Randy Dotinga

SAN DIEGO – While an “exciting” ketamine-based product is finally available and approved to treat treatment-resistant depression (TRD), there are still plenty of questions about the use of intranasal esketamine, a psychiatrist told colleagues.

“We have a lot of unmet needs in terms of research,” said Sanjay J. Mathew, MD, of Baylor College of Medicine and Michael E. Debakey Veterans Affairs Medical Center, both in Houston, at the annual Psych Congress. “What do we do in the long term? What are the dosing strategies and response predictors? What about elderly patients?”

The Food and Drug Administration approved esketamine nasal spray (Spravato) for TRD in March 2019. Patients with TRD are defined as those with major depressive disorder who have failed at least two different antidepressants.

Dr. Mathew highlighted a 2019 randomized, double-blind, controlled study of patients who reached stable remission after 16 weeks on esketamine. It revealed there’s “a significant enhancement of the time to relapse for patients who remained on ketamine [compared with placebo] – a 51% risk reduction in the median number of days to relapse” (JAMA Psychiatry. 2019;76[9]:893-903).

However, about a quarter of patients still relapsed over the time of the study, Dr. Mathew said. “While this is certainly exciting, we need to talk to our patients about this and set expectations. And we need to emphasize close vigilance, follow-up, and psychotherapy.”

Patients should understand that, if patients are doing remarkably well at 16 weeks, “you’re not out of the woods. You really need to take it long term,” he said.

Dr. Mathew emphasized that patients must take the drug under supervision in a certified facility. “It’s a quick and simple process to do it [get certified] and get registered,” he said. Patients must be monitored over 2 hours and not drive for the rest of the day.

“You need space for some privacy, so a busy [postanesthesia care unit] or ER setting may not be optimal,” he said, adding that, “if you only have one office, it’s hard to pull this off for a number of logistical reasons.”

Dr. Mathew recommended lowering the level of stimulation in the room where the drug is administered. “We have a VA setting that can be loud with code greens blasting over the speaker,” he said. “That is not optimal, but at least we have a private room for our IV infusions. Keep the lights muted, let the patient listen to peaceful music that they enjoy. Having a family member close by can be helpful and comforting to them.”

He added that “you do need a way to recline the head. Having a barber-type chair would be necessary.”

Side effects are common, he said. Sedation is a major risk (49%-61%), as is dissociation (61%-75%). “It’s primarily a sense of alteration – perceptual alterations, altered sense of time, unreality, being disconnected from body, feeling unusually big in fingers or hands, or feeling like you’re unusually tall or skinny.”

Moving forward, more data about long-term effects and ideal doses are needed. “There are many clinics that go above 0.5 milligrams per kg, and some even go to 2. We have no good data,” he said.

People aged over 65 years have lower response rates, and men seem to respond less than women. Dr. Mathew also noted that the studies into the drug generally limited the number of antidepressant failures in patients: “Are there patients too refractory to be considered for this? How refractory is too refractory?”

Dr. Mathew reported various disclosures including a relationship with Janssen, manufacturer of intranasal esketamine.

SAN DIEGO – While an “exciting” ketamine-based product is finally available and approved to treat treatment-resistant depression (TRD), there are still plenty of questions about the use of intranasal esketamine, a psychiatrist told colleagues.

“We have a lot of unmet needs in terms of research,” said Sanjay J. Mathew, MD, of Baylor College of Medicine and Michael E. Debakey Veterans Affairs Medical Center, both in Houston, at the annual Psych Congress. “What do we do in the long term? What are the dosing strategies and response predictors? What about elderly patients?”

The Food and Drug Administration approved esketamine nasal spray (Spravato) for TRD in March 2019. Patients with TRD are defined as those with major depressive disorder who have failed at least two different antidepressants.

Dr. Mathew highlighted a 2019 randomized, double-blind, controlled study of patients who reached stable remission after 16 weeks on esketamine. It revealed there’s “a significant enhancement of the time to relapse for patients who remained on ketamine [compared with placebo] – a 51% risk reduction in the median number of days to relapse” (JAMA Psychiatry. 2019;76[9]:893-903).

However, about a quarter of patients still relapsed over the time of the study, Dr. Mathew said. “While this is certainly exciting, we need to talk to our patients about this and set expectations. And we need to emphasize close vigilance, follow-up, and psychotherapy.”

Patients should understand that, if patients are doing remarkably well at 16 weeks, “you’re not out of the woods. You really need to take it long term,” he said.

Dr. Mathew emphasized that patients must take the drug under supervision in a certified facility. “It’s a quick and simple process to do it [get certified] and get registered,” he said. Patients must be monitored over 2 hours and not drive for the rest of the day.

“You need space for some privacy, so a busy [postanesthesia care unit] or ER setting may not be optimal,” he said, adding that, “if you only have one office, it’s hard to pull this off for a number of logistical reasons.”

Dr. Mathew recommended lowering the level of stimulation in the room where the drug is administered. “We have a VA setting that can be loud with code greens blasting over the speaker,” he said. “That is not optimal, but at least we have a private room for our IV infusions. Keep the lights muted, let the patient listen to peaceful music that they enjoy. Having a family member close by can be helpful and comforting to them.”

He added that “you do need a way to recline the head. Having a barber-type chair would be necessary.”

Side effects are common, he said. Sedation is a major risk (49%-61%), as is dissociation (61%-75%). “It’s primarily a sense of alteration – perceptual alterations, altered sense of time, unreality, being disconnected from body, feeling unusually big in fingers or hands, or feeling like you’re unusually tall or skinny.”

Moving forward, more data about long-term effects and ideal doses are needed. “There are many clinics that go above 0.5 milligrams per kg, and some even go to 2. We have no good data,” he said.

People aged over 65 years have lower response rates, and men seem to respond less than women. Dr. Mathew also noted that the studies into the drug generally limited the number of antidepressant failures in patients: “Are there patients too refractory to be considered for this? How refractory is too refractory?”

Dr. Mathew reported various disclosures including a relationship with Janssen, manufacturer of intranasal esketamine.

SAN DIEGO – While an “exciting” ketamine-based product is finally available and approved to treat treatment-resistant depression (TRD), there are still plenty of questions about the use of intranasal esketamine, a psychiatrist told colleagues.

“We have a lot of unmet needs in terms of research,” said Sanjay J. Mathew, MD, of Baylor College of Medicine and Michael E. Debakey Veterans Affairs Medical Center, both in Houston, at the annual Psych Congress. “What do we do in the long term? What are the dosing strategies and response predictors? What about elderly patients?”

The Food and Drug Administration approved esketamine nasal spray (Spravato) for TRD in March 2019. Patients with TRD are defined as those with major depressive disorder who have failed at least two different antidepressants.

Dr. Mathew highlighted a 2019 randomized, double-blind, controlled study of patients who reached stable remission after 16 weeks on esketamine. It revealed there’s “a significant enhancement of the time to relapse for patients who remained on ketamine [compared with placebo] – a 51% risk reduction in the median number of days to relapse” (JAMA Psychiatry. 2019;76[9]:893-903).

However, about a quarter of patients still relapsed over the time of the study, Dr. Mathew said. “While this is certainly exciting, we need to talk to our patients about this and set expectations. And we need to emphasize close vigilance, follow-up, and psychotherapy.”

Patients should understand that, if patients are doing remarkably well at 16 weeks, “you’re not out of the woods. You really need to take it long term,” he said.

Dr. Mathew emphasized that patients must take the drug under supervision in a certified facility. “It’s a quick and simple process to do it [get certified] and get registered,” he said. Patients must be monitored over 2 hours and not drive for the rest of the day.

“You need space for some privacy, so a busy [postanesthesia care unit] or ER setting may not be optimal,” he said, adding that, “if you only have one office, it’s hard to pull this off for a number of logistical reasons.”

Dr. Mathew recommended lowering the level of stimulation in the room where the drug is administered. “We have a VA setting that can be loud with code greens blasting over the speaker,” he said. “That is not optimal, but at least we have a private room for our IV infusions. Keep the lights muted, let the patient listen to peaceful music that they enjoy. Having a family member close by can be helpful and comforting to them.”

He added that “you do need a way to recline the head. Having a barber-type chair would be necessary.”

Side effects are common, he said. Sedation is a major risk (49%-61%), as is dissociation (61%-75%). “It’s primarily a sense of alteration – perceptual alterations, altered sense of time, unreality, being disconnected from body, feeling unusually big in fingers or hands, or feeling like you’re unusually tall or skinny.”

Moving forward, more data about long-term effects and ideal doses are needed. “There are many clinics that go above 0.5 milligrams per kg, and some even go to 2. We have no good data,” he said.

People aged over 65 years have lower response rates, and men seem to respond less than women. Dr. Mathew also noted that the studies into the drug generally limited the number of antidepressant failures in patients: “Are there patients too refractory to be considered for this? How refractory is too refractory?”

Dr. Mathew reported various disclosures including a relationship with Janssen, manufacturer of intranasal esketamine.

SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.

She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.

Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.

But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.

Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”

Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”

The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”

Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.

The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.

The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.

When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.

But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.

Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.

“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’ We need to change our language so patients feel less shame.”

She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”

And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”

Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).

SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.

She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.

Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.

But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.

Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”

Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”

The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”

Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.

The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.

The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.

When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.

But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.

Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.

“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’ We need to change our language so patients feel less shame.”

She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”

And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”

Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).

SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.

She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.

Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.

But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.

Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”

Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”

The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”

Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.

The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.

The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.

When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.

But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.

Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.

“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’ We need to change our language so patients feel less shame.”

She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”

And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”

Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).

Patients with hidradenitis suppurativa (HS) were found to be at a significantly higher risk of long-term opioid use compared with those who did not have HS, in a retrospective cohort study.

“These results suggest that periodic assessment of pain and screening for long-term opioid use may be warranted, particularly among patients who are older, who smoke tobacco, or who have depression and other medical comorbidities,” wrote the authors of the study (JAMA Dermatol. 2019 Sep 11. doi: 10.1001/jamadermatol.2019.2610).

Researchers led by Sarah Reddy, BA, of the Zucker School of Medicine at Hofstra/ Northwell, New Hyde Park, N.Y., used data from a health-care database that represents an estimated 17% of the U.S. population. They focused on opioid-naive adults who were in the database for at least 3 years from 2008-2018 and monitored whether they began opioid use and then maintained use for at least 1 year.

Nearly 829,000 patients were in the control group, and 22,277 were in the HS group. The mean age of those with HS was 41 years, 76% were women, and 59% were white.

Over 1 year, the crude incidence of long-term opioid use among HS patients who were opioid naive was 0.33%, compared with 0.14% of controls (P less than .001).

An analysis, adjusted for potential confounding factors, found that compared with controls, those with HS were more likely to develop long-term opioid use (odds ratio [OR], 1.53, 95% confidence interval, 1.20-1.95; P less than .001). In the adjusted analysis, long-term opioid use was increased among those in the HS group who had ever smoked tobacco (OR, 3.64, 95% CI, 2.06-6.41; P less than .001), compared with patients with HS who had never smoked; and those who had a history of depression (OR, 1.97, 95% CI, 1.21-3.19; P = .006), compared with HS patients who had not had depression.

The risk of long-term opioid use among those with HS increased by 2% with each additional year in age.

In addition, 5% of patients with HS and long-term opioid use were diagnosed with opioid use disorder over the study period. “Sex, race/ethnicity, disease duration, established dermatologic care, alcohol abuse, and nonopioid substance abuse were not associated with increased risk of long-term opioid use among patients with HS,” the authors wrote.

Emphasizing that these results “should not further stigmatize” people with HS, they said, “our hope is that the medical community, including dermatologists, will further embrace and engage in an integrated care plan that comprehensively supports the needs of patients with HS, including pain management.”

Future research, they added, “should include evaluating the association between disease severity and risk of opioid use, the role of disease-modifying therapies in reducing opioid use, and the development of effective and appropriate multimodal pain management strategies for HS.”

An educational grant to a study author from AbbVie partially funded the study. No other study funding was reported. Ms. Reddy had no disclosures; one author disclosed having received grants and personal fees from AbbVie and UCB during the study.

SOURCE: Reddy S et al. JAMA Dermatol. 2019 Sep 11. doi: 10.1001/jamadermatol.2019.2610.

Patients with hidradenitis suppurativa (HS) were found to be at a significantly higher risk of long-term opioid use compared with those who did not have HS, in a retrospective cohort study.

“These results suggest that periodic assessment of pain and screening for long-term opioid use may be warranted, particularly among patients who are older, who smoke tobacco, or who have depression and other medical comorbidities,” wrote the authors of the study (JAMA Dermatol. 2019 Sep 11. doi: 10.1001/jamadermatol.2019.2610).

Researchers led by Sarah Reddy, BA, of the Zucker School of Medicine at Hofstra/ Northwell, New Hyde Park, N.Y., used data from a health-care database that represents an estimated 17% of the U.S. population. They focused on opioid-naive adults who were in the database for at least 3 years from 2008-2018 and monitored whether they began opioid use and then maintained use for at least 1 year.

Nearly 829,000 patients were in the control group, and 22,277 were in the HS group. The mean age of those with HS was 41 years, 76% were women, and 59% were white.

Over 1 year, the crude incidence of long-term opioid use among HS patients who were opioid naive was 0.33%, compared with 0.14% of controls (P less than .001).

An analysis, adjusted for potential confounding factors, found that compared with controls, those with HS were more likely to develop long-term opioid use (odds ratio [OR], 1.53, 95% confidence interval, 1.20-1.95; P less than .001). In the adjusted analysis, long-term opioid use was increased among those in the HS group who had ever smoked tobacco (OR, 3.64, 95% CI, 2.06-6.41; P less than .001), compared with patients with HS who had never smoked; and those who had a history of depression (OR, 1.97, 95% CI, 1.21-3.19; P = .006), compared with HS patients who had not had depression.

The risk of long-term opioid use among those with HS increased by 2% with each additional year in age.

In addition, 5% of patients with HS and long-term opioid use were diagnosed with opioid use disorder over the study period. “Sex, race/ethnicity, disease duration, established dermatologic care, alcohol abuse, and nonopioid substance abuse were not associated with increased risk of long-term opioid use among patients with HS,” the authors wrote.

Emphasizing that these results “should not further stigmatize” people with HS, they said, “our hope is that the medical community, including dermatologists, will further embrace and engage in an integrated care plan that comprehensively supports the needs of patients with HS, including pain management.”

Future research, they added, “should include evaluating the association between disease severity and risk of opioid use, the role of disease-modifying therapies in reducing opioid use, and the development of effective and appropriate multimodal pain management strategies for HS.”

An educational grant to a study author from AbbVie partially funded the study. No other study funding was reported. Ms. Reddy had no disclosures; one author disclosed having received grants and personal fees from AbbVie and UCB during the study.

SOURCE: Reddy S et al. JAMA Dermatol. 2019 Sep 11. doi: 10.1001/jamadermatol.2019.2610.

Patients with hidradenitis suppurativa (HS) were found to be at a significantly higher risk of long-term opioid use compared with those who did not have HS, in a retrospective cohort study.

“These results suggest that periodic assessment of pain and screening for long-term opioid use may be warranted, particularly among patients who are older, who smoke tobacco, or who have depression and other medical comorbidities,” wrote the authors of the study (JAMA Dermatol. 2019 Sep 11. doi: 10.1001/jamadermatol.2019.2610).

Researchers led by Sarah Reddy, BA, of the Zucker School of Medicine at Hofstra/ Northwell, New Hyde Park, N.Y., used data from a health-care database that represents an estimated 17% of the U.S. population. They focused on opioid-naive adults who were in the database for at least 3 years from 2008-2018 and monitored whether they began opioid use and then maintained use for at least 1 year.

Nearly 829,000 patients were in the control group, and 22,277 were in the HS group. The mean age of those with HS was 41 years, 76% were women, and 59% were white.

Over 1 year, the crude incidence of long-term opioid use among HS patients who were opioid naive was 0.33%, compared with 0.14% of controls (P less than .001).

An analysis, adjusted for potential confounding factors, found that compared with controls, those with HS were more likely to develop long-term opioid use (odds ratio [OR], 1.53, 95% confidence interval, 1.20-1.95; P less than .001). In the adjusted analysis, long-term opioid use was increased among those in the HS group who had ever smoked tobacco (OR, 3.64, 95% CI, 2.06-6.41; P less than .001), compared with patients with HS who had never smoked; and those who had a history of depression (OR, 1.97, 95% CI, 1.21-3.19; P = .006), compared with HS patients who had not had depression.

The risk of long-term opioid use among those with HS increased by 2% with each additional year in age.

In addition, 5% of patients with HS and long-term opioid use were diagnosed with opioid use disorder over the study period. “Sex, race/ethnicity, disease duration, established dermatologic care, alcohol abuse, and nonopioid substance abuse were not associated with increased risk of long-term opioid use among patients with HS,” the authors wrote.

Emphasizing that these results “should not further stigmatize” people with HS, they said, “our hope is that the medical community, including dermatologists, will further embrace and engage in an integrated care plan that comprehensively supports the needs of patients with HS, including pain management.”

Future research, they added, “should include evaluating the association between disease severity and risk of opioid use, the role of disease-modifying therapies in reducing opioid use, and the development of effective and appropriate multimodal pain management strategies for HS.”

An educational grant to a study author from AbbVie partially funded the study. No other study funding was reported. Ms. Reddy had no disclosures; one author disclosed having received grants and personal fees from AbbVie and UCB during the study.

SOURCE: Reddy S et al. JAMA Dermatol. 2019 Sep 11. doi: 10.1001/jamadermatol.2019.2610.

MINNEAPOLIS -- Oncologist Mark Klein, MD, may have just stepped down as president of the Association of VA Hematology/Oncology (AVAHO), but his main legacy—a foundation that AVAHO can call its own—is set in stone.

Over the past year, Klein has guided AVAHO as it leveraged its remarkable growth in recent years into the landmark creation of a foundation devoted to research. “We want to provide funds to researchers and support access to clinical trials for patients within the VA,” said Klein in an interview after he stepped down as association president at the 2019 AVAHO annual meeting.

Dr. Klein, who works for the Minneapolis VA Healthcare System and University of Minnesota in Minneapolis said the foundation is being seeded with $250,000. One goal is to use the foundation to support unique research projects that may not otherwise draw funding, he said.

For example, he said, the foundation could fund a research project by dietitians into severe weight loss in cancer. Or it could support a study by speech pathologists into swallowing in cancer patients.

In addition, he said, the foundation will focus on providing grants to support junior faculty, including researchers who aren’t MDs. And its funds will be used to boost access to clinical trials in cancer.

Klein said he has also focused on strategic planning and developing partnerships with industry and the leadership of both the VA and the National Cancer Institute. “We’re working to come up with unique ways to get people thinking about the barriers to clinical trials and providing better access for veterans.”

He is especially proud of AVAHO’s partnership with National Association of Veterans’ Research and Education Foundations, which includes partial support of a program manager position.

On the corporate front, he said, “we’re going to start offering corporate memberships so that we can form more industry relationships. That’s another new change and a step in our growth as we work to help more veterans and make a bigger difference.”

MINNEAPOLIS -- Oncologist Mark Klein, MD, may have just stepped down as president of the Association of VA Hematology/Oncology (AVAHO), but his main legacy—a foundation that AVAHO can call its own—is set in stone.

Over the past year, Klein has guided AVAHO as it leveraged its remarkable growth in recent years into the landmark creation of a foundation devoted to research. “We want to provide funds to researchers and support access to clinical trials for patients within the VA,” said Klein in an interview after he stepped down as association president at the 2019 AVAHO annual meeting.

Dr. Klein, who works for the Minneapolis VA Healthcare System and University of Minnesota in Minneapolis said the foundation is being seeded with $250,000. One goal is to use the foundation to support unique research projects that may not otherwise draw funding, he said.

For example, he said, the foundation could fund a research project by dietitians into severe weight loss in cancer. Or it could support a study by speech pathologists into swallowing in cancer patients.

In addition, he said, the foundation will focus on providing grants to support junior faculty, including researchers who aren’t MDs. And its funds will be used to boost access to clinical trials in cancer.

Klein said he has also focused on strategic planning and developing partnerships with industry and the leadership of both the VA and the National Cancer Institute. “We’re working to come up with unique ways to get people thinking about the barriers to clinical trials and providing better access for veterans.”

He is especially proud of AVAHO’s partnership with National Association of Veterans’ Research and Education Foundations, which includes partial support of a program manager position.

On the corporate front, he said, “we’re going to start offering corporate memberships so that we can form more industry relationships. That’s another new change and a step in our growth as we work to help more veterans and make a bigger difference.”

MINNEAPOLIS -- Oncologist Mark Klein, MD, may have just stepped down as president of the Association of VA Hematology/Oncology (AVAHO), but his main legacy—a foundation that AVAHO can call its own—is set in stone.

Over the past year, Klein has guided AVAHO as it leveraged its remarkable growth in recent years into the landmark creation of a foundation devoted to research. “We want to provide funds to researchers and support access to clinical trials for patients within the VA,” said Klein in an interview after he stepped down as association president at the 2019 AVAHO annual meeting.

Dr. Klein, who works for the Minneapolis VA Healthcare System and University of Minnesota in Minneapolis said the foundation is being seeded with $250,000. One goal is to use the foundation to support unique research projects that may not otherwise draw funding, he said.

For example, he said, the foundation could fund a research project by dietitians into severe weight loss in cancer. Or it could support a study by speech pathologists into swallowing in cancer patients.

In addition, he said, the foundation will focus on providing grants to support junior faculty, including researchers who aren’t MDs. And its funds will be used to boost access to clinical trials in cancer.

Klein said he has also focused on strategic planning and developing partnerships with industry and the leadership of both the VA and the National Cancer Institute. “We’re working to come up with unique ways to get people thinking about the barriers to clinical trials and providing better access for veterans.”

He is especially proud of AVAHO’s partnership with National Association of Veterans’ Research and Education Foundations, which includes partial support of a program manager position.

On the corporate front, he said, “we’re going to start offering corporate memberships so that we can form more industry relationships. That’s another new change and a step in our growth as we work to help more veterans and make a bigger difference.”

MINNEAPOLIS -- When William “Bill” Wachsman, MD, PhD, joined the executive board of the Association of VA Hematology/Oncology earlier this decade, the organization revolved around its annual meeting. Now, AVAHO is expanding its horizons, and Dr. Wachsman plans to push for a wider focus and greater impact as its new president.

“We’re a group of like-minded individuals who came together about 15 years ago and said we want to take better care of our patients, coordinate our services, and better educate ourselves,” said Dr. Wachsman, a hematologist/oncologist with US Department of Veterans Affairs (VA) San Diego Health Care System, University of California San Diego School of Medicine, and Moores Cancer Center. “We’re still dedicated to this mission. Moving forward, I want to improve educational opportunities, encourage our interest groups to develop initiatives, and utilize our foundation to support medical professionals and improve patient care within the VA.”

Dr. Wachsman took over as AVAHO’s president on the last day of the organization’s annual meeting in Minneapolis. He replaces immediate past president Mark Klein, MD, and will serve for 1 year.

According to Dr. Wachsman, AVAHO is unique among cancer/hematology associations because it’s not limited to physicians. “Everyone who’s involved with the care of patients with hematologic or oncologic disease can be involved. You don’t need to be an employee of the VA.”

Indeed, AVAHO’s approximately 800 members include medical oncologists and hematologists, surgical oncologists, radiation oncologists, pharmacists, nurses, nurse practitioners, advanced practice registered nurses, physician assistants, social workers, cancer registrars, and other allied health professionals.

AVAHO is also unique because it’s not a VA organization. “It’s an association of people are interested in better care for patients at the VA,” Dr. Wachsman said.

Over the next year, Dr. Wachsman hopes to form a community advisory board “that can not only give us advice, but reach out to other associations in the VA and in oncology to spread the word about what we’re doing.” Other forms of outreach can help AVAHO gain influence among policymakers, he said.

As for AVAHO’s foundation, he hopes to bring in funding through grants to support fellowship awards and to help VA sites around the nation develop infrastructure to support clinical trials.

On another national level, he said, AVAHO can improve its relationship with the VA with a goal of promoting honest and productive communication that goes both ways. “You have to get to know each other,” he said, “before you jump into the same pool and begin to swim.”

MINNEAPOLIS -- When William “Bill” Wachsman, MD, PhD, joined the executive board of the Association of VA Hematology/Oncology earlier this decade, the organization revolved around its annual meeting. Now, AVAHO is expanding its horizons, and Dr. Wachsman plans to push for a wider focus and greater impact as its new president.

“We’re a group of like-minded individuals who came together about 15 years ago and said we want to take better care of our patients, coordinate our services, and better educate ourselves,” said Dr. Wachsman, a hematologist/oncologist with US Department of Veterans Affairs (VA) San Diego Health Care System, University of California San Diego School of Medicine, and Moores Cancer Center. “We’re still dedicated to this mission. Moving forward, I want to improve educational opportunities, encourage our interest groups to develop initiatives, and utilize our foundation to support medical professionals and improve patient care within the VA.”

Dr. Wachsman took over as AVAHO’s president on the last day of the organization’s annual meeting in Minneapolis. He replaces immediate past president Mark Klein, MD, and will serve for 1 year.

According to Dr. Wachsman, AVAHO is unique among cancer/hematology associations because it’s not limited to physicians. “Everyone who’s involved with the care of patients with hematologic or oncologic disease can be involved. You don’t need to be an employee of the VA.”

Indeed, AVAHO’s approximately 800 members include medical oncologists and hematologists, surgical oncologists, radiation oncologists, pharmacists, nurses, nurse practitioners, advanced practice registered nurses, physician assistants, social workers, cancer registrars, and other allied health professionals.

AVAHO is also unique because it’s not a VA organization. “It’s an association of people are interested in better care for patients at the VA,” Dr. Wachsman said.

Over the next year, Dr. Wachsman hopes to form a community advisory board “that can not only give us advice, but reach out to other associations in the VA and in oncology to spread the word about what we’re doing.” Other forms of outreach can help AVAHO gain influence among policymakers, he said.

As for AVAHO’s foundation, he hopes to bring in funding through grants to support fellowship awards and to help VA sites around the nation develop infrastructure to support clinical trials.

On another national level, he said, AVAHO can improve its relationship with the VA with a goal of promoting honest and productive communication that goes both ways. “You have to get to know each other,” he said, “before you jump into the same pool and begin to swim.”

MINNEAPOLIS -- When William “Bill” Wachsman, MD, PhD, joined the executive board of the Association of VA Hematology/Oncology earlier this decade, the organization revolved around its annual meeting. Now, AVAHO is expanding its horizons, and Dr. Wachsman plans to push for a wider focus and greater impact as its new president.

“We’re a group of like-minded individuals who came together about 15 years ago and said we want to take better care of our patients, coordinate our services, and better educate ourselves,” said Dr. Wachsman, a hematologist/oncologist with US Department of Veterans Affairs (VA) San Diego Health Care System, University of California San Diego School of Medicine, and Moores Cancer Center. “We’re still dedicated to this mission. Moving forward, I want to improve educational opportunities, encourage our interest groups to develop initiatives, and utilize our foundation to support medical professionals and improve patient care within the VA.”

Dr. Wachsman took over as AVAHO’s president on the last day of the organization’s annual meeting in Minneapolis. He replaces immediate past president Mark Klein, MD, and will serve for 1 year.

According to Dr. Wachsman, AVAHO is unique among cancer/hematology associations because it’s not limited to physicians. “Everyone who’s involved with the care of patients with hematologic or oncologic disease can be involved. You don’t need to be an employee of the VA.”

Indeed, AVAHO’s approximately 800 members include medical oncologists and hematologists, surgical oncologists, radiation oncologists, pharmacists, nurses, nurse practitioners, advanced practice registered nurses, physician assistants, social workers, cancer registrars, and other allied health professionals.

AVAHO is also unique because it’s not a VA organization. “It’s an association of people are interested in better care for patients at the VA,” Dr. Wachsman said.

Over the next year, Dr. Wachsman hopes to form a community advisory board “that can not only give us advice, but reach out to other associations in the VA and in oncology to spread the word about what we’re doing.” Other forms of outreach can help AVAHO gain influence among policymakers, he said.

As for AVAHO’s foundation, he hopes to bring in funding through grants to support fellowship awards and to help VA sites around the nation develop infrastructure to support clinical trials.

On another national level, he said, AVAHO can improve its relationship with the VA with a goal of promoting honest and productive communication that goes both ways. “You have to get to know each other,” he said, “before you jump into the same pool and begin to swim.”

MINNEAPOLIS -- Picture this: A patient with cancer wants to get better and needs your help. But he or she refuses to hear the prognosis or understand the treatment options. The patient, in essence, has embraced a personal don’t-ask, don’t-tell policy.

What should you do as a medical professional? Get help from a psychologist and consider the ethics of the situation, advised a VA psychologist in a presentation at the September 2019 annual meeting of the Association of VA Hematology/Oncology.

Alyssa Ford, PhD, psychosocial oncology coordinator at VA Pittsburgh Healthcare System in Pennsylvania, said she has faced this situation. “We didn’t know the staging yet, but the veteran did not want to know about their prognosis or the treatment options,” she recalled. “They just wanted to fight this cancer.”

At issue in this case, she said, is this question: “What do we do when a patient opts out about receiving sufficient information to make an informed choice?”

As she explained, the key is to understand the person’s capacity—the ability to make an informed decision. “It can be assessed by any licensed health care provider who understands the components of capacity and is able to assess them.”

Ford evaluates a patient’s capacity by analyzing whether he or she can perform 4 tasks: Make decisions, live independently, manage finances, and grant power of attorney.  “Often,” she said, “they have 1 but not all.” 

Other components of capacity include the ability to understand one’s medical situation, an appreciation of the pros and cons of treatment options, the consistency of choices over time, and the ability to reason. “Can the patient consider the risks and benefits of each option and consider quality of life vs quantity of life in light of their own cultural identity and personal values?”

Keep in mind that levels of capacity can change over time, Ford said, and remember that these judgements are not arbitrary or punitive.

When someone doesn’t have capacity, she said, “it doesn’t necessarily tell us why or whether it will come back. But it does say they can’t provide informed consent.”

What happened to the determinedly reluctant patient who simply wanted to “fight” and not make decisions?

“The oncology provider chose to have the psychology provider in the room while staging information and prognosis was shared,” Ford said in an interview following her presentation. “And the psychology provider assisted with ensuring that the veteran received education in simple terms and in promoting active coping.”

In addition, she said, “the psychologist provider also spent several minutes after the visit giving the veteran an opportunity to discuss their feelings. And the provider physically escorted the veteran to the laboratory to ensure that the impact of receiving difficult news did not impair mood or cognition to the point that the veteran left the medical center instead of engaging in the next step of needed medical care.”

Ford reports no relevant disclosures.

MINNEAPOLIS -- Picture this: A patient with cancer wants to get better and needs your help. But he or she refuses to hear the prognosis or understand the treatment options. The patient, in essence, has embraced a personal don’t-ask, don’t-tell policy.

What should you do as a medical professional? Get help from a psychologist and consider the ethics of the situation, advised a VA psychologist in a presentation at the September 2019 annual meeting of the Association of VA Hematology/Oncology.

Alyssa Ford, PhD, psychosocial oncology coordinator at VA Pittsburgh Healthcare System in Pennsylvania, said she has faced this situation. “We didn’t know the staging yet, but the veteran did not want to know about their prognosis or the treatment options,” she recalled. “They just wanted to fight this cancer.”

At issue in this case, she said, is this question: “What do we do when a patient opts out about receiving sufficient information to make an informed choice?”

As she explained, the key is to understand the person’s capacity—the ability to make an informed decision. “It can be assessed by any licensed health care provider who understands the components of capacity and is able to assess them.”

Ford evaluates a patient’s capacity by analyzing whether he or she can perform 4 tasks: Make decisions, live independently, manage finances, and grant power of attorney.  “Often,” she said, “they have 1 but not all.” 

Other components of capacity include the ability to understand one’s medical situation, an appreciation of the pros and cons of treatment options, the consistency of choices over time, and the ability to reason. “Can the patient consider the risks and benefits of each option and consider quality of life vs quantity of life in light of their own cultural identity and personal values?”

Keep in mind that levels of capacity can change over time, Ford said, and remember that these judgements are not arbitrary or punitive.

When someone doesn’t have capacity, she said, “it doesn’t necessarily tell us why or whether it will come back. But it does say they can’t provide informed consent.”

What happened to the determinedly reluctant patient who simply wanted to “fight” and not make decisions?

“The oncology provider chose to have the psychology provider in the room while staging information and prognosis was shared,” Ford said in an interview following her presentation. “And the psychology provider assisted with ensuring that the veteran received education in simple terms and in promoting active coping.”

In addition, she said, “the psychologist provider also spent several minutes after the visit giving the veteran an opportunity to discuss their feelings. And the provider physically escorted the veteran to the laboratory to ensure that the impact of receiving difficult news did not impair mood or cognition to the point that the veteran left the medical center instead of engaging in the next step of needed medical care.”

Ford reports no relevant disclosures.

MINNEAPOLIS -- Picture this: A patient with cancer wants to get better and needs your help. But he or she refuses to hear the prognosis or understand the treatment options. The patient, in essence, has embraced a personal don’t-ask, don’t-tell policy.

What should you do as a medical professional? Get help from a psychologist and consider the ethics of the situation, advised a VA psychologist in a presentation at the September 2019 annual meeting of the Association of VA Hematology/Oncology.

Alyssa Ford, PhD, psychosocial oncology coordinator at VA Pittsburgh Healthcare System in Pennsylvania, said she has faced this situation. “We didn’t know the staging yet, but the veteran did not want to know about their prognosis or the treatment options,” she recalled. “They just wanted to fight this cancer.”

At issue in this case, she said, is this question: “What do we do when a patient opts out about receiving sufficient information to make an informed choice?”

As she explained, the key is to understand the person’s capacity—the ability to make an informed decision. “It can be assessed by any licensed health care provider who understands the components of capacity and is able to assess them.”

Ford evaluates a patient’s capacity by analyzing whether he or she can perform 4 tasks: Make decisions, live independently, manage finances, and grant power of attorney.  “Often,” she said, “they have 1 but not all.” 

Other components of capacity include the ability to understand one’s medical situation, an appreciation of the pros and cons of treatment options, the consistency of choices over time, and the ability to reason. “Can the patient consider the risks and benefits of each option and consider quality of life vs quantity of life in light of their own cultural identity and personal values?”

Keep in mind that levels of capacity can change over time, Ford said, and remember that these judgements are not arbitrary or punitive.

When someone doesn’t have capacity, she said, “it doesn’t necessarily tell us why or whether it will come back. But it does say they can’t provide informed consent.”

What happened to the determinedly reluctant patient who simply wanted to “fight” and not make decisions?

“The oncology provider chose to have the psychology provider in the room while staging information and prognosis was shared,” Ford said in an interview following her presentation. “And the psychology provider assisted with ensuring that the veteran received education in simple terms and in promoting active coping.”

In addition, she said, “the psychologist provider also spent several minutes after the visit giving the veteran an opportunity to discuss their feelings. And the provider physically escorted the veteran to the laboratory to ensure that the impact of receiving difficult news did not impair mood or cognition to the point that the veteran left the medical center instead of engaging in the next step of needed medical care.”

Ford reports no relevant disclosures.

MINNEAPOLIS -- A new era of systemic treatment for bladder cancer has arrived, a US Department of Veterans Affairs (VA) hematologist/oncologist told colleagues, and more changes await on the horizon.

“After a historically long dry spell, you're seeing novel drugs and combinations under investigation,” said Elizabeth Henry, MD, of Edward Hines, Jr. VA Hospital and Loyola University Medical Center in Chicago, Illinois, in a presentation at the annual meeting of the Association of VA Hematology/Oncology. “Our treatment paradigm will almost certainly continue to change.”

There’s a major need for new approaches in bladder cancer, Dr. Henry said. While the median survival for patients with metastatic disease treated has risen, it remains low at about 15 months. And, she said, the 5-year survival rate is about 15% with modern treatments.

Platinum-based chemotherapy is still the first-line treatment, she said, and cisplatin-based combos remain the standard. However, many patients are not eligible to take cisplatin because of factors such as reduced performance status, impaired renal function, peripheral neuropathy, hearing loss and heart failure. “Many patients have renal insufficiency and are platinum ineligible from the get-go,” Dr. Henry said.

In these patients, immune checkpoint inhibitors are an option, but research suggests they may lead to poorer survival in those with PDL1-low tumors. In 2018, the US Food and Drug Administration (FDA) advised their use as first-line treatment only in PDL1-high, cisplatin-ineligible patients or those who can’t undergo chemotherapy, she said.

As second-line therapy after platinum treatment, Dr. Henry said, several drugs targeting the PD1/PDL1 pathway are now FDA-approved with response rates at 15% to 25%; only 1 (pembrolizumab) has level 1 evidence from a phase 3 randomized clinical trial.

Single-agent chemotherapy is an option for patients who have worsened or cannot undergo treatment with immune checkpoint inhibitors. However, according to Dr. Henry, response rates are low (about 10%-15%) and there's no prospective or randomized control trial data showing a survival benefit.

What now? Targeted approaches are entering the picture. For example, fibroblast growth factor receptor inhibitors, which target a pathway that often mutates in bladder cancer. One drug, erdafitinib (Balversa), received FDA approval earlier this year based on a phase 2 trial data that showed an objective response rate (ORR) of 40%. Dr. Henry cautioned that unusual adverse effects can occur, including hyperphosphatemia (a disorder that boosts phosphate levels), ocular toxicity (which can lead to retinal detachment), and toxicity of the skin and hair.

“Patients need to be closely followed if they're starting this as a targeted drug,” Dr. Henry said.

Anti-Nectin-4 antibody drug conjugate, which targets urothelial carcinomas with uniformly high expression of the Nectin-4 cell surface marker, also is showing promise. Recent research suggests a “remarkable” ORR of 42% and nearly 8 months duration of response, she said.

Adverse effects include rash, peripheral neuropathy, and hyperglycemia. “Overall, this is thought to be a relatively well-tolerated therapy,” she said.

In terms of other advances, “we are moving closer to an era of molecular subtype-specific therapeutic strategies,” Dr. Henry said, and the National Comprehensive Cancer Network recommends early molecular testing in stage IIIB/IV urothelial cancer. “It can help facilitate treatment decisions and prevent delays in later lines of therapy, although we're still limited by development of individualized biomarker assays for specific drugs.”

Moving forward, she said, “continued research is needed to learn how to incorporate predictive molecular profiles to optimize treatment selection.”

Dr. Henry reported no relevant disclosures.

MINNEAPOLIS -- A new era of systemic treatment for bladder cancer has arrived, a US Department of Veterans Affairs (VA) hematologist/oncologist told colleagues, and more changes await on the horizon.

“After a historically long dry spell, you're seeing novel drugs and combinations under investigation,” said Elizabeth Henry, MD, of Edward Hines, Jr. VA Hospital and Loyola University Medical Center in Chicago, Illinois, in a presentation at the annual meeting of the Association of VA Hematology/Oncology. “Our treatment paradigm will almost certainly continue to change.”

There’s a major need for new approaches in bladder cancer, Dr. Henry said. While the median survival for patients with metastatic disease treated has risen, it remains low at about 15 months. And, she said, the 5-year survival rate is about 15% with modern treatments.

Platinum-based chemotherapy is still the first-line treatment, she said, and cisplatin-based combos remain the standard. However, many patients are not eligible to take cisplatin because of factors such as reduced performance status, impaired renal function, peripheral neuropathy, hearing loss and heart failure. “Many patients have renal insufficiency and are platinum ineligible from the get-go,” Dr. Henry said.

In these patients, immune checkpoint inhibitors are an option, but research suggests they may lead to poorer survival in those with PDL1-low tumors. In 2018, the US Food and Drug Administration (FDA) advised their use as first-line treatment only in PDL1-high, cisplatin-ineligible patients or those who can’t undergo chemotherapy, she said.

As second-line therapy after platinum treatment, Dr. Henry said, several drugs targeting the PD1/PDL1 pathway are now FDA-approved with response rates at 15% to 25%; only 1 (pembrolizumab) has level 1 evidence from a phase 3 randomized clinical trial.

Single-agent chemotherapy is an option for patients who have worsened or cannot undergo treatment with immune checkpoint inhibitors. However, according to Dr. Henry, response rates are low (about 10%-15%) and there's no prospective or randomized control trial data showing a survival benefit.

What now? Targeted approaches are entering the picture. For example, fibroblast growth factor receptor inhibitors, which target a pathway that often mutates in bladder cancer. One drug, erdafitinib (Balversa), received FDA approval earlier this year based on a phase 2 trial data that showed an objective response rate (ORR) of 40%. Dr. Henry cautioned that unusual adverse effects can occur, including hyperphosphatemia (a disorder that boosts phosphate levels), ocular toxicity (which can lead to retinal detachment), and toxicity of the skin and hair.

“Patients need to be closely followed if they're starting this as a targeted drug,” Dr. Henry said.

Anti-Nectin-4 antibody drug conjugate, which targets urothelial carcinomas with uniformly high expression of the Nectin-4 cell surface marker, also is showing promise. Recent research suggests a “remarkable” ORR of 42% and nearly 8 months duration of response, she said.

Adverse effects include rash, peripheral neuropathy, and hyperglycemia. “Overall, this is thought to be a relatively well-tolerated therapy,” she said.

In terms of other advances, “we are moving closer to an era of molecular subtype-specific therapeutic strategies,” Dr. Henry said, and the National Comprehensive Cancer Network recommends early molecular testing in stage IIIB/IV urothelial cancer. “It can help facilitate treatment decisions and prevent delays in later lines of therapy, although we're still limited by development of individualized biomarker assays for specific drugs.”

Moving forward, she said, “continued research is needed to learn how to incorporate predictive molecular profiles to optimize treatment selection.”

Dr. Henry reported no relevant disclosures.

MINNEAPOLIS -- A new era of systemic treatment for bladder cancer has arrived, a US Department of Veterans Affairs (VA) hematologist/oncologist told colleagues, and more changes await on the horizon.

“After a historically long dry spell, you're seeing novel drugs and combinations under investigation,” said Elizabeth Henry, MD, of Edward Hines, Jr. VA Hospital and Loyola University Medical Center in Chicago, Illinois, in a presentation at the annual meeting of the Association of VA Hematology/Oncology. “Our treatment paradigm will almost certainly continue to change.”

There’s a major need for new approaches in bladder cancer, Dr. Henry said. While the median survival for patients with metastatic disease treated has risen, it remains low at about 15 months. And, she said, the 5-year survival rate is about 15% with modern treatments.

Platinum-based chemotherapy is still the first-line treatment, she said, and cisplatin-based combos remain the standard. However, many patients are not eligible to take cisplatin because of factors such as reduced performance status, impaired renal function, peripheral neuropathy, hearing loss and heart failure. “Many patients have renal insufficiency and are platinum ineligible from the get-go,” Dr. Henry said.

In these patients, immune checkpoint inhibitors are an option, but research suggests they may lead to poorer survival in those with PDL1-low tumors. In 2018, the US Food and Drug Administration (FDA) advised their use as first-line treatment only in PDL1-high, cisplatin-ineligible patients or those who can’t undergo chemotherapy, she said.

As second-line therapy after platinum treatment, Dr. Henry said, several drugs targeting the PD1/PDL1 pathway are now FDA-approved with response rates at 15% to 25%; only 1 (pembrolizumab) has level 1 evidence from a phase 3 randomized clinical trial.

Single-agent chemotherapy is an option for patients who have worsened or cannot undergo treatment with immune checkpoint inhibitors. However, according to Dr. Henry, response rates are low (about 10%-15%) and there's no prospective or randomized control trial data showing a survival benefit.

What now? Targeted approaches are entering the picture. For example, fibroblast growth factor receptor inhibitors, which target a pathway that often mutates in bladder cancer. One drug, erdafitinib (Balversa), received FDA approval earlier this year based on a phase 2 trial data that showed an objective response rate (ORR) of 40%. Dr. Henry cautioned that unusual adverse effects can occur, including hyperphosphatemia (a disorder that boosts phosphate levels), ocular toxicity (which can lead to retinal detachment), and toxicity of the skin and hair.

“Patients need to be closely followed if they're starting this as a targeted drug,” Dr. Henry said.

Anti-Nectin-4 antibody drug conjugate, which targets urothelial carcinomas with uniformly high expression of the Nectin-4 cell surface marker, also is showing promise. Recent research suggests a “remarkable” ORR of 42% and nearly 8 months duration of response, she said.

Adverse effects include rash, peripheral neuropathy, and hyperglycemia. “Overall, this is thought to be a relatively well-tolerated therapy,” she said.

In terms of other advances, “we are moving closer to an era of molecular subtype-specific therapeutic strategies,” Dr. Henry said, and the National Comprehensive Cancer Network recommends early molecular testing in stage IIIB/IV urothelial cancer. “It can help facilitate treatment decisions and prevent delays in later lines of therapy, although we're still limited by development of individualized biomarker assays for specific drugs.”

Moving forward, she said, “continued research is needed to learn how to incorporate predictive molecular profiles to optimize treatment selection.”

Dr. Henry reported no relevant disclosures.

MINNEAPOLIS -- Clinical trials should be considered standard of care in oncology, the president of the Association of VA Hematology/Oncology (AVAHO) declared, and he urged colleagues to bypass obstacles and embrace them in patient care.

Clinical trials help many people, not just those in the studies, as they are indicators of robust oncology programs. “There’s a significant correlation between clinical trial activity [at sites] and improvement in survival in cancer,” said oncologist Mark Klein, MD, of the Minneapolis VA Health Care System and University of Minnesota, in a presentation at the 2019 annual meeting of AVAHO.  

But the numbers suggest that the VA has lagged behind on the clinical trial front, Dr. Klein said. He pointed to internal statistics from 2001 to 2003, reported in 2010, which found clinical trial participation rates among men in the VA were lower (0.37%) than those of the national rates (0.74%).

Specifically, the VA and national participation rates were 1.16% and 0.30%, respectively, for colorectal cancer, 0.67% and 0.30% for lung cancer, 0.70% and 0.47% for prostate cancer, 0.52% and 0.74% for myeloma. According to Dr. Klein, lung and prostate cancer account for about half of all cancer diagnoses in the VA.

But the participation rates were much higher among the VA hospitals that took part in clinical trials, he said, at 2% for colorectal cancer, 1.4% for lung cancer, 2.5% for prostate cancer, 18.2% for myeloma and 2.07% overall. These numbers make it clear, he said, that it’s possible to improve: “We can do better.”

Dr. Klein pointed to other numbers that suggest the VA facilities that do participate in clinical trials typically do not take part in more than 1 or 2. In 2016, he said, an analysis found that open interventional trials were in progress at 82 VA facilities. About 35 facilities had little activity with only 1 trial in progress. “It has changed since then, but not dramatically.”

Meanwhile, he said, 2016 numbers also showed that about two-thirds of open interventional trials in the VA only included a single VA site. “We weren’t playing together, having consortia and working as a team.”

There are obstacles to improvement, he said, and fixes will take time. “It probably takes 5, 10-plus years,” he said.

These barriers include:

• Lack of adequate trial offering. Changing regulations is key here;
• Strict eligibility criteria. Easing the criteria and more effective screening are helpful;
• Long distances to travel to cancer clinics. Telemedicine could make a difference on this front;
• Patient concerns about being a “guinea pig.” Patient education can help;
• Provider concerns such as worry about extra work. The VA can work to ease burdens and provide incentives for trial enrollment; and
• High costs. Study sponsors may pay for trial drugs, helping facilities to lower expenses or even reach cost neutrality. 

There are more solutions to boost participation, Dr. Klein said, including education, engagement and partnerships.

On the partnership front, he highlighted NAVIGATE, an interagency consortium of the VA and the National Cancer Institute. This collaboration aims to boost enrollment of VA patients in clinical trials, he said, and there are designated NAVIGATE sites across the country from coast to coast.

A partnership between AVAHO and the National Association of Veterans’ Research and Education Foundations is also boosting clinical trials in VA oncology. Thanks to this partnership, 1 trial has completed accrual, 6 multisite trials are active, and 5 are starting up, according to Dr. Klein.

In the big picture, Dr. Klein said, it’s clear that “we’ve got a lot of barriers in the VA. Anybody who works in the VA knows that. But I’ve seen this meeting grow and grow, and I’ve seen teamwork and partnerships form.”

MINNEAPOLIS -- Clinical trials should be considered standard of care in oncology, the president of the Association of VA Hematology/Oncology (AVAHO) declared, and he urged colleagues to bypass obstacles and embrace them in patient care.

Clinical trials help many people, not just those in the studies, as they are indicators of robust oncology programs. “There’s a significant correlation between clinical trial activity [at sites] and improvement in survival in cancer,” said oncologist Mark Klein, MD, of the Minneapolis VA Health Care System and University of Minnesota, in a presentation at the 2019 annual meeting of AVAHO.  

But the numbers suggest that the VA has lagged behind on the clinical trial front, Dr. Klein said. He pointed to internal statistics from 2001 to 2003, reported in 2010, which found clinical trial participation rates among men in the VA were lower (0.37%) than those of the national rates (0.74%).

Specifically, the VA and national participation rates were 1.16% and 0.30%, respectively, for colorectal cancer, 0.67% and 0.30% for lung cancer, 0.70% and 0.47% for prostate cancer, 0.52% and 0.74% for myeloma. According to Dr. Klein, lung and prostate cancer account for about half of all cancer diagnoses in the VA.

But the participation rates were much higher among the VA hospitals that took part in clinical trials, he said, at 2% for colorectal cancer, 1.4% for lung cancer, 2.5% for prostate cancer, 18.2% for myeloma and 2.07% overall. These numbers make it clear, he said, that it’s possible to improve: “We can do better.”

Dr. Klein pointed to other numbers that suggest the VA facilities that do participate in clinical trials typically do not take part in more than 1 or 2. In 2016, he said, an analysis found that open interventional trials were in progress at 82 VA facilities. About 35 facilities had little activity with only 1 trial in progress. “It has changed since then, but not dramatically.”

Meanwhile, he said, 2016 numbers also showed that about two-thirds of open interventional trials in the VA only included a single VA site. “We weren’t playing together, having consortia and working as a team.”

There are obstacles to improvement, he said, and fixes will take time. “It probably takes 5, 10-plus years,” he said.

These barriers include:

• Lack of adequate trial offering. Changing regulations is key here;
• Strict eligibility criteria. Easing the criteria and more effective screening are helpful;
• Long distances to travel to cancer clinics. Telemedicine could make a difference on this front;
• Patient concerns about being a “guinea pig.” Patient education can help;
• Provider concerns such as worry about extra work. The VA can work to ease burdens and provide incentives for trial enrollment; and
• High costs. Study sponsors may pay for trial drugs, helping facilities to lower expenses or even reach cost neutrality. 

There are more solutions to boost participation, Dr. Klein said, including education, engagement and partnerships.

On the partnership front, he highlighted NAVIGATE, an interagency consortium of the VA and the National Cancer Institute. This collaboration aims to boost enrollment of VA patients in clinical trials, he said, and there are designated NAVIGATE sites across the country from coast to coast.

A partnership between AVAHO and the National Association of Veterans’ Research and Education Foundations is also boosting clinical trials in VA oncology. Thanks to this partnership, 1 trial has completed accrual, 6 multisite trials are active, and 5 are starting up, according to Dr. Klein.

In the big picture, Dr. Klein said, it’s clear that “we’ve got a lot of barriers in the VA. Anybody who works in the VA knows that. But I’ve seen this meeting grow and grow, and I’ve seen teamwork and partnerships form.”

MINNEAPOLIS -- Clinical trials should be considered standard of care in oncology, the president of the Association of VA Hematology/Oncology (AVAHO) declared, and he urged colleagues to bypass obstacles and embrace them in patient care.

Clinical trials help many people, not just those in the studies, as they are indicators of robust oncology programs. “There’s a significant correlation between clinical trial activity [at sites] and improvement in survival in cancer,” said oncologist Mark Klein, MD, of the Minneapolis VA Health Care System and University of Minnesota, in a presentation at the 2019 annual meeting of AVAHO.  

But the numbers suggest that the VA has lagged behind on the clinical trial front, Dr. Klein said. He pointed to internal statistics from 2001 to 2003, reported in 2010, which found clinical trial participation rates among men in the VA were lower (0.37%) than those of the national rates (0.74%).

Specifically, the VA and national participation rates were 1.16% and 0.30%, respectively, for colorectal cancer, 0.67% and 0.30% for lung cancer, 0.70% and 0.47% for prostate cancer, 0.52% and 0.74% for myeloma. According to Dr. Klein, lung and prostate cancer account for about half of all cancer diagnoses in the VA.

But the participation rates were much higher among the VA hospitals that took part in clinical trials, he said, at 2% for colorectal cancer, 1.4% for lung cancer, 2.5% for prostate cancer, 18.2% for myeloma and 2.07% overall. These numbers make it clear, he said, that it’s possible to improve: “We can do better.”

Dr. Klein pointed to other numbers that suggest the VA facilities that do participate in clinical trials typically do not take part in more than 1 or 2. In 2016, he said, an analysis found that open interventional trials were in progress at 82 VA facilities. About 35 facilities had little activity with only 1 trial in progress. “It has changed since then, but not dramatically.”

Meanwhile, he said, 2016 numbers also showed that about two-thirds of open interventional trials in the VA only included a single VA site. “We weren’t playing together, having consortia and working as a team.”

There are obstacles to improvement, he said, and fixes will take time. “It probably takes 5, 10-plus years,” he said.

These barriers include:

• Lack of adequate trial offering. Changing regulations is key here;
• Strict eligibility criteria. Easing the criteria and more effective screening are helpful;
• Long distances to travel to cancer clinics. Telemedicine could make a difference on this front;
• Patient concerns about being a “guinea pig.” Patient education can help;
• Provider concerns such as worry about extra work. The VA can work to ease burdens and provide incentives for trial enrollment; and
• High costs. Study sponsors may pay for trial drugs, helping facilities to lower expenses or even reach cost neutrality. 

There are more solutions to boost participation, Dr. Klein said, including education, engagement and partnerships.

On the partnership front, he highlighted NAVIGATE, an interagency consortium of the VA and the National Cancer Institute. This collaboration aims to boost enrollment of VA patients in clinical trials, he said, and there are designated NAVIGATE sites across the country from coast to coast.

A partnership between AVAHO and the National Association of Veterans’ Research and Education Foundations is also boosting clinical trials in VA oncology. Thanks to this partnership, 1 trial has completed accrual, 6 multisite trials are active, and 5 are starting up, according to Dr. Klein.

In the big picture, Dr. Klein said, it’s clear that “we’ve got a lot of barriers in the VA. Anybody who works in the VA knows that. But I’ve seen this meeting grow and grow, and I’ve seen teamwork and partnerships form.”

Introduce whole milk before lowfat or nonfat milk, avoid fruit juice or limit it to just a few sips a day, and stay away from “toddler milk” and chocolate milk entirely. A coalition of health and nutrition organizations offered all this and more in a new set of sometimes surprising recommendations about beverage consumption in children from birth to age 5 years.

LP7/E+/Getty Images

The recommendations “are based on the best available evidence, combined with sound expert judgment, and provide consistent messages that can be used by a variety of stakeholders to improve the beverage intake patterns of young children,” the report authors wrote. “It is imperative to capitalize on early childhood as a critical window of opportunity during which dietary patterns are both impressionable and capable of setting the stage for lifelong eating behaviors.”

The Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association released their recommendations titled “Healthy Beverage Consumption in Early Childhood” in a report published Sept. 18.

The organizations convened expert panels and analyzed research to develop consensus beverage recommendations. Here are some highlights from the report, the writing of which was led by Megan Lott, MPH, RDN, of Healthy Eating Research and Duke Global Health Institute at Duke University, Durham, N.C.

• Breast milk or formula. This is what babies should be drinking for the first year of life.
• Plain drinking water. None is needed in the first 6 months of life. Introduce 0.5-1.0 cups/day over the next 6 months in cups and during meals when solid food is introduced. Then 1-4 cups/day are recommended from age 1-3 years, then 1.5-5 cups by age 4-5 years.
• Plain, pasteurized milk. None during the first year, then 2-3 cups a day of whole milk at age 12-24 months; if weight gain is excessive or family history is positive for obesity, dyslipidemia, or other cardiovascular disease, the pediatrician may recommend skim or lowfat milk at 12-24 months. Then provide up to 2 cups (age 2-3 years) then 2.5 cups (age 4-5 years) per day of skim /fat-free milk or low fat/1% milk
• 100% juice. None until 12 months. Then it can be provided, although whole fruit is preferred. No more than 0.5 cup per day until age 4-5 years, when no more than 0.5-0.75 cup per day is recommended.
• Plant-based milks and non-dairy beverages. None from age 0-1 year. And at ages 1-5 years, they only should be consumed when medically indicated, such as when a child has an allergy or per a preferred diet such as a vegan one. The panel didn’t recommend them as full replacements for dairy milk from age 12-24 months, and it noted that “consumption of these beverages as a full replacement for dairy milk should be undertaken in consultation with a health care provider so that adequate intake of key nutrients commonly obtained from dairy milk can be considered in dietary planning.”
• Other beverages. Flavored milk (like chocolate milk), “toddler milk,” sugar-sweetened drinks (including soft drinks, flavored water, and various fruit drinks), low-calorie sweetened drinks, and caffeinated drinks are not recommended at any age from 0-5 years. Toddler milk products “offer no unique nutritional value beyond what a nutritionally adequate diet provides and may contribute added sugars to the diet and undermine sustained breastfeeding,” the report authors said.

Lillian M. Beard, MD, said in an interview, “Pediatricians and other child health providers have major roles of influence in parents’ choices of foods and beverages for their infants and young children.

“Following these first-ever consensus recommendations on healthy drinks will alter family grocery shopping patterns, and not only improve the overall health of children under age 5 years, but also may improve the health outcomes of everyone in the household.” Dr. Beard is a clinical professor of pediatrics at George Washington University, Washington. She was not one of the report authors and was asked to comment on the report.

The report was supported by the Healthy Eating Research, a national program of the Robert Wood Johnson Foundation.

SOURCE: Lott M et al. Healthy Beverage Consumption in Early Childhood: Recommendations from Key National Health and Nutrition Organizations. Technical Scientific Report. (Durham, NC: Healthy Eating Research, 2019).

Introduce whole milk before lowfat or nonfat milk, avoid fruit juice or limit it to just a few sips a day, and stay away from “toddler milk” and chocolate milk entirely. A coalition of health and nutrition organizations offered all this and more in a new set of sometimes surprising recommendations about beverage consumption in children from birth to age 5 years.

LP7/E+/Getty Images

The recommendations “are based on the best available evidence, combined with sound expert judgment, and provide consistent messages that can be used by a variety of stakeholders to improve the beverage intake patterns of young children,” the report authors wrote. “It is imperative to capitalize on early childhood as a critical window of opportunity during which dietary patterns are both impressionable and capable of setting the stage for lifelong eating behaviors.”

The Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association released their recommendations titled “Healthy Beverage Consumption in Early Childhood” in a report published Sept. 18.

The organizations convened expert panels and analyzed research to develop consensus beverage recommendations. Here are some highlights from the report, the writing of which was led by Megan Lott, MPH, RDN, of Healthy Eating Research and Duke Global Health Institute at Duke University, Durham, N.C.

• Breast milk or formula. This is what babies should be drinking for the first year of life.
• Plain drinking water. None is needed in the first 6 months of life. Introduce 0.5-1.0 cups/day over the next 6 months in cups and during meals when solid food is introduced. Then 1-4 cups/day are recommended from age 1-3 years, then 1.5-5 cups by age 4-5 years.
• Plain, pasteurized milk. None during the first year, then 2-3 cups a day of whole milk at age 12-24 months; if weight gain is excessive or family history is positive for obesity, dyslipidemia, or other cardiovascular disease, the pediatrician may recommend skim or lowfat milk at 12-24 months. Then provide up to 2 cups (age 2-3 years) then 2.5 cups (age 4-5 years) per day of skim /fat-free milk or low fat/1% milk
• 100% juice. None until 12 months. Then it can be provided, although whole fruit is preferred. No more than 0.5 cup per day until age 4-5 years, when no more than 0.5-0.75 cup per day is recommended.
• Plant-based milks and non-dairy beverages. None from age 0-1 year. And at ages 1-5 years, they only should be consumed when medically indicated, such as when a child has an allergy or per a preferred diet such as a vegan one. The panel didn’t recommend them as full replacements for dairy milk from age 12-24 months, and it noted that “consumption of these beverages as a full replacement for dairy milk should be undertaken in consultation with a health care provider so that adequate intake of key nutrients commonly obtained from dairy milk can be considered in dietary planning.”
• Other beverages. Flavored milk (like chocolate milk), “toddler milk,” sugar-sweetened drinks (including soft drinks, flavored water, and various fruit drinks), low-calorie sweetened drinks, and caffeinated drinks are not recommended at any age from 0-5 years. Toddler milk products “offer no unique nutritional value beyond what a nutritionally adequate diet provides and may contribute added sugars to the diet and undermine sustained breastfeeding,” the report authors said.

Lillian M. Beard, MD, said in an interview, “Pediatricians and other child health providers have major roles of influence in parents’ choices of foods and beverages for their infants and young children.

“Following these first-ever consensus recommendations on healthy drinks will alter family grocery shopping patterns, and not only improve the overall health of children under age 5 years, but also may improve the health outcomes of everyone in the household.” Dr. Beard is a clinical professor of pediatrics at George Washington University, Washington. She was not one of the report authors and was asked to comment on the report.

The report was supported by the Healthy Eating Research, a national program of the Robert Wood Johnson Foundation.

SOURCE: Lott M et al. Healthy Beverage Consumption in Early Childhood: Recommendations from Key National Health and Nutrition Organizations. Technical Scientific Report. (Durham, NC: Healthy Eating Research, 2019).

Introduce whole milk before lowfat or nonfat milk, avoid fruit juice or limit it to just a few sips a day, and stay away from “toddler milk” and chocolate milk entirely. A coalition of health and nutrition organizations offered all this and more in a new set of sometimes surprising recommendations about beverage consumption in children from birth to age 5 years.

LP7/E+/Getty Images

The recommendations “are based on the best available evidence, combined with sound expert judgment, and provide consistent messages that can be used by a variety of stakeholders to improve the beverage intake patterns of young children,” the report authors wrote. “It is imperative to capitalize on early childhood as a critical window of opportunity during which dietary patterns are both impressionable and capable of setting the stage for lifelong eating behaviors.”

The Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association released their recommendations titled “Healthy Beverage Consumption in Early Childhood” in a report published Sept. 18.

The organizations convened expert panels and analyzed research to develop consensus beverage recommendations. Here are some highlights from the report, the writing of which was led by Megan Lott, MPH, RDN, of Healthy Eating Research and Duke Global Health Institute at Duke University, Durham, N.C.

• Breast milk or formula. This is what babies should be drinking for the first year of life.
• Plain drinking water. None is needed in the first 6 months of life. Introduce 0.5-1.0 cups/day over the next 6 months in cups and during meals when solid food is introduced. Then 1-4 cups/day are recommended from age 1-3 years, then 1.5-5 cups by age 4-5 years.
• Plain, pasteurized milk. None during the first year, then 2-3 cups a day of whole milk at age 12-24 months; if weight gain is excessive or family history is positive for obesity, dyslipidemia, or other cardiovascular disease, the pediatrician may recommend skim or lowfat milk at 12-24 months. Then provide up to 2 cups (age 2-3 years) then 2.5 cups (age 4-5 years) per day of skim /fat-free milk or low fat/1% milk
• 100% juice. None until 12 months. Then it can be provided, although whole fruit is preferred. No more than 0.5 cup per day until age 4-5 years, when no more than 0.5-0.75 cup per day is recommended.
• Plant-based milks and non-dairy beverages. None from age 0-1 year. And at ages 1-5 years, they only should be consumed when medically indicated, such as when a child has an allergy or per a preferred diet such as a vegan one. The panel didn’t recommend them as full replacements for dairy milk from age 12-24 months, and it noted that “consumption of these beverages as a full replacement for dairy milk should be undertaken in consultation with a health care provider so that adequate intake of key nutrients commonly obtained from dairy milk can be considered in dietary planning.”
• Other beverages. Flavored milk (like chocolate milk), “toddler milk,” sugar-sweetened drinks (including soft drinks, flavored water, and various fruit drinks), low-calorie sweetened drinks, and caffeinated drinks are not recommended at any age from 0-5 years. Toddler milk products “offer no unique nutritional value beyond what a nutritionally adequate diet provides and may contribute added sugars to the diet and undermine sustained breastfeeding,” the report authors said.

Lillian M. Beard, MD, said in an interview, “Pediatricians and other child health providers have major roles of influence in parents’ choices of foods and beverages for their infants and young children.

“Following these first-ever consensus recommendations on healthy drinks will alter family grocery shopping patterns, and not only improve the overall health of children under age 5 years, but also may improve the health outcomes of everyone in the household.” Dr. Beard is a clinical professor of pediatrics at George Washington University, Washington. She was not one of the report authors and was asked to comment on the report.

The report was supported by the Healthy Eating Research, a national program of the Robert Wood Johnson Foundation.

SOURCE: Lott M et al. Healthy Beverage Consumption in Early Childhood: Recommendations from Key National Health and Nutrition Organizations. Technical Scientific Report. (Durham, NC: Healthy Eating Research, 2019).

“Fast MRI,” which allows scans to be taken quickly without sedation, is a “reasonable alternative” to screen certain younger children for traumatic brain injury, a new study found.

gorodenkoff/Getty Images

The fast MRI option has “the potential to eliminate ionizing radiation exposure for thousands of children each year,” the study authors wrote in Pediatrics. “The ability to complete imaging in about 6 minutes, without the need for anesthesia or sedation, suggests that fast MRI is appropriate even in acute settings, where patient throughput is a priority.”

Daniel M. Lindberg, MD, of the University of Colorado at Denver, Aurora, and associates wrote that children make between 600,000 and 1.6 million ED visits in the United States each year for evaluation of possible traumatic brain injury (TBI). While the incidence of clinically significant injury from TBI is low, 20%-70% of these children are exposed to potentially dangerous radiation as they undergo CT.

The new study focuses on fast MRI. Unlike traditional MRI, it doesn’t require children to remain motionless – typically with the help of sedation – to be scanned.

The researchers performed fast MRI in 223 children aged younger than 6 years (median age, 12.6 months; interquartile range, 4.7-32.6) who sought emergency care at a level 1 pediatric trauma center from 2015 to 2018. They had all had CT scans performed.

CT identified TBI in 111 (50%) of the subjects, while fast MRI identified it in 103 (sensitivity, 92.8%; 95% confidence interval, 86.3-96.8). Fast MRI missed six participants with isolated skull fractures and two with subarachnoid hemorrhage; CT missed five participants with subdural hematomas, parenchymal contusions, and subarachnoid hemorrhage.

While the researchers hoped for a higher sensitivity level, they wrote that “we feel that the benefit of avoiding radiation exposure outweighs the concern for missed injury.”

In a commentary, Brett Burstein, MDCM, PhD, MPH, and Christine Saint-Martin, MDCM, MSc, of Montreal Children’s Hospital and McGill University Health Center, also in Montreal, wrote that the study is “well conducted.”

However, they noted that “the reported feasibility reflects a highly selected cohort of stable patients in whom fast MRI is already likely to succeed. Feasibility results in a more generalizable population of head-injured children cannot be extrapolated.”

And, they added, “fast MRI was unavailable for 65 of 299 consenting, eligible patients because of lack of overnight staffing. Although not included among the outcome definitions of imaging time, this would be an important ‘feasibility’ consideration in most centers.”

Dr. Burstein and Dr. Saint-Martin wrote that “centers migrating toward this modality for neuroimaging children with head injuries should still use clinical judgment and highly sensitive, validated clinical decision rules when determining the need for any neuroimaging for head-injured children.”

The study was funded by the Colorado Traumatic Brain Injury Trust Fund (MindSource) and the Colorado Clinical and Translational Sciences Institute. The study and commentary authors reported no relevant financial disclosures.

SOURCES: Lindberg DM et al. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-0419; Burstein B, Saint-Martin C. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-2387.

“Fast MRI,” which allows scans to be taken quickly without sedation, is a “reasonable alternative” to screen certain younger children for traumatic brain injury, a new study found.

gorodenkoff/Getty Images

The fast MRI option has “the potential to eliminate ionizing radiation exposure for thousands of children each year,” the study authors wrote in Pediatrics. “The ability to complete imaging in about 6 minutes, without the need for anesthesia or sedation, suggests that fast MRI is appropriate even in acute settings, where patient throughput is a priority.”

Daniel M. Lindberg, MD, of the University of Colorado at Denver, Aurora, and associates wrote that children make between 600,000 and 1.6 million ED visits in the United States each year for evaluation of possible traumatic brain injury (TBI). While the incidence of clinically significant injury from TBI is low, 20%-70% of these children are exposed to potentially dangerous radiation as they undergo CT.

The new study focuses on fast MRI. Unlike traditional MRI, it doesn’t require children to remain motionless – typically with the help of sedation – to be scanned.

The researchers performed fast MRI in 223 children aged younger than 6 years (median age, 12.6 months; interquartile range, 4.7-32.6) who sought emergency care at a level 1 pediatric trauma center from 2015 to 2018. They had all had CT scans performed.

CT identified TBI in 111 (50%) of the subjects, while fast MRI identified it in 103 (sensitivity, 92.8%; 95% confidence interval, 86.3-96.8). Fast MRI missed six participants with isolated skull fractures and two with subarachnoid hemorrhage; CT missed five participants with subdural hematomas, parenchymal contusions, and subarachnoid hemorrhage.

While the researchers hoped for a higher sensitivity level, they wrote that “we feel that the benefit of avoiding radiation exposure outweighs the concern for missed injury.”

In a commentary, Brett Burstein, MDCM, PhD, MPH, and Christine Saint-Martin, MDCM, MSc, of Montreal Children’s Hospital and McGill University Health Center, also in Montreal, wrote that the study is “well conducted.”

However, they noted that “the reported feasibility reflects a highly selected cohort of stable patients in whom fast MRI is already likely to succeed. Feasibility results in a more generalizable population of head-injured children cannot be extrapolated.”

And, they added, “fast MRI was unavailable for 65 of 299 consenting, eligible patients because of lack of overnight staffing. Although not included among the outcome definitions of imaging time, this would be an important ‘feasibility’ consideration in most centers.”

Dr. Burstein and Dr. Saint-Martin wrote that “centers migrating toward this modality for neuroimaging children with head injuries should still use clinical judgment and highly sensitive, validated clinical decision rules when determining the need for any neuroimaging for head-injured children.”

The study was funded by the Colorado Traumatic Brain Injury Trust Fund (MindSource) and the Colorado Clinical and Translational Sciences Institute. The study and commentary authors reported no relevant financial disclosures.

SOURCES: Lindberg DM et al. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-0419; Burstein B, Saint-Martin C. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-2387.

“Fast MRI,” which allows scans to be taken quickly without sedation, is a “reasonable alternative” to screen certain younger children for traumatic brain injury, a new study found.

gorodenkoff/Getty Images

The fast MRI option has “the potential to eliminate ionizing radiation exposure for thousands of children each year,” the study authors wrote in Pediatrics. “The ability to complete imaging in about 6 minutes, without the need for anesthesia or sedation, suggests that fast MRI is appropriate even in acute settings, where patient throughput is a priority.”

Daniel M. Lindberg, MD, of the University of Colorado at Denver, Aurora, and associates wrote that children make between 600,000 and 1.6 million ED visits in the United States each year for evaluation of possible traumatic brain injury (TBI). While the incidence of clinically significant injury from TBI is low, 20%-70% of these children are exposed to potentially dangerous radiation as they undergo CT.

The new study focuses on fast MRI. Unlike traditional MRI, it doesn’t require children to remain motionless – typically with the help of sedation – to be scanned.

The researchers performed fast MRI in 223 children aged younger than 6 years (median age, 12.6 months; interquartile range, 4.7-32.6) who sought emergency care at a level 1 pediatric trauma center from 2015 to 2018. They had all had CT scans performed.

CT identified TBI in 111 (50%) of the subjects, while fast MRI identified it in 103 (sensitivity, 92.8%; 95% confidence interval, 86.3-96.8). Fast MRI missed six participants with isolated skull fractures and two with subarachnoid hemorrhage; CT missed five participants with subdural hematomas, parenchymal contusions, and subarachnoid hemorrhage.

While the researchers hoped for a higher sensitivity level, they wrote that “we feel that the benefit of avoiding radiation exposure outweighs the concern for missed injury.”

In a commentary, Brett Burstein, MDCM, PhD, MPH, and Christine Saint-Martin, MDCM, MSc, of Montreal Children’s Hospital and McGill University Health Center, also in Montreal, wrote that the study is “well conducted.”

However, they noted that “the reported feasibility reflects a highly selected cohort of stable patients in whom fast MRI is already likely to succeed. Feasibility results in a more generalizable population of head-injured children cannot be extrapolated.”

And, they added, “fast MRI was unavailable for 65 of 299 consenting, eligible patients because of lack of overnight staffing. Although not included among the outcome definitions of imaging time, this would be an important ‘feasibility’ consideration in most centers.”

Dr. Burstein and Dr. Saint-Martin wrote that “centers migrating toward this modality for neuroimaging children with head injuries should still use clinical judgment and highly sensitive, validated clinical decision rules when determining the need for any neuroimaging for head-injured children.”

The study was funded by the Colorado Traumatic Brain Injury Trust Fund (MindSource) and the Colorado Clinical and Translational Sciences Institute. The study and commentary authors reported no relevant financial disclosures.

SOURCES: Lindberg DM et al. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-0419; Burstein B, Saint-Martin C. Pediatrics. 2019 Sep 18. doi: 10.1542/peds.2019-2387.