The end of August brought a small-but-second-consecutive increase in weekly COVID-19 cases among children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.

Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.

Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.

Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.

Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.

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The end of August brought a small-but-second-consecutive increase in weekly COVID-19 cases among children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.

Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.

Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.

Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.

Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.

[email protected]

The end of August brought a small-but-second-consecutive increase in weekly COVID-19 cases among children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.

Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.

Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.

Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.

Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.

[email protected]

When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.

Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.

It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022, 42% of physicians see patients with a substance use disorder often in their practices. However, identifying substance use disorders and treating or referring patients for them is a complex problem.

According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.

Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
 

A courageous conversation

Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.

Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.

In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.

Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.

Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.

Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”

“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
 

Patients don’t often ask for help

In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.

“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.

Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.

Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.

“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”

“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.

“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
 

Check the prescription drugs they’re taking

Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.

“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.

He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.

It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
 

Other barriers physicians face

Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.

In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.

Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
 

The issue of reimbursement

Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.

For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.

Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.

At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.

Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.

“There needs to be time to talk about it.”

A version of this article first appeared on Medscape.com.

When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.

Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.

It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022, 42% of physicians see patients with a substance use disorder often in their practices. However, identifying substance use disorders and treating or referring patients for them is a complex problem.

According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.

Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
 

A courageous conversation

Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.

Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.

In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.

Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.

Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.

Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”

“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
 

Patients don’t often ask for help

In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.

“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.

Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.

Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.

“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”

“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.

“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
 

Check the prescription drugs they’re taking

Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.

“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.

He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.

It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
 

Other barriers physicians face

Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.

In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.

Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
 

The issue of reimbursement

Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.

For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.

Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.

At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.

Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.

“There needs to be time to talk about it.”

A version of this article first appeared on Medscape.com.

When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.

Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.

It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022, 42% of physicians see patients with a substance use disorder often in their practices. However, identifying substance use disorders and treating or referring patients for them is a complex problem.

According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.

Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
 

A courageous conversation

Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.

Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.

In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.

Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.

Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.

Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”

“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
 

Patients don’t often ask for help

In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.

“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.

Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.

Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.

“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”

“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.

“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
 

Check the prescription drugs they’re taking

Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.

“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.

He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.

It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
 

Other barriers physicians face

Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.

In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.

Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
 

The issue of reimbursement

Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.

For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.

Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.

At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.

Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.

“There needs to be time to talk about it.”

A version of this article first appeared on Medscape.com.

In recent weeks, the COVID-19 vaccine arsenal has grown more robust. Here’s what you need to know:

Variant-specific boosters. On September 1, the Advisory Committee on Immunization Practices (ACIP) adopted a recommendation for a booster of either a new bivalent Pfizer-BioNTech COVID-19 vaccine (for individuals ages 12 years and older) or bivalent Moderna COVID-19 vaccine (for individuals ages 18 years and older) at least 2 months after receipt of a primary series or prior monovalent booster dose. Both bivalent vaccines were recently approved by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) and offer protection against one of the more common circulating strains of SARS-COV-2 (BA.1) while boosting immunity to the original strain. Both options are approved only as booster shots, not as an original COVID vaccine series.¹

Novavax vaccine. This summer, the FDA issued an EUA for the Novavax COVID-19 vaccine in adults and a later EUA for adolescents (ages 12 to 17 years).² Novavax is the fourth vaccine available to combat COVID-19 infection. This newest addition to the COVID armamentarium consists of coronavirus protein subunits, produced using recombinant technology, and a matrix adjuvant. The primary series consists of 2 doses administered at least 3 weeks apart.^3,4

A few caveats: The Novavax vaccine comes in 10-dose vials, which should be kept refrigerated until use. Once the first dose is used, the vial should be discarded after 6 hours. This may present some scheduling and logistical issues. Also, the Novavax vaccine is not currently approved for use in children younger than 12 years, or as a booster to other vaccines.^3,4

The effectiveness and safety of the Novavax vaccine appears to be comparable to that of the other vaccines approved to date, although measuring vaccine effectiveness is a tricky business given the rapid mutation of the virus and changing dominant strains.^3,4 The Novavax vaccine’s efficacy against currently circulating Omicron variants of the virus (eg, BA.2.12.1, BA.4, BA.5) remains to be determined.

As far as safety, preliminary studies indicate that Novavax may be associated with rare cases of myocarditis.^3,4 Myocarditis can result from the COVID infection itself at an overall rate of 1 to 2 per 1000, which is 16 times the rate in adults without COVID.⁵

Could it provide reassurance to the hesitant? The Novavax COVID vaccine was developed using a vaccine platform and production process similar to that of other commonly administered vaccines, such as hepatitis B vaccine and human papillomavirus vaccine. This may make it an appealing option for patients who have shown hesitancy toward new vaccine technologies.

And, of course, there are the Pfizer and Moderna vaccines. Currently, there are 2 vaccines approved under the normal licensing process for adults, both of which are mRNA-based vaccines: Pfizer/BioNTech (Comirnaty) for those ages 12 years and older and Moderna (Spikevax) for those ages 18 and older. A third COVID vaccine option is manufactured by Johnson & Johnson (Janssen) and uses an adenovirus platform. The FDA revised its EUA in May to limit its use.⁶ The Johnson & Johnson vaccine has been associated with rare but serious reactions called thrombosis with thrombocytopenia. ACIP recommends all other vaccines in preference to the Johnson & Johnson vaccine.

For more on COVID vaccination for patients of all ages, see: www.cdc.gov/vaccines/covid-19/downloads/COVID-19-immunization-schedule-ages-6months-older.pdf

In recent weeks, the COVID-19 vaccine arsenal has grown more robust. Here’s what you need to know:

Variant-specific boosters. On September 1, the Advisory Committee on Immunization Practices (ACIP) adopted a recommendation for a booster of either a new bivalent Pfizer-BioNTech COVID-19 vaccine (for individuals ages 12 years and older) or bivalent Moderna COVID-19 vaccine (for individuals ages 18 years and older) at least 2 months after receipt of a primary series or prior monovalent booster dose. Both bivalent vaccines were recently approved by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) and offer protection against one of the more common circulating strains of SARS-COV-2 (BA.1) while boosting immunity to the original strain. Both options are approved only as booster shots, not as an original COVID vaccine series.¹

Novavax vaccine. This summer, the FDA issued an EUA for the Novavax COVID-19 vaccine in adults and a later EUA for adolescents (ages 12 to 17 years).² Novavax is the fourth vaccine available to combat COVID-19 infection. This newest addition to the COVID armamentarium consists of coronavirus protein subunits, produced using recombinant technology, and a matrix adjuvant. The primary series consists of 2 doses administered at least 3 weeks apart.^3,4

A few caveats: The Novavax vaccine comes in 10-dose vials, which should be kept refrigerated until use. Once the first dose is used, the vial should be discarded after 6 hours. This may present some scheduling and logistical issues. Also, the Novavax vaccine is not currently approved for use in children younger than 12 years, or as a booster to other vaccines.^3,4

The effectiveness and safety of the Novavax vaccine appears to be comparable to that of the other vaccines approved to date, although measuring vaccine effectiveness is a tricky business given the rapid mutation of the virus and changing dominant strains.^3,4 The Novavax vaccine’s efficacy against currently circulating Omicron variants of the virus (eg, BA.2.12.1, BA.4, BA.5) remains to be determined.

As far as safety, preliminary studies indicate that Novavax may be associated with rare cases of myocarditis.^3,4 Myocarditis can result from the COVID infection itself at an overall rate of 1 to 2 per 1000, which is 16 times the rate in adults without COVID.⁵

Could it provide reassurance to the hesitant? The Novavax COVID vaccine was developed using a vaccine platform and production process similar to that of other commonly administered vaccines, such as hepatitis B vaccine and human papillomavirus vaccine. This may make it an appealing option for patients who have shown hesitancy toward new vaccine technologies.

And, of course, there are the Pfizer and Moderna vaccines. Currently, there are 2 vaccines approved under the normal licensing process for adults, both of which are mRNA-based vaccines: Pfizer/BioNTech (Comirnaty) for those ages 12 years and older and Moderna (Spikevax) for those ages 18 and older. A third COVID vaccine option is manufactured by Johnson & Johnson (Janssen) and uses an adenovirus platform. The FDA revised its EUA in May to limit its use.⁶ The Johnson & Johnson vaccine has been associated with rare but serious reactions called thrombosis with thrombocytopenia. ACIP recommends all other vaccines in preference to the Johnson & Johnson vaccine.

For more on COVID vaccination for patients of all ages, see: www.cdc.gov/vaccines/covid-19/downloads/COVID-19-immunization-schedule-ages-6months-older.pdf

In recent weeks, the COVID-19 vaccine arsenal has grown more robust. Here’s what you need to know:

Variant-specific boosters. On September 1, the Advisory Committee on Immunization Practices (ACIP) adopted a recommendation for a booster of either a new bivalent Pfizer-BioNTech COVID-19 vaccine (for individuals ages 12 years and older) or bivalent Moderna COVID-19 vaccine (for individuals ages 18 years and older) at least 2 months after receipt of a primary series or prior monovalent booster dose. Both bivalent vaccines were recently approved by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) and offer protection against one of the more common circulating strains of SARS-COV-2 (BA.1) while boosting immunity to the original strain. Both options are approved only as booster shots, not as an original COVID vaccine series.¹

Novavax vaccine. This summer, the FDA issued an EUA for the Novavax COVID-19 vaccine in adults and a later EUA for adolescents (ages 12 to 17 years).² Novavax is the fourth vaccine available to combat COVID-19 infection. This newest addition to the COVID armamentarium consists of coronavirus protein subunits, produced using recombinant technology, and a matrix adjuvant. The primary series consists of 2 doses administered at least 3 weeks apart.^3,4

A few caveats: The Novavax vaccine comes in 10-dose vials, which should be kept refrigerated until use. Once the first dose is used, the vial should be discarded after 6 hours. This may present some scheduling and logistical issues. Also, the Novavax vaccine is not currently approved for use in children younger than 12 years, or as a booster to other vaccines.^3,4

The effectiveness and safety of the Novavax vaccine appears to be comparable to that of the other vaccines approved to date, although measuring vaccine effectiveness is a tricky business given the rapid mutation of the virus and changing dominant strains.^3,4 The Novavax vaccine’s efficacy against currently circulating Omicron variants of the virus (eg, BA.2.12.1, BA.4, BA.5) remains to be determined.

As far as safety, preliminary studies indicate that Novavax may be associated with rare cases of myocarditis.^3,4 Myocarditis can result from the COVID infection itself at an overall rate of 1 to 2 per 1000, which is 16 times the rate in adults without COVID.⁵

Could it provide reassurance to the hesitant? The Novavax COVID vaccine was developed using a vaccine platform and production process similar to that of other commonly administered vaccines, such as hepatitis B vaccine and human papillomavirus vaccine. This may make it an appealing option for patients who have shown hesitancy toward new vaccine technologies.

And, of course, there are the Pfizer and Moderna vaccines. Currently, there are 2 vaccines approved under the normal licensing process for adults, both of which are mRNA-based vaccines: Pfizer/BioNTech (Comirnaty) for those ages 12 years and older and Moderna (Spikevax) for those ages 18 and older. A third COVID vaccine option is manufactured by Johnson & Johnson (Janssen) and uses an adenovirus platform. The FDA revised its EUA in May to limit its use.⁶ The Johnson & Johnson vaccine has been associated with rare but serious reactions called thrombosis with thrombocytopenia. ACIP recommends all other vaccines in preference to the Johnson & Johnson vaccine.

For more on COVID vaccination for patients of all ages, see: www.cdc.gov/vaccines/covid-19/downloads/COVID-19-immunization-schedule-ages-6months-older.pdf

Caring for patients with short bowel syndrome (SBS) requires a multidisciplinary approach involving dietitians, nurses, surgeons, gastroenterologists or internists, and social workers experienced in SBS care, according to a clinical practice update expert review from the American Gastroenterological Association.

Kishore Iyer, MD, from Mount Sinai Hospital New York; John K. DiBaise, MD, from Mayo Clinic in Scottsdale, Ariz.; and Alberto Rubio-Tapia, MD, from the Cleveland Clinic, Ohio, developed 12 best practice advice statements based on available evidence. The items focus on adult patients with SBS; however, there was some overlap with the management of pediatric SBS. The review was published online in Clinical Gastroenterology and Hepatology.
 

Defining SBS

One update concerns defining SBS. The authors recommend that surgeons performing massive resections should report the residual bowel length, rather than the length of bowel resected.

“It is only the former that dictates outcome,” they wrote.

There is general agreement that a residual small intestinal length of 200 cm or less meets criteria for SBS. Measurement should be taken from “along the antimesenteric border of unstretched bowel, from the duodenojejunal flexure to the ileocecal junction, the site of any small bowel–colon anastomosis, or to the end-ostomy.”

Based on the residual bowel length, patients can be classified into three groups: end-jejunostomy, jejuno-colic, and jejuno-ileo-colic.
 

Assessing nutritional status

A dietitian experienced in SBS should perform a thorough nutritional assessment on all SBS patients. Long-term monitoring should include laboratory studies checking electrolytes and liver and kidney function, fluid balance, weight change, serum micronutrients, and bone density. Bone density should be repeated periodically, every 2-3 years.

Fluid and electrolyte problems may affect outcomes for SBS patients, particularly for those without a colon.
 

Adjusting diets

Most adult patients with SBS have significant malabsorption, so dietary intake “must be increased by at least 50% from their estimated needs,” the authors wrote. It’s best if the patient consumes the increased quantity throughout the day in 5-6 meals, they noted.

An experienced dietitian should counsel the patient based on the patient’s eating preferences. Incorporating preferences can help increase compliance with the adjustments that may become necessary based on symptoms, stool output, and weight.
 

Using pharmacologic therapy

Using antisecretory medications, including proton pump inhibitors or histamine-2 receptor antagonists, helps reduce gastric secretions, the damage of acid on the upper gut mucosa, and the function of pancreatic exocrine enzymes.

Antidiarrheals reduce intestinal motility but also cause a slight reduction in intestinal secretion. Common agents include loperamide, diphenoxylate with atropine, codeine, and tincture of opium. The review authors say loperamide should get preference over opiate drugs because it is not addictive or sedative.

Use of antidiarrheals should be guided by their effect on stool output.

“Loperamide and codeine may have a synergistic effect when used together,” the authors wrote.

Clonidine, which can be given transdermally, has also shown some benefit in treating high-output stool losses, presumably because of its effects on intestinal motility and secretion.

Weighing risks and benefits of teduglutide

The glucagonlike peptide–2 teduglutide is of particular interest for its ability to help improve intestinal absorption and hopefully wean patients off parenteral nutrition and some will achieve enteral autonomy, the authors wrote. “The very short half-life of native GLP-2 has been extended to allow daily subcutaneous injection in the recombinant molecule, teduglutide.”

However, because teduglutide is a growth factor and can boost the growth of polyps and cancer, it is contraindicated in patients with active gastrointestinal malignancies. Patients should undergo colonoscopy before treatment and periodically thereafter, the authors advised. The benefits of its use in patients with nongastrointestinal malignancy should be weighed carefully with these risks.

“The significant side effects of teduglutide and the cost mandate that teduglutide is employed only after optimizing diet and the more conventional SBS treatments described previously in carefully selected patients with [short bowel syndrome–intestinal failure],” the authors wrote.
 

Dosing drugs effectively

Medications in tablet form need to dissolve before being absorbed. Most oral medications are absorbed within the proximal jejunum, so they can be used in patients with SBS.

“However,” the authors noted, “sustained- and delayed-release medications should be avoided.”

They suggested that, when applicable, alternatives such as liquids and topical medications should be considered, as should the monitoring of medication levels in the blood.

If a patient does not respond, approaches to consider may include increasing a dose, changing dose frequency, or changing drug formulation or route of administration, such as intravenous, subcutaneous, or transdermal.
 

Including parenteral nutrition and oral rehydration

Almost all patients with SBS will need parenteral nutrition (PN) support following resection, and few will be able to stop it before discharge from the hospital.

“Although more than 50% of adults with SBS are able to be weaned completely from PN within 5 years of diagnosis, the probability of eliminating PN use is less than 6% if not successfully accomplished in the first 2 years following the individual’s last bowel resection,” the authors wrote.

For long-term PN, tunneled central venous catheters are preferred over peripherally inserted central venous catheters because of the higher risk of thrombosis and issues related to self-administration of PN with the central catheters. Also, tunneled catheters are preferred over totally implanted devices, or ports, for long-term patients because the main benefit of the port is not realized given that the device needs to be continually accessed and exchanged weekly.

“When calculating PN volume and content, changes in the patient’s weight, laboratory results, stool or ostomy output, urine output, and complaints of thirst should be monitored,” the authors noted.

The authors also discussed oral rehydration solution because patients lose more water and sodium from their stoma than they take in by mouth. Careful consideration of the glucose and sodium levels in oral fluids is important because inappropriate fluids will exacerbate fluid losses in SBS. For example, hypotonic (including water, tea, coffee, alcohol) and hypertonic (including fruit juices and sodas) solutions should be limited.

“A major misconception on the part of patients is that they should drink large quantities of water; however, this generally leads to an increase in ostomy output and creates a vicious cycle further exacerbating fluid and electrolyte disturbances,” they wrote, instead advising glucose–electrolyte rehydration solution to enhance absorption and reduce secretion.
 

Preventing complications

“A knowledge of these complications is critical for those caring for these patients to be able to not only identify and treat them when they occur but also to prevent their occurrence whenever possible,” the authors wrote. Although they considered it beyond the scope of the review to outline every complication, they indicated some complications and management strategies via an included table. These complications can include cirrhosis, osteoporosis, acute kidney disease, and central venous catheter–related infection or occlusion.

Considering further surgery or intestinal transplantation

The authors noted that any further surgery should be carefully considered, with the following three contexts having possible value: “(1) to recruit unused distal bowel, (2) to augment the function of residual bowel through specific lengthening and tapering operations, or (3) to slow intestinal transit.”

Surgeons involved in managing SBS may need to confront complex intra-abdominal problems such as massive desmoid tumors, mesenteric ischemia, or complex enterocutaneous fistulae; a multidisciplinary intestinal rehabilitation team may be better able to help these patients. The authors noted that care for patients starts even before the first operation, by taking every measure to avoid massive bowel resection and the resulting SBS.

The authors noted the importance of early referral for intestinal transplantation consideration for patients with refractory dependency on parenteral nutrition or even onset of parenteral nutrition failure, which refers to complications such as intestinal failure–associated liver disease.

“At present, nearly 50% of patients being considered for ITX are also requiring simultaneous liver replacement, indicating late referral for ITX,” they wrote, citing a data from a report by the Centers for Medicare and Medicaid.

They also noted that data have shown short- and medium-term outcomes are steadily improving; however, long-term outcomes have been challenged by opportunistic infections, long-term graft attrition, and other impediments that may be preventing early referral for intestinal transplantation.
 

Educating patients, caregivers

Long-term PN may restrict activity for patients, but patients and caregivers should know about some modifications.

One is to cycle the PN over 10-14 hours overnight to allow freedom from the infusion pump during the day. Infusion pumps can be programmable, and some can be carried in a backpack for infusing during the day.

Authors recommend patient support groups, such as the Oley Foundation, which can help with issues surrounding body image and travel.

Because of the relative rarity of SBS, nonspecialist physicians may care for patients without a dedicated multidisciplinary team and may need education support in managing patients with complex care needs. One source the authors recommend is the Learn Intestinal Failure Tele-ECHO (Expanding Community Healthcare Outcomes) (LIFT-ECHO) project. The LIFT-ECHO project has become an online educational community with case-based learning in SBS, intestinal failure, and PN.

The authors disclose relationships with Takeda, Zealand, VectivBio, Napo, and Hanmi.

Caring for patients with short bowel syndrome (SBS) requires a multidisciplinary approach involving dietitians, nurses, surgeons, gastroenterologists or internists, and social workers experienced in SBS care, according to a clinical practice update expert review from the American Gastroenterological Association.

Kishore Iyer, MD, from Mount Sinai Hospital New York; John K. DiBaise, MD, from Mayo Clinic in Scottsdale, Ariz.; and Alberto Rubio-Tapia, MD, from the Cleveland Clinic, Ohio, developed 12 best practice advice statements based on available evidence. The items focus on adult patients with SBS; however, there was some overlap with the management of pediatric SBS. The review was published online in Clinical Gastroenterology and Hepatology.
 

Defining SBS

One update concerns defining SBS. The authors recommend that surgeons performing massive resections should report the residual bowel length, rather than the length of bowel resected.

“It is only the former that dictates outcome,” they wrote.

There is general agreement that a residual small intestinal length of 200 cm or less meets criteria for SBS. Measurement should be taken from “along the antimesenteric border of unstretched bowel, from the duodenojejunal flexure to the ileocecal junction, the site of any small bowel–colon anastomosis, or to the end-ostomy.”

Based on the residual bowel length, patients can be classified into three groups: end-jejunostomy, jejuno-colic, and jejuno-ileo-colic.
 

Assessing nutritional status

A dietitian experienced in SBS should perform a thorough nutritional assessment on all SBS patients. Long-term monitoring should include laboratory studies checking electrolytes and liver and kidney function, fluid balance, weight change, serum micronutrients, and bone density. Bone density should be repeated periodically, every 2-3 years.

Fluid and electrolyte problems may affect outcomes for SBS patients, particularly for those without a colon.
 

Adjusting diets

Most adult patients with SBS have significant malabsorption, so dietary intake “must be increased by at least 50% from their estimated needs,” the authors wrote. It’s best if the patient consumes the increased quantity throughout the day in 5-6 meals, they noted.

An experienced dietitian should counsel the patient based on the patient’s eating preferences. Incorporating preferences can help increase compliance with the adjustments that may become necessary based on symptoms, stool output, and weight.
 

Using pharmacologic therapy

Using antisecretory medications, including proton pump inhibitors or histamine-2 receptor antagonists, helps reduce gastric secretions, the damage of acid on the upper gut mucosa, and the function of pancreatic exocrine enzymes.

Antidiarrheals reduce intestinal motility but also cause a slight reduction in intestinal secretion. Common agents include loperamide, diphenoxylate with atropine, codeine, and tincture of opium. The review authors say loperamide should get preference over opiate drugs because it is not addictive or sedative.

Use of antidiarrheals should be guided by their effect on stool output.

“Loperamide and codeine may have a synergistic effect when used together,” the authors wrote.

Clonidine, which can be given transdermally, has also shown some benefit in treating high-output stool losses, presumably because of its effects on intestinal motility and secretion.

Weighing risks and benefits of teduglutide

The glucagonlike peptide–2 teduglutide is of particular interest for its ability to help improve intestinal absorption and hopefully wean patients off parenteral nutrition and some will achieve enteral autonomy, the authors wrote. “The very short half-life of native GLP-2 has been extended to allow daily subcutaneous injection in the recombinant molecule, teduglutide.”

However, because teduglutide is a growth factor and can boost the growth of polyps and cancer, it is contraindicated in patients with active gastrointestinal malignancies. Patients should undergo colonoscopy before treatment and periodically thereafter, the authors advised. The benefits of its use in patients with nongastrointestinal malignancy should be weighed carefully with these risks.

“The significant side effects of teduglutide and the cost mandate that teduglutide is employed only after optimizing diet and the more conventional SBS treatments described previously in carefully selected patients with [short bowel syndrome–intestinal failure],” the authors wrote.
 

Dosing drugs effectively

Medications in tablet form need to dissolve before being absorbed. Most oral medications are absorbed within the proximal jejunum, so they can be used in patients with SBS.

“However,” the authors noted, “sustained- and delayed-release medications should be avoided.”

They suggested that, when applicable, alternatives such as liquids and topical medications should be considered, as should the monitoring of medication levels in the blood.

If a patient does not respond, approaches to consider may include increasing a dose, changing dose frequency, or changing drug formulation or route of administration, such as intravenous, subcutaneous, or transdermal.
 

Including parenteral nutrition and oral rehydration

Almost all patients with SBS will need parenteral nutrition (PN) support following resection, and few will be able to stop it before discharge from the hospital.

“Although more than 50% of adults with SBS are able to be weaned completely from PN within 5 years of diagnosis, the probability of eliminating PN use is less than 6% if not successfully accomplished in the first 2 years following the individual’s last bowel resection,” the authors wrote.

For long-term PN, tunneled central venous catheters are preferred over peripherally inserted central venous catheters because of the higher risk of thrombosis and issues related to self-administration of PN with the central catheters. Also, tunneled catheters are preferred over totally implanted devices, or ports, for long-term patients because the main benefit of the port is not realized given that the device needs to be continually accessed and exchanged weekly.

“When calculating PN volume and content, changes in the patient’s weight, laboratory results, stool or ostomy output, urine output, and complaints of thirst should be monitored,” the authors noted.

The authors also discussed oral rehydration solution because patients lose more water and sodium from their stoma than they take in by mouth. Careful consideration of the glucose and sodium levels in oral fluids is important because inappropriate fluids will exacerbate fluid losses in SBS. For example, hypotonic (including water, tea, coffee, alcohol) and hypertonic (including fruit juices and sodas) solutions should be limited.

“A major misconception on the part of patients is that they should drink large quantities of water; however, this generally leads to an increase in ostomy output and creates a vicious cycle further exacerbating fluid and electrolyte disturbances,” they wrote, instead advising glucose–electrolyte rehydration solution to enhance absorption and reduce secretion.
 

Preventing complications

“A knowledge of these complications is critical for those caring for these patients to be able to not only identify and treat them when they occur but also to prevent their occurrence whenever possible,” the authors wrote. Although they considered it beyond the scope of the review to outline every complication, they indicated some complications and management strategies via an included table. These complications can include cirrhosis, osteoporosis, acute kidney disease, and central venous catheter–related infection or occlusion.

Considering further surgery or intestinal transplantation

The authors noted that any further surgery should be carefully considered, with the following three contexts having possible value: “(1) to recruit unused distal bowel, (2) to augment the function of residual bowel through specific lengthening and tapering operations, or (3) to slow intestinal transit.”

Surgeons involved in managing SBS may need to confront complex intra-abdominal problems such as massive desmoid tumors, mesenteric ischemia, or complex enterocutaneous fistulae; a multidisciplinary intestinal rehabilitation team may be better able to help these patients. The authors noted that care for patients starts even before the first operation, by taking every measure to avoid massive bowel resection and the resulting SBS.

The authors noted the importance of early referral for intestinal transplantation consideration for patients with refractory dependency on parenteral nutrition or even onset of parenteral nutrition failure, which refers to complications such as intestinal failure–associated liver disease.

“At present, nearly 50% of patients being considered for ITX are also requiring simultaneous liver replacement, indicating late referral for ITX,” they wrote, citing a data from a report by the Centers for Medicare and Medicaid.

They also noted that data have shown short- and medium-term outcomes are steadily improving; however, long-term outcomes have been challenged by opportunistic infections, long-term graft attrition, and other impediments that may be preventing early referral for intestinal transplantation.
 

Educating patients, caregivers

Long-term PN may restrict activity for patients, but patients and caregivers should know about some modifications.

One is to cycle the PN over 10-14 hours overnight to allow freedom from the infusion pump during the day. Infusion pumps can be programmable, and some can be carried in a backpack for infusing during the day.

Authors recommend patient support groups, such as the Oley Foundation, which can help with issues surrounding body image and travel.

Because of the relative rarity of SBS, nonspecialist physicians may care for patients without a dedicated multidisciplinary team and may need education support in managing patients with complex care needs. One source the authors recommend is the Learn Intestinal Failure Tele-ECHO (Expanding Community Healthcare Outcomes) (LIFT-ECHO) project. The LIFT-ECHO project has become an online educational community with case-based learning in SBS, intestinal failure, and PN.

The authors disclose relationships with Takeda, Zealand, VectivBio, Napo, and Hanmi.

Caring for patients with short bowel syndrome (SBS) requires a multidisciplinary approach involving dietitians, nurses, surgeons, gastroenterologists or internists, and social workers experienced in SBS care, according to a clinical practice update expert review from the American Gastroenterological Association.

Kishore Iyer, MD, from Mount Sinai Hospital New York; John K. DiBaise, MD, from Mayo Clinic in Scottsdale, Ariz.; and Alberto Rubio-Tapia, MD, from the Cleveland Clinic, Ohio, developed 12 best practice advice statements based on available evidence. The items focus on adult patients with SBS; however, there was some overlap with the management of pediatric SBS. The review was published online in Clinical Gastroenterology and Hepatology.
 

Defining SBS

One update concerns defining SBS. The authors recommend that surgeons performing massive resections should report the residual bowel length, rather than the length of bowel resected.

“It is only the former that dictates outcome,” they wrote.

There is general agreement that a residual small intestinal length of 200 cm or less meets criteria for SBS. Measurement should be taken from “along the antimesenteric border of unstretched bowel, from the duodenojejunal flexure to the ileocecal junction, the site of any small bowel–colon anastomosis, or to the end-ostomy.”

Based on the residual bowel length, patients can be classified into three groups: end-jejunostomy, jejuno-colic, and jejuno-ileo-colic.
 

Assessing nutritional status

A dietitian experienced in SBS should perform a thorough nutritional assessment on all SBS patients. Long-term monitoring should include laboratory studies checking electrolytes and liver and kidney function, fluid balance, weight change, serum micronutrients, and bone density. Bone density should be repeated periodically, every 2-3 years.

Fluid and electrolyte problems may affect outcomes for SBS patients, particularly for those without a colon.
 

Adjusting diets

Most adult patients with SBS have significant malabsorption, so dietary intake “must be increased by at least 50% from their estimated needs,” the authors wrote. It’s best if the patient consumes the increased quantity throughout the day in 5-6 meals, they noted.

An experienced dietitian should counsel the patient based on the patient’s eating preferences. Incorporating preferences can help increase compliance with the adjustments that may become necessary based on symptoms, stool output, and weight.
 

Using pharmacologic therapy

Using antisecretory medications, including proton pump inhibitors or histamine-2 receptor antagonists, helps reduce gastric secretions, the damage of acid on the upper gut mucosa, and the function of pancreatic exocrine enzymes.

Antidiarrheals reduce intestinal motility but also cause a slight reduction in intestinal secretion. Common agents include loperamide, diphenoxylate with atropine, codeine, and tincture of opium. The review authors say loperamide should get preference over opiate drugs because it is not addictive or sedative.

Use of antidiarrheals should be guided by their effect on stool output.

“Loperamide and codeine may have a synergistic effect when used together,” the authors wrote.

Clonidine, which can be given transdermally, has also shown some benefit in treating high-output stool losses, presumably because of its effects on intestinal motility and secretion.

Weighing risks and benefits of teduglutide

The glucagonlike peptide–2 teduglutide is of particular interest for its ability to help improve intestinal absorption and hopefully wean patients off parenteral nutrition and some will achieve enteral autonomy, the authors wrote. “The very short half-life of native GLP-2 has been extended to allow daily subcutaneous injection in the recombinant molecule, teduglutide.”

However, because teduglutide is a growth factor and can boost the growth of polyps and cancer, it is contraindicated in patients with active gastrointestinal malignancies. Patients should undergo colonoscopy before treatment and periodically thereafter, the authors advised. The benefits of its use in patients with nongastrointestinal malignancy should be weighed carefully with these risks.

“The significant side effects of teduglutide and the cost mandate that teduglutide is employed only after optimizing diet and the more conventional SBS treatments described previously in carefully selected patients with [short bowel syndrome–intestinal failure],” the authors wrote.
 

Dosing drugs effectively

Medications in tablet form need to dissolve before being absorbed. Most oral medications are absorbed within the proximal jejunum, so they can be used in patients with SBS.

“However,” the authors noted, “sustained- and delayed-release medications should be avoided.”

They suggested that, when applicable, alternatives such as liquids and topical medications should be considered, as should the monitoring of medication levels in the blood.

If a patient does not respond, approaches to consider may include increasing a dose, changing dose frequency, or changing drug formulation or route of administration, such as intravenous, subcutaneous, or transdermal.
 

Including parenteral nutrition and oral rehydration

Almost all patients with SBS will need parenteral nutrition (PN) support following resection, and few will be able to stop it before discharge from the hospital.

“Although more than 50% of adults with SBS are able to be weaned completely from PN within 5 years of diagnosis, the probability of eliminating PN use is less than 6% if not successfully accomplished in the first 2 years following the individual’s last bowel resection,” the authors wrote.

For long-term PN, tunneled central venous catheters are preferred over peripherally inserted central venous catheters because of the higher risk of thrombosis and issues related to self-administration of PN with the central catheters. Also, tunneled catheters are preferred over totally implanted devices, or ports, for long-term patients because the main benefit of the port is not realized given that the device needs to be continually accessed and exchanged weekly.

“When calculating PN volume and content, changes in the patient’s weight, laboratory results, stool or ostomy output, urine output, and complaints of thirst should be monitored,” the authors noted.

The authors also discussed oral rehydration solution because patients lose more water and sodium from their stoma than they take in by mouth. Careful consideration of the glucose and sodium levels in oral fluids is important because inappropriate fluids will exacerbate fluid losses in SBS. For example, hypotonic (including water, tea, coffee, alcohol) and hypertonic (including fruit juices and sodas) solutions should be limited.

“A major misconception on the part of patients is that they should drink large quantities of water; however, this generally leads to an increase in ostomy output and creates a vicious cycle further exacerbating fluid and electrolyte disturbances,” they wrote, instead advising glucose–electrolyte rehydration solution to enhance absorption and reduce secretion.
 

Preventing complications

“A knowledge of these complications is critical for those caring for these patients to be able to not only identify and treat them when they occur but also to prevent their occurrence whenever possible,” the authors wrote. Although they considered it beyond the scope of the review to outline every complication, they indicated some complications and management strategies via an included table. These complications can include cirrhosis, osteoporosis, acute kidney disease, and central venous catheter–related infection or occlusion.

Considering further surgery or intestinal transplantation

The authors noted that any further surgery should be carefully considered, with the following three contexts having possible value: “(1) to recruit unused distal bowel, (2) to augment the function of residual bowel through specific lengthening and tapering operations, or (3) to slow intestinal transit.”

Surgeons involved in managing SBS may need to confront complex intra-abdominal problems such as massive desmoid tumors, mesenteric ischemia, or complex enterocutaneous fistulae; a multidisciplinary intestinal rehabilitation team may be better able to help these patients. The authors noted that care for patients starts even before the first operation, by taking every measure to avoid massive bowel resection and the resulting SBS.

The authors noted the importance of early referral for intestinal transplantation consideration for patients with refractory dependency on parenteral nutrition or even onset of parenteral nutrition failure, which refers to complications such as intestinal failure–associated liver disease.

“At present, nearly 50% of patients being considered for ITX are also requiring simultaneous liver replacement, indicating late referral for ITX,” they wrote, citing a data from a report by the Centers for Medicare and Medicaid.

They also noted that data have shown short- and medium-term outcomes are steadily improving; however, long-term outcomes have been challenged by opportunistic infections, long-term graft attrition, and other impediments that may be preventing early referral for intestinal transplantation.
 

Educating patients, caregivers

Long-term PN may restrict activity for patients, but patients and caregivers should know about some modifications.

One is to cycle the PN over 10-14 hours overnight to allow freedom from the infusion pump during the day. Infusion pumps can be programmable, and some can be carried in a backpack for infusing during the day.

Authors recommend patient support groups, such as the Oley Foundation, which can help with issues surrounding body image and travel.

Because of the relative rarity of SBS, nonspecialist physicians may care for patients without a dedicated multidisciplinary team and may need education support in managing patients with complex care needs. One source the authors recommend is the Learn Intestinal Failure Tele-ECHO (Expanding Community Healthcare Outcomes) (LIFT-ECHO) project. The LIFT-ECHO project has become an online educational community with case-based learning in SBS, intestinal failure, and PN.

The authors disclose relationships with Takeda, Zealand, VectivBio, Napo, and Hanmi.

Endoscopic training is increasingly complex as benchmarks for quality evolve and tools and procedures advance with innovation.

A team of experts, led by Matthew J. Whitson, MD, with Hofstra University/Northwell Health in Hempstead, N.Y., aimed to simplify challenges for educators and clinical endoscopists with a review of tools and techniques for education, as well as assessment methods.

Their review was published in the Techniques and Innovations in Gastrointestinal Endoscopy.
 

Giving feedback

Key steps to effective feedback include first talking about the goals for the endoscopy session, then careful observation, but minimal feedback during the endoscopy. Most of the feedback should come after the endoscopy, the authors wrote.

A paper by Walsh et al. demonstrated that with beginning endoscopists, giving feedback afterward led to long-term skill development as compared with short-term benefits of frequent feedback in the middle of procedures.

Feedback should be constructive and specific with emphasis on goals for the next procedure. It should be delivered in a respectful, nonthreatening way for greatest effectiveness.
 

Mastery learning

In this model, each trainee must achieve competence in specific skills to progress to the next level.

“For example, the trainee must master retroflexion in the stomach prior to attempting clip hemostasis in the stomach,” the authors wrote.

Repetitively practicing the skill is coupled with direct feedback.

Mastery learning is often paired with simulation so trainees can practice in a safe space before working with patients.
 

Cognitive load theory

Knowing the challenges of learners can help educators with instruction techniques. An important concept is cognitive load theory (CLT). CLT is focused on the working memory of a learner and the harm that an overload of information can have on learning. A learner’s working memory can process only a few pieces of information at any given time, the theory states.

One mitigation strategy by educators may be to assign a trainee a smaller piece of a specific task appropriate to the trainee’s skill level.

“For example, an early trainee endoscopist may be able to inject epinephrine for a bleeding vessel, but not be ready to perform effective BiCap cautery,” the authors suggested.
 

Different learning styles

Learning styles include visual, aural, reading/writing, and kinesthetic styles (when learners need to touch or manipulate to learn a skill).

“A study of surgical trainees demonstrated that kinesthetic learning was the most preferred unimodal learning style of those entering the field,” the authors wrote.

Dr. Whitson and coauthors gave examples of working with trainees with different learning styles.

A trainee who learns visually, they say, might need to learn about “loop reduction” by looking at images of alpha or beta loops or using ScopeGuide during endoscopy. A kinesthetic learner may need to feel a successful loop reduction with hands on the endoscope during simulation to understand the skill better.

“There is some suggestion that the millennial generation – the demographic of the current gastroenterology fellows – may have higher preferences for kinesthetic learning,” the authors wrote.
 

Role of simulation

The Accreditation Council for Graduate Medical Education, which oversees Gastroenterology Fellowship training, mandates simulation in gastroenterology education but does not specify endoscopic simulation. The American Board of Surgeons, however, does require their trainees to complete the flexible endoscopic curriculum, which is simulation-based.

Simulator use appears particularly helpful early in training. One study demonstrated that colonoscopy simulation has benefit in the first 30 colonoscopies in depth of insertion, independent completion, and ability to identify landmarks.

However, another study showed simulation after 50 colonoscopies has shown no benefit, the authors wrote. Finding uses for simulators beyond diagnostics will be important for justifying buying more of them for medical centers given the high cost.
 

Procedural volume

Dr. Whitson and colleagues wrote that using sheer volume of procedures as a measure of competency is falling out of favor and there is recognition in the field that competency will come at different times and at different volumes for individual trainees.

A study assessing competency in esophagogastroduodenoscopy (EGD), for example, demonstrated that, while most trainees will achieve independent intubation rates of the second part of the duodenum by 150 procedures, it will take between 200 and 250 for the average fellow to reach competency of all motor skills for a standard EGD, and 300 to become efficient (Gastrointest Endosc. 2019;90(4):613-20).

Assessment of skills has evolved from numbers of procedures to competency-based assessments to the development of direct observation tools.
 

Coaching for the practicing endoscopist

Most studies on coaching have focused on trainees, but coaching can be used with experienced endoscopists as well.

One study investigated use of direct verbal coaching to train experienced practitioners in water immersion colonoscopy “which resulted in shorter cecal intubation times, improved [adenoma detection rate], and less use of sedation during procedures,” the authors noted. Another study currently underway in the United Kingdom uses electronic feedback coupled with education and training to change behaviors to improve polyp detection performance in colonoscopy.

The authors noted that using one of these tools or strategies does not preclude using another.

“[I]n fact educators likely will recognize the utility of incorporating multiple of these techniques in the same endoscopy session with a trainee,” the authors wrote.

One author holds stock in Boston Scientific. The remaining authors disclose no conflicts.

Endoscopic training is increasingly complex as benchmarks for quality evolve and tools and procedures advance with innovation.

A team of experts, led by Matthew J. Whitson, MD, with Hofstra University/Northwell Health in Hempstead, N.Y., aimed to simplify challenges for educators and clinical endoscopists with a review of tools and techniques for education, as well as assessment methods.

Their review was published in the Techniques and Innovations in Gastrointestinal Endoscopy.
 

Giving feedback

Key steps to effective feedback include first talking about the goals for the endoscopy session, then careful observation, but minimal feedback during the endoscopy. Most of the feedback should come after the endoscopy, the authors wrote.

A paper by Walsh et al. demonstrated that with beginning endoscopists, giving feedback afterward led to long-term skill development as compared with short-term benefits of frequent feedback in the middle of procedures.

Feedback should be constructive and specific with emphasis on goals for the next procedure. It should be delivered in a respectful, nonthreatening way for greatest effectiveness.
 

Mastery learning

In this model, each trainee must achieve competence in specific skills to progress to the next level.

“For example, the trainee must master retroflexion in the stomach prior to attempting clip hemostasis in the stomach,” the authors wrote.

Repetitively practicing the skill is coupled with direct feedback.

Mastery learning is often paired with simulation so trainees can practice in a safe space before working with patients.
 

Cognitive load theory

Knowing the challenges of learners can help educators with instruction techniques. An important concept is cognitive load theory (CLT). CLT is focused on the working memory of a learner and the harm that an overload of information can have on learning. A learner’s working memory can process only a few pieces of information at any given time, the theory states.

One mitigation strategy by educators may be to assign a trainee a smaller piece of a specific task appropriate to the trainee’s skill level.

“For example, an early trainee endoscopist may be able to inject epinephrine for a bleeding vessel, but not be ready to perform effective BiCap cautery,” the authors suggested.
 

Different learning styles

Learning styles include visual, aural, reading/writing, and kinesthetic styles (when learners need to touch or manipulate to learn a skill).

“A study of surgical trainees demonstrated that kinesthetic learning was the most preferred unimodal learning style of those entering the field,” the authors wrote.

Dr. Whitson and coauthors gave examples of working with trainees with different learning styles.

A trainee who learns visually, they say, might need to learn about “loop reduction” by looking at images of alpha or beta loops or using ScopeGuide during endoscopy. A kinesthetic learner may need to feel a successful loop reduction with hands on the endoscope during simulation to understand the skill better.

“There is some suggestion that the millennial generation – the demographic of the current gastroenterology fellows – may have higher preferences for kinesthetic learning,” the authors wrote.
 

Role of simulation

The Accreditation Council for Graduate Medical Education, which oversees Gastroenterology Fellowship training, mandates simulation in gastroenterology education but does not specify endoscopic simulation. The American Board of Surgeons, however, does require their trainees to complete the flexible endoscopic curriculum, which is simulation-based.

Simulator use appears particularly helpful early in training. One study demonstrated that colonoscopy simulation has benefit in the first 30 colonoscopies in depth of insertion, independent completion, and ability to identify landmarks.

However, another study showed simulation after 50 colonoscopies has shown no benefit, the authors wrote. Finding uses for simulators beyond diagnostics will be important for justifying buying more of them for medical centers given the high cost.
 

Procedural volume

Dr. Whitson and colleagues wrote that using sheer volume of procedures as a measure of competency is falling out of favor and there is recognition in the field that competency will come at different times and at different volumes for individual trainees.

A study assessing competency in esophagogastroduodenoscopy (EGD), for example, demonstrated that, while most trainees will achieve independent intubation rates of the second part of the duodenum by 150 procedures, it will take between 200 and 250 for the average fellow to reach competency of all motor skills for a standard EGD, and 300 to become efficient (Gastrointest Endosc. 2019;90(4):613-20).

Assessment of skills has evolved from numbers of procedures to competency-based assessments to the development of direct observation tools.
 

Coaching for the practicing endoscopist

Most studies on coaching have focused on trainees, but coaching can be used with experienced endoscopists as well.

One study investigated use of direct verbal coaching to train experienced practitioners in water immersion colonoscopy “which resulted in shorter cecal intubation times, improved [adenoma detection rate], and less use of sedation during procedures,” the authors noted. Another study currently underway in the United Kingdom uses electronic feedback coupled with education and training to change behaviors to improve polyp detection performance in colonoscopy.

The authors noted that using one of these tools or strategies does not preclude using another.

“[I]n fact educators likely will recognize the utility of incorporating multiple of these techniques in the same endoscopy session with a trainee,” the authors wrote.

One author holds stock in Boston Scientific. The remaining authors disclose no conflicts.

Endoscopic training is increasingly complex as benchmarks for quality evolve and tools and procedures advance with innovation.

A team of experts, led by Matthew J. Whitson, MD, with Hofstra University/Northwell Health in Hempstead, N.Y., aimed to simplify challenges for educators and clinical endoscopists with a review of tools and techniques for education, as well as assessment methods.

Their review was published in the Techniques and Innovations in Gastrointestinal Endoscopy.
 

Giving feedback

Key steps to effective feedback include first talking about the goals for the endoscopy session, then careful observation, but minimal feedback during the endoscopy. Most of the feedback should come after the endoscopy, the authors wrote.

A paper by Walsh et al. demonstrated that with beginning endoscopists, giving feedback afterward led to long-term skill development as compared with short-term benefits of frequent feedback in the middle of procedures.

Feedback should be constructive and specific with emphasis on goals for the next procedure. It should be delivered in a respectful, nonthreatening way for greatest effectiveness.
 

Mastery learning

In this model, each trainee must achieve competence in specific skills to progress to the next level.

“For example, the trainee must master retroflexion in the stomach prior to attempting clip hemostasis in the stomach,” the authors wrote.

Repetitively practicing the skill is coupled with direct feedback.

Mastery learning is often paired with simulation so trainees can practice in a safe space before working with patients.
 

Cognitive load theory

Knowing the challenges of learners can help educators with instruction techniques. An important concept is cognitive load theory (CLT). CLT is focused on the working memory of a learner and the harm that an overload of information can have on learning. A learner’s working memory can process only a few pieces of information at any given time, the theory states.

One mitigation strategy by educators may be to assign a trainee a smaller piece of a specific task appropriate to the trainee’s skill level.

“For example, an early trainee endoscopist may be able to inject epinephrine for a bleeding vessel, but not be ready to perform effective BiCap cautery,” the authors suggested.
 

Different learning styles

Learning styles include visual, aural, reading/writing, and kinesthetic styles (when learners need to touch or manipulate to learn a skill).

“A study of surgical trainees demonstrated that kinesthetic learning was the most preferred unimodal learning style of those entering the field,” the authors wrote.

Dr. Whitson and coauthors gave examples of working with trainees with different learning styles.

A trainee who learns visually, they say, might need to learn about “loop reduction” by looking at images of alpha or beta loops or using ScopeGuide during endoscopy. A kinesthetic learner may need to feel a successful loop reduction with hands on the endoscope during simulation to understand the skill better.

“There is some suggestion that the millennial generation – the demographic of the current gastroenterology fellows – may have higher preferences for kinesthetic learning,” the authors wrote.
 

Role of simulation

The Accreditation Council for Graduate Medical Education, which oversees Gastroenterology Fellowship training, mandates simulation in gastroenterology education but does not specify endoscopic simulation. The American Board of Surgeons, however, does require their trainees to complete the flexible endoscopic curriculum, which is simulation-based.

Simulator use appears particularly helpful early in training. One study demonstrated that colonoscopy simulation has benefit in the first 30 colonoscopies in depth of insertion, independent completion, and ability to identify landmarks.

However, another study showed simulation after 50 colonoscopies has shown no benefit, the authors wrote. Finding uses for simulators beyond diagnostics will be important for justifying buying more of them for medical centers given the high cost.
 

Procedural volume

Dr. Whitson and colleagues wrote that using sheer volume of procedures as a measure of competency is falling out of favor and there is recognition in the field that competency will come at different times and at different volumes for individual trainees.

A study assessing competency in esophagogastroduodenoscopy (EGD), for example, demonstrated that, while most trainees will achieve independent intubation rates of the second part of the duodenum by 150 procedures, it will take between 200 and 250 for the average fellow to reach competency of all motor skills for a standard EGD, and 300 to become efficient (Gastrointest Endosc. 2019;90(4):613-20).

Assessment of skills has evolved from numbers of procedures to competency-based assessments to the development of direct observation tools.
 

Coaching for the practicing endoscopist

Most studies on coaching have focused on trainees, but coaching can be used with experienced endoscopists as well.

One study investigated use of direct verbal coaching to train experienced practitioners in water immersion colonoscopy “which resulted in shorter cecal intubation times, improved [adenoma detection rate], and less use of sedation during procedures,” the authors noted. Another study currently underway in the United Kingdom uses electronic feedback coupled with education and training to change behaviors to improve polyp detection performance in colonoscopy.

The authors noted that using one of these tools or strategies does not preclude using another.

“[I]n fact educators likely will recognize the utility of incorporating multiple of these techniques in the same endoscopy session with a trainee,” the authors wrote.

One author holds stock in Boston Scientific. The remaining authors disclose no conflicts.

Many sodium-glucose cotransporter-2 (SGLT2) inhibitors are approved for use at two doses, but there are few clinical data regarding the metabolic impact of uptitrating an SGLT2 inhibitor from the lower to the higher dose in clinical practice. Matsumura and colleagues published the results of a retrospective, longitudinal study at a single institution in Japan. A total of 52 participants who were treated with 10 mg empagliflozin once daily were analyzed at 26 weeks after the dose had been increased to 25 mg once daily. The researchers reported a 0.6 kg weight reduction, a 0.15% reduction in A1c, and a 22.1 mg/dL reduction in triglycerides in the participants on the higher dose of empagliflozin. Although the benefits of the higher dose were rather small, this study does aid the clinician regarding the clinical impact of increasing the dose of empagliflozin.

Outcome studies with SGLT2 inhibitors have shown reductions in major adverse cardiovascular events (MACE), heart failure hospitalization, and mortality. However, clinicians may be reluctant to initiate SGLT2 inhibitors in frail individuals as they are often excluded from randomized trials and may be more likely to have side effects from this class of medications. Wood and colleagues conducted a cohort study in Australia, comparing the effectiveness of SGLT2 inhibitors to that of dipeptidyl peptidase-4 (DPP-4) inhibitors. The study was done with individuals with type 2 diabetes who were initiated on these agents within 60 days of a hospital discharge. It was noted that SGLT2 inhibitors significantly reduced MACE, heart failure hospitalization, and mortality compared with DPP-4 inhibitors, and this benefit was present in both frail and nonfrail individuals. The study did not report on tolerability issues and is limited by the cohort design, but it does suggest a cardiovascular benefit among frail patients with type 2 diabetes who are treated with SGLT2 inhibitors, and it may be reassuring when considering an SGLT2 inhibitor in a frail person.

In my July 2022 commentary, I discussed the results of AWARD-PEDS, which demonstrated a significant A1c reduction but no weight loss with the glucagon-like peptide-1 receptor agonist (GLP-1RA) dulaglutide in youth with type 2 diabetes. Tamborlane and colleagues have now reported the results of a randomized trial that studied the efficacy and safety of 2 mg exenatide once weekly in youth with type 2 diabetes. Similarly to the AWARD-PEDS study, A1c was significantly reduced compared with placebo, with a difference of -0.85% at 24 weeks. Also similarly to AWARD-PEDS, there was no significant difference in body weight between the GLP-1RA and placebo groups. There are now three studies showing glycemic benefits but little weight loss with GLP-1RA treatment in youth with type 2 diabetes, and while the glycemic benefits are encouraging, it remains perplexing why these studies have not demonstrated the weight loss that has consistently been demonstrated in adult studies of GLP-1RA.

Clinicians often choose a second-generation basal insulin analog (glargine U300, degludec) over a first-generation basal analog (glargine U100, detemir) because of lower rates of hypoglycemia. Randomized clinical trials and real-world evidence (RWE) studies comparing glargine U100 vs degludec have shown somewhat inconsistent results. In the newest RWE study comparing these two second-generation analogs, RESTORE-2 NAIVE, Fadini and colleagues reported that 6 months after initiating either glargine U300 or degludec in insulin-naive type 2 diabetes, there was a similar improvement in glycemia, no weight gain, and low hypoglycemia rates in each group. RESTORE-2 is another study demonstrating similar results between the two second-generation insulin analogs and helps build our understanding that these two insulins are more similar than different.

Many sodium-glucose cotransporter-2 (SGLT2) inhibitors are approved for use at two doses, but there are few clinical data regarding the metabolic impact of uptitrating an SGLT2 inhibitor from the lower to the higher dose in clinical practice. Matsumura and colleagues published the results of a retrospective, longitudinal study at a single institution in Japan. A total of 52 participants who were treated with 10 mg empagliflozin once daily were analyzed at 26 weeks after the dose had been increased to 25 mg once daily. The researchers reported a 0.6 kg weight reduction, a 0.15% reduction in A1c, and a 22.1 mg/dL reduction in triglycerides in the participants on the higher dose of empagliflozin. Although the benefits of the higher dose were rather small, this study does aid the clinician regarding the clinical impact of increasing the dose of empagliflozin.

Outcome studies with SGLT2 inhibitors have shown reductions in major adverse cardiovascular events (MACE), heart failure hospitalization, and mortality. However, clinicians may be reluctant to initiate SGLT2 inhibitors in frail individuals as they are often excluded from randomized trials and may be more likely to have side effects from this class of medications. Wood and colleagues conducted a cohort study in Australia, comparing the effectiveness of SGLT2 inhibitors to that of dipeptidyl peptidase-4 (DPP-4) inhibitors. The study was done with individuals with type 2 diabetes who were initiated on these agents within 60 days of a hospital discharge. It was noted that SGLT2 inhibitors significantly reduced MACE, heart failure hospitalization, and mortality compared with DPP-4 inhibitors, and this benefit was present in both frail and nonfrail individuals. The study did not report on tolerability issues and is limited by the cohort design, but it does suggest a cardiovascular benefit among frail patients with type 2 diabetes who are treated with SGLT2 inhibitors, and it may be reassuring when considering an SGLT2 inhibitor in a frail person.

In my July 2022 commentary, I discussed the results of AWARD-PEDS, which demonstrated a significant A1c reduction but no weight loss with the glucagon-like peptide-1 receptor agonist (GLP-1RA) dulaglutide in youth with type 2 diabetes. Tamborlane and colleagues have now reported the results of a randomized trial that studied the efficacy and safety of 2 mg exenatide once weekly in youth with type 2 diabetes. Similarly to the AWARD-PEDS study, A1c was significantly reduced compared with placebo, with a difference of -0.85% at 24 weeks. Also similarly to AWARD-PEDS, there was no significant difference in body weight between the GLP-1RA and placebo groups. There are now three studies showing glycemic benefits but little weight loss with GLP-1RA treatment in youth with type 2 diabetes, and while the glycemic benefits are encouraging, it remains perplexing why these studies have not demonstrated the weight loss that has consistently been demonstrated in adult studies of GLP-1RA.

Clinicians often choose a second-generation basal insulin analog (glargine U300, degludec) over a first-generation basal analog (glargine U100, detemir) because of lower rates of hypoglycemia. Randomized clinical trials and real-world evidence (RWE) studies comparing glargine U100 vs degludec have shown somewhat inconsistent results. In the newest RWE study comparing these two second-generation analogs, RESTORE-2 NAIVE, Fadini and colleagues reported that 6 months after initiating either glargine U300 or degludec in insulin-naive type 2 diabetes, there was a similar improvement in glycemia, no weight gain, and low hypoglycemia rates in each group. RESTORE-2 is another study demonstrating similar results between the two second-generation insulin analogs and helps build our understanding that these two insulins are more similar than different.

Many sodium-glucose cotransporter-2 (SGLT2) inhibitors are approved for use at two doses, but there are few clinical data regarding the metabolic impact of uptitrating an SGLT2 inhibitor from the lower to the higher dose in clinical practice. Matsumura and colleagues published the results of a retrospective, longitudinal study at a single institution in Japan. A total of 52 participants who were treated with 10 mg empagliflozin once daily were analyzed at 26 weeks after the dose had been increased to 25 mg once daily. The researchers reported a 0.6 kg weight reduction, a 0.15% reduction in A1c, and a 22.1 mg/dL reduction in triglycerides in the participants on the higher dose of empagliflozin. Although the benefits of the higher dose were rather small, this study does aid the clinician regarding the clinical impact of increasing the dose of empagliflozin.

Outcome studies with SGLT2 inhibitors have shown reductions in major adverse cardiovascular events (MACE), heart failure hospitalization, and mortality. However, clinicians may be reluctant to initiate SGLT2 inhibitors in frail individuals as they are often excluded from randomized trials and may be more likely to have side effects from this class of medications. Wood and colleagues conducted a cohort study in Australia, comparing the effectiveness of SGLT2 inhibitors to that of dipeptidyl peptidase-4 (DPP-4) inhibitors. The study was done with individuals with type 2 diabetes who were initiated on these agents within 60 days of a hospital discharge. It was noted that SGLT2 inhibitors significantly reduced MACE, heart failure hospitalization, and mortality compared with DPP-4 inhibitors, and this benefit was present in both frail and nonfrail individuals. The study did not report on tolerability issues and is limited by the cohort design, but it does suggest a cardiovascular benefit among frail patients with type 2 diabetes who are treated with SGLT2 inhibitors, and it may be reassuring when considering an SGLT2 inhibitor in a frail person.

In my July 2022 commentary, I discussed the results of AWARD-PEDS, which demonstrated a significant A1c reduction but no weight loss with the glucagon-like peptide-1 receptor agonist (GLP-1RA) dulaglutide in youth with type 2 diabetes. Tamborlane and colleagues have now reported the results of a randomized trial that studied the efficacy and safety of 2 mg exenatide once weekly in youth with type 2 diabetes. Similarly to the AWARD-PEDS study, A1c was significantly reduced compared with placebo, with a difference of -0.85% at 24 weeks. Also similarly to AWARD-PEDS, there was no significant difference in body weight between the GLP-1RA and placebo groups. There are now three studies showing glycemic benefits but little weight loss with GLP-1RA treatment in youth with type 2 diabetes, and while the glycemic benefits are encouraging, it remains perplexing why these studies have not demonstrated the weight loss that has consistently been demonstrated in adult studies of GLP-1RA.

Clinicians often choose a second-generation basal insulin analog (glargine U300, degludec) over a first-generation basal analog (glargine U100, detemir) because of lower rates of hypoglycemia. Randomized clinical trials and real-world evidence (RWE) studies comparing glargine U100 vs degludec have shown somewhat inconsistent results. In the newest RWE study comparing these two second-generation analogs, RESTORE-2 NAIVE, Fadini and colleagues reported that 6 months after initiating either glargine U300 or degludec in insulin-naive type 2 diabetes, there was a similar improvement in glycemia, no weight gain, and low hypoglycemia rates in each group. RESTORE-2 is another study demonstrating similar results between the two second-generation insulin analogs and helps build our understanding that these two insulins are more similar than different.

Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.

Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.

Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.

“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”

Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.

“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.

Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.

Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.

Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).

Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.

[email protected]

Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.

Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.

Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.

“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”

Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.

“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.

Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.

Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.

Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).

Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.

[email protected]

Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.

Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.

Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.

“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”

Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.

“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.

Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.

Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.

Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).

Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.

[email protected]

Federal authorities have reached an agreement with the Indiana State Nursing Board regarding claims the board violated the Americans With Disabilities Act (ADA) by discriminating against nurses with opioid use disorder (OUD), according to a statement released Sept. 1.

In March, the U.S. Department of Justice (DOJ) announced the findings of its investigation, stating that the board “violated the ADA by prohibiting nurses who take medication to treat OUD from participating in the Indiana State Nursing Assistance Program [ISNAP].”

ISNAP rehabilitates and monitors nurses with substance use disorders, and the nursing board contracts with vendors to administer the program. Nurses seeking recovery must typically enroll in ISNAP and complete the 1-year program to maintain an active nursing license or have a license reinstated.

Following the investigation, the nursing board was instructed to implement corrective measures, such as revising policies and handbooks and training nursing board staff and vendors on ADA guidelines and nondiscriminatory practices.

The state’s professional organization for nurses said the remediation efforts will help nurses who are struggling with opioid addiction.

Katherine Feley, DNP, RN, chief executive officer of the Indiana State Nurses Association, told this news organization, “Allowing nurses who take medication to treat OUD to remain on their medication when participating in [ISNAP] will avoid making nurses choose between their health and their profession. This improvement will increase access to treatment resources, enabling more nurses to complete treatment and progress toward a safe return to work.”

The DOJ opened an investigation after receiving a complaint from a nurse in which she alleged that she was denied participation in ISNAP because of her use of prescription medication for OUD. In 2013, while participating in a methadone maintenance program, the nurse was told she had to taper off the medication because ISNAP utilizes an “abstinence-based” model. Because of these restrictions, she could not complete the program, and her nursing license was suspended in late 2014.

In 2016, her physician prescribed a new medication, buprenorphine, and the nurse attempted to enroll in ISNAP again. The program vendor instructed her to taper off the drug within 3 months of enrollment, something her physician believed “would come with a significant risk of relapse [and possibly] death.” The nurse was unable to qualify for reinstatement of her license.

As part of the settlement, the nursing board has agreed to pay a total of $70,000 in damages to the complainant and report compliance with new guidelines to the DOJ every 6 months.

The DOJ says ISNAP’s OUD abstinence policy does not conform with the state’s statute, which mandates that substance abuse rehabilitation services be provided for nurses.

“Indiana may not deny individuals lifesaving medications, including medications that treat [OUD], based on stereotypes and misinformation,” Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division said of the settlement. “Requiring nurses to stop taking prescribed medication as a condition of maintaining a nursing license violates the ADA and not only creates barriers to recovery but inappropriately limits employment opportunities based on disability.”

In April, the DOJ issued guidance for protecting the civil rights of people with OUD under the ADA to ensure that individuals seeking treatment or recovery can continue participating in society and the workplace.

“The opioid epidemic has greatly impacted professionals and families of all walks of life, and Indiana nurses have the right to seek medically approved treatment for [OUD] under federal law,” U.S. Attorney Zachary A. Myers, of the Southern District of Indiana, said of the settlement. “Following the Justice Department’s findings and the parties’ settlement agreement, Indiana must now enact policies to ensure that Hoosier nurses will not be forced to choose between their recovery and their livelihoods.”

Under the terms of the agreement, the nursing board must allow nurses who are taking OUD medication to participate in ISNAP when the medication is prescribed by a licensed practitioner as part of a medically necessary treatment plan and is incorporated into a recovery monitoring agreement.

A version of this article first appeared on Medscape.com.

Federal authorities have reached an agreement with the Indiana State Nursing Board regarding claims the board violated the Americans With Disabilities Act (ADA) by discriminating against nurses with opioid use disorder (OUD), according to a statement released Sept. 1.

In March, the U.S. Department of Justice (DOJ) announced the findings of its investigation, stating that the board “violated the ADA by prohibiting nurses who take medication to treat OUD from participating in the Indiana State Nursing Assistance Program [ISNAP].”

ISNAP rehabilitates and monitors nurses with substance use disorders, and the nursing board contracts with vendors to administer the program. Nurses seeking recovery must typically enroll in ISNAP and complete the 1-year program to maintain an active nursing license or have a license reinstated.

Following the investigation, the nursing board was instructed to implement corrective measures, such as revising policies and handbooks and training nursing board staff and vendors on ADA guidelines and nondiscriminatory practices.

The state’s professional organization for nurses said the remediation efforts will help nurses who are struggling with opioid addiction.

Katherine Feley, DNP, RN, chief executive officer of the Indiana State Nurses Association, told this news organization, “Allowing nurses who take medication to treat OUD to remain on their medication when participating in [ISNAP] will avoid making nurses choose between their health and their profession. This improvement will increase access to treatment resources, enabling more nurses to complete treatment and progress toward a safe return to work.”

The DOJ opened an investigation after receiving a complaint from a nurse in which she alleged that she was denied participation in ISNAP because of her use of prescription medication for OUD. In 2013, while participating in a methadone maintenance program, the nurse was told she had to taper off the medication because ISNAP utilizes an “abstinence-based” model. Because of these restrictions, she could not complete the program, and her nursing license was suspended in late 2014.

In 2016, her physician prescribed a new medication, buprenorphine, and the nurse attempted to enroll in ISNAP again. The program vendor instructed her to taper off the drug within 3 months of enrollment, something her physician believed “would come with a significant risk of relapse [and possibly] death.” The nurse was unable to qualify for reinstatement of her license.

As part of the settlement, the nursing board has agreed to pay a total of $70,000 in damages to the complainant and report compliance with new guidelines to the DOJ every 6 months.

The DOJ says ISNAP’s OUD abstinence policy does not conform with the state’s statute, which mandates that substance abuse rehabilitation services be provided for nurses.

“Indiana may not deny individuals lifesaving medications, including medications that treat [OUD], based on stereotypes and misinformation,” Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division said of the settlement. “Requiring nurses to stop taking prescribed medication as a condition of maintaining a nursing license violates the ADA and not only creates barriers to recovery but inappropriately limits employment opportunities based on disability.”

In April, the DOJ issued guidance for protecting the civil rights of people with OUD under the ADA to ensure that individuals seeking treatment or recovery can continue participating in society and the workplace.

“The opioid epidemic has greatly impacted professionals and families of all walks of life, and Indiana nurses have the right to seek medically approved treatment for [OUD] under federal law,” U.S. Attorney Zachary A. Myers, of the Southern District of Indiana, said of the settlement. “Following the Justice Department’s findings and the parties’ settlement agreement, Indiana must now enact policies to ensure that Hoosier nurses will not be forced to choose between their recovery and their livelihoods.”

Under the terms of the agreement, the nursing board must allow nurses who are taking OUD medication to participate in ISNAP when the medication is prescribed by a licensed practitioner as part of a medically necessary treatment plan and is incorporated into a recovery monitoring agreement.

A version of this article first appeared on Medscape.com.

Federal authorities have reached an agreement with the Indiana State Nursing Board regarding claims the board violated the Americans With Disabilities Act (ADA) by discriminating against nurses with opioid use disorder (OUD), according to a statement released Sept. 1.

In March, the U.S. Department of Justice (DOJ) announced the findings of its investigation, stating that the board “violated the ADA by prohibiting nurses who take medication to treat OUD from participating in the Indiana State Nursing Assistance Program [ISNAP].”

ISNAP rehabilitates and monitors nurses with substance use disorders, and the nursing board contracts with vendors to administer the program. Nurses seeking recovery must typically enroll in ISNAP and complete the 1-year program to maintain an active nursing license or have a license reinstated.

Following the investigation, the nursing board was instructed to implement corrective measures, such as revising policies and handbooks and training nursing board staff and vendors on ADA guidelines and nondiscriminatory practices.

The state’s professional organization for nurses said the remediation efforts will help nurses who are struggling with opioid addiction.

Katherine Feley, DNP, RN, chief executive officer of the Indiana State Nurses Association, told this news organization, “Allowing nurses who take medication to treat OUD to remain on their medication when participating in [ISNAP] will avoid making nurses choose between their health and their profession. This improvement will increase access to treatment resources, enabling more nurses to complete treatment and progress toward a safe return to work.”

The DOJ opened an investigation after receiving a complaint from a nurse in which she alleged that she was denied participation in ISNAP because of her use of prescription medication for OUD. In 2013, while participating in a methadone maintenance program, the nurse was told she had to taper off the medication because ISNAP utilizes an “abstinence-based” model. Because of these restrictions, she could not complete the program, and her nursing license was suspended in late 2014.

In 2016, her physician prescribed a new medication, buprenorphine, and the nurse attempted to enroll in ISNAP again. The program vendor instructed her to taper off the drug within 3 months of enrollment, something her physician believed “would come with a significant risk of relapse [and possibly] death.” The nurse was unable to qualify for reinstatement of her license.

As part of the settlement, the nursing board has agreed to pay a total of $70,000 in damages to the complainant and report compliance with new guidelines to the DOJ every 6 months.

The DOJ says ISNAP’s OUD abstinence policy does not conform with the state’s statute, which mandates that substance abuse rehabilitation services be provided for nurses.

“Indiana may not deny individuals lifesaving medications, including medications that treat [OUD], based on stereotypes and misinformation,” Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division said of the settlement. “Requiring nurses to stop taking prescribed medication as a condition of maintaining a nursing license violates the ADA and not only creates barriers to recovery but inappropriately limits employment opportunities based on disability.”

In April, the DOJ issued guidance for protecting the civil rights of people with OUD under the ADA to ensure that individuals seeking treatment or recovery can continue participating in society and the workplace.

“The opioid epidemic has greatly impacted professionals and families of all walks of life, and Indiana nurses have the right to seek medically approved treatment for [OUD] under federal law,” U.S. Attorney Zachary A. Myers, of the Southern District of Indiana, said of the settlement. “Following the Justice Department’s findings and the parties’ settlement agreement, Indiana must now enact policies to ensure that Hoosier nurses will not be forced to choose between their recovery and their livelihoods.”

Under the terms of the agreement, the nursing board must allow nurses who are taking OUD medication to participate in ISNAP when the medication is prescribed by a licensed practitioner as part of a medically necessary treatment plan and is incorporated into a recovery monitoring agreement.

A version of this article first appeared on Medscape.com.

Statins have, overall, been a remarkably beneficial class of drugs. Yes, you occasionally get patients who see them as part of some huge pharma-government conspiracy (along with vaccines and 5G, presumably) but the data are there to support them.

One of the issues with them is myalgias. We all see this to varying degrees. We all warn patients about it, as do their pharmacists, the information sheets from the pharmacy, some TV show, a Facebook friend, that guy in their Tuesday bowling league ... etc.

It is a legitimate concern. Some people definitely do get muscle cramps from them and need to come off. Scanning the medication list of someone who comes in with muscle cramps is a key part of the case.

Recently, the Lancet published a meta-analysis on the subject and found that, in 9 out of 10 patients who complained of muscle cramps on statins, the symptoms were unrelated to the drug. While previous data suggested rates of myalgias as high as 29%, this paper found it was closer to 7% compared with placebo. Only one in 15 of the muscle-related reports by patients while taking statins were clearly caused by the drug.

The power of suggestion is remarkable indeed.

The study is interesting. It might be correct.

But try telling that to the patients.

We all have patients who will get pretty much any side effect we mention, or that they read about online. That’s just human nature for some. But even reasonable adults can confuse things. The guy who starts Lipitor one week then helps his daughter move into her apartment the next. The lady who starts Crestor while training for a half-marathon. And so on.

The fact is that a lot of people take statins. And a lot of people (like, pretty much all of us) do things that can cause muscle injuries. Sooner or later these lines are going to intersect, but that doesn’t mean they have anything to do with each other.

It’s a lot harder to explain that, and have people believe it, once they’ve convinced themselves otherwise. Pravachol definitely did this, Dr. Google said so. It doesn’t help that trust in doctors, and health care science in general, has been eroded by political pundits and nonmedical experts during the COVID-19 pandemic. To some people our years of experience and training are nothing compared to what an anonymous guy on Parler told them.

Certainly this paper will help. A lot of people can benefit from statins. With this data maybe we can convince some to give them a fair shot.

But, as we’ve all experienced in practice, sometimes no amount of solid data will change the mind of someone who’s already made theirs up.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Statins have, overall, been a remarkably beneficial class of drugs. Yes, you occasionally get patients who see them as part of some huge pharma-government conspiracy (along with vaccines and 5G, presumably) but the data are there to support them.

One of the issues with them is myalgias. We all see this to varying degrees. We all warn patients about it, as do their pharmacists, the information sheets from the pharmacy, some TV show, a Facebook friend, that guy in their Tuesday bowling league ... etc.

It is a legitimate concern. Some people definitely do get muscle cramps from them and need to come off. Scanning the medication list of someone who comes in with muscle cramps is a key part of the case.

Recently, the Lancet published a meta-analysis on the subject and found that, in 9 out of 10 patients who complained of muscle cramps on statins, the symptoms were unrelated to the drug. While previous data suggested rates of myalgias as high as 29%, this paper found it was closer to 7% compared with placebo. Only one in 15 of the muscle-related reports by patients while taking statins were clearly caused by the drug.

The power of suggestion is remarkable indeed.

The study is interesting. It might be correct.

But try telling that to the patients.

We all have patients who will get pretty much any side effect we mention, or that they read about online. That’s just human nature for some. But even reasonable adults can confuse things. The guy who starts Lipitor one week then helps his daughter move into her apartment the next. The lady who starts Crestor while training for a half-marathon. And so on.

The fact is that a lot of people take statins. And a lot of people (like, pretty much all of us) do things that can cause muscle injuries. Sooner or later these lines are going to intersect, but that doesn’t mean they have anything to do with each other.

It’s a lot harder to explain that, and have people believe it, once they’ve convinced themselves otherwise. Pravachol definitely did this, Dr. Google said so. It doesn’t help that trust in doctors, and health care science in general, has been eroded by political pundits and nonmedical experts during the COVID-19 pandemic. To some people our years of experience and training are nothing compared to what an anonymous guy on Parler told them.

Certainly this paper will help. A lot of people can benefit from statins. With this data maybe we can convince some to give them a fair shot.

But, as we’ve all experienced in practice, sometimes no amount of solid data will change the mind of someone who’s already made theirs up.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Statins have, overall, been a remarkably beneficial class of drugs. Yes, you occasionally get patients who see them as part of some huge pharma-government conspiracy (along with vaccines and 5G, presumably) but the data are there to support them.

One of the issues with them is myalgias. We all see this to varying degrees. We all warn patients about it, as do their pharmacists, the information sheets from the pharmacy, some TV show, a Facebook friend, that guy in their Tuesday bowling league ... etc.

It is a legitimate concern. Some people definitely do get muscle cramps from them and need to come off. Scanning the medication list of someone who comes in with muscle cramps is a key part of the case.

Recently, the Lancet published a meta-analysis on the subject and found that, in 9 out of 10 patients who complained of muscle cramps on statins, the symptoms were unrelated to the drug. While previous data suggested rates of myalgias as high as 29%, this paper found it was closer to 7% compared with placebo. Only one in 15 of the muscle-related reports by patients while taking statins were clearly caused by the drug.

The power of suggestion is remarkable indeed.

The study is interesting. It might be correct.

But try telling that to the patients.

We all have patients who will get pretty much any side effect we mention, or that they read about online. That’s just human nature for some. But even reasonable adults can confuse things. The guy who starts Lipitor one week then helps his daughter move into her apartment the next. The lady who starts Crestor while training for a half-marathon. And so on.

The fact is that a lot of people take statins. And a lot of people (like, pretty much all of us) do things that can cause muscle injuries. Sooner or later these lines are going to intersect, but that doesn’t mean they have anything to do with each other.

It’s a lot harder to explain that, and have people believe it, once they’ve convinced themselves otherwise. Pravachol definitely did this, Dr. Google said so. It doesn’t help that trust in doctors, and health care science in general, has been eroded by political pundits and nonmedical experts during the COVID-19 pandemic. To some people our years of experience and training are nothing compared to what an anonymous guy on Parler told them.

Certainly this paper will help. A lot of people can benefit from statins. With this data maybe we can convince some to give them a fair shot.

But, as we’ve all experienced in practice, sometimes no amount of solid data will change the mind of someone who’s already made theirs up.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) leads to improved birth outcomes and lower infant mortality, and possibly better preventive childcare, suggests new research.

How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.

The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.

The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.

All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.

“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”

Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.

Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
 

Growing evidence should drive enrollment

“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.

Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.

“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”

Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.

“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
 

Goals of future research

Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.

“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”

Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.

Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.

“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.

Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”

She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.

Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.

“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”

The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) leads to improved birth outcomes and lower infant mortality, and possibly better preventive childcare, suggests new research.

How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.

The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.

The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.

All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.

“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”

Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.

Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
 

Growing evidence should drive enrollment

“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.

Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.

“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”

Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.

“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
 

Goals of future research

Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.

“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”

Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.

Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.

“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.

Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”

She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.

Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.

“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”

The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) leads to improved birth outcomes and lower infant mortality, and possibly better preventive childcare, suggests new research.

How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.

The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.

The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.

All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.

“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”

Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.

Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
 

Growing evidence should drive enrollment

“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.

Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.

“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”

Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.

“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
 

Goals of future research

Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.

“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”

Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.

Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.

“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.

Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”

She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.

Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.

“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”

The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.