from Pfizer, which sponsored the ATTR-ACT trial. Simultaneous with his presentation in Munich, the study results were published online at NEJM.org (doi: 10.1056/NEJMoa1805689). Dr. George reported no financial conflicts.

bjancin@mdedge.com

MUNICH – The big news in the field of heart failure at the annual congress of the European Society of Cardiology concerned an obscure form of the disease traditionally considered rare: transthyretin amyloid cardiomyopathy (TAC).

Bruce Jancin/MDedge News

It turns out that TAC is far more common than previously recognized; it can now be diagnosed and staged noninvasively; and – most important of all – there is for the first time an effective disease-modifying treatment in the form of a novel oral drug called tafamidis, as demonstrated in the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) presented at the meeting.

“This is the first phase 3 trial that can offer a chance for people with a terrible, severe disease. And within the last year, while the trial was being conducted, it became clear that this disease is much more underdiagnosed than rare,” said Claudio Rapezzi, MD, ATTR-ACT principal investigator and director of the school of cardiovascular diseases at the University of Bologna, Italy.

ATTR-ACT participants randomized to tafamidis showed significant reductions in all-cause mortality and cardiovascular hospitalizations, compared with placebo-treated controls at 30 months follow-up. They also experienced significantly lesser declines in both quality of life as reflected in Kansas City Cardiomyopathy Questionnaire scores and in physical function as captured in 6-minute walk distance.

Bruce Jancin/MDedge News

Designated discussant Jacob George, MD, was over the moon regarding the results.

“This is a pioneering, game-changing trial that is likely to transform the way we diagnose and treat patients with cardiac amyloidosis,” said Dr. George of Kaplan Medical Center in Rehovot, Israel.

“We’re now in an era that, to my opinion, any patient with nonischemic unexplained heart failure should be screened for the presence of amyloidosis because, first, we now know how to prognosticate these patients, and second, we can offer them a real disease-modifying agent,” he added.
 

An underdiagnosed disease

Transthyretin amyloid cardiomyopathy occurs when transthyretin, a transport protein, becomes destabilized and misfolds, promoting deposition of amyloid fibrils in the myocardium. This results in progressive ventricular wall thickening and stiffness, manifest as restrictive cardiomyopathy and progressive heart failure. The cause of transthyretin destabilization can be either autosomal dominant inheritance of any of more than 100 pathogenic mutations in the transthyretin gene identified to date or a spontaneous wild type protein.

Think of TAC as a sort of dementia of the heart. As Dr. George noted, the cardiac disease bears “remarkable similarities” to Alzheimer’s disease, with both conditions entailing extracellular deposition of amyloid.

In the heritable form of TAC, patients typically present with heart failure symptoms at about age 50-55, while the wild type form becomes symptomatic much later at a mean age of about 75. Average survival from time of diagnosis is only about 3 years.

Recent studies from multiple centers have reported that the prevalence of TAC was 16% in patients undergoing transcatheter aortic valve replacement for severe aortic stenosis, 13% among patients with heart failure with preserved ejection fraction, and 5% in patients who had been presumed to have hypertrophic cardiomyopathy: So, not a rare condition.

“In our clinic, vast and surprising numbers of patients with unexplained nonischemic heart failure are scan positive [for TAC],” according to Dr. George.
 

Breakthroughs in diagnosis and staging

The echocardiographic red flag for TAC in a patient with heart failure symptoms is symmetric hypertrophy with a normal end-diastolic volume and thickened ventricles. The end-diastolic interventricular septal wall thickness is typically about 15 mm. The left ventricular ejection fraction is typically in the normal range, “but the clue is not the preservation of the ejection fraction, it’s the [normal] quality of the volume,” Dr. Rapezzi said.

A clinical clue suggestive of TAC upon physical examination, even in the absence of heart failure symptoms, is development of bilateral carpal tunnel syndrome in an older man. That’s because the same disease process that results in TAC can involve deposition of amyloid fibrils in peripheral nerves. Indeed, tafamidis is already approved in Europe and Japan under the trade name Vyndaqel as a treatment for familial amyloid polyneuropathy. For TAC, however, tafamidis remains investigational with fast-track status provided by both the Food and Drug Administration and the European Medicines Agency.

When TAC is suspected, it’s no longer necessary to subject patients to an onerous myocardial biopsy. Total body scintigraphy with bone tracers has been shown to be nearly as sensitive and specific as biopsy for the diagnosis.

Staging can now be done noninvasively as well. Investigators at the U.K. National Amyloidosis Centre recently reported that patients with TAC can be accurately staged using two biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP) and estimated glomerular filtration rate (eGFR). In their series of 869 patients with TAC, median survival for those with stage I disease as defined by their protocol was 69 months, compared with 47 months for stage II disease and 24 months for those with stage III disease. This simple U.K. staging system was then validated in a separate French cohort of TAC patients (Eur Heart J. 2018 Aug 7;39[30]:2799-806).
 

The ATTR-ACT trial

Dr. Rapezzi reported on 441 patients with TAC who were randomized to oral tafamidis at either 20 mg or 80 mg per day or placebo and followed prospectively for 30 months in the 13-country, double-blind, phase 3 trial. At 30 months, all-cause mortality was 29.5% in patients who received tafamidis, compared with 42.9% in controls, for a 30% relative risk reduction. The rate of cardiovascular hospitalizations was 0.48 per year with tafamidis, compared with 0.70 per year with placebo, for a 38% relative risk reduction. The mortality benefit didn’t achieve significance until 15-18 months into the trial, as to be expected given tafamidis’ mechanism of action, which involves binding to transthyretin, gradually stabilizing it, and curbing amyloid fibril deposition.

Of note, the benefit was similar regardless of the dose used and whether patients had hereditary or wild type TAC.

Tafamidis proved safe and well tolerated, with a side-effect profile similar to placebo. While diarrhea and urinary tract infections have been an issue in tafamidis-treated patients with familial amyloid polyneuropathy, these adverse events were actually less common in TAC patients who received tafamidis than with placebo, according to Dr. Rapezzi.

A key point, the cardiologist emphasized, is that the benefits of active treatment were greatest in patients with earlier-stage disease. Therefore it’s vital that the diagnosis of TAC be made early, with prompt initiation of treatment to follow, in order to catch the disease at a more reversible stage. That could mean there will be a whole lot more bone scintigraphy being done in patients with unexplained nonischemic heart failure.

Dr. Rapezzi reported receiving research grants, speaker honoraria, and consulting fees from Pfizer, which sponsored the ATTR-ACT trial. Simultaneous with his presentation in Munich, the study results were published online at NEJM.org (doi: 10.1056/NEJMoa1805689). Dr. George reported no financial conflicts.

bjancin@mdedge.com

MUNICH – The big news in the field of heart failure at the annual congress of the European Society of Cardiology concerned an obscure form of the disease traditionally considered rare: transthyretin amyloid cardiomyopathy (TAC).

Bruce Jancin/MDedge News

It turns out that TAC is far more common than previously recognized; it can now be diagnosed and staged noninvasively; and – most important of all – there is for the first time an effective disease-modifying treatment in the form of a novel oral drug called tafamidis, as demonstrated in the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) presented at the meeting.

“This is the first phase 3 trial that can offer a chance for people with a terrible, severe disease. And within the last year, while the trial was being conducted, it became clear that this disease is much more underdiagnosed than rare,” said Claudio Rapezzi, MD, ATTR-ACT principal investigator and director of the school of cardiovascular diseases at the University of Bologna, Italy.

ATTR-ACT participants randomized to tafamidis showed significant reductions in all-cause mortality and cardiovascular hospitalizations, compared with placebo-treated controls at 30 months follow-up. They also experienced significantly lesser declines in both quality of life as reflected in Kansas City Cardiomyopathy Questionnaire scores and in physical function as captured in 6-minute walk distance.

Bruce Jancin/MDedge News

Designated discussant Jacob George, MD, was over the moon regarding the results.

“This is a pioneering, game-changing trial that is likely to transform the way we diagnose and treat patients with cardiac amyloidosis,” said Dr. George of Kaplan Medical Center in Rehovot, Israel.

“We’re now in an era that, to my opinion, any patient with nonischemic unexplained heart failure should be screened for the presence of amyloidosis because, first, we now know how to prognosticate these patients, and second, we can offer them a real disease-modifying agent,” he added.
 

An underdiagnosed disease

Transthyretin amyloid cardiomyopathy occurs when transthyretin, a transport protein, becomes destabilized and misfolds, promoting deposition of amyloid fibrils in the myocardium. This results in progressive ventricular wall thickening and stiffness, manifest as restrictive cardiomyopathy and progressive heart failure. The cause of transthyretin destabilization can be either autosomal dominant inheritance of any of more than 100 pathogenic mutations in the transthyretin gene identified to date or a spontaneous wild type protein.

Think of TAC as a sort of dementia of the heart. As Dr. George noted, the cardiac disease bears “remarkable similarities” to Alzheimer’s disease, with both conditions entailing extracellular deposition of amyloid.

In the heritable form of TAC, patients typically present with heart failure symptoms at about age 50-55, while the wild type form becomes symptomatic much later at a mean age of about 75. Average survival from time of diagnosis is only about 3 years.

Recent studies from multiple centers have reported that the prevalence of TAC was 16% in patients undergoing transcatheter aortic valve replacement for severe aortic stenosis, 13% among patients with heart failure with preserved ejection fraction, and 5% in patients who had been presumed to have hypertrophic cardiomyopathy: So, not a rare condition.

“In our clinic, vast and surprising numbers of patients with unexplained nonischemic heart failure are scan positive [for TAC],” according to Dr. George.
 

Breakthroughs in diagnosis and staging

The echocardiographic red flag for TAC in a patient with heart failure symptoms is symmetric hypertrophy with a normal end-diastolic volume and thickened ventricles. The end-diastolic interventricular septal wall thickness is typically about 15 mm. The left ventricular ejection fraction is typically in the normal range, “but the clue is not the preservation of the ejection fraction, it’s the [normal] quality of the volume,” Dr. Rapezzi said.

A clinical clue suggestive of TAC upon physical examination, even in the absence of heart failure symptoms, is development of bilateral carpal tunnel syndrome in an older man. That’s because the same disease process that results in TAC can involve deposition of amyloid fibrils in peripheral nerves. Indeed, tafamidis is already approved in Europe and Japan under the trade name Vyndaqel as a treatment for familial amyloid polyneuropathy. For TAC, however, tafamidis remains investigational with fast-track status provided by both the Food and Drug Administration and the European Medicines Agency.

When TAC is suspected, it’s no longer necessary to subject patients to an onerous myocardial biopsy. Total body scintigraphy with bone tracers has been shown to be nearly as sensitive and specific as biopsy for the diagnosis.

Staging can now be done noninvasively as well. Investigators at the U.K. National Amyloidosis Centre recently reported that patients with TAC can be accurately staged using two biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP) and estimated glomerular filtration rate (eGFR). In their series of 869 patients with TAC, median survival for those with stage I disease as defined by their protocol was 69 months, compared with 47 months for stage II disease and 24 months for those with stage III disease. This simple U.K. staging system was then validated in a separate French cohort of TAC patients (Eur Heart J. 2018 Aug 7;39[30]:2799-806).
 

The ATTR-ACT trial

Dr. Rapezzi reported on 441 patients with TAC who were randomized to oral tafamidis at either 20 mg or 80 mg per day or placebo and followed prospectively for 30 months in the 13-country, double-blind, phase 3 trial. At 30 months, all-cause mortality was 29.5% in patients who received tafamidis, compared with 42.9% in controls, for a 30% relative risk reduction. The rate of cardiovascular hospitalizations was 0.48 per year with tafamidis, compared with 0.70 per year with placebo, for a 38% relative risk reduction. The mortality benefit didn’t achieve significance until 15-18 months into the trial, as to be expected given tafamidis’ mechanism of action, which involves binding to transthyretin, gradually stabilizing it, and curbing amyloid fibril deposition.

Of note, the benefit was similar regardless of the dose used and whether patients had hereditary or wild type TAC.

Tafamidis proved safe and well tolerated, with a side-effect profile similar to placebo. While diarrhea and urinary tract infections have been an issue in tafamidis-treated patients with familial amyloid polyneuropathy, these adverse events were actually less common in TAC patients who received tafamidis than with placebo, according to Dr. Rapezzi.

A key point, the cardiologist emphasized, is that the benefits of active treatment were greatest in patients with earlier-stage disease. Therefore it’s vital that the diagnosis of TAC be made early, with prompt initiation of treatment to follow, in order to catch the disease at a more reversible stage. That could mean there will be a whole lot more bone scintigraphy being done in patients with unexplained nonischemic heart failure.

Dr. Rapezzi reported receiving research grants, speaker honoraria, and consulting fees from Pfizer, which sponsored the ATTR-ACT trial. Simultaneous with his presentation in Munich, the study results were published online at NEJM.org (doi: 10.1056/NEJMoa1805689). Dr. George reported no financial conflicts.

bjancin@mdedge.com

A suicide attempt can be devastating for family members. For a son or daughter, the fallout can include feelings of guilt at missing the warning signs and the knowledge that they may have contributed to the despair that might have driven their loved one to trying to end their own lives.

PhotoDisk

There also can be the feeling that the attempt to deliberately exit this life is an indication that those left behind are not valued.

As related in a StoryCorps episode, which described the attempted suicide of Linda Kwong and the toll on her daughter Emily, Linda’s longstanding suicidal depression was separate from her love for her family.

The news of the suicide attempt rocked Emily. “I described our family as a table, and you were the most important leg. So you disappearing just knocked the whole thing over,” she says.

Yet, the past had seen Emily distancing herself from Linda, with the reality of her mother’s ongoing darkness. “I thought if I spent too much time with you, I would become like you,” Emily says to Linda during their StoryCorps interview.

In the aftermath of Linda’s suicide attempt, the mother-daughter bond could have been shattered. Instead, in the intervening 5 years, it has been stripped down and rebuilt, with both individuals coming to a better understanding of one another and the pain in their lives.

“I mean, I know it’s not over yet, but seeing you come back from this, I couldn’t be more proud of you,” Emily says to Linda.

“I can’t believe that you can use the word ‘proud,’ but it makes me feel like that bond between us will always be there,” Linda says. “And that means the world to me.”

Click here to listen to their StoryCorps episode, broadcast on NPR.

A suicide attempt can be devastating for family members. For a son or daughter, the fallout can include feelings of guilt at missing the warning signs and the knowledge that they may have contributed to the despair that might have driven their loved one to trying to end their own lives.

PhotoDisk

There also can be the feeling that the attempt to deliberately exit this life is an indication that those left behind are not valued.

As related in a StoryCorps episode, which described the attempted suicide of Linda Kwong and the toll on her daughter Emily, Linda’s longstanding suicidal depression was separate from her love for her family.

The news of the suicide attempt rocked Emily. “I described our family as a table, and you were the most important leg. So you disappearing just knocked the whole thing over,” she says.

Yet, the past had seen Emily distancing herself from Linda, with the reality of her mother’s ongoing darkness. “I thought if I spent too much time with you, I would become like you,” Emily says to Linda during their StoryCorps interview.

In the aftermath of Linda’s suicide attempt, the mother-daughter bond could have been shattered. Instead, in the intervening 5 years, it has been stripped down and rebuilt, with both individuals coming to a better understanding of one another and the pain in their lives.

“I mean, I know it’s not over yet, but seeing you come back from this, I couldn’t be more proud of you,” Emily says to Linda.

“I can’t believe that you can use the word ‘proud,’ but it makes me feel like that bond between us will always be there,” Linda says. “And that means the world to me.”

Click here to listen to their StoryCorps episode, broadcast on NPR.

A suicide attempt can be devastating for family members. For a son or daughter, the fallout can include feelings of guilt at missing the warning signs and the knowledge that they may have contributed to the despair that might have driven their loved one to trying to end their own lives.

PhotoDisk

There also can be the feeling that the attempt to deliberately exit this life is an indication that those left behind are not valued.

As related in a StoryCorps episode, which described the attempted suicide of Linda Kwong and the toll on her daughter Emily, Linda’s longstanding suicidal depression was separate from her love for her family.

The news of the suicide attempt rocked Emily. “I described our family as a table, and you were the most important leg. So you disappearing just knocked the whole thing over,” she says.

Yet, the past had seen Emily distancing herself from Linda, with the reality of her mother’s ongoing darkness. “I thought if I spent too much time with you, I would become like you,” Emily says to Linda during their StoryCorps interview.

In the aftermath of Linda’s suicide attempt, the mother-daughter bond could have been shattered. Instead, in the intervening 5 years, it has been stripped down and rebuilt, with both individuals coming to a better understanding of one another and the pain in their lives.

“I mean, I know it’s not over yet, but seeing you come back from this, I couldn’t be more proud of you,” Emily says to Linda.

“I can’t believe that you can use the word ‘proud,’ but it makes me feel like that bond between us will always be there,” Linda says. “And that means the world to me.”

Click here to listen to their StoryCorps episode, broadcast on NPR.

SURGICAL SITE WOUND THERAPY

PICO NPWT is a negative-pressure wound therapy device to treat surgical site infection (SSI). According to Smith & Nephew, a new meta-analysis demonstrates that the prophylactic application of PICO with AIRLOCK™ Technology significantly reduces surgical site complications by 58%, the rate of dehiscence by 26%, and length of stay by one-half day when compared with standard care.

The PICO System is canister-free and disposable. Patients can be discharged safely with PICO in place. Seven days of therapy are provided in each kit, with 1 pump, 2 dressings, and fixation strips to allow for a dressing change.

PICO uses a 4-layer multifunction dressing design in which the layers work together to ensure that negative pressure is delivered to the wound bed and exudate is removed through absorption and evaporation. Approximately 20% of fluid still remains in the dressing. The top film layer has a high-moisture vapor transmission rate to transpire as much as 80% of the exudate, says Smith & Nephew.

FOR MORE INFORMATION, VISIT: http://www.smith-nephew.com/

SHIELDED LAPAROSCOPIC INSTRUMENTS PREVENT BURNS

Encision’s patented Active Electrode Monitoring (AEM®) Shielded Laparoscopic Instruments eliminate patient burns and the associated complications.

Every 90 minutes in the United States, a patient is severely injured from a stray energy burn during laparoscopic surgery, according to Encision. The AEM® Shielded Instruments are designed to eliminate burns caused by monopolar energy insulation failure and capacitive coupling, reducing complications and re-admissions.

In addition to helping health care professionals improve patient safety in line with a recent FDA safety communication, Active Electrode Monitoring is a recommended practice of AORN and AAGL.

Encision offers a complete line of premium laparoscopic monopolar surgical instruments with integrated AEM® technology as well as complimentary products to improve clinical effectiveness and patient safety, including bipolar and cold instrumentation.

FOR MORE INFORMATION, VISIT: https://www.encision.com/

iSORT: 7-DAY BLUETOOTH PILLBOX

TimerCap has a new Bluetooth-enabled 7-day pill box called the iSort that sends reminders to take medication to a patient’s phone using a free TimerCap App found at the AppStore and Android Market.

The iSort automatically records and stores the times when each door/slot is opened and closed. It knows which door has been used and seamlessly updates the TimerCap App. The app will notify the patient and, if designated, a caregiver, whenever a dose is due or missed using pictures to show what and how many meds are scheduled. More than one iSort box can be used with the app.

iSort provides reminders that help improve adherence to medication dosing instructions and eliminates annoying false alarms, double entries, and unnecessary reminders when pills already have been taken. The portable iSort uses 2 AA batteries that need to be changed about once per year.

FOR MORE INFORMATION, VISIT: https://www.timercap.com/isort

PLATFORM TO COORDINATE HEALTH AND TECHNOLOGY

The American Medical Association (AMA) recently has established a new initiative that introduces a solution to improve, organize, and share health care information. The Integrated Health Model Initiative (IHMI) is a platform that coordinates the health and technology sectors around a common data model. IHMI fills the national imperative to pioneer a shared framework for organizing health data, emphasizing patient-centric information, and refining data elements to those most predictive of better outcomes. The AMA says that evolving available health data to depict a complete picture of a patient’s journey from wellness to illness to treatment and beyond allows health care delivery to fully focus on patient outcomes, goals, and wellness. Participation in IHMI is open to all health care and technology stakeholders.

FOR MORE INFORMATION, VISIT: www.ama-assn.org/ihmi

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice. 

SURGICAL SITE WOUND THERAPY

PICO NPWT is a negative-pressure wound therapy device to treat surgical site infection (SSI). According to Smith & Nephew, a new meta-analysis demonstrates that the prophylactic application of PICO with AIRLOCK™ Technology significantly reduces surgical site complications by 58%, the rate of dehiscence by 26%, and length of stay by one-half day when compared with standard care.

The PICO System is canister-free and disposable. Patients can be discharged safely with PICO in place. Seven days of therapy are provided in each kit, with 1 pump, 2 dressings, and fixation strips to allow for a dressing change.

PICO uses a 4-layer multifunction dressing design in which the layers work together to ensure that negative pressure is delivered to the wound bed and exudate is removed through absorption and evaporation. Approximately 20% of fluid still remains in the dressing. The top film layer has a high-moisture vapor transmission rate to transpire as much as 80% of the exudate, says Smith & Nephew.

FOR MORE INFORMATION, VISIT: http://www.smith-nephew.com/

SHIELDED LAPAROSCOPIC INSTRUMENTS PREVENT BURNS

Encision’s patented Active Electrode Monitoring (AEM®) Shielded Laparoscopic Instruments eliminate patient burns and the associated complications.

Every 90 minutes in the United States, a patient is severely injured from a stray energy burn during laparoscopic surgery, according to Encision. The AEM® Shielded Instruments are designed to eliminate burns caused by monopolar energy insulation failure and capacitive coupling, reducing complications and re-admissions.

In addition to helping health care professionals improve patient safety in line with a recent FDA safety communication, Active Electrode Monitoring is a recommended practice of AORN and AAGL.

Encision offers a complete line of premium laparoscopic monopolar surgical instruments with integrated AEM® technology as well as complimentary products to improve clinical effectiveness and patient safety, including bipolar and cold instrumentation.

FOR MORE INFORMATION, VISIT: https://www.encision.com/

iSORT: 7-DAY BLUETOOTH PILLBOX

TimerCap has a new Bluetooth-enabled 7-day pill box called the iSort that sends reminders to take medication to a patient’s phone using a free TimerCap App found at the AppStore and Android Market.

The iSort automatically records and stores the times when each door/slot is opened and closed. It knows which door has been used and seamlessly updates the TimerCap App. The app will notify the patient and, if designated, a caregiver, whenever a dose is due or missed using pictures to show what and how many meds are scheduled. More than one iSort box can be used with the app.

iSort provides reminders that help improve adherence to medication dosing instructions and eliminates annoying false alarms, double entries, and unnecessary reminders when pills already have been taken. The portable iSort uses 2 AA batteries that need to be changed about once per year.

FOR MORE INFORMATION, VISIT: https://www.timercap.com/isort

PLATFORM TO COORDINATE HEALTH AND TECHNOLOGY

The American Medical Association (AMA) recently has established a new initiative that introduces a solution to improve, organize, and share health care information. The Integrated Health Model Initiative (IHMI) is a platform that coordinates the health and technology sectors around a common data model. IHMI fills the national imperative to pioneer a shared framework for organizing health data, emphasizing patient-centric information, and refining data elements to those most predictive of better outcomes. The AMA says that evolving available health data to depict a complete picture of a patient’s journey from wellness to illness to treatment and beyond allows health care delivery to fully focus on patient outcomes, goals, and wellness. Participation in IHMI is open to all health care and technology stakeholders.

FOR MORE INFORMATION, VISIT: www.ama-assn.org/ihmi

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice. 

SURGICAL SITE WOUND THERAPY

PICO NPWT is a negative-pressure wound therapy device to treat surgical site infection (SSI). According to Smith & Nephew, a new meta-analysis demonstrates that the prophylactic application of PICO with AIRLOCK™ Technology significantly reduces surgical site complications by 58%, the rate of dehiscence by 26%, and length of stay by one-half day when compared with standard care.

The PICO System is canister-free and disposable. Patients can be discharged safely with PICO in place. Seven days of therapy are provided in each kit, with 1 pump, 2 dressings, and fixation strips to allow for a dressing change.

PICO uses a 4-layer multifunction dressing design in which the layers work together to ensure that negative pressure is delivered to the wound bed and exudate is removed through absorption and evaporation. Approximately 20% of fluid still remains in the dressing. The top film layer has a high-moisture vapor transmission rate to transpire as much as 80% of the exudate, says Smith & Nephew.

FOR MORE INFORMATION, VISIT: http://www.smith-nephew.com/

SHIELDED LAPAROSCOPIC INSTRUMENTS PREVENT BURNS

Encision’s patented Active Electrode Monitoring (AEM®) Shielded Laparoscopic Instruments eliminate patient burns and the associated complications.

Every 90 minutes in the United States, a patient is severely injured from a stray energy burn during laparoscopic surgery, according to Encision. The AEM® Shielded Instruments are designed to eliminate burns caused by monopolar energy insulation failure and capacitive coupling, reducing complications and re-admissions.

In addition to helping health care professionals improve patient safety in line with a recent FDA safety communication, Active Electrode Monitoring is a recommended practice of AORN and AAGL.

Encision offers a complete line of premium laparoscopic monopolar surgical instruments with integrated AEM® technology as well as complimentary products to improve clinical effectiveness and patient safety, including bipolar and cold instrumentation.

FOR MORE INFORMATION, VISIT: https://www.encision.com/

iSORT: 7-DAY BLUETOOTH PILLBOX

TimerCap has a new Bluetooth-enabled 7-day pill box called the iSort that sends reminders to take medication to a patient’s phone using a free TimerCap App found at the AppStore and Android Market.

The iSort automatically records and stores the times when each door/slot is opened and closed. It knows which door has been used and seamlessly updates the TimerCap App. The app will notify the patient and, if designated, a caregiver, whenever a dose is due or missed using pictures to show what and how many meds are scheduled. More than one iSort box can be used with the app.

iSort provides reminders that help improve adherence to medication dosing instructions and eliminates annoying false alarms, double entries, and unnecessary reminders when pills already have been taken. The portable iSort uses 2 AA batteries that need to be changed about once per year.

FOR MORE INFORMATION, VISIT: https://www.timercap.com/isort

PLATFORM TO COORDINATE HEALTH AND TECHNOLOGY

The American Medical Association (AMA) recently has established a new initiative that introduces a solution to improve, organize, and share health care information. The Integrated Health Model Initiative (IHMI) is a platform that coordinates the health and technology sectors around a common data model. IHMI fills the national imperative to pioneer a shared framework for organizing health data, emphasizing patient-centric information, and refining data elements to those most predictive of better outcomes. The AMA says that evolving available health data to depict a complete picture of a patient’s journey from wellness to illness to treatment and beyond allows health care delivery to fully focus on patient outcomes, goals, and wellness. Participation in IHMI is open to all health care and technology stakeholders.

FOR MORE INFORMATION, VISIT: www.ama-assn.org/ihmi

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice. 

The number of children diagnosed with ADHD has reached more than 10%, a significant increase during the past 20 years, according to a recent study in JAMA.

The rise was most pronounced in minority groups, suggesting that better access to health insurance and mental health treatment through the Affordable Care Act might have played some role in the increase. The rate of diagnosis during that time period doubled in girls, although it was still much lower than in boys.

But the researchers say they found no evidence confirming frequent complaints that the condition is overdiagnosed or misdiagnosed.

The United States has significantly more instances of ADHD than do other developed countries, which researchers said has led some to think Americans are overdiagnosing children. Wei Bao, MD, PhD, lead author of the study, said in an interview that a review of studies around the world does not support that.

”I don’t think overdiagnosis is the main issue,” he said.

Nonetheless, those doubts persist. Stephen Hinshaw, MD, who coauthored a 2014 book called “The ADHD Explosion: Myths, Medication, Money, and Today’s Push for Performance,” compared ADHD with depression. He said in an interview that neither condition has unequivocal biological markers, which makes it hard to determine if a patient truly has the condition without lengthy psychological evaluations. Symptoms of ADHD can include inattention, fidgety behavior, and impulsivity.

“It’s probably not a true epidemic of ADHD,” said Dr. Hinshaw, a professor of psychology at the University of California, Berkeley, and a professor of psychiatry at University of California, San Francisco. “It might be an epidemic of diagnosing it.”

In interpreting their results, however, the study’s authors tied the higher numbers to better understanding of the condition by doctors and the public, new standards for diagnosis and an increase in access to health insurance through the ACA.

Because of the ACA, “some low-income families have improved access to services and referrals,” said Dr. Bao, an epidemiologist at the University of Iowa College of Public Health in Iowa City.

The study, published in JAMA Network Open, used data from the National Health Interview Survey, an annual federal survey of about 35,000 households. It found a steady increase in diagnoses in children from about 6% during 1997-1998 to more than 10% during 2015-2016.

Advances in medical technology also may have contributed to the increase, according to the research. Twenty years ago, preterm or low-birth-weight babies had a harder time surviving. Those factors increase the risk of being diagnosed with ADHD.

The study also suggests that fewer stigmas about mental health care in minority communities also may lead to more people receiving an ADHD diagnosis.

In the late 1990s, 7.2% of non-Hispanic white children, 4.7% of non-Hispanic black children, and 3.6% of Hispanic children were diagnosed with ADHD, according to the study. By 2016, it was 12% of white kids, 12.8% of blacks, and 6.1% of Hispanics.

Over the past several decades, Dr. Hinshaw said, there’s been an expanded view of who can develop ADHD. It’s no longer viewed as a disease that affects only white middle-class boys, as eating disorders are no longer seen as afflicting only white middle-class girls.

Still, he cautioned against overdiagnosing ADHD in communities in which behavioral issues could be the result of social or environmental factors such as overcrowded classrooms.

The study found rates of ADHD among girls rose from 3% to more than 6% over the study period. It said that was partly a result of a change in how the condition is classified. For years, ADHD pertained to children who were hyperactive. But in recent years, the American Psychiatric Association added to its guide of mental health conditions that diagnosis should also include some children who are inattentive, Dr. Bao said. That raised the number of girls, he explained, because it seems they are more likely to be in that second subtype.

“If we compare these two, you can easily imagine people will easily recognize hyperactivity,” he said.

That rang true for Ruth Hay, a 25-year-old student and cook from New York who now lives in Jerusalem. She was diagnosed with what was then called ADD the summer between second and third grade.

Ms. Hay said her hyperactive tendencies aren’t as “loud” as some people’s. She’s less likely to bounce around a room than she is to bounce in her chair, she said.

Yet, despite her early diagnosis, Ms. Hay said, no one ever told her about other symptoms. For example, she said, she suffers from executive dysfunction, which leaves her feeling unable to accomplish tasks, no matter how much she wanted to or tried.

“I grew up being called lazy in periods of time when I wasn’t,” Ms. Hay said. “If you look at a list of all the various ADHD symptoms, I have all of them to one degree or another, but the only ones ever discussed with me was you might be less focused and more fidgety.”

“I don’t know how my brain would be if I didn’t have it,” she added. “I don’t know if I’d still be me, but all it has been for me is a disability.”

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The number of children diagnosed with ADHD has reached more than 10%, a significant increase during the past 20 years, according to a recent study in JAMA.

The rise was most pronounced in minority groups, suggesting that better access to health insurance and mental health treatment through the Affordable Care Act might have played some role in the increase. The rate of diagnosis during that time period doubled in girls, although it was still much lower than in boys.

But the researchers say they found no evidence confirming frequent complaints that the condition is overdiagnosed or misdiagnosed.

The United States has significantly more instances of ADHD than do other developed countries, which researchers said has led some to think Americans are overdiagnosing children. Wei Bao, MD, PhD, lead author of the study, said in an interview that a review of studies around the world does not support that.

”I don’t think overdiagnosis is the main issue,” he said.

Nonetheless, those doubts persist. Stephen Hinshaw, MD, who coauthored a 2014 book called “The ADHD Explosion: Myths, Medication, Money, and Today’s Push for Performance,” compared ADHD with depression. He said in an interview that neither condition has unequivocal biological markers, which makes it hard to determine if a patient truly has the condition without lengthy psychological evaluations. Symptoms of ADHD can include inattention, fidgety behavior, and impulsivity.

“It’s probably not a true epidemic of ADHD,” said Dr. Hinshaw, a professor of psychology at the University of California, Berkeley, and a professor of psychiatry at University of California, San Francisco. “It might be an epidemic of diagnosing it.”

In interpreting their results, however, the study’s authors tied the higher numbers to better understanding of the condition by doctors and the public, new standards for diagnosis and an increase in access to health insurance through the ACA.

Because of the ACA, “some low-income families have improved access to services and referrals,” said Dr. Bao, an epidemiologist at the University of Iowa College of Public Health in Iowa City.

The study, published in JAMA Network Open, used data from the National Health Interview Survey, an annual federal survey of about 35,000 households. It found a steady increase in diagnoses in children from about 6% during 1997-1998 to more than 10% during 2015-2016.

Advances in medical technology also may have contributed to the increase, according to the research. Twenty years ago, preterm or low-birth-weight babies had a harder time surviving. Those factors increase the risk of being diagnosed with ADHD.

The study also suggests that fewer stigmas about mental health care in minority communities also may lead to more people receiving an ADHD diagnosis.

In the late 1990s, 7.2% of non-Hispanic white children, 4.7% of non-Hispanic black children, and 3.6% of Hispanic children were diagnosed with ADHD, according to the study. By 2016, it was 12% of white kids, 12.8% of blacks, and 6.1% of Hispanics.

Over the past several decades, Dr. Hinshaw said, there’s been an expanded view of who can develop ADHD. It’s no longer viewed as a disease that affects only white middle-class boys, as eating disorders are no longer seen as afflicting only white middle-class girls.

Still, he cautioned against overdiagnosing ADHD in communities in which behavioral issues could be the result of social or environmental factors such as overcrowded classrooms.

The study found rates of ADHD among girls rose from 3% to more than 6% over the study period. It said that was partly a result of a change in how the condition is classified. For years, ADHD pertained to children who were hyperactive. But in recent years, the American Psychiatric Association added to its guide of mental health conditions that diagnosis should also include some children who are inattentive, Dr. Bao said. That raised the number of girls, he explained, because it seems they are more likely to be in that second subtype.

“If we compare these two, you can easily imagine people will easily recognize hyperactivity,” he said.

That rang true for Ruth Hay, a 25-year-old student and cook from New York who now lives in Jerusalem. She was diagnosed with what was then called ADD the summer between second and third grade.

Ms. Hay said her hyperactive tendencies aren’t as “loud” as some people’s. She’s less likely to bounce around a room than she is to bounce in her chair, she said.

Yet, despite her early diagnosis, Ms. Hay said, no one ever told her about other symptoms. For example, she said, she suffers from executive dysfunction, which leaves her feeling unable to accomplish tasks, no matter how much she wanted to or tried.

“I grew up being called lazy in periods of time when I wasn’t,” Ms. Hay said. “If you look at a list of all the various ADHD symptoms, I have all of them to one degree or another, but the only ones ever discussed with me was you might be less focused and more fidgety.”

“I don’t know how my brain would be if I didn’t have it,” she added. “I don’t know if I’d still be me, but all it has been for me is a disability.”

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The number of children diagnosed with ADHD has reached more than 10%, a significant increase during the past 20 years, according to a recent study in JAMA.

The rise was most pronounced in minority groups, suggesting that better access to health insurance and mental health treatment through the Affordable Care Act might have played some role in the increase. The rate of diagnosis during that time period doubled in girls, although it was still much lower than in boys.

But the researchers say they found no evidence confirming frequent complaints that the condition is overdiagnosed or misdiagnosed.

The United States has significantly more instances of ADHD than do other developed countries, which researchers said has led some to think Americans are overdiagnosing children. Wei Bao, MD, PhD, lead author of the study, said in an interview that a review of studies around the world does not support that.

”I don’t think overdiagnosis is the main issue,” he said.

Nonetheless, those doubts persist. Stephen Hinshaw, MD, who coauthored a 2014 book called “The ADHD Explosion: Myths, Medication, Money, and Today’s Push for Performance,” compared ADHD with depression. He said in an interview that neither condition has unequivocal biological markers, which makes it hard to determine if a patient truly has the condition without lengthy psychological evaluations. Symptoms of ADHD can include inattention, fidgety behavior, and impulsivity.

“It’s probably not a true epidemic of ADHD,” said Dr. Hinshaw, a professor of psychology at the University of California, Berkeley, and a professor of psychiatry at University of California, San Francisco. “It might be an epidemic of diagnosing it.”

In interpreting their results, however, the study’s authors tied the higher numbers to better understanding of the condition by doctors and the public, new standards for diagnosis and an increase in access to health insurance through the ACA.

Because of the ACA, “some low-income families have improved access to services and referrals,” said Dr. Bao, an epidemiologist at the University of Iowa College of Public Health in Iowa City.

The study, published in JAMA Network Open, used data from the National Health Interview Survey, an annual federal survey of about 35,000 households. It found a steady increase in diagnoses in children from about 6% during 1997-1998 to more than 10% during 2015-2016.

Advances in medical technology also may have contributed to the increase, according to the research. Twenty years ago, preterm or low-birth-weight babies had a harder time surviving. Those factors increase the risk of being diagnosed with ADHD.

The study also suggests that fewer stigmas about mental health care in minority communities also may lead to more people receiving an ADHD diagnosis.

In the late 1990s, 7.2% of non-Hispanic white children, 4.7% of non-Hispanic black children, and 3.6% of Hispanic children were diagnosed with ADHD, according to the study. By 2016, it was 12% of white kids, 12.8% of blacks, and 6.1% of Hispanics.

Over the past several decades, Dr. Hinshaw said, there’s been an expanded view of who can develop ADHD. It’s no longer viewed as a disease that affects only white middle-class boys, as eating disorders are no longer seen as afflicting only white middle-class girls.

Still, he cautioned against overdiagnosing ADHD in communities in which behavioral issues could be the result of social or environmental factors such as overcrowded classrooms.

The study found rates of ADHD among girls rose from 3% to more than 6% over the study period. It said that was partly a result of a change in how the condition is classified. For years, ADHD pertained to children who were hyperactive. But in recent years, the American Psychiatric Association added to its guide of mental health conditions that diagnosis should also include some children who are inattentive, Dr. Bao said. That raised the number of girls, he explained, because it seems they are more likely to be in that second subtype.

“If we compare these two, you can easily imagine people will easily recognize hyperactivity,” he said.

That rang true for Ruth Hay, a 25-year-old student and cook from New York who now lives in Jerusalem. She was diagnosed with what was then called ADD the summer between second and third grade.

Ms. Hay said her hyperactive tendencies aren’t as “loud” as some people’s. She’s less likely to bounce around a room than she is to bounce in her chair, she said.

Yet, despite her early diagnosis, Ms. Hay said, no one ever told her about other symptoms. For example, she said, she suffers from executive dysfunction, which leaves her feeling unable to accomplish tasks, no matter how much she wanted to or tried.

“I grew up being called lazy in periods of time when I wasn’t,” Ms. Hay said. “If you look at a list of all the various ADHD symptoms, I have all of them to one degree or another, but the only ones ever discussed with me was you might be less focused and more fidgety.”

“I don’t know how my brain would be if I didn’t have it,” she added. “I don’t know if I’d still be me, but all it has been for me is a disability.”

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Almost 11 million adults use e-cigarettes in the United States, and the majority are under the age of 35 years, according to the American Heart Association.

As of 2016, an estimated 4.5% of adults – more than 10.8 million individuals – used e-cigarettes every day or some days, which defined current use for the 466,842 people who responded to the Behavioral Risk Factor Surveillance System survey and were included in the study conducted by the AHA’s Tobacco Regulation and Addiction Center and published in the Annals of Internal Medicine.

Based on that survey data, an estimated 51% of current users were under the age of 35 years in 2016. Daily use was highest among those aged 18-24 years, and of those respondents, 44% said that they had never been regular cigarette users. “It’s particularly disturbing to see these younger people who have never been regular cigarette smokers taking up the use of e-cigarettes, perhaps with the assumption that this alternative nicotine delivery system has been proven to be safe,” said Rose Marie Robertson, MD, who is the AHA’s chief science and medical officer.

The analysis also showed that about 60% of e-cigarette users were men and that use was higher among LGBT people. The first-ever estimates of current use by state put the prevalence highest in Oklahoma at 7.0% and lowest in South Dakota (3.1%) and the District of Columbia (2.3%), the AHA said.

The study was funded through a grant from the National Institutes of Health and the Food and Drug Administration’s Center for Tobacco Products.

rfranki@mdedge.com

SOURCE: Mirbolouk M et al. Ann Intern Med. 2018 Aug 28. doi: 10.7326/M17-3440.

Almost 11 million adults use e-cigarettes in the United States, and the majority are under the age of 35 years, according to the American Heart Association.

As of 2016, an estimated 4.5% of adults – more than 10.8 million individuals – used e-cigarettes every day or some days, which defined current use for the 466,842 people who responded to the Behavioral Risk Factor Surveillance System survey and were included in the study conducted by the AHA’s Tobacco Regulation and Addiction Center and published in the Annals of Internal Medicine.

Based on that survey data, an estimated 51% of current users were under the age of 35 years in 2016. Daily use was highest among those aged 18-24 years, and of those respondents, 44% said that they had never been regular cigarette users. “It’s particularly disturbing to see these younger people who have never been regular cigarette smokers taking up the use of e-cigarettes, perhaps with the assumption that this alternative nicotine delivery system has been proven to be safe,” said Rose Marie Robertson, MD, who is the AHA’s chief science and medical officer.

The analysis also showed that about 60% of e-cigarette users were men and that use was higher among LGBT people. The first-ever estimates of current use by state put the prevalence highest in Oklahoma at 7.0% and lowest in South Dakota (3.1%) and the District of Columbia (2.3%), the AHA said.

The study was funded through a grant from the National Institutes of Health and the Food and Drug Administration’s Center for Tobacco Products.

rfranki@mdedge.com

SOURCE: Mirbolouk M et al. Ann Intern Med. 2018 Aug 28. doi: 10.7326/M17-3440.

Almost 11 million adults use e-cigarettes in the United States, and the majority are under the age of 35 years, according to the American Heart Association.

As of 2016, an estimated 4.5% of adults – more than 10.8 million individuals – used e-cigarettes every day or some days, which defined current use for the 466,842 people who responded to the Behavioral Risk Factor Surveillance System survey and were included in the study conducted by the AHA’s Tobacco Regulation and Addiction Center and published in the Annals of Internal Medicine.

Based on that survey data, an estimated 51% of current users were under the age of 35 years in 2016. Daily use was highest among those aged 18-24 years, and of those respondents, 44% said that they had never been regular cigarette users. “It’s particularly disturbing to see these younger people who have never been regular cigarette smokers taking up the use of e-cigarettes, perhaps with the assumption that this alternative nicotine delivery system has been proven to be safe,” said Rose Marie Robertson, MD, who is the AHA’s chief science and medical officer.

The analysis also showed that about 60% of e-cigarette users were men and that use was higher among LGBT people. The first-ever estimates of current use by state put the prevalence highest in Oklahoma at 7.0% and lowest in South Dakota (3.1%) and the District of Columbia (2.3%), the AHA said.

The study was funded through a grant from the National Institutes of Health and the Food and Drug Administration’s Center for Tobacco Products.

rfranki@mdedge.com

SOURCE: Mirbolouk M et al. Ann Intern Med. 2018 Aug 28. doi: 10.7326/M17-3440.

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the United States and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as do urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center, Seattle, said in a statement.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr. Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

A minority of patients (19.4%, n = 7,184) were from rural locations. They were significantly more likely than were urban patients to be 65 years or older (P less than .001) and significantly less likely to be black (vs. all other races; P less than .001).

However, there was no significant between-group differences in sex, and all major U.S. geographic regions (West, Midwest, South, and Northeast) were represented.

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-–negative, progesterone receptor–negative breast cancer. Rural patients with this cancer didn’t live as long as did their urban counterparts. The hazard ratio (HR) was 1.27 (95% confidence interval, 1.06-1.51; P = .008) for OS and 1.26 (95% CI, 1.04-1.52; P = .02) for cancer-specific survival.

The researchers said this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML, but slightly worse OS if they had MM or advanced aggressive NHL.

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL.

The researchers said these findings suggest it is access to care, and not other characteristics, that drives the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr. Unger said.

The National Cancer Institute and the HOPE Foundation supported the study. The researchers reported financial relationships with various pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Unger JM et al. JAMA Network Open. 2018;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235.

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the United States and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as do urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center, Seattle, said in a statement.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr. Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

A minority of patients (19.4%, n = 7,184) were from rural locations. They were significantly more likely than were urban patients to be 65 years or older (P less than .001) and significantly less likely to be black (vs. all other races; P less than .001).

However, there was no significant between-group differences in sex, and all major U.S. geographic regions (West, Midwest, South, and Northeast) were represented.

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-–negative, progesterone receptor–negative breast cancer. Rural patients with this cancer didn’t live as long as did their urban counterparts. The hazard ratio (HR) was 1.27 (95% confidence interval, 1.06-1.51; P = .008) for OS and 1.26 (95% CI, 1.04-1.52; P = .02) for cancer-specific survival.

The researchers said this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML, but slightly worse OS if they had MM or advanced aggressive NHL.

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL.

The researchers said these findings suggest it is access to care, and not other characteristics, that drives the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr. Unger said.

The National Cancer Institute and the HOPE Foundation supported the study. The researchers reported financial relationships with various pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Unger JM et al. JAMA Network Open. 2018;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235.

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the United States and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as do urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center, Seattle, said in a statement.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr. Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

A minority of patients (19.4%, n = 7,184) were from rural locations. They were significantly more likely than were urban patients to be 65 years or older (P less than .001) and significantly less likely to be black (vs. all other races; P less than .001).

However, there was no significant between-group differences in sex, and all major U.S. geographic regions (West, Midwest, South, and Northeast) were represented.

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-–negative, progesterone receptor–negative breast cancer. Rural patients with this cancer didn’t live as long as did their urban counterparts. The hazard ratio (HR) was 1.27 (95% confidence interval, 1.06-1.51; P = .008) for OS and 1.26 (95% CI, 1.04-1.52; P = .02) for cancer-specific survival.

The researchers said this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML, but slightly worse OS if they had MM or advanced aggressive NHL.

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL.

The researchers said these findings suggest it is access to care, and not other characteristics, that drives the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr. Unger said.

The National Cancer Institute and the HOPE Foundation supported the study. The researchers reported financial relationships with various pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Unger JM et al. JAMA Network Open. 2018;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235.

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

aotto@frontlinemedcom.com

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

aotto@frontlinemedcom.com

ATLANTA – In just 7 months, the University of North Carolina Children’s Hospital, Chapel Hill, dropped the length of stay for neonatal abstinence syndrome from about 11 days to 5 days by moving from scheduled to PRN morphine dosing and abandoning the Finnegan score, according to a report at the Pediatric Hospital Medicine meeting.

The use of morphine fell from 93% of infants transferred to the hospital’s inpatient floors for neonatal abstinence syndrome (NAS) to just 12%, with no downsides for infants or moms.

“Our results have been incredibly encouraging,” said lead investigator and pediatrics resident Thomas Blount, MD. The take-home message is to treat the infant, rather than relying on the Finnegan score.

UNC Children’s, which treats about 50 infants a year for NAS on its inpatient floors, had been using the traditional approach: babies were automatically scheduled for morphine and Finnegan scoring – a withdrawal symptom checklist – every 4 hours, regardless of need. Sometimes infants weren’t even assessed to see if they actually needed morphine before the next dose was given.

“Waking babies up every 4 hours just seemed crazy; of course, they were going to have heightened neurologic signs and symptoms.” Meanwhile, families and providers were frustrated that infants who were otherwise doing well were held for an extra week or more to wean them off morphine, Dr. Blount said at the meeting.

In Nov. 2017, the hospital switched to the eat/sleep/console (ESC) model for NAS on its inpatient floors. The model emphasizes what’s been shown to work in recent years: keeping the infant with the mother; encouraging breast feeding, skin-on-skin contact, and other comfort measures; and supplementing feeds to help with weight gain. Morphine is reserved for when those measures fail and given only with a needs assessment (Hosp Pediatr. 2018 Jan;8(1):1-6).

The hospital ditched Finnegan scoring on its inpatient floors. Nurses were asked instead to check if infants were feeding adequately, sleeping at least an hour between feedings, and able to be consoled within 10 minutes when upset. If the infants met all three of those ESC criteria, providers moved on. They left the baby swaddled, relied on ambient white noise of ocean waves, and checked back on them later. “They didn’t mess with them,” Dr. Blount said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Finnegan scoring “was causing so much anxiety. Staff and families became hypervigilant,” set off by every little twitch and yawn the baby made. It was a good thing when it was abandoned; everyone relaxed, he said.

The changes made a huge difference. The average number of morphine doses dropped from 39 per infant to just 7 total doses among 23 infants in the first 7 months of the ESC initiative. Currently, morphine is used in only about 1 of 10 cases. “We estimate that we’ve given over 900 fewer doses” since ESC was put in place, Dr. Blount said.

Courtesy UNC Children's Hospital

“We had a lot of pushback initially, mostly from nursing staff and residents wondering how this was going to work. It quickly went away,” Dr. Blount said.

His team is now considering rolling ESC out to the newborn nursery and NICU.

There was no industry funding for the work, and Dr. Blount didn’t have any disclosures.

aotto@frontlinemedcom.com

The European Commission has expanded the approved indication for blinatumomab (Blincyto), a bispecific, CD19-directed, CD3 T-cell engager immunotherapy.

Blinatumomab is now approved as monotherapy for children aged 1 year or older who have relapsed/refractory, Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The patients must have received at least two prior therapies, or they must have relapsed after allogeneic hematopoietic stem cell transplant.

The European Commission’s (EC) new approval of blinatumomab extends to all countries in the European Union, as well as Norway, Iceland, and Liechtenstein.

In 2015, the EC approved blinatumomab to treat adults with Philadelphia chromosome–negative, relapsed/refractory B-cell precursor ALL.The EC’s approval of blinatumomab in pediatric patients is based on results from a phase 1/2 study published in the Journal of Clinical Oncology in 2016. The study included 93 pediatric patients with relapsed/refractory B-cell precursor ALL. Patients received blinatumomab as a continuous intravenous infusion – 49 patients in the phase 1 portion of the trial and 44 in phase 2. The patients were followed for 2 years.

There were four dose-limiting toxicities during the phase 1 portion of the trial, two of which were fatal. Three patients had grade 4 cytokine release syndrome (CRS), one had grade 5 cardiac failure (as well as grade 4 CRS), and one had grade 5 respiratory failure. Based on the dose-limiting toxicities, the maximum tolerated dose of blinatumomab was 15 mcg/m2 per day, but a stepwise dosage was recommended to reduce the risk of CRS.

The recommended dose was 5 mcg/m² per day on days 1-7 and 15 mcg/m² per day on days 8-28 for cycle 1, and 15 mcg/m² per day on days 1-28 for subsequent cycles, according to the study results.Among the 70 patients who received the recommended dose of blinatumomab, 27 (39%) achieved a complete response within the first two cycles. A total of 14 of these patients (52%) achieved minimal residual disease negativity.

jensmith@mdedge.com

The European Commission has expanded the approved indication for blinatumomab (Blincyto), a bispecific, CD19-directed, CD3 T-cell engager immunotherapy.

Blinatumomab is now approved as monotherapy for children aged 1 year or older who have relapsed/refractory, Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The patients must have received at least two prior therapies, or they must have relapsed after allogeneic hematopoietic stem cell transplant.

The European Commission’s (EC) new approval of blinatumomab extends to all countries in the European Union, as well as Norway, Iceland, and Liechtenstein.

In 2015, the EC approved blinatumomab to treat adults with Philadelphia chromosome–negative, relapsed/refractory B-cell precursor ALL.The EC’s approval of blinatumomab in pediatric patients is based on results from a phase 1/2 study published in the Journal of Clinical Oncology in 2016. The study included 93 pediatric patients with relapsed/refractory B-cell precursor ALL. Patients received blinatumomab as a continuous intravenous infusion – 49 patients in the phase 1 portion of the trial and 44 in phase 2. The patients were followed for 2 years.

There were four dose-limiting toxicities during the phase 1 portion of the trial, two of which were fatal. Three patients had grade 4 cytokine release syndrome (CRS), one had grade 5 cardiac failure (as well as grade 4 CRS), and one had grade 5 respiratory failure. Based on the dose-limiting toxicities, the maximum tolerated dose of blinatumomab was 15 mcg/m2 per day, but a stepwise dosage was recommended to reduce the risk of CRS.

The recommended dose was 5 mcg/m² per day on days 1-7 and 15 mcg/m² per day on days 8-28 for cycle 1, and 15 mcg/m² per day on days 1-28 for subsequent cycles, according to the study results.Among the 70 patients who received the recommended dose of blinatumomab, 27 (39%) achieved a complete response within the first two cycles. A total of 14 of these patients (52%) achieved minimal residual disease negativity.

jensmith@mdedge.com

The European Commission has expanded the approved indication for blinatumomab (Blincyto), a bispecific, CD19-directed, CD3 T-cell engager immunotherapy.

Blinatumomab is now approved as monotherapy for children aged 1 year or older who have relapsed/refractory, Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The patients must have received at least two prior therapies, or they must have relapsed after allogeneic hematopoietic stem cell transplant.

The European Commission’s (EC) new approval of blinatumomab extends to all countries in the European Union, as well as Norway, Iceland, and Liechtenstein.

In 2015, the EC approved blinatumomab to treat adults with Philadelphia chromosome–negative, relapsed/refractory B-cell precursor ALL.The EC’s approval of blinatumomab in pediatric patients is based on results from a phase 1/2 study published in the Journal of Clinical Oncology in 2016. The study included 93 pediatric patients with relapsed/refractory B-cell precursor ALL. Patients received blinatumomab as a continuous intravenous infusion – 49 patients in the phase 1 portion of the trial and 44 in phase 2. The patients were followed for 2 years.

There were four dose-limiting toxicities during the phase 1 portion of the trial, two of which were fatal. Three patients had grade 4 cytokine release syndrome (CRS), one had grade 5 cardiac failure (as well as grade 4 CRS), and one had grade 5 respiratory failure. Based on the dose-limiting toxicities, the maximum tolerated dose of blinatumomab was 15 mcg/m2 per day, but a stepwise dosage was recommended to reduce the risk of CRS.

The recommended dose was 5 mcg/m² per day on days 1-7 and 15 mcg/m² per day on days 8-28 for cycle 1, and 15 mcg/m² per day on days 1-28 for subsequent cycles, according to the study results.Among the 70 patients who received the recommended dose of blinatumomab, 27 (39%) achieved a complete response within the first two cycles. A total of 14 of these patients (52%) achieved minimal residual disease negativity.

jensmith@mdedge.com