MDedge Psychiatry

Antihypertensive medications that stimulate rather than inhibit type 2 and 4 angiotensin II receptors can lower the rate of dementia among new users of these medications, new research suggests.

Results from a cohort study of more than 57,000 older Medicare beneficiaries showed that the initiation of antihypertensives that stimulate the receptors was linked to a 16% lower risk for incident Alzheimer’s disease and related dementia (ADRD) and an 18% lower risk for vascular dementia compared with those that inhibit the receptors.

“Achieving appropriate blood pressure control is essential for maximizing brain health, and this promising research suggests certain antihypertensives could yield brain benefit compared to others,” lead study author Zachary A. Marcum, PharmD, PhD, associate professor, University of Washington School of Pharmacy, Seattle, told this news organization.

The findings were published online in JAMA Network Open.
 

Medicare beneficiaries

Previous observational studies showed that antihypertensive medications that stimulate type 2 and 4 angiotensin II receptors, in comparison with those that don’t, were associated with lower rates of dementia. However, those studies included individuals with prevalent hypertension and were relatively small.

The new retrospective cohort study included a random sample of 57,773 Medicare beneficiaries aged at least 65 years with new-onset hypertension. The mean age of participants was 73.8 years, 62.9% were women, and 86.9% were White.

Over the course of the study, some participants filled at least one prescription for a stimulating angiotensin II receptor type 2 and 4, such as angiotensin II receptor type 1 blockers, dihydropyridine calcium channel blockers, and thiazide diuretics.

Others participants filled a prescription for an inhibiting type 2 and 4 angiotensin II receptors, including angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and nondihydropyridine calcium channel blockers.

“All these medications lower blood pressure, but they do it in different ways,” said Dr. Marcum.

The researchers were interested in the varying activity of these drugs at the type 2 and 4 angiotensin II receptors.

For each 30-day interval, they categorized beneficiaries into four groups: a stimulating medication group (n = 4,879) consisting of individuals mostly taking stimulating antihypertensives; an inhibiting medication group (n = 10,303) that mostly included individuals prescribed this type of antihypertensive; a mixed group (n = 2,179) that included a combination of the first two classifications; and a nonuser group (n = 40,413) of individuals who were not using either type of drug.

The primary outcome was time to first occurrence of ADRD. The secondary outcome was time to first occurrence of vascular dementia.

Researchers controlled for cardiovascular risk factors and sociodemographic characteristics, such as age, sex, race/ethnicity, and receipt of low-income subsidy.
 

Unanswered questions

After adjustments, results showed that initiation of an antihypertensive medication regimen that exclusively stimulates, rather than inhibits, type 2 and 4 angiotensin II receptors was associated with a 16% lower risk for incident ADRD over a follow-up of just under 7 years (hazard ratio, 0.84; 95% confidence interval, 0.79-0.90; P < .001).

The mixed regimen was also associated with statistically significant (P = .001) reduced odds of ADRD compared with the inhibiting medications.

As for vascular dementia, use of stimulating vs. inhibiting medications was associated with an 18% lower risk (HR, 0.82; 95% CI, 0.69-0.96; P = .02).

Again, use of the mixed regimen was associated with reduced risk of vascular dementia compared with the inhibiting medications (P = .03).

A variety of potential mechanisms might explain the superiority of stimulating agents when it comes to dementia risk, said Dr. Marcum. These could include, for example, increased blood flow to the brain and reduced amyloid.

“But more mechanistic work is needed as well as evaluation of dose responses, because that’s not something we looked at in this study,” Dr. Marcum said. “There are still a lot of unanswered questions.”
 

Stimulators instead of inhibitors?

The results of the current analysis come on the heels of some previous work showing the benefits of lowering blood pressure. For example, the Systolic Blood Pressure Intervention Trial (SPRINT) showed that targeting a systolic blood pressure below 120 mm Hg significantly reduces risk for heart disease, stroke, and death from these diseases.

But in contrast to previous research, the current study included only beneficiaries with incident hypertension and new use of antihypertensive medications, and it adjusted for time-varying confounding.

Prescribing stimulating instead of inhibiting treatments could make a difference at the population level, Dr. Marcum noted.

“If we could shift the prescribing a little bit from inhibiting to stimulating, that could possibly reduce dementia risk,” he said.

However, “we’re not suggesting [that all patients] have their regimen switched,” he added.

That’s because inhibiting medications still have an important place in the antihypertensive treatment armamentarium, Dr. Marcum noted. As an example, beta-blockers are used post heart attack.

As well, factors such as cost and side effects should be taken into consideration when prescribing an antihypertensive drug.

The new results could be used to set up a comparison in a future randomized controlled trial that would provide the strongest evidence for estimating causal effects of treatments, said Dr. Marcum.
 

‘More convincing’

Carlos G. Santos-Gallego, MD, Icahn School of Medicine at Mount Sinai, New York, said the study is “more convincing” than previous related research, as it has a larger sample size and a longer follow-up.

“And the exquisite statistical analysis gives more robustness, more solidity, to the hypothesis that drugs that stimulate type 2 and 4 angiotensin II receptors might be protective for dementia,” said Dr. Santos-Gallego, who was not involved with the research.

However, he noted that the retrospective study had some limitations, including the underdiagnosis of dementia. “The diagnosis of dementia is, honestly, very poorly done in the clinical setting,” he said.

As well, the study could be subject to “confounding by indication,” Dr. Santos-Gallego said. “There could be a third variable, another confounding factor, that’s responsible both for the dementia and for the prescription of these drugs,” he added.

For example, he noted that comorbidities such as atrial fibrillation, myocardial infarction, and heart failure might increase the risk of dementia.

He agreed with the investigators that a randomized clinical trial would address these limitations. “All comorbidities would be equally shared” in the randomized groups, and all participants would be given “a specific test for dementia at the same time,” Dr. Santos-Gallego said.

Still, he noted that the new results are in keeping with hypertension guidelines that recommend stimulating drugs.

“This trial definitely shows that the current hypertension guidelines are good treatment for our patients, not only to control blood pressure and not only to prevent infarction to prevent stroke but also to prevent dementia,” said Dr. Santos-Gallego.

Also commenting for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, said the new data provide “clarity” on why previous research had differing results on the effect of antihypertensives on cognition.

Among the caveats of this new analysis is that “it’s unclear if the demographics in this study are fully representative of Medicare beneficiaries,” said Dr. Snyder.

She, too, said a clinical trial is important “to understand if there is a preventative and/or treatment potential in the medications that stimulate type 2 and 4 angiotensin II receptors.”

The study received funding from the National Institute on Aging. Dr. Marcum and Dr. Santos-Gallego have reported no relevant financial relationships.

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

Antihypertensive medications that stimulate rather than inhibit type 2 and 4 angiotensin II receptors can lower the rate of dementia among new users of these medications, new research suggests.

Results from a cohort study of more than 57,000 older Medicare beneficiaries showed that the initiation of antihypertensives that stimulate the receptors was linked to a 16% lower risk for incident Alzheimer’s disease and related dementia (ADRD) and an 18% lower risk for vascular dementia compared with those that inhibit the receptors.

“Achieving appropriate blood pressure control is essential for maximizing brain health, and this promising research suggests certain antihypertensives could yield brain benefit compared to others,” lead study author Zachary A. Marcum, PharmD, PhD, associate professor, University of Washington School of Pharmacy, Seattle, told this news organization.

The findings were published online in JAMA Network Open.
 

Medicare beneficiaries

Previous observational studies showed that antihypertensive medications that stimulate type 2 and 4 angiotensin II receptors, in comparison with those that don’t, were associated with lower rates of dementia. However, those studies included individuals with prevalent hypertension and were relatively small.

The new retrospective cohort study included a random sample of 57,773 Medicare beneficiaries aged at least 65 years with new-onset hypertension. The mean age of participants was 73.8 years, 62.9% were women, and 86.9% were White.

Over the course of the study, some participants filled at least one prescription for a stimulating angiotensin II receptor type 2 and 4, such as angiotensin II receptor type 1 blockers, dihydropyridine calcium channel blockers, and thiazide diuretics.

Others participants filled a prescription for an inhibiting type 2 and 4 angiotensin II receptors, including angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and nondihydropyridine calcium channel blockers.

“All these medications lower blood pressure, but they do it in different ways,” said Dr. Marcum.

The researchers were interested in the varying activity of these drugs at the type 2 and 4 angiotensin II receptors.

For each 30-day interval, they categorized beneficiaries into four groups: a stimulating medication group (n = 4,879) consisting of individuals mostly taking stimulating antihypertensives; an inhibiting medication group (n = 10,303) that mostly included individuals prescribed this type of antihypertensive; a mixed group (n = 2,179) that included a combination of the first two classifications; and a nonuser group (n = 40,413) of individuals who were not using either type of drug.

The primary outcome was time to first occurrence of ADRD. The secondary outcome was time to first occurrence of vascular dementia.

Researchers controlled for cardiovascular risk factors and sociodemographic characteristics, such as age, sex, race/ethnicity, and receipt of low-income subsidy.
 

Unanswered questions

After adjustments, results showed that initiation of an antihypertensive medication regimen that exclusively stimulates, rather than inhibits, type 2 and 4 angiotensin II receptors was associated with a 16% lower risk for incident ADRD over a follow-up of just under 7 years (hazard ratio, 0.84; 95% confidence interval, 0.79-0.90; P < .001).

The mixed regimen was also associated with statistically significant (P = .001) reduced odds of ADRD compared with the inhibiting medications.

As for vascular dementia, use of stimulating vs. inhibiting medications was associated with an 18% lower risk (HR, 0.82; 95% CI, 0.69-0.96; P = .02).

Again, use of the mixed regimen was associated with reduced risk of vascular dementia compared with the inhibiting medications (P = .03).

A variety of potential mechanisms might explain the superiority of stimulating agents when it comes to dementia risk, said Dr. Marcum. These could include, for example, increased blood flow to the brain and reduced amyloid.

“But more mechanistic work is needed as well as evaluation of dose responses, because that’s not something we looked at in this study,” Dr. Marcum said. “There are still a lot of unanswered questions.”
 

Stimulators instead of inhibitors?

The results of the current analysis come on the heels of some previous work showing the benefits of lowering blood pressure. For example, the Systolic Blood Pressure Intervention Trial (SPRINT) showed that targeting a systolic blood pressure below 120 mm Hg significantly reduces risk for heart disease, stroke, and death from these diseases.

But in contrast to previous research, the current study included only beneficiaries with incident hypertension and new use of antihypertensive medications, and it adjusted for time-varying confounding.

Prescribing stimulating instead of inhibiting treatments could make a difference at the population level, Dr. Marcum noted.

“If we could shift the prescribing a little bit from inhibiting to stimulating, that could possibly reduce dementia risk,” he said.

However, “we’re not suggesting [that all patients] have their regimen switched,” he added.

That’s because inhibiting medications still have an important place in the antihypertensive treatment armamentarium, Dr. Marcum noted. As an example, beta-blockers are used post heart attack.

As well, factors such as cost and side effects should be taken into consideration when prescribing an antihypertensive drug.

The new results could be used to set up a comparison in a future randomized controlled trial that would provide the strongest evidence for estimating causal effects of treatments, said Dr. Marcum.
 

‘More convincing’

Carlos G. Santos-Gallego, MD, Icahn School of Medicine at Mount Sinai, New York, said the study is “more convincing” than previous related research, as it has a larger sample size and a longer follow-up.

“And the exquisite statistical analysis gives more robustness, more solidity, to the hypothesis that drugs that stimulate type 2 and 4 angiotensin II receptors might be protective for dementia,” said Dr. Santos-Gallego, who was not involved with the research.

However, he noted that the retrospective study had some limitations, including the underdiagnosis of dementia. “The diagnosis of dementia is, honestly, very poorly done in the clinical setting,” he said.

As well, the study could be subject to “confounding by indication,” Dr. Santos-Gallego said. “There could be a third variable, another confounding factor, that’s responsible both for the dementia and for the prescription of these drugs,” he added.

For example, he noted that comorbidities such as atrial fibrillation, myocardial infarction, and heart failure might increase the risk of dementia.

He agreed with the investigators that a randomized clinical trial would address these limitations. “All comorbidities would be equally shared” in the randomized groups, and all participants would be given “a specific test for dementia at the same time,” Dr. Santos-Gallego said.

Still, he noted that the new results are in keeping with hypertension guidelines that recommend stimulating drugs.

“This trial definitely shows that the current hypertension guidelines are good treatment for our patients, not only to control blood pressure and not only to prevent infarction to prevent stroke but also to prevent dementia,” said Dr. Santos-Gallego.

Also commenting for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, said the new data provide “clarity” on why previous research had differing results on the effect of antihypertensives on cognition.

Among the caveats of this new analysis is that “it’s unclear if the demographics in this study are fully representative of Medicare beneficiaries,” said Dr. Snyder.

She, too, said a clinical trial is important “to understand if there is a preventative and/or treatment potential in the medications that stimulate type 2 and 4 angiotensin II receptors.”

The study received funding from the National Institute on Aging. Dr. Marcum and Dr. Santos-Gallego have reported no relevant financial relationships.

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

Antihypertensive medications that stimulate rather than inhibit type 2 and 4 angiotensin II receptors can lower the rate of dementia among new users of these medications, new research suggests.

Results from a cohort study of more than 57,000 older Medicare beneficiaries showed that the initiation of antihypertensives that stimulate the receptors was linked to a 16% lower risk for incident Alzheimer’s disease and related dementia (ADRD) and an 18% lower risk for vascular dementia compared with those that inhibit the receptors.

“Achieving appropriate blood pressure control is essential for maximizing brain health, and this promising research suggests certain antihypertensives could yield brain benefit compared to others,” lead study author Zachary A. Marcum, PharmD, PhD, associate professor, University of Washington School of Pharmacy, Seattle, told this news organization.

The findings were published online in JAMA Network Open.
 

Medicare beneficiaries

Previous observational studies showed that antihypertensive medications that stimulate type 2 and 4 angiotensin II receptors, in comparison with those that don’t, were associated with lower rates of dementia. However, those studies included individuals with prevalent hypertension and were relatively small.

The new retrospective cohort study included a random sample of 57,773 Medicare beneficiaries aged at least 65 years with new-onset hypertension. The mean age of participants was 73.8 years, 62.9% were women, and 86.9% were White.

Over the course of the study, some participants filled at least one prescription for a stimulating angiotensin II receptor type 2 and 4, such as angiotensin II receptor type 1 blockers, dihydropyridine calcium channel blockers, and thiazide diuretics.

Others participants filled a prescription for an inhibiting type 2 and 4 angiotensin II receptors, including angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and nondihydropyridine calcium channel blockers.

“All these medications lower blood pressure, but they do it in different ways,” said Dr. Marcum.

The researchers were interested in the varying activity of these drugs at the type 2 and 4 angiotensin II receptors.

For each 30-day interval, they categorized beneficiaries into four groups: a stimulating medication group (n = 4,879) consisting of individuals mostly taking stimulating antihypertensives; an inhibiting medication group (n = 10,303) that mostly included individuals prescribed this type of antihypertensive; a mixed group (n = 2,179) that included a combination of the first two classifications; and a nonuser group (n = 40,413) of individuals who were not using either type of drug.

The primary outcome was time to first occurrence of ADRD. The secondary outcome was time to first occurrence of vascular dementia.

Researchers controlled for cardiovascular risk factors and sociodemographic characteristics, such as age, sex, race/ethnicity, and receipt of low-income subsidy.
 

Unanswered questions

After adjustments, results showed that initiation of an antihypertensive medication regimen that exclusively stimulates, rather than inhibits, type 2 and 4 angiotensin II receptors was associated with a 16% lower risk for incident ADRD over a follow-up of just under 7 years (hazard ratio, 0.84; 95% confidence interval, 0.79-0.90; P < .001).

The mixed regimen was also associated with statistically significant (P = .001) reduced odds of ADRD compared with the inhibiting medications.

As for vascular dementia, use of stimulating vs. inhibiting medications was associated with an 18% lower risk (HR, 0.82; 95% CI, 0.69-0.96; P = .02).

Again, use of the mixed regimen was associated with reduced risk of vascular dementia compared with the inhibiting medications (P = .03).

A variety of potential mechanisms might explain the superiority of stimulating agents when it comes to dementia risk, said Dr. Marcum. These could include, for example, increased blood flow to the brain and reduced amyloid.

“But more mechanistic work is needed as well as evaluation of dose responses, because that’s not something we looked at in this study,” Dr. Marcum said. “There are still a lot of unanswered questions.”
 

Stimulators instead of inhibitors?

The results of the current analysis come on the heels of some previous work showing the benefits of lowering blood pressure. For example, the Systolic Blood Pressure Intervention Trial (SPRINT) showed that targeting a systolic blood pressure below 120 mm Hg significantly reduces risk for heart disease, stroke, and death from these diseases.

But in contrast to previous research, the current study included only beneficiaries with incident hypertension and new use of antihypertensive medications, and it adjusted for time-varying confounding.

Prescribing stimulating instead of inhibiting treatments could make a difference at the population level, Dr. Marcum noted.

“If we could shift the prescribing a little bit from inhibiting to stimulating, that could possibly reduce dementia risk,” he said.

However, “we’re not suggesting [that all patients] have their regimen switched,” he added.

That’s because inhibiting medications still have an important place in the antihypertensive treatment armamentarium, Dr. Marcum noted. As an example, beta-blockers are used post heart attack.

As well, factors such as cost and side effects should be taken into consideration when prescribing an antihypertensive drug.

The new results could be used to set up a comparison in a future randomized controlled trial that would provide the strongest evidence for estimating causal effects of treatments, said Dr. Marcum.
 

‘More convincing’

Carlos G. Santos-Gallego, MD, Icahn School of Medicine at Mount Sinai, New York, said the study is “more convincing” than previous related research, as it has a larger sample size and a longer follow-up.

“And the exquisite statistical analysis gives more robustness, more solidity, to the hypothesis that drugs that stimulate type 2 and 4 angiotensin II receptors might be protective for dementia,” said Dr. Santos-Gallego, who was not involved with the research.

However, he noted that the retrospective study had some limitations, including the underdiagnosis of dementia. “The diagnosis of dementia is, honestly, very poorly done in the clinical setting,” he said.

As well, the study could be subject to “confounding by indication,” Dr. Santos-Gallego said. “There could be a third variable, another confounding factor, that’s responsible both for the dementia and for the prescription of these drugs,” he added.

For example, he noted that comorbidities such as atrial fibrillation, myocardial infarction, and heart failure might increase the risk of dementia.

He agreed with the investigators that a randomized clinical trial would address these limitations. “All comorbidities would be equally shared” in the randomized groups, and all participants would be given “a specific test for dementia at the same time,” Dr. Santos-Gallego said.

Still, he noted that the new results are in keeping with hypertension guidelines that recommend stimulating drugs.

“This trial definitely shows that the current hypertension guidelines are good treatment for our patients, not only to control blood pressure and not only to prevent infarction to prevent stroke but also to prevent dementia,” said Dr. Santos-Gallego.

Also commenting for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, said the new data provide “clarity” on why previous research had differing results on the effect of antihypertensives on cognition.

Among the caveats of this new analysis is that “it’s unclear if the demographics in this study are fully representative of Medicare beneficiaries,” said Dr. Snyder.

She, too, said a clinical trial is important “to understand if there is a preventative and/or treatment potential in the medications that stimulate type 2 and 4 angiotensin II receptors.”

The study received funding from the National Institute on Aging. Dr. Marcum and Dr. Santos-Gallego have reported no relevant financial relationships.

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

You discuss and decide on the best course of treatment for your patients, write prescriptions, and recommend lifestyle modifications to enhance treatment outcomes and overall wellness. But once they leave your office, following through is up to the patient. What happens when they don’t listen?

The term “nonadherent” has gradually replaced “noncompliant” in the physician lexicon as a nod to the evolving doctor-patient relationship. Noncompliance implies that a patient isn’t following their doctor’s orders. Adherence, on the other hand, is a measure of how closely your patient’s behavior matches the recommendations you’ve made. It’s a subtle difference but an important distinction in approaching care.

“Noncompliance is inherently negative feedback to the patient, whereas there’s a reason for nonadherence, and it’s usually external,” said Sharon Rabinovitz, MD, president of the Georgia Academy of Family Physicians.
 

Why won’t patients listen?

The reasons behind a patient’s nonadherence are multifaceted, but they are often driven by social determinants of health, such as transportation, poor health literacy, finances, and lack of access to pharmacies.

Other times, patients don’t want to take medicine, don’t prioritize their health, or they find the dietary and lifestyle modifications doctors suggest too hard to make or they struggle at losing weight, eating more healthfully, or cutting back on alcohol, for instance.

“When you come down to it, the big hindrance of it all is cost and the ability for the patient to be able to afford some of the things that we think they should be able to do,” said Teresa Lovins, MD, a physician in private practice Columbus, Ind., and a member of the board of directors of the American Academy of Family Physicians.

Another common deterrent to treatment is undesired side effects that a patient may not want to mention.

“For example, a lot of patients who are taking antidepressants have sexual dysfunction associated with those medications,” said Dr. Rabinovitz. “If you don’t ask the right questions, you’re not going to be able to fully assess the experience the patient is having and a reason why they might not take it [the medication].”

Much nonadherence is intentional and is based on experience, belief systems, and knowledge. For example, the American Medical Association finds that patients may not understand why they need a certain treatment (and therefore dismiss it), or they may be overloaded with multiple medications, fear dependency on a drug, have a mistrust of pharmaceutical companies or the medical system as a whole, or have symptoms of depression that make taking healthy actions more difficult. In addition, patients may be unable to afford their medication, or their lack of symptoms may lead them to believe they don’t really need the prescription, as occurs with disorders such as hypertension or high cholesterol.

“In my training, we did something called Balint training, where we would get together as a group with attendings and discuss cases that were difficult from a biopsychosocial perspective and consider all the factors in the patient perspective, including family dynamics, social systems, and economic realities,” said Russell Blackwelder, MD, director of geriatric education and associate professor of family medicine at the Medical University of South Carolina, Charleston.

“That training was, for me, very helpful for opening up and being more empathetic and really examining the patient’s point of view and everything that impacts them.”

Dr. Lovins agreed that it’s crucial to establish a good rapport and build mutual trust.

“If you don’t know the patient, you have a harder time asking the right questions to get to the meat of why they’re not taking their medicine or what they’re not doing to help their health,” she said. “It takes a little bit of trust on both parts to get to that question that really gets to the heart of why they’re not doing what you’re asking them to do.”
 

How to encourage adherence

Although there may not be a one-size-fits-all approach for achieving general adherence or adherence to a medication regimen, some methods may increase success.

Kenneth Zweig, MD, an internist at Northern Virginia Family Practice Associates, Alexandria, said that convincing patients to make one small change that they can sustain can get the ball rolling.

“I had one patient who was very overweight and had high blood pressure, high cholesterol, back pain, insomnia, and depression, who was also drinking three to four beers a night,” Dr. Zweig said. “After a long discussion, I challenged him to stop all alcohol for 1 week. At the end of the week, he noticed that he slept better, lost some weight, had lower blood pressure, and had more energy. Once he saw the benefits of this one change, he was motivated to improve other aspects of his health as well. He improved his diet, started exercising, and lost over 50 pounds. He has persisted with these lifestyle changes ever since.”

A team-based approach may also increase treatment understanding and adherence. In one older study, patients who were assigned to team-based care, including care by pharmacists, were significantly more adherent to medication regimens. Patients were more comfortable asking questions and raising concerns when they felt their treatment plan was a collaboration between several providers and themselves.

Dr. Lovins said to always approach the patient with a positive. “Say, what can we do together to make this work? What are your questions about this medication? And try and focus on the positive things that you can change instead of leaving the patient with a negative feeling or that you’re angry with them or that you’re unhappy with their choices. Patients respond better when they are treated as part of the team.”

Fear of judgment can also be a barrier to honesty between patients and their doctors. Shame creates a reluctance to admit nonadherence. Dr. Lovins said in an interview that it’s the physician’s responsibility to create a blame-free space for patients to speak openly about their struggles with treatment and reasons for nonadherence.
 

When should you redirect care?

Ultimately, the goal is good care and treatment of disease. However, if you and your patient are at an impasse and progress is stalling or failing, it may be appropriate to encourage the patient to seek care elsewhere.

“Just like any relationship, some physician-patient relationships are just not a good fit,” said Dr. Blackwelder. And this may be the reason why the patient is nonadherent — something between the two of you doesn’t click.

While there are ethical considerations for this decision, most medical boards have guidelines on how to go about it, Dr. Blackwelder said in an interview. “In the state of South Carolina, we have to be available to provide urgent coverage for at least 30 days and notify the patient in writing that they need to find somebody else and to help them find somebody else if we can.”

Just as with care, a clear conversation is the best practice if you’re proposing a potential shift away from a physician-patient relationship. You might say: We’re not making the kind of progress I’d like to see, and I’m wondering if you think working with another doctor may help you.

“The most important thing is being very honest and transparent with the patient that you’re concerned you’re not making the appropriate strides forward,” said Dr. Rabinovitz. Then you can ask, ‘Am I the right doctor to help you reach your goals? And if not, how can I help you get to where you need to be?’ ”

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

You discuss and decide on the best course of treatment for your patients, write prescriptions, and recommend lifestyle modifications to enhance treatment outcomes and overall wellness. But once they leave your office, following through is up to the patient. What happens when they don’t listen?

The term “nonadherent” has gradually replaced “noncompliant” in the physician lexicon as a nod to the evolving doctor-patient relationship. Noncompliance implies that a patient isn’t following their doctor’s orders. Adherence, on the other hand, is a measure of how closely your patient’s behavior matches the recommendations you’ve made. It’s a subtle difference but an important distinction in approaching care.

“Noncompliance is inherently negative feedback to the patient, whereas there’s a reason for nonadherence, and it’s usually external,” said Sharon Rabinovitz, MD, president of the Georgia Academy of Family Physicians.
 

Why won’t patients listen?

The reasons behind a patient’s nonadherence are multifaceted, but they are often driven by social determinants of health, such as transportation, poor health literacy, finances, and lack of access to pharmacies.

Other times, patients don’t want to take medicine, don’t prioritize their health, or they find the dietary and lifestyle modifications doctors suggest too hard to make or they struggle at losing weight, eating more healthfully, or cutting back on alcohol, for instance.

“When you come down to it, the big hindrance of it all is cost and the ability for the patient to be able to afford some of the things that we think they should be able to do,” said Teresa Lovins, MD, a physician in private practice Columbus, Ind., and a member of the board of directors of the American Academy of Family Physicians.

Another common deterrent to treatment is undesired side effects that a patient may not want to mention.

“For example, a lot of patients who are taking antidepressants have sexual dysfunction associated with those medications,” said Dr. Rabinovitz. “If you don’t ask the right questions, you’re not going to be able to fully assess the experience the patient is having and a reason why they might not take it [the medication].”

Much nonadherence is intentional and is based on experience, belief systems, and knowledge. For example, the American Medical Association finds that patients may not understand why they need a certain treatment (and therefore dismiss it), or they may be overloaded with multiple medications, fear dependency on a drug, have a mistrust of pharmaceutical companies or the medical system as a whole, or have symptoms of depression that make taking healthy actions more difficult. In addition, patients may be unable to afford their medication, or their lack of symptoms may lead them to believe they don’t really need the prescription, as occurs with disorders such as hypertension or high cholesterol.

“In my training, we did something called Balint training, where we would get together as a group with attendings and discuss cases that were difficult from a biopsychosocial perspective and consider all the factors in the patient perspective, including family dynamics, social systems, and economic realities,” said Russell Blackwelder, MD, director of geriatric education and associate professor of family medicine at the Medical University of South Carolina, Charleston.

“That training was, for me, very helpful for opening up and being more empathetic and really examining the patient’s point of view and everything that impacts them.”

Dr. Lovins agreed that it’s crucial to establish a good rapport and build mutual trust.

“If you don’t know the patient, you have a harder time asking the right questions to get to the meat of why they’re not taking their medicine or what they’re not doing to help their health,” she said. “It takes a little bit of trust on both parts to get to that question that really gets to the heart of why they’re not doing what you’re asking them to do.”
 

How to encourage adherence

Although there may not be a one-size-fits-all approach for achieving general adherence or adherence to a medication regimen, some methods may increase success.

Kenneth Zweig, MD, an internist at Northern Virginia Family Practice Associates, Alexandria, said that convincing patients to make one small change that they can sustain can get the ball rolling.

“I had one patient who was very overweight and had high blood pressure, high cholesterol, back pain, insomnia, and depression, who was also drinking three to four beers a night,” Dr. Zweig said. “After a long discussion, I challenged him to stop all alcohol for 1 week. At the end of the week, he noticed that he slept better, lost some weight, had lower blood pressure, and had more energy. Once he saw the benefits of this one change, he was motivated to improve other aspects of his health as well. He improved his diet, started exercising, and lost over 50 pounds. He has persisted with these lifestyle changes ever since.”

A team-based approach may also increase treatment understanding and adherence. In one older study, patients who were assigned to team-based care, including care by pharmacists, were significantly more adherent to medication regimens. Patients were more comfortable asking questions and raising concerns when they felt their treatment plan was a collaboration between several providers and themselves.

Dr. Lovins said to always approach the patient with a positive. “Say, what can we do together to make this work? What are your questions about this medication? And try and focus on the positive things that you can change instead of leaving the patient with a negative feeling or that you’re angry with them or that you’re unhappy with their choices. Patients respond better when they are treated as part of the team.”

Fear of judgment can also be a barrier to honesty between patients and their doctors. Shame creates a reluctance to admit nonadherence. Dr. Lovins said in an interview that it’s the physician’s responsibility to create a blame-free space for patients to speak openly about their struggles with treatment and reasons for nonadherence.
 

When should you redirect care?

Ultimately, the goal is good care and treatment of disease. However, if you and your patient are at an impasse and progress is stalling or failing, it may be appropriate to encourage the patient to seek care elsewhere.

“Just like any relationship, some physician-patient relationships are just not a good fit,” said Dr. Blackwelder. And this may be the reason why the patient is nonadherent — something between the two of you doesn’t click.

While there are ethical considerations for this decision, most medical boards have guidelines on how to go about it, Dr. Blackwelder said in an interview. “In the state of South Carolina, we have to be available to provide urgent coverage for at least 30 days and notify the patient in writing that they need to find somebody else and to help them find somebody else if we can.”

Just as with care, a clear conversation is the best practice if you’re proposing a potential shift away from a physician-patient relationship. You might say: We’re not making the kind of progress I’d like to see, and I’m wondering if you think working with another doctor may help you.

“The most important thing is being very honest and transparent with the patient that you’re concerned you’re not making the appropriate strides forward,” said Dr. Rabinovitz. Then you can ask, ‘Am I the right doctor to help you reach your goals? And if not, how can I help you get to where you need to be?’ ”

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

You discuss and decide on the best course of treatment for your patients, write prescriptions, and recommend lifestyle modifications to enhance treatment outcomes and overall wellness. But once they leave your office, following through is up to the patient. What happens when they don’t listen?

The term “nonadherent” has gradually replaced “noncompliant” in the physician lexicon as a nod to the evolving doctor-patient relationship. Noncompliance implies that a patient isn’t following their doctor’s orders. Adherence, on the other hand, is a measure of how closely your patient’s behavior matches the recommendations you’ve made. It’s a subtle difference but an important distinction in approaching care.

“Noncompliance is inherently negative feedback to the patient, whereas there’s a reason for nonadherence, and it’s usually external,” said Sharon Rabinovitz, MD, president of the Georgia Academy of Family Physicians.
 

Why won’t patients listen?

The reasons behind a patient’s nonadherence are multifaceted, but they are often driven by social determinants of health, such as transportation, poor health literacy, finances, and lack of access to pharmacies.

Other times, patients don’t want to take medicine, don’t prioritize their health, or they find the dietary and lifestyle modifications doctors suggest too hard to make or they struggle at losing weight, eating more healthfully, or cutting back on alcohol, for instance.

“When you come down to it, the big hindrance of it all is cost and the ability for the patient to be able to afford some of the things that we think they should be able to do,” said Teresa Lovins, MD, a physician in private practice Columbus, Ind., and a member of the board of directors of the American Academy of Family Physicians.

Another common deterrent to treatment is undesired side effects that a patient may not want to mention.

“For example, a lot of patients who are taking antidepressants have sexual dysfunction associated with those medications,” said Dr. Rabinovitz. “If you don’t ask the right questions, you’re not going to be able to fully assess the experience the patient is having and a reason why they might not take it [the medication].”

Much nonadherence is intentional and is based on experience, belief systems, and knowledge. For example, the American Medical Association finds that patients may not understand why they need a certain treatment (and therefore dismiss it), or they may be overloaded with multiple medications, fear dependency on a drug, have a mistrust of pharmaceutical companies or the medical system as a whole, or have symptoms of depression that make taking healthy actions more difficult. In addition, patients may be unable to afford their medication, or their lack of symptoms may lead them to believe they don’t really need the prescription, as occurs with disorders such as hypertension or high cholesterol.

“In my training, we did something called Balint training, where we would get together as a group with attendings and discuss cases that were difficult from a biopsychosocial perspective and consider all the factors in the patient perspective, including family dynamics, social systems, and economic realities,” said Russell Blackwelder, MD, director of geriatric education and associate professor of family medicine at the Medical University of South Carolina, Charleston.

“That training was, for me, very helpful for opening up and being more empathetic and really examining the patient’s point of view and everything that impacts them.”

Dr. Lovins agreed that it’s crucial to establish a good rapport and build mutual trust.

“If you don’t know the patient, you have a harder time asking the right questions to get to the meat of why they’re not taking their medicine or what they’re not doing to help their health,” she said. “It takes a little bit of trust on both parts to get to that question that really gets to the heart of why they’re not doing what you’re asking them to do.”
 

How to encourage adherence

Although there may not be a one-size-fits-all approach for achieving general adherence or adherence to a medication regimen, some methods may increase success.

Kenneth Zweig, MD, an internist at Northern Virginia Family Practice Associates, Alexandria, said that convincing patients to make one small change that they can sustain can get the ball rolling.

“I had one patient who was very overweight and had high blood pressure, high cholesterol, back pain, insomnia, and depression, who was also drinking three to four beers a night,” Dr. Zweig said. “After a long discussion, I challenged him to stop all alcohol for 1 week. At the end of the week, he noticed that he slept better, lost some weight, had lower blood pressure, and had more energy. Once he saw the benefits of this one change, he was motivated to improve other aspects of his health as well. He improved his diet, started exercising, and lost over 50 pounds. He has persisted with these lifestyle changes ever since.”

A team-based approach may also increase treatment understanding and adherence. In one older study, patients who were assigned to team-based care, including care by pharmacists, were significantly more adherent to medication regimens. Patients were more comfortable asking questions and raising concerns when they felt their treatment plan was a collaboration between several providers and themselves.

Dr. Lovins said to always approach the patient with a positive. “Say, what can we do together to make this work? What are your questions about this medication? And try and focus on the positive things that you can change instead of leaving the patient with a negative feeling or that you’re angry with them or that you’re unhappy with their choices. Patients respond better when they are treated as part of the team.”

Fear of judgment can also be a barrier to honesty between patients and their doctors. Shame creates a reluctance to admit nonadherence. Dr. Lovins said in an interview that it’s the physician’s responsibility to create a blame-free space for patients to speak openly about their struggles with treatment and reasons for nonadherence.
 

When should you redirect care?

Ultimately, the goal is good care and treatment of disease. However, if you and your patient are at an impasse and progress is stalling or failing, it may be appropriate to encourage the patient to seek care elsewhere.

“Just like any relationship, some physician-patient relationships are just not a good fit,” said Dr. Blackwelder. And this may be the reason why the patient is nonadherent — something between the two of you doesn’t click.

While there are ethical considerations for this decision, most medical boards have guidelines on how to go about it, Dr. Blackwelder said in an interview. “In the state of South Carolina, we have to be available to provide urgent coverage for at least 30 days and notify the patient in writing that they need to find somebody else and to help them find somebody else if we can.”

Just as with care, a clear conversation is the best practice if you’re proposing a potential shift away from a physician-patient relationship. You might say: We’re not making the kind of progress I’d like to see, and I’m wondering if you think working with another doctor may help you.

“The most important thing is being very honest and transparent with the patient that you’re concerned you’re not making the appropriate strides forward,” said Dr. Rabinovitz. Then you can ask, ‘Am I the right doctor to help you reach your goals? And if not, how can I help you get to where you need to be?’ ”

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

Dementia prevalence is 61% higher among older people with moderate to severe hearing loss compared with those with normal hearing, new national data show.

Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.

“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore, Md., told this news organization.

The findings were published online in JAMA.
 

Dose-dependent effect

For the study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.

Data from the study were collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.

“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.

Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.

Those with moderate to severe hearing loss were 61% more likely to have dementia than those with normal hearing (prevalence ratio, 1.61; 95% confidence interval, 1.09-2.38).

Dementia prevalence increased with increasing severity of hearing loss: normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate/severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).

Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).

Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assistive devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). This news organization last month reported on similar data published in JAMA Neurology suggesting that hearing aids reduce dementia risk.

“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
 

Robust association

Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.

“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”

Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.

“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.

“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.

The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships.

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

Dementia prevalence is 61% higher among older people with moderate to severe hearing loss compared with those with normal hearing, new national data show.

Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.

“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore, Md., told this news organization.

The findings were published online in JAMA.
 

Dose-dependent effect

For the study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.

Data from the study were collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.

“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.

Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.

Those with moderate to severe hearing loss were 61% more likely to have dementia than those with normal hearing (prevalence ratio, 1.61; 95% confidence interval, 1.09-2.38).

Dementia prevalence increased with increasing severity of hearing loss: normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate/severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).

Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).

Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assistive devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). This news organization last month reported on similar data published in JAMA Neurology suggesting that hearing aids reduce dementia risk.

“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
 

Robust association

Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.

“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”

Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.

“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.

“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.

The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships.

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

Dementia prevalence is 61% higher among older people with moderate to severe hearing loss compared with those with normal hearing, new national data show.

Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.

“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore, Md., told this news organization.

The findings were published online in JAMA.
 

Dose-dependent effect

For the study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.

Data from the study were collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.

“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.

Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.

Those with moderate to severe hearing loss were 61% more likely to have dementia than those with normal hearing (prevalence ratio, 1.61; 95% confidence interval, 1.09-2.38).

Dementia prevalence increased with increasing severity of hearing loss: normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate/severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).

Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).

Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assistive devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). This news organization last month reported on similar data published in JAMA Neurology suggesting that hearing aids reduce dementia risk.

“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
 

Robust association

Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.

“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”

Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.

“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.

“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.

The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships.

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

Telehealth parent-child interaction therapy improved the behavior of 3-year-olds with developmental delay in a randomized controlled trial.

The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.

Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.

Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.

Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.

In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.

The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.

The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.

Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.

Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.

Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.

In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.

For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.

iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
 

Data support iPCIT potential

Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.

“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.

The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.

The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
 

Practical pediatric takeaways

“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.

“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.

“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”

That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
 

Benefits and barriers

“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.

“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.

Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.

The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

Telehealth parent-child interaction therapy improved the behavior of 3-year-olds with developmental delay in a randomized controlled trial.

The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.

Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.

Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.

Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.

In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.

The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.

The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.

Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.

Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.

Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.

In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.

For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.

iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
 

Data support iPCIT potential

Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.

“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.

The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.

The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
 

Practical pediatric takeaways

“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.

“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.

“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”

That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
 

Benefits and barriers

“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.

“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.

Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.

The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

Telehealth parent-child interaction therapy improved the behavior of 3-year-olds with developmental delay in a randomized controlled trial.

The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.

Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.

Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.

Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.

In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.

The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.

The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.

Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.

Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.

Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.

In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.

For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.

iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
 

Data support iPCIT potential

Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.

“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.

The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.

The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
 

Practical pediatric takeaways

“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.

“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.

“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”

That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
 

Benefits and barriers

“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.

“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.

Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.

The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Joining me today is Sandeep Jauhar, a practicing cardiologist and professor of medicine at Northwell Health, a frequent New York Times op-ed contributor, and highly regarded author of the upcoming book “My Father’s Brain: Life in the Shadow of Alzheimer’s.”

We are here today to discuss the rationale for age competency exams for practicing physicians.

Sandeep Jauhar, MD: Thanks for having me.

Dr. Glatter: Your recent op-ed piece in the New York Times caught my eye. In your piece, you refer to a 2020 survey in which almost one-third of licensed doctors in the United States were 60 years of age or older, up from a quarter in 2010. You also state that, due to a 20% prevalence of mild cognitive impairment in persons older than 65, practicing physicians above this age should probably be screened by a battery of tests to ensure that their reasoning and cognitive abilities are intact. The title of the article is “How Would You Feel About a 100-Year-Old Doctor?”

How would you envision such a process? What aspects of day-to-day functioning would the exams truly be evaluating?

Dr. Jauhar: A significant number of people over 65 have measurable cognitive impairment. By cognitive impairment, we’re not talking about dementia. The best estimates are that 1 in 10 people over age 65 have dementia, and roughly 1 in 5 have what’s called MCI, or mild cognitive impairment, which is cognitive impairment out of proportion to what you’d expect from normal aging. It’s a significant issue.

The argument that I made in the op-ed is that neurocognitive assessment is important. That’s not to say that everyone over age 65 has significant cognitive impairment or that older doctors can’t practice medicine safely and effectively. They absolutely can. The question is, do we leave neurocognitive assessment to physicians who may possibly be suffering from impairment?

In dementia, people very often have impaired self-awareness, a condition called anosognosia, which is a neurological term for not being aware of your own impairment because of your impairment.

I would argue that, instead of having voluntary neurocognitive screening, it should be mandated. The question is how to do that effectively, fairly, and transparently.

One could argue a gerontocracy in medicine today, where there are so many older physicians. What do we do about that? That really is something that I think needs to be debated.

Dr. Glatter: The question I have is, if we (that is, physicians and the health care profession) don’t take care of this, someone’s going to do it for us. We need to jump on this now while we have the opportunity. The AMA has been opposed to this, except when you have reason to suspect cognitive decline or are concerned about patient safety. A mandatory age of retirement is certainly something they’re not for, and we know this.

Your argument in your op-ed piece is very well thought out, and you lay the groundwork for testing (looking at someone’s memory, coordination, processing speed, and other executive functions). Certainly, for a psychiatrist, hearing is important, and for a dermatologist, vision is important. For a surgeon, there are other issues. Based on the specialty, we must be careful to see the important aspects of functioning. I am sure you would agree with this.

Dr. Jauhar: Obviously, the hand skills that are important for ophthalmological surgery certainly aren’t required for office-based psychological counseling, for example. We have to be smart about how we assess impairment.

You describe the spectrum of actions. On the one hand, there’s mandatory retirement at the age of 65 or 70 years. We know that commercial pilots are mandated to essentially retire at 65, and air-traffic controllers must retire in their late 50s.

We know that there’s a large amount of variability in competence. There are internists in their 80s with whom I’ve worked, and I’m absolutely wowed by their experience and judgment. There are new medical resident graduates who don’t really seem to have the requisite level of competence that would make me feel comfortable to have them as my doctor or a doctor for a member of my family.

To mandate retirement, I think the AMA is absolutely right. To not call for any kind of competency testing, to me, seems equally unwise. Because at the end of the day, you have to balance individual physician needs or wants to continue practicing with patient safety. I haven’t really come across too many physicians who say, “There’s absolutely no need for a competency testing.”

We have to meet somewhere in the middle. The middle is either voluntary cognitive competency testing or mandatory. I would argue that, because we know that as the brain changes we have cognitive impairment, but we’re not always aware that we need help, mandatory testing is the way.

One other thing that you mentioned was about having the solution imposed on us. You and I are doctors. We deal with bureaucracy. We deal with poorly thought-out solutions to issues in health care that make our lives that much more difficult. I don’t want that solution imposed on us by some outside agency. I think we need to figure this out within medicine and figure out the right way of doing it.

The AMA is on board with this. They haven’t called for mandatory testing, but they have said that if testing were to occur, these are the guidelines. The guidelines are fair and equitable, not too time-consuming, transparent, and not punitive. If someone comes out and doesn’t test well, we shouldn’t force them out of the profession. We can find ways to use their experience to help train younger doctors, for example.

Dr. Glatter: I wanted to segue to an area where there has been some challenge to the legality of these mandatory types of age restrictions and imposing the exams as well. There’s been a lawsuit as well by the EEOC [Equal Employment Opportunity Commission], on behalf of Yale. Basically, there’s been a concern that ageism is part of what’s going on. Yale now screens their providers beginning at age 70, and they have a program. UCSD [University of California, San Diego] has a program in place. Obviously, these institutions are looking at it. This is a very small part of the overall picture.

Health care systems overall, we’re talking about a fraction of them in the country are really addressing the issue of competency exams. The question is, where do we go from here? How do we get engagement or adoption and get physicians as a whole to embrace this concept?

Dr. Jauhar: The EEOC filed a lawsuit on behalf of the Yale medical staff that argued that Yale’s plan to do vision testing and neurocognitive screening – there may be a physical exam also – constitutes age discrimination because it’s reserved for doctors over the age of 70. Those are the physicians who are most likely to have cognitive impairment.

We have rules already for impaired physicians who are, for example, addicted to illicit drugs or have alcohol abuse. We already have some of those measures in place. This is focused on cognitive impairment in aging physicians because cognitive impairment is an issue that arises with aging. We have to be clear about that.

Most younger physicians will not have measurable cognitive impairment that would impair their ability to practice. To force young physicians (for example, physicians in their forties) to undergo such screening, all in the name of preventing age discrimination, doesn’t strike me as being a good use of resources. They’re more likely to be false positives, as you know from Bayesian statistics. When you have low pretest probability, you’re more likely to get false positives.

How are we going to screen hundreds of thousands of physicians? We have to make a choice about the group that really is more likely to benefit from such screening. Very few hospitals are addressing this issue and it’s going to become more important.

Dr. Glatter: Surgeons have been particularly active in pushing for age-based screening. In 2016, the American College of Surgeons started making surgeons at age 65-70 undergo voluntary health and neurocognitive assessments, and encouraged physicians to disclose any concerning findings as part of their professional obligation, which is pretty impressive in my mind.

Surgeons’ skill set is quite demanding physically and technically. That the Society of Surgical Chairs took it upon themselves to institute this is pretty telling.

Dr. Jauhar: The overall society called for screening, but then in a separate survey of surgical chairs, the idea was advanced that we should have mandatory retirement. Now, I don’t particularly agree with that.

I’ve seen it, where you have the aging surgeon who was a star in their day, and no one wants to say anything when their skills have visibly degraded, and no one wants to carry that torch and tell them that they need to retire. What happens is people whisper, and unfortunately, bad outcomes have to occur before people tend to get involved, and that’s what I’m trying to prevent.

Dr. Glatter: The question is whether older physicians have worse patient outcomes. The evidence is inconclusive, but studies have shown higher mortality rates for cardiovascular surgeons in terms of the procedures that they do. On the flip side, there are also higher mortality rates for GI surgery performed by younger surgeons. It’s a mixed bag.

Dr. Jauhar: For specialized surgery, you need the accrual of a certain amount of experience. The optimal age is about 60, because they’ve seen many things and they’ve seen complications. They don’t have a hand tremor yet so they’re still functioning well, and they’ve accrued a lot of experience. We have to be smart about who we screen.

There’s a learning curve in surgery. By no means am I arguing that younger surgeons are better surgeons. I would say that there’s probably a tipping point where once you get past a certain age and physical deterioration starts to take effect, that can overshadow the accrual of cognitive and surgical experience. We have to balance those things.

I would say neurocognitive screening and vision testing are important, but exactly what do you measure? How much of a hand tremor would constitute a risk? These things have to be figured out. I just want doctors to be leading the charge here and not have this imposed by bureaucrats.

Dr. Glatter: I was reading that some doctors have had these exams administered and they can really pass cognitive aspects of the exam, but there have been nuances in the actual practicing of medicine, day-to-day functioning, which they’re not good at.

Someone made a comment that the only way to know if a doctor can do well in practice is to observe their practice and observe them taking care of patients. In other words, you can game the system and pass the cognitive exam in some form but then have a problem practicing medicine.

Dr. Jauhar: Ultimately, outcomes have to be measured. We can’t adopt such a granular approach for every aging physician. There has to be some sort of screening that maybe raises a red flag and then hospitals and department chairs need to investigate further. What are the outcomes? What are people saying in the operating room? I think the screening is just that; it’s a way of opening the door to further investigation, but it’s not a witch hunt.

I have the highest respect for older physicians, and I learn from them every day, honestly, especially in my field (cardiology), because some of the older physicians can hear and see things on physical exam that I didn’t even know existed. There’s much to be learned from them.

This is not intended to be a witch hunt or to try to get rid of older physicians – by any means. We want to avoid some of the outcomes that I read about in the New York Times comments section. It’s not fair to our patients not to do at least some sort of screening to prevent those kinds of mistakes.

Dr. Glatter: I wanted to go back to data from Yale between October 2016 and January 2019, where 141 Yale clinicians who ranged in age from 69 to 92 years completed cognitive assessments. Of those, 18 clinicians, or about 13% of those tested, demonstrated cognitive deficits that were “deemed likely to impair their ability to practice medicine independently.” That’s telling. These are subtleties, but they’re important to identify. I would love to get your comment on that.

Dr. Jauhar: It’s in keeping with what we know about the proportion of our older citizens who have cognitive impairment. About 10% have dementia and about 20% have at least mild cognitive impairment. That’s in keeping with what we know, and this was a general screening.

There are certain programs, like in San Diego, for example, where physicians are referred, and so there’s a selection bias. But this was just general screening. It’s worrisome. I’m an aging physician myself. I want fairness in this process because I’m going to be assessed as well.

I just don’t really understand yet why there’s so much circling of the wagons and so much resistance. It seems like it would be good for physicians also to be removed from situations where they might get into potential litigation because of mistakes and physical or visual impairment. It seems like it’d be good for patients and physicians alike.

Dr. Glatter: It’s difficult to give up your profession, change fields, or become administrative at some point, and [decide] when to make that transition. As we all get older, we’re not going to have the ability to do what we did in our 20s, 30s, and so forth.

Dr. Jauhar: Much of the resistance is coming from doctors who are used to high levels of autonomy. I’m certainly sympathetic to that because I don’t want anyone telling me how to practice. The reason this is coming up and hasn’t come up in the past is not because of loss of autonomy but because of an actual demographic change. Many physicians were trained in the 1960s, ’70s, or ’80s. They’re getting to retirement age but they’re not retiring, and we can speculate as to why that is.

In America’s educational system, doctors incur a huge amount of debt. I know physicians who are still paying off their debt and they’re in their 50s and 60s, so I’m very sympathetic to that. I’m not trying to force doctors out of practicing. I just want whoever is practicing to be competent and to practice safely. We have to figure out how to do that.

Dr. Glatter: The fact that there is a shortage of physicians forecast in the next 10-15 years makes many physicians reluctant to retire. They feel like they want to be part of that support network and we don’t want to have a dire situation, especially in the rural areas. We’re not immune from aging. We’re human beings. We all have to realize that.

Dr. Jauhar: I know that the ACC is starting to debate this issue, in part because of my op-ed. My hope is that it will start a conversation and we will institute a plan that comes from physicians and serves our patients, and doesn’t serve some cottage industry of testing or serve the needs of insurers or bureaucrats. It has to serve the doctor-patient relationship.

Dr. Glatter: In some random surveys that I’ve read, up to 30%-40% of physicians do support some type of age-based screening or competency assessment. The needle’s moving. It’s just not there yet. I think that wider adoption is coming.

Dr. Jauhar: Data are coming as more hospitals start to adopt these late practitioner programs. Some of the data that came out of Yale, for example, are very important. We’re going to see more published data in this area, and it will clarify what we need to do and how big the problem is.

Dr. Glatter: I want to thank you again for your time and for writing the op-ed because it certainly was well read and opened the eyes of not only physicians, but also the public at large. It’s a conversation that has to be had. Thank you for doing this.

Dr. Jauhar: Thanks for inviting me, Robert. It was a pleasure to talk to you.

Dr. Glatter is assistant professor of emergency medicine, department of emergency medicine, at Hofstra University, Hempstead, N.Y. Dr. Jauhar is director of the heart failure program, Long Island Jewish Medical Center, New Hyde Park, N.Y. Neither Dr. Glatter nor Dr. Jauhar reported any relevant conflicts of interest.

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

This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Joining me today is Sandeep Jauhar, a practicing cardiologist and professor of medicine at Northwell Health, a frequent New York Times op-ed contributor, and highly regarded author of the upcoming book “My Father’s Brain: Life in the Shadow of Alzheimer’s.”

We are here today to discuss the rationale for age competency exams for practicing physicians.

Sandeep Jauhar, MD: Thanks for having me.

Dr. Glatter: Your recent op-ed piece in the New York Times caught my eye. In your piece, you refer to a 2020 survey in which almost one-third of licensed doctors in the United States were 60 years of age or older, up from a quarter in 2010. You also state that, due to a 20% prevalence of mild cognitive impairment in persons older than 65, practicing physicians above this age should probably be screened by a battery of tests to ensure that their reasoning and cognitive abilities are intact. The title of the article is “How Would You Feel About a 100-Year-Old Doctor?”

How would you envision such a process? What aspects of day-to-day functioning would the exams truly be evaluating?

Dr. Jauhar: A significant number of people over 65 have measurable cognitive impairment. By cognitive impairment, we’re not talking about dementia. The best estimates are that 1 in 10 people over age 65 have dementia, and roughly 1 in 5 have what’s called MCI, or mild cognitive impairment, which is cognitive impairment out of proportion to what you’d expect from normal aging. It’s a significant issue.

The argument that I made in the op-ed is that neurocognitive assessment is important. That’s not to say that everyone over age 65 has significant cognitive impairment or that older doctors can’t practice medicine safely and effectively. They absolutely can. The question is, do we leave neurocognitive assessment to physicians who may possibly be suffering from impairment?

In dementia, people very often have impaired self-awareness, a condition called anosognosia, which is a neurological term for not being aware of your own impairment because of your impairment.

I would argue that, instead of having voluntary neurocognitive screening, it should be mandated. The question is how to do that effectively, fairly, and transparently.

One could argue a gerontocracy in medicine today, where there are so many older physicians. What do we do about that? That really is something that I think needs to be debated.

Dr. Glatter: The question I have is, if we (that is, physicians and the health care profession) don’t take care of this, someone’s going to do it for us. We need to jump on this now while we have the opportunity. The AMA has been opposed to this, except when you have reason to suspect cognitive decline or are concerned about patient safety. A mandatory age of retirement is certainly something they’re not for, and we know this.

Your argument in your op-ed piece is very well thought out, and you lay the groundwork for testing (looking at someone’s memory, coordination, processing speed, and other executive functions). Certainly, for a psychiatrist, hearing is important, and for a dermatologist, vision is important. For a surgeon, there are other issues. Based on the specialty, we must be careful to see the important aspects of functioning. I am sure you would agree with this.

Dr. Jauhar: Obviously, the hand skills that are important for ophthalmological surgery certainly aren’t required for office-based psychological counseling, for example. We have to be smart about how we assess impairment.

You describe the spectrum of actions. On the one hand, there’s mandatory retirement at the age of 65 or 70 years. We know that commercial pilots are mandated to essentially retire at 65, and air-traffic controllers must retire in their late 50s.

We know that there’s a large amount of variability in competence. There are internists in their 80s with whom I’ve worked, and I’m absolutely wowed by their experience and judgment. There are new medical resident graduates who don’t really seem to have the requisite level of competence that would make me feel comfortable to have them as my doctor or a doctor for a member of my family.

To mandate retirement, I think the AMA is absolutely right. To not call for any kind of competency testing, to me, seems equally unwise. Because at the end of the day, you have to balance individual physician needs or wants to continue practicing with patient safety. I haven’t really come across too many physicians who say, “There’s absolutely no need for a competency testing.”

We have to meet somewhere in the middle. The middle is either voluntary cognitive competency testing or mandatory. I would argue that, because we know that as the brain changes we have cognitive impairment, but we’re not always aware that we need help, mandatory testing is the way.

One other thing that you mentioned was about having the solution imposed on us. You and I are doctors. We deal with bureaucracy. We deal with poorly thought-out solutions to issues in health care that make our lives that much more difficult. I don’t want that solution imposed on us by some outside agency. I think we need to figure this out within medicine and figure out the right way of doing it.

The AMA is on board with this. They haven’t called for mandatory testing, but they have said that if testing were to occur, these are the guidelines. The guidelines are fair and equitable, not too time-consuming, transparent, and not punitive. If someone comes out and doesn’t test well, we shouldn’t force them out of the profession. We can find ways to use their experience to help train younger doctors, for example.

Dr. Glatter: I wanted to segue to an area where there has been some challenge to the legality of these mandatory types of age restrictions and imposing the exams as well. There’s been a lawsuit as well by the EEOC [Equal Employment Opportunity Commission], on behalf of Yale. Basically, there’s been a concern that ageism is part of what’s going on. Yale now screens their providers beginning at age 70, and they have a program. UCSD [University of California, San Diego] has a program in place. Obviously, these institutions are looking at it. This is a very small part of the overall picture.

Health care systems overall, we’re talking about a fraction of them in the country are really addressing the issue of competency exams. The question is, where do we go from here? How do we get engagement or adoption and get physicians as a whole to embrace this concept?

Dr. Jauhar: The EEOC filed a lawsuit on behalf of the Yale medical staff that argued that Yale’s plan to do vision testing and neurocognitive screening – there may be a physical exam also – constitutes age discrimination because it’s reserved for doctors over the age of 70. Those are the physicians who are most likely to have cognitive impairment.

We have rules already for impaired physicians who are, for example, addicted to illicit drugs or have alcohol abuse. We already have some of those measures in place. This is focused on cognitive impairment in aging physicians because cognitive impairment is an issue that arises with aging. We have to be clear about that.

Most younger physicians will not have measurable cognitive impairment that would impair their ability to practice. To force young physicians (for example, physicians in their forties) to undergo such screening, all in the name of preventing age discrimination, doesn’t strike me as being a good use of resources. They’re more likely to be false positives, as you know from Bayesian statistics. When you have low pretest probability, you’re more likely to get false positives.

How are we going to screen hundreds of thousands of physicians? We have to make a choice about the group that really is more likely to benefit from such screening. Very few hospitals are addressing this issue and it’s going to become more important.

Dr. Glatter: Surgeons have been particularly active in pushing for age-based screening. In 2016, the American College of Surgeons started making surgeons at age 65-70 undergo voluntary health and neurocognitive assessments, and encouraged physicians to disclose any concerning findings as part of their professional obligation, which is pretty impressive in my mind.

Surgeons’ skill set is quite demanding physically and technically. That the Society of Surgical Chairs took it upon themselves to institute this is pretty telling.

Dr. Jauhar: The overall society called for screening, but then in a separate survey of surgical chairs, the idea was advanced that we should have mandatory retirement. Now, I don’t particularly agree with that.

I’ve seen it, where you have the aging surgeon who was a star in their day, and no one wants to say anything when their skills have visibly degraded, and no one wants to carry that torch and tell them that they need to retire. What happens is people whisper, and unfortunately, bad outcomes have to occur before people tend to get involved, and that’s what I’m trying to prevent.

Dr. Glatter: The question is whether older physicians have worse patient outcomes. The evidence is inconclusive, but studies have shown higher mortality rates for cardiovascular surgeons in terms of the procedures that they do. On the flip side, there are also higher mortality rates for GI surgery performed by younger surgeons. It’s a mixed bag.

Dr. Jauhar: For specialized surgery, you need the accrual of a certain amount of experience. The optimal age is about 60, because they’ve seen many things and they’ve seen complications. They don’t have a hand tremor yet so they’re still functioning well, and they’ve accrued a lot of experience. We have to be smart about who we screen.

There’s a learning curve in surgery. By no means am I arguing that younger surgeons are better surgeons. I would say that there’s probably a tipping point where once you get past a certain age and physical deterioration starts to take effect, that can overshadow the accrual of cognitive and surgical experience. We have to balance those things.

I would say neurocognitive screening and vision testing are important, but exactly what do you measure? How much of a hand tremor would constitute a risk? These things have to be figured out. I just want doctors to be leading the charge here and not have this imposed by bureaucrats.

Dr. Glatter: I was reading that some doctors have had these exams administered and they can really pass cognitive aspects of the exam, but there have been nuances in the actual practicing of medicine, day-to-day functioning, which they’re not good at.

Someone made a comment that the only way to know if a doctor can do well in practice is to observe their practice and observe them taking care of patients. In other words, you can game the system and pass the cognitive exam in some form but then have a problem practicing medicine.

Dr. Jauhar: Ultimately, outcomes have to be measured. We can’t adopt such a granular approach for every aging physician. There has to be some sort of screening that maybe raises a red flag and then hospitals and department chairs need to investigate further. What are the outcomes? What are people saying in the operating room? I think the screening is just that; it’s a way of opening the door to further investigation, but it’s not a witch hunt.

I have the highest respect for older physicians, and I learn from them every day, honestly, especially in my field (cardiology), because some of the older physicians can hear and see things on physical exam that I didn’t even know existed. There’s much to be learned from them.

This is not intended to be a witch hunt or to try to get rid of older physicians – by any means. We want to avoid some of the outcomes that I read about in the New York Times comments section. It’s not fair to our patients not to do at least some sort of screening to prevent those kinds of mistakes.

Dr. Glatter: I wanted to go back to data from Yale between October 2016 and January 2019, where 141 Yale clinicians who ranged in age from 69 to 92 years completed cognitive assessments. Of those, 18 clinicians, or about 13% of those tested, demonstrated cognitive deficits that were “deemed likely to impair their ability to practice medicine independently.” That’s telling. These are subtleties, but they’re important to identify. I would love to get your comment on that.

Dr. Jauhar: It’s in keeping with what we know about the proportion of our older citizens who have cognitive impairment. About 10% have dementia and about 20% have at least mild cognitive impairment. That’s in keeping with what we know, and this was a general screening.

There are certain programs, like in San Diego, for example, where physicians are referred, and so there’s a selection bias. But this was just general screening. It’s worrisome. I’m an aging physician myself. I want fairness in this process because I’m going to be assessed as well.

I just don’t really understand yet why there’s so much circling of the wagons and so much resistance. It seems like it would be good for physicians also to be removed from situations where they might get into potential litigation because of mistakes and physical or visual impairment. It seems like it’d be good for patients and physicians alike.

Dr. Glatter: It’s difficult to give up your profession, change fields, or become administrative at some point, and [decide] when to make that transition. As we all get older, we’re not going to have the ability to do what we did in our 20s, 30s, and so forth.

Dr. Jauhar: Much of the resistance is coming from doctors who are used to high levels of autonomy. I’m certainly sympathetic to that because I don’t want anyone telling me how to practice. The reason this is coming up and hasn’t come up in the past is not because of loss of autonomy but because of an actual demographic change. Many physicians were trained in the 1960s, ’70s, or ’80s. They’re getting to retirement age but they’re not retiring, and we can speculate as to why that is.

In America’s educational system, doctors incur a huge amount of debt. I know physicians who are still paying off their debt and they’re in their 50s and 60s, so I’m very sympathetic to that. I’m not trying to force doctors out of practicing. I just want whoever is practicing to be competent and to practice safely. We have to figure out how to do that.

Dr. Glatter: The fact that there is a shortage of physicians forecast in the next 10-15 years makes many physicians reluctant to retire. They feel like they want to be part of that support network and we don’t want to have a dire situation, especially in the rural areas. We’re not immune from aging. We’re human beings. We all have to realize that.

Dr. Jauhar: I know that the ACC is starting to debate this issue, in part because of my op-ed. My hope is that it will start a conversation and we will institute a plan that comes from physicians and serves our patients, and doesn’t serve some cottage industry of testing or serve the needs of insurers or bureaucrats. It has to serve the doctor-patient relationship.

Dr. Glatter: In some random surveys that I’ve read, up to 30%-40% of physicians do support some type of age-based screening or competency assessment. The needle’s moving. It’s just not there yet. I think that wider adoption is coming.

Dr. Jauhar: Data are coming as more hospitals start to adopt these late practitioner programs. Some of the data that came out of Yale, for example, are very important. We’re going to see more published data in this area, and it will clarify what we need to do and how big the problem is.

Dr. Glatter: I want to thank you again for your time and for writing the op-ed because it certainly was well read and opened the eyes of not only physicians, but also the public at large. It’s a conversation that has to be had. Thank you for doing this.

Dr. Jauhar: Thanks for inviting me, Robert. It was a pleasure to talk to you.

Dr. Glatter is assistant professor of emergency medicine, department of emergency medicine, at Hofstra University, Hempstead, N.Y. Dr. Jauhar is director of the heart failure program, Long Island Jewish Medical Center, New Hyde Park, N.Y. Neither Dr. Glatter nor Dr. Jauhar reported any relevant conflicts of interest.

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

This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Joining me today is Sandeep Jauhar, a practicing cardiologist and professor of medicine at Northwell Health, a frequent New York Times op-ed contributor, and highly regarded author of the upcoming book “My Father’s Brain: Life in the Shadow of Alzheimer’s.”

We are here today to discuss the rationale for age competency exams for practicing physicians.

Sandeep Jauhar, MD: Thanks for having me.

Dr. Glatter: Your recent op-ed piece in the New York Times caught my eye. In your piece, you refer to a 2020 survey in which almost one-third of licensed doctors in the United States were 60 years of age or older, up from a quarter in 2010. You also state that, due to a 20% prevalence of mild cognitive impairment in persons older than 65, practicing physicians above this age should probably be screened by a battery of tests to ensure that their reasoning and cognitive abilities are intact. The title of the article is “How Would You Feel About a 100-Year-Old Doctor?”

How would you envision such a process? What aspects of day-to-day functioning would the exams truly be evaluating?

Dr. Jauhar: A significant number of people over 65 have measurable cognitive impairment. By cognitive impairment, we’re not talking about dementia. The best estimates are that 1 in 10 people over age 65 have dementia, and roughly 1 in 5 have what’s called MCI, or mild cognitive impairment, which is cognitive impairment out of proportion to what you’d expect from normal aging. It’s a significant issue.

The argument that I made in the op-ed is that neurocognitive assessment is important. That’s not to say that everyone over age 65 has significant cognitive impairment or that older doctors can’t practice medicine safely and effectively. They absolutely can. The question is, do we leave neurocognitive assessment to physicians who may possibly be suffering from impairment?

In dementia, people very often have impaired self-awareness, a condition called anosognosia, which is a neurological term for not being aware of your own impairment because of your impairment.

I would argue that, instead of having voluntary neurocognitive screening, it should be mandated. The question is how to do that effectively, fairly, and transparently.

One could argue a gerontocracy in medicine today, where there are so many older physicians. What do we do about that? That really is something that I think needs to be debated.

Dr. Glatter: The question I have is, if we (that is, physicians and the health care profession) don’t take care of this, someone’s going to do it for us. We need to jump on this now while we have the opportunity. The AMA has been opposed to this, except when you have reason to suspect cognitive decline or are concerned about patient safety. A mandatory age of retirement is certainly something they’re not for, and we know this.

Your argument in your op-ed piece is very well thought out, and you lay the groundwork for testing (looking at someone’s memory, coordination, processing speed, and other executive functions). Certainly, for a psychiatrist, hearing is important, and for a dermatologist, vision is important. For a surgeon, there are other issues. Based on the specialty, we must be careful to see the important aspects of functioning. I am sure you would agree with this.

Dr. Jauhar: Obviously, the hand skills that are important for ophthalmological surgery certainly aren’t required for office-based psychological counseling, for example. We have to be smart about how we assess impairment.

You describe the spectrum of actions. On the one hand, there’s mandatory retirement at the age of 65 or 70 years. We know that commercial pilots are mandated to essentially retire at 65, and air-traffic controllers must retire in their late 50s.

We know that there’s a large amount of variability in competence. There are internists in their 80s with whom I’ve worked, and I’m absolutely wowed by their experience and judgment. There are new medical resident graduates who don’t really seem to have the requisite level of competence that would make me feel comfortable to have them as my doctor or a doctor for a member of my family.

To mandate retirement, I think the AMA is absolutely right. To not call for any kind of competency testing, to me, seems equally unwise. Because at the end of the day, you have to balance individual physician needs or wants to continue practicing with patient safety. I haven’t really come across too many physicians who say, “There’s absolutely no need for a competency testing.”

We have to meet somewhere in the middle. The middle is either voluntary cognitive competency testing or mandatory. I would argue that, because we know that as the brain changes we have cognitive impairment, but we’re not always aware that we need help, mandatory testing is the way.

One other thing that you mentioned was about having the solution imposed on us. You and I are doctors. We deal with bureaucracy. We deal with poorly thought-out solutions to issues in health care that make our lives that much more difficult. I don’t want that solution imposed on us by some outside agency. I think we need to figure this out within medicine and figure out the right way of doing it.

The AMA is on board with this. They haven’t called for mandatory testing, but they have said that if testing were to occur, these are the guidelines. The guidelines are fair and equitable, not too time-consuming, transparent, and not punitive. If someone comes out and doesn’t test well, we shouldn’t force them out of the profession. We can find ways to use their experience to help train younger doctors, for example.

Dr. Glatter: I wanted to segue to an area where there has been some challenge to the legality of these mandatory types of age restrictions and imposing the exams as well. There’s been a lawsuit as well by the EEOC [Equal Employment Opportunity Commission], on behalf of Yale. Basically, there’s been a concern that ageism is part of what’s going on. Yale now screens their providers beginning at age 70, and they have a program. UCSD [University of California, San Diego] has a program in place. Obviously, these institutions are looking at it. This is a very small part of the overall picture.

Health care systems overall, we’re talking about a fraction of them in the country are really addressing the issue of competency exams. The question is, where do we go from here? How do we get engagement or adoption and get physicians as a whole to embrace this concept?

Dr. Jauhar: The EEOC filed a lawsuit on behalf of the Yale medical staff that argued that Yale’s plan to do vision testing and neurocognitive screening – there may be a physical exam also – constitutes age discrimination because it’s reserved for doctors over the age of 70. Those are the physicians who are most likely to have cognitive impairment.

We have rules already for impaired physicians who are, for example, addicted to illicit drugs or have alcohol abuse. We already have some of those measures in place. This is focused on cognitive impairment in aging physicians because cognitive impairment is an issue that arises with aging. We have to be clear about that.

Most younger physicians will not have measurable cognitive impairment that would impair their ability to practice. To force young physicians (for example, physicians in their forties) to undergo such screening, all in the name of preventing age discrimination, doesn’t strike me as being a good use of resources. They’re more likely to be false positives, as you know from Bayesian statistics. When you have low pretest probability, you’re more likely to get false positives.

How are we going to screen hundreds of thousands of physicians? We have to make a choice about the group that really is more likely to benefit from such screening. Very few hospitals are addressing this issue and it’s going to become more important.

Dr. Glatter: Surgeons have been particularly active in pushing for age-based screening. In 2016, the American College of Surgeons started making surgeons at age 65-70 undergo voluntary health and neurocognitive assessments, and encouraged physicians to disclose any concerning findings as part of their professional obligation, which is pretty impressive in my mind.

Surgeons’ skill set is quite demanding physically and technically. That the Society of Surgical Chairs took it upon themselves to institute this is pretty telling.

Dr. Jauhar: The overall society called for screening, but then in a separate survey of surgical chairs, the idea was advanced that we should have mandatory retirement. Now, I don’t particularly agree with that.

I’ve seen it, where you have the aging surgeon who was a star in their day, and no one wants to say anything when their skills have visibly degraded, and no one wants to carry that torch and tell them that they need to retire. What happens is people whisper, and unfortunately, bad outcomes have to occur before people tend to get involved, and that’s what I’m trying to prevent.

Dr. Glatter: The question is whether older physicians have worse patient outcomes. The evidence is inconclusive, but studies have shown higher mortality rates for cardiovascular surgeons in terms of the procedures that they do. On the flip side, there are also higher mortality rates for GI surgery performed by younger surgeons. It’s a mixed bag.

Dr. Jauhar: For specialized surgery, you need the accrual of a certain amount of experience. The optimal age is about 60, because they’ve seen many things and they’ve seen complications. They don’t have a hand tremor yet so they’re still functioning well, and they’ve accrued a lot of experience. We have to be smart about who we screen.

There’s a learning curve in surgery. By no means am I arguing that younger surgeons are better surgeons. I would say that there’s probably a tipping point where once you get past a certain age and physical deterioration starts to take effect, that can overshadow the accrual of cognitive and surgical experience. We have to balance those things.

I would say neurocognitive screening and vision testing are important, but exactly what do you measure? How much of a hand tremor would constitute a risk? These things have to be figured out. I just want doctors to be leading the charge here and not have this imposed by bureaucrats.

Dr. Glatter: I was reading that some doctors have had these exams administered and they can really pass cognitive aspects of the exam, but there have been nuances in the actual practicing of medicine, day-to-day functioning, which they’re not good at.

Someone made a comment that the only way to know if a doctor can do well in practice is to observe their practice and observe them taking care of patients. In other words, you can game the system and pass the cognitive exam in some form but then have a problem practicing medicine.

Dr. Jauhar: Ultimately, outcomes have to be measured. We can’t adopt such a granular approach for every aging physician. There has to be some sort of screening that maybe raises a red flag and then hospitals and department chairs need to investigate further. What are the outcomes? What are people saying in the operating room? I think the screening is just that; it’s a way of opening the door to further investigation, but it’s not a witch hunt.

I have the highest respect for older physicians, and I learn from them every day, honestly, especially in my field (cardiology), because some of the older physicians can hear and see things on physical exam that I didn’t even know existed. There’s much to be learned from them.

This is not intended to be a witch hunt or to try to get rid of older physicians – by any means. We want to avoid some of the outcomes that I read about in the New York Times comments section. It’s not fair to our patients not to do at least some sort of screening to prevent those kinds of mistakes.

Dr. Glatter: I wanted to go back to data from Yale between October 2016 and January 2019, where 141 Yale clinicians who ranged in age from 69 to 92 years completed cognitive assessments. Of those, 18 clinicians, or about 13% of those tested, demonstrated cognitive deficits that were “deemed likely to impair their ability to practice medicine independently.” That’s telling. These are subtleties, but they’re important to identify. I would love to get your comment on that.

Dr. Jauhar: It’s in keeping with what we know about the proportion of our older citizens who have cognitive impairment. About 10% have dementia and about 20% have at least mild cognitive impairment. That’s in keeping with what we know, and this was a general screening.

There are certain programs, like in San Diego, for example, where physicians are referred, and so there’s a selection bias. But this was just general screening. It’s worrisome. I’m an aging physician myself. I want fairness in this process because I’m going to be assessed as well.

I just don’t really understand yet why there’s so much circling of the wagons and so much resistance. It seems like it would be good for physicians also to be removed from situations where they might get into potential litigation because of mistakes and physical or visual impairment. It seems like it’d be good for patients and physicians alike.

Dr. Glatter: It’s difficult to give up your profession, change fields, or become administrative at some point, and [decide] when to make that transition. As we all get older, we’re not going to have the ability to do what we did in our 20s, 30s, and so forth.

Dr. Jauhar: Much of the resistance is coming from doctors who are used to high levels of autonomy. I’m certainly sympathetic to that because I don’t want anyone telling me how to practice. The reason this is coming up and hasn’t come up in the past is not because of loss of autonomy but because of an actual demographic change. Many physicians were trained in the 1960s, ’70s, or ’80s. They’re getting to retirement age but they’re not retiring, and we can speculate as to why that is.

In America’s educational system, doctors incur a huge amount of debt. I know physicians who are still paying off their debt and they’re in their 50s and 60s, so I’m very sympathetic to that. I’m not trying to force doctors out of practicing. I just want whoever is practicing to be competent and to practice safely. We have to figure out how to do that.

Dr. Glatter: The fact that there is a shortage of physicians forecast in the next 10-15 years makes many physicians reluctant to retire. They feel like they want to be part of that support network and we don’t want to have a dire situation, especially in the rural areas. We’re not immune from aging. We’re human beings. We all have to realize that.

Dr. Jauhar: I know that the ACC is starting to debate this issue, in part because of my op-ed. My hope is that it will start a conversation and we will institute a plan that comes from physicians and serves our patients, and doesn’t serve some cottage industry of testing or serve the needs of insurers or bureaucrats. It has to serve the doctor-patient relationship.

Dr. Glatter: In some random surveys that I’ve read, up to 30%-40% of physicians do support some type of age-based screening or competency assessment. The needle’s moving. It’s just not there yet. I think that wider adoption is coming.

Dr. Jauhar: Data are coming as more hospitals start to adopt these late practitioner programs. Some of the data that came out of Yale, for example, are very important. We’re going to see more published data in this area, and it will clarify what we need to do and how big the problem is.

Dr. Glatter: I want to thank you again for your time and for writing the op-ed because it certainly was well read and opened the eyes of not only physicians, but also the public at large. It’s a conversation that has to be had. Thank you for doing this.

Dr. Jauhar: Thanks for inviting me, Robert. It was a pleasure to talk to you.

Dr. Glatter is assistant professor of emergency medicine, department of emergency medicine, at Hofstra University, Hempstead, N.Y. Dr. Jauhar is director of the heart failure program, Long Island Jewish Medical Center, New Hyde Park, N.Y. Neither Dr. Glatter nor Dr. Jauhar reported any relevant conflicts of interest.

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

Almost one-third of patients with chronic pain report using medical cannabis to manage that pain, with more than half of them decreasing use of other pain medications, including opioids, new research shows.

“That patients report substituting cannabis for pain medicines so much really underscores the need for research on the benefits and risks of using cannabis for chronic pain,” lead author Mark C. Bicket, MD, PhD, assistant professor, department of anesthesiology, and director, Opioid Prescribing Engagement Network, University of Michigan, Ann Arbor, said in an interview.

However, he added, the question is whether they’re turning to cannabis and away from other pain treatments. “What’s not clear and one of the gaps that we wanted to address in the study was if medical cannabis use is changing the use of other treatments for chronic pain,” said Dr. Bicket.

The study was published online in JAMA Network Open.
 

Decreased opioid use

The survey included a representative sample of 1724 American adults aged 18 years or older with chronic noncancer pain living in areas with a medical cannabis program.

Respondents were asked about their use of three categories of pain treatments. This included medical cannabis; pharmacologic treatments including prescription opioids, nonopioid analgesics, and over-the-counter analgesics; and common nonpharmacologic treatments such as physical therapy, meditation, and cognitive-behavioral therapy (CBT).

Just over 96% of respondents completed the full survey. About 57% of the sample was female and the mean age of the study sample was 52.3 years.

Among study participants, 31% (95% CI, 28.2% - 34.1%) reported having ever used cannabis to manage pain; 25.9% (95% confidence interval, 23.2%-28.8%) reported use in the past 12 months, and 23.2% (95% CI, 20.6%-26%) reported use in the past 30 days.

“This translates into a large number of individuals who are using cannabis in an intended medical way” to treat chronic condition such as low back pain, migraine, and fibromyalgia, said Dr. Bicket.

More than half of survey respondents reported their medical cannabis use led to a decrease in prescription opioid use, prescription nonopioid use and use of over-the-counter medications.

Dr. Bicket noted “almost no one” said medical cannabis use led to higher use of these drugs.

As for nonpharmacologic treatments, 38.7% reported their use of cannabis led to decreased use of physical therapy, 19.1% to lower use of meditation, and 26% to less CBT. At the same time, 5.9%, 23.7% and 17.1%, respectively, reported it led to increased use of physical therapy, meditation, and CBT.

Medical cannabis is regulated at a state level. On a federal level, it’s considered a Schedule I substance, which means it’s deemed not to have a therapeutic use, although some groups are trying to change that categorization, said Dr. Bicket.

As a result, cannabis products “are quite variable” in terms of how they’re used (smoked, eaten etc.) and in their composition, including percentage of cannabidiol and tetrahydrocannabinol.

“We really don’t have a good sense of the relative risks and benefits that could come from cannabis as a treatment for chronic pain,” said Dr. Bicket. “As a physician, it’s difficult to have discussions with patients because I’m not able to understand the products they’re using based on this regulatory environment we have.”

He added clinicians “are operating in an area of uncertainty right now.”

What’s needed is research to determine how safe and effective medical cannabis is for chronic pain, he said.
 

Pain a leading indication

Commenting on the findings, Jason W. Busse, PhD, professor, department of anesthesia, and associate director, Centre for Medicinal Cannabis Research, McMaster University, Hamilton, Ont., said the study reinforces results of some prior research.

“It gives us current information certainly highlighting the high rate of use of medical cannabis among individuals with chronic pain once it becomes legally available.”

In addition, this high rate of use “means we desperately need information about the benefits and harms” of medical marijuana, he said.

Dr. Busse noted the survey didn’t provide information on the types of cannabis being used or the mode of administration. Oil drops and sprays cause less pulmonary harm than smoked versions, he said. It’s also not clear from the survey if participants are taking formulations with high levels of tetrahydrocannabinol that are associated with greater risk of harm.

He noted cannabis may interact with prescription drugs to make them less effective or, in some cases, to augment their adverse effects.

Dr. Busse pointed out some patients could be using fewer opioids because providers are under “enormous pressure” to reduce prescriptions of these drugs in the wake of spikes in opioid overdoses and deaths.

Chronic pain is “absolutely the leading indication” for medical marijuana, said Dr. Busse. U.S. reimbursement data suggest up to 65% of individuals get cannabis to treat a listed indication for chronic pain.

He said he hopes this new study will increase interest in funding new trials “so we can have better evidence to guide practice to help patients make decisions.”

The study received support from the National Institute on Drug Abuse. Dr. Bicket reported receiving personal fees from Axial Healthcare as well as grants from the National Institutes of Health, the Centers for Disease Control and Prevention, Michigan Department of Health and Human Services, Arnold Foundation, and the Patient-Centered Outcomes Research Institute outside the submitted work. Dr. Busse reported no relevant financial relationships.

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

Almost one-third of patients with chronic pain report using medical cannabis to manage that pain, with more than half of them decreasing use of other pain medications, including opioids, new research shows.

“That patients report substituting cannabis for pain medicines so much really underscores the need for research on the benefits and risks of using cannabis for chronic pain,” lead author Mark C. Bicket, MD, PhD, assistant professor, department of anesthesiology, and director, Opioid Prescribing Engagement Network, University of Michigan, Ann Arbor, said in an interview.

However, he added, the question is whether they’re turning to cannabis and away from other pain treatments. “What’s not clear and one of the gaps that we wanted to address in the study was if medical cannabis use is changing the use of other treatments for chronic pain,” said Dr. Bicket.

The study was published online in JAMA Network Open.
 

Decreased opioid use

The survey included a representative sample of 1724 American adults aged 18 years or older with chronic noncancer pain living in areas with a medical cannabis program.

Respondents were asked about their use of three categories of pain treatments. This included medical cannabis; pharmacologic treatments including prescription opioids, nonopioid analgesics, and over-the-counter analgesics; and common nonpharmacologic treatments such as physical therapy, meditation, and cognitive-behavioral therapy (CBT).

Just over 96% of respondents completed the full survey. About 57% of the sample was female and the mean age of the study sample was 52.3 years.

Among study participants, 31% (95% CI, 28.2% - 34.1%) reported having ever used cannabis to manage pain; 25.9% (95% confidence interval, 23.2%-28.8%) reported use in the past 12 months, and 23.2% (95% CI, 20.6%-26%) reported use in the past 30 days.

“This translates into a large number of individuals who are using cannabis in an intended medical way” to treat chronic condition such as low back pain, migraine, and fibromyalgia, said Dr. Bicket.

More than half of survey respondents reported their medical cannabis use led to a decrease in prescription opioid use, prescription nonopioid use and use of over-the-counter medications.

Dr. Bicket noted “almost no one” said medical cannabis use led to higher use of these drugs.

As for nonpharmacologic treatments, 38.7% reported their use of cannabis led to decreased use of physical therapy, 19.1% to lower use of meditation, and 26% to less CBT. At the same time, 5.9%, 23.7% and 17.1%, respectively, reported it led to increased use of physical therapy, meditation, and CBT.

Medical cannabis is regulated at a state level. On a federal level, it’s considered a Schedule I substance, which means it’s deemed not to have a therapeutic use, although some groups are trying to change that categorization, said Dr. Bicket.

As a result, cannabis products “are quite variable” in terms of how they’re used (smoked, eaten etc.) and in their composition, including percentage of cannabidiol and tetrahydrocannabinol.

“We really don’t have a good sense of the relative risks and benefits that could come from cannabis as a treatment for chronic pain,” said Dr. Bicket. “As a physician, it’s difficult to have discussions with patients because I’m not able to understand the products they’re using based on this regulatory environment we have.”

He added clinicians “are operating in an area of uncertainty right now.”

What’s needed is research to determine how safe and effective medical cannabis is for chronic pain, he said.
 

Pain a leading indication

Commenting on the findings, Jason W. Busse, PhD, professor, department of anesthesia, and associate director, Centre for Medicinal Cannabis Research, McMaster University, Hamilton, Ont., said the study reinforces results of some prior research.

“It gives us current information certainly highlighting the high rate of use of medical cannabis among individuals with chronic pain once it becomes legally available.”

In addition, this high rate of use “means we desperately need information about the benefits and harms” of medical marijuana, he said.

Dr. Busse noted the survey didn’t provide information on the types of cannabis being used or the mode of administration. Oil drops and sprays cause less pulmonary harm than smoked versions, he said. It’s also not clear from the survey if participants are taking formulations with high levels of tetrahydrocannabinol that are associated with greater risk of harm.

He noted cannabis may interact with prescription drugs to make them less effective or, in some cases, to augment their adverse effects.

Dr. Busse pointed out some patients could be using fewer opioids because providers are under “enormous pressure” to reduce prescriptions of these drugs in the wake of spikes in opioid overdoses and deaths.

Chronic pain is “absolutely the leading indication” for medical marijuana, said Dr. Busse. U.S. reimbursement data suggest up to 65% of individuals get cannabis to treat a listed indication for chronic pain.

He said he hopes this new study will increase interest in funding new trials “so we can have better evidence to guide practice to help patients make decisions.”

The study received support from the National Institute on Drug Abuse. Dr. Bicket reported receiving personal fees from Axial Healthcare as well as grants from the National Institutes of Health, the Centers for Disease Control and Prevention, Michigan Department of Health and Human Services, Arnold Foundation, and the Patient-Centered Outcomes Research Institute outside the submitted work. Dr. Busse reported no relevant financial relationships.

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

Almost one-third of patients with chronic pain report using medical cannabis to manage that pain, with more than half of them decreasing use of other pain medications, including opioids, new research shows.

“That patients report substituting cannabis for pain medicines so much really underscores the need for research on the benefits and risks of using cannabis for chronic pain,” lead author Mark C. Bicket, MD, PhD, assistant professor, department of anesthesiology, and director, Opioid Prescribing Engagement Network, University of Michigan, Ann Arbor, said in an interview.

However, he added, the question is whether they’re turning to cannabis and away from other pain treatments. “What’s not clear and one of the gaps that we wanted to address in the study was if medical cannabis use is changing the use of other treatments for chronic pain,” said Dr. Bicket.

The study was published online in JAMA Network Open.
 

Decreased opioid use

The survey included a representative sample of 1724 American adults aged 18 years or older with chronic noncancer pain living in areas with a medical cannabis program.

Respondents were asked about their use of three categories of pain treatments. This included medical cannabis; pharmacologic treatments including prescription opioids, nonopioid analgesics, and over-the-counter analgesics; and common nonpharmacologic treatments such as physical therapy, meditation, and cognitive-behavioral therapy (CBT).

Just over 96% of respondents completed the full survey. About 57% of the sample was female and the mean age of the study sample was 52.3 years.

Among study participants, 31% (95% CI, 28.2% - 34.1%) reported having ever used cannabis to manage pain; 25.9% (95% confidence interval, 23.2%-28.8%) reported use in the past 12 months, and 23.2% (95% CI, 20.6%-26%) reported use in the past 30 days.

“This translates into a large number of individuals who are using cannabis in an intended medical way” to treat chronic condition such as low back pain, migraine, and fibromyalgia, said Dr. Bicket.

More than half of survey respondents reported their medical cannabis use led to a decrease in prescription opioid use, prescription nonopioid use and use of over-the-counter medications.

Dr. Bicket noted “almost no one” said medical cannabis use led to higher use of these drugs.

As for nonpharmacologic treatments, 38.7% reported their use of cannabis led to decreased use of physical therapy, 19.1% to lower use of meditation, and 26% to less CBT. At the same time, 5.9%, 23.7% and 17.1%, respectively, reported it led to increased use of physical therapy, meditation, and CBT.

Medical cannabis is regulated at a state level. On a federal level, it’s considered a Schedule I substance, which means it’s deemed not to have a therapeutic use, although some groups are trying to change that categorization, said Dr. Bicket.

As a result, cannabis products “are quite variable” in terms of how they’re used (smoked, eaten etc.) and in their composition, including percentage of cannabidiol and tetrahydrocannabinol.

“We really don’t have a good sense of the relative risks and benefits that could come from cannabis as a treatment for chronic pain,” said Dr. Bicket. “As a physician, it’s difficult to have discussions with patients because I’m not able to understand the products they’re using based on this regulatory environment we have.”

He added clinicians “are operating in an area of uncertainty right now.”

What’s needed is research to determine how safe and effective medical cannabis is for chronic pain, he said.
 

Pain a leading indication

Commenting on the findings, Jason W. Busse, PhD, professor, department of anesthesia, and associate director, Centre for Medicinal Cannabis Research, McMaster University, Hamilton, Ont., said the study reinforces results of some prior research.

“It gives us current information certainly highlighting the high rate of use of medical cannabis among individuals with chronic pain once it becomes legally available.”

In addition, this high rate of use “means we desperately need information about the benefits and harms” of medical marijuana, he said.

Dr. Busse noted the survey didn’t provide information on the types of cannabis being used or the mode of administration. Oil drops and sprays cause less pulmonary harm than smoked versions, he said. It’s also not clear from the survey if participants are taking formulations with high levels of tetrahydrocannabinol that are associated with greater risk of harm.

He noted cannabis may interact with prescription drugs to make them less effective or, in some cases, to augment their adverse effects.

Dr. Busse pointed out some patients could be using fewer opioids because providers are under “enormous pressure” to reduce prescriptions of these drugs in the wake of spikes in opioid overdoses and deaths.

Chronic pain is “absolutely the leading indication” for medical marijuana, said Dr. Busse. U.S. reimbursement data suggest up to 65% of individuals get cannabis to treat a listed indication for chronic pain.

He said he hopes this new study will increase interest in funding new trials “so we can have better evidence to guide practice to help patients make decisions.”

The study received support from the National Institute on Drug Abuse. Dr. Bicket reported receiving personal fees from Axial Healthcare as well as grants from the National Institutes of Health, the Centers for Disease Control and Prevention, Michigan Department of Health and Human Services, Arnold Foundation, and the Patient-Centered Outcomes Research Institute outside the submitted work. Dr. Busse reported no relevant financial relationships.

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

Attention-deficit/hyperactivity disorder (ADHD) is often a very challenging condition for parents to manage, both because of the “gleeful mayhem” children with ADHD manifest and because of the nature of effective treatments. Multiple randomized controlled studies and meta-analyses have demonstrated that stimulant medication with behavioral interventions is the optimal first-line treatment for children with both subtypes of ADHD, and that medications alone are superior to behavioral interventions alone. By improving attention and impulse control, the medications effectively decrease the many negative interactions with teachers, peers, and parents, aiding development and healthy self-esteem.

But many parents feel anxious about treating their young children with stimulants. Importantly, how children with ADHD will fare as adults is not predicted by their symptom level, but instead by the quality of their relationships with their parents, their ability to perform at school, and their social skills. Bring this framework to parents as you listen to their questions and help them decide on the best approach for their family. To assist you in these conversations, we will review the evidence for (or against) several of the most common alternatives to medication that parents are likely to ask about.
 

Diets and supplements

Dietary modifications are among the most popular “natural” approaches to managing ADHD in children. Diets that eliminate processed sugars or food additives (particularly artificial food coloring) are among the most common approaches discussed in the lay press. These diets are usually very time-consuming and disruptive for families to follow, and there is no evidence to support their general use in ADHD management. Those studies that rigorously examined them suggest that, for children with severe impairment who have failed to respond to medications for ADHD, a workup for food intolerance or nutritional deficits may reveal a different problem underlying their behavioral difficulties.¹

Similarly, supplementation with high-dose omega-3 fatty acids is modestly helpful only in a subset of children with ADHD symptoms, and not nearly as effective as medications or behavioral interventions. Spending time on an exacting diet or buying expensive supplements is very unlikely to relieve the children’s symptoms and may only add to their stress at home. The “sugar high” parents note may be the rare joy of eating a candy bar and not sugar causing ADHD. Offer parents the guidance to focus on a healthy diet, high in fruits and vegetables, whole grains, and healthy protein, and on meals that emphasize family time instead of struggles around food.
 

Neurofeedback

Neurofeedback is an approach that grew out of the observation that many adults with ADHD had resting patterns of brain wave activity different from those of neurotypical adults. In neurofeedback, patients learn strategies that amplify the brain waves associated with focused mental activity, rather than listless or hyperactive states. Businesses market this service for all sorts of illnesses and challenges, ADHD chief among them. Despite the marketing, there are very few randomized controlled studies of this intervention for ADHD in youth, and those have shown only the possibility of a benefit.

While there is no evidence of serious side effects, these treatments are time-consuming and expensive and unlikely to be covered by any insurance. You might suggest to parents that they could achieve some of the same theoretical benefits by looking for hobbies that invite sustained focus in their children. That is, they should think about activities that interest the children, such as music lessons or karate, that they could practice in classes and at home. If the children find these activities even somewhat interesting (or just enjoy the reward of their parents’ or teachers’ attention), regular practice will be supporting their developing attention while building social skills and authentic self-confidence, rather than the activities feeling like a treatment for an illness or condition.

Sleep and exercise

There are not many businesses or books selling worried and exhausted parents a quick nonmedication solution for their children’s ADHD in the form of healthy sleep and exercise habits. But these are safe and healthy ways to reduce symptoms and support development. Children with ADHD often enjoy and benefit from participating in a sport, and daily exercise can help with sleep and regulating their energy. They also often have difficulty with sleep initiation, and commonly do not get adequate or restful sleep. Inadequate sleep exacerbates inattention, distractibility, and irritability. Children with untreated ADHD also often spend a lot of time on screens, as it is difficult for them to shift away from rewarding activities, and parents can find screen time to be a welcome break from hyperactivity and negative interactions. But excessive screen time, especially close to bedtime, can worsen irritability and make sleep more difficult. Talk with parents about the value of establishing a routine around screen time, modest daily physical activity, and sleep that everyone can follow. If their family life is currently marked by late bedtimes and long hours in front of video games, this change will take effort. But within a few weeks, it could lead to significant improvements in energy, attention, and interactions at home.

Behavioral treatments

Effective behavioral treatments for ADHD do not change ADHD symptoms, but they do help children learn how to manage them. In “parent management training,” younger children and parents learn together how to avoid negative cycles of behavior (i.e., temper outbursts) by focusing on consistent routines and consequences that support children calmly learning to manage their impulses. The only other evidence-based treatment focuses on helping school age and older children develop executive functions – their planning, organization, and time management skills – with a range of age-appropriate tools. Both of these therapies may be more effective if the children are also receiving medication, but medication is not necessary for them to be helpful. It is important to note that play therapy and other evidence-based psychotherapies are not effective for management of ADHD, although they may treat comorbid problems.

Parent treatment

You may have diagnosed children with ADHD only to hear their parents respond by saying that they suspect (or know) that they (or their spouses) also have ADHD. This would not be surprising, as ADHD has one of the highest rates of heritability of psychiatric disorders, at 80%. Somewhere between 25% and 50% of parents of children with ADHD have ADHD themselves.² Screening for adults with ADHD, such as the Adult ADHD Self-Report Scale, is widely available and free. Speak with parents about the fact that behavioral treatments for their children’s ADHD are demanding. Such treatments require patience, calm, organization, and consistency.

If parents have ADHD, it may be very helpful for them to prioritize their own effective treatments, so that their attention and impulse control will support their parenting. They may be interested in learning about how treatment might also improve their performance at work and even the quality of their relationships. While there is some evidence that their children’s treatment outcome will hinge on the parents’ treatment,³ they deserve good care independent of the expectations of parenting.

Families benefit from a comprehensive “ADHD plan” for their children. This would start with an assessment of the severity of their children’s symptoms, specifying their impairment at home, school, and in social relationships. It would include their nonacademic performance, exploration of interests, and developing self-confidence. All of these considerations lead to setting reasonable expectations so the children can feel successful. Parents should think about how best to structure their children’s schedules to promote healthy sleep, exercise, and nutrition, and to expand opportunities for building their frustration tolerance, social skills, and executive function.

Parents will need to consider what kind of supports they themselves need to offer this structure. There are good resources available online for information and support, including Children and Adults with ADHD (chadd.org) and the ADHD Resource Center from the American Academy of Child and Adolescent Psychiatry (aacap.org). This approach may help parents to evaluate the potential risks and benefits of medications as a component of treatment. Most of the quick fixes for childhood ADHD on the market will take a family’s time and money without providing meaningful improvement. Parents should focus instead on the tried-and-true routines and supports that will help them to create the setting at home that will enable their children to flourish.
 

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

References

1. Millichap JG and Yee MM. Pediatrics. 2012 Feb;129(2):330-7.

2. Grimm O et al. Curr Psychiatry Rep. 2020 Feb 27;22(4):18.

3. Chronis-Tuscano A et al. J Abnorm Child Psychol. 2017 Apr;45(3):501-7.

Attention-deficit/hyperactivity disorder (ADHD) is often a very challenging condition for parents to manage, both because of the “gleeful mayhem” children with ADHD manifest and because of the nature of effective treatments. Multiple randomized controlled studies and meta-analyses have demonstrated that stimulant medication with behavioral interventions is the optimal first-line treatment for children with both subtypes of ADHD, and that medications alone are superior to behavioral interventions alone. By improving attention and impulse control, the medications effectively decrease the many negative interactions with teachers, peers, and parents, aiding development and healthy self-esteem.

But many parents feel anxious about treating their young children with stimulants. Importantly, how children with ADHD will fare as adults is not predicted by their symptom level, but instead by the quality of their relationships with their parents, their ability to perform at school, and their social skills. Bring this framework to parents as you listen to their questions and help them decide on the best approach for their family. To assist you in these conversations, we will review the evidence for (or against) several of the most common alternatives to medication that parents are likely to ask about.
 

Diets and supplements

Dietary modifications are among the most popular “natural” approaches to managing ADHD in children. Diets that eliminate processed sugars or food additives (particularly artificial food coloring) are among the most common approaches discussed in the lay press. These diets are usually very time-consuming and disruptive for families to follow, and there is no evidence to support their general use in ADHD management. Those studies that rigorously examined them suggest that, for children with severe impairment who have failed to respond to medications for ADHD, a workup for food intolerance or nutritional deficits may reveal a different problem underlying their behavioral difficulties.¹

Similarly, supplementation with high-dose omega-3 fatty acids is modestly helpful only in a subset of children with ADHD symptoms, and not nearly as effective as medications or behavioral interventions. Spending time on an exacting diet or buying expensive supplements is very unlikely to relieve the children’s symptoms and may only add to their stress at home. The “sugar high” parents note may be the rare joy of eating a candy bar and not sugar causing ADHD. Offer parents the guidance to focus on a healthy diet, high in fruits and vegetables, whole grains, and healthy protein, and on meals that emphasize family time instead of struggles around food.
 

Neurofeedback

Neurofeedback is an approach that grew out of the observation that many adults with ADHD had resting patterns of brain wave activity different from those of neurotypical adults. In neurofeedback, patients learn strategies that amplify the brain waves associated with focused mental activity, rather than listless or hyperactive states. Businesses market this service for all sorts of illnesses and challenges, ADHD chief among them. Despite the marketing, there are very few randomized controlled studies of this intervention for ADHD in youth, and those have shown only the possibility of a benefit.

While there is no evidence of serious side effects, these treatments are time-consuming and expensive and unlikely to be covered by any insurance. You might suggest to parents that they could achieve some of the same theoretical benefits by looking for hobbies that invite sustained focus in their children. That is, they should think about activities that interest the children, such as music lessons or karate, that they could practice in classes and at home. If the children find these activities even somewhat interesting (or just enjoy the reward of their parents’ or teachers’ attention), regular practice will be supporting their developing attention while building social skills and authentic self-confidence, rather than the activities feeling like a treatment for an illness or condition.

Sleep and exercise

There are not many businesses or books selling worried and exhausted parents a quick nonmedication solution for their children’s ADHD in the form of healthy sleep and exercise habits. But these are safe and healthy ways to reduce symptoms and support development. Children with ADHD often enjoy and benefit from participating in a sport, and daily exercise can help with sleep and regulating their energy. They also often have difficulty with sleep initiation, and commonly do not get adequate or restful sleep. Inadequate sleep exacerbates inattention, distractibility, and irritability. Children with untreated ADHD also often spend a lot of time on screens, as it is difficult for them to shift away from rewarding activities, and parents can find screen time to be a welcome break from hyperactivity and negative interactions. But excessive screen time, especially close to bedtime, can worsen irritability and make sleep more difficult. Talk with parents about the value of establishing a routine around screen time, modest daily physical activity, and sleep that everyone can follow. If their family life is currently marked by late bedtimes and long hours in front of video games, this change will take effort. But within a few weeks, it could lead to significant improvements in energy, attention, and interactions at home.

Behavioral treatments

Effective behavioral treatments for ADHD do not change ADHD symptoms, but they do help children learn how to manage them. In “parent management training,” younger children and parents learn together how to avoid negative cycles of behavior (i.e., temper outbursts) by focusing on consistent routines and consequences that support children calmly learning to manage their impulses. The only other evidence-based treatment focuses on helping school age and older children develop executive functions – their planning, organization, and time management skills – with a range of age-appropriate tools. Both of these therapies may be more effective if the children are also receiving medication, but medication is not necessary for them to be helpful. It is important to note that play therapy and other evidence-based psychotherapies are not effective for management of ADHD, although they may treat comorbid problems.

Parent treatment

You may have diagnosed children with ADHD only to hear their parents respond by saying that they suspect (or know) that they (or their spouses) also have ADHD. This would not be surprising, as ADHD has one of the highest rates of heritability of psychiatric disorders, at 80%. Somewhere between 25% and 50% of parents of children with ADHD have ADHD themselves.² Screening for adults with ADHD, such as the Adult ADHD Self-Report Scale, is widely available and free. Speak with parents about the fact that behavioral treatments for their children’s ADHD are demanding. Such treatments require patience, calm, organization, and consistency.

If parents have ADHD, it may be very helpful for them to prioritize their own effective treatments, so that their attention and impulse control will support their parenting. They may be interested in learning about how treatment might also improve their performance at work and even the quality of their relationships. While there is some evidence that their children’s treatment outcome will hinge on the parents’ treatment,³ they deserve good care independent of the expectations of parenting.

Families benefit from a comprehensive “ADHD plan” for their children. This would start with an assessment of the severity of their children’s symptoms, specifying their impairment at home, school, and in social relationships. It would include their nonacademic performance, exploration of interests, and developing self-confidence. All of these considerations lead to setting reasonable expectations so the children can feel successful. Parents should think about how best to structure their children’s schedules to promote healthy sleep, exercise, and nutrition, and to expand opportunities for building their frustration tolerance, social skills, and executive function.

Parents will need to consider what kind of supports they themselves need to offer this structure. There are good resources available online for information and support, including Children and Adults with ADHD (chadd.org) and the ADHD Resource Center from the American Academy of Child and Adolescent Psychiatry (aacap.org). This approach may help parents to evaluate the potential risks and benefits of medications as a component of treatment. Most of the quick fixes for childhood ADHD on the market will take a family’s time and money without providing meaningful improvement. Parents should focus instead on the tried-and-true routines and supports that will help them to create the setting at home that will enable their children to flourish.
 

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

References

1. Millichap JG and Yee MM. Pediatrics. 2012 Feb;129(2):330-7.

2. Grimm O et al. Curr Psychiatry Rep. 2020 Feb 27;22(4):18.

3. Chronis-Tuscano A et al. J Abnorm Child Psychol. 2017 Apr;45(3):501-7.

Attention-deficit/hyperactivity disorder (ADHD) is often a very challenging condition for parents to manage, both because of the “gleeful mayhem” children with ADHD manifest and because of the nature of effective treatments. Multiple randomized controlled studies and meta-analyses have demonstrated that stimulant medication with behavioral interventions is the optimal first-line treatment for children with both subtypes of ADHD, and that medications alone are superior to behavioral interventions alone. By improving attention and impulse control, the medications effectively decrease the many negative interactions with teachers, peers, and parents, aiding development and healthy self-esteem.

But many parents feel anxious about treating their young children with stimulants. Importantly, how children with ADHD will fare as adults is not predicted by their symptom level, but instead by the quality of their relationships with their parents, their ability to perform at school, and their social skills. Bring this framework to parents as you listen to their questions and help them decide on the best approach for their family. To assist you in these conversations, we will review the evidence for (or against) several of the most common alternatives to medication that parents are likely to ask about.
 

Diets and supplements

Dietary modifications are among the most popular “natural” approaches to managing ADHD in children. Diets that eliminate processed sugars or food additives (particularly artificial food coloring) are among the most common approaches discussed in the lay press. These diets are usually very time-consuming and disruptive for families to follow, and there is no evidence to support their general use in ADHD management. Those studies that rigorously examined them suggest that, for children with severe impairment who have failed to respond to medications for ADHD, a workup for food intolerance or nutritional deficits may reveal a different problem underlying their behavioral difficulties.¹

Similarly, supplementation with high-dose omega-3 fatty acids is modestly helpful only in a subset of children with ADHD symptoms, and not nearly as effective as medications or behavioral interventions. Spending time on an exacting diet or buying expensive supplements is very unlikely to relieve the children’s symptoms and may only add to their stress at home. The “sugar high” parents note may be the rare joy of eating a candy bar and not sugar causing ADHD. Offer parents the guidance to focus on a healthy diet, high in fruits and vegetables, whole grains, and healthy protein, and on meals that emphasize family time instead of struggles around food.
 

Neurofeedback

Neurofeedback is an approach that grew out of the observation that many adults with ADHD had resting patterns of brain wave activity different from those of neurotypical adults. In neurofeedback, patients learn strategies that amplify the brain waves associated with focused mental activity, rather than listless or hyperactive states. Businesses market this service for all sorts of illnesses and challenges, ADHD chief among them. Despite the marketing, there are very few randomized controlled studies of this intervention for ADHD in youth, and those have shown only the possibility of a benefit.

While there is no evidence of serious side effects, these treatments are time-consuming and expensive and unlikely to be covered by any insurance. You might suggest to parents that they could achieve some of the same theoretical benefits by looking for hobbies that invite sustained focus in their children. That is, they should think about activities that interest the children, such as music lessons or karate, that they could practice in classes and at home. If the children find these activities even somewhat interesting (or just enjoy the reward of their parents’ or teachers’ attention), regular practice will be supporting their developing attention while building social skills and authentic self-confidence, rather than the activities feeling like a treatment for an illness or condition.

Sleep and exercise

There are not many businesses or books selling worried and exhausted parents a quick nonmedication solution for their children’s ADHD in the form of healthy sleep and exercise habits. But these are safe and healthy ways to reduce symptoms and support development. Children with ADHD often enjoy and benefit from participating in a sport, and daily exercise can help with sleep and regulating their energy. They also often have difficulty with sleep initiation, and commonly do not get adequate or restful sleep. Inadequate sleep exacerbates inattention, distractibility, and irritability. Children with untreated ADHD also often spend a lot of time on screens, as it is difficult for them to shift away from rewarding activities, and parents can find screen time to be a welcome break from hyperactivity and negative interactions. But excessive screen time, especially close to bedtime, can worsen irritability and make sleep more difficult. Talk with parents about the value of establishing a routine around screen time, modest daily physical activity, and sleep that everyone can follow. If their family life is currently marked by late bedtimes and long hours in front of video games, this change will take effort. But within a few weeks, it could lead to significant improvements in energy, attention, and interactions at home.

Behavioral treatments

Effective behavioral treatments for ADHD do not change ADHD symptoms, but they do help children learn how to manage them. In “parent management training,” younger children and parents learn together how to avoid negative cycles of behavior (i.e., temper outbursts) by focusing on consistent routines and consequences that support children calmly learning to manage their impulses. The only other evidence-based treatment focuses on helping school age and older children develop executive functions – their planning, organization, and time management skills – with a range of age-appropriate tools. Both of these therapies may be more effective if the children are also receiving medication, but medication is not necessary for them to be helpful. It is important to note that play therapy and other evidence-based psychotherapies are not effective for management of ADHD, although they may treat comorbid problems.

Parent treatment

You may have diagnosed children with ADHD only to hear their parents respond by saying that they suspect (or know) that they (or their spouses) also have ADHD. This would not be surprising, as ADHD has one of the highest rates of heritability of psychiatric disorders, at 80%. Somewhere between 25% and 50% of parents of children with ADHD have ADHD themselves.² Screening for adults with ADHD, such as the Adult ADHD Self-Report Scale, is widely available and free. Speak with parents about the fact that behavioral treatments for their children’s ADHD are demanding. Such treatments require patience, calm, organization, and consistency.

If parents have ADHD, it may be very helpful for them to prioritize their own effective treatments, so that their attention and impulse control will support their parenting. They may be interested in learning about how treatment might also improve their performance at work and even the quality of their relationships. While there is some evidence that their children’s treatment outcome will hinge on the parents’ treatment,³ they deserve good care independent of the expectations of parenting.

Families benefit from a comprehensive “ADHD plan” for their children. This would start with an assessment of the severity of their children’s symptoms, specifying their impairment at home, school, and in social relationships. It would include their nonacademic performance, exploration of interests, and developing self-confidence. All of these considerations lead to setting reasonable expectations so the children can feel successful. Parents should think about how best to structure their children’s schedules to promote healthy sleep, exercise, and nutrition, and to expand opportunities for building their frustration tolerance, social skills, and executive function.

Parents will need to consider what kind of supports they themselves need to offer this structure. There are good resources available online for information and support, including Children and Adults with ADHD (chadd.org) and the ADHD Resource Center from the American Academy of Child and Adolescent Psychiatry (aacap.org). This approach may help parents to evaluate the potential risks and benefits of medications as a component of treatment. Most of the quick fixes for childhood ADHD on the market will take a family’s time and money without providing meaningful improvement. Parents should focus instead on the tried-and-true routines and supports that will help them to create the setting at home that will enable their children to flourish.
 

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

References

1. Millichap JG and Yee MM. Pediatrics. 2012 Feb;129(2):330-7.

2. Grimm O et al. Curr Psychiatry Rep. 2020 Feb 27;22(4):18.

3. Chronis-Tuscano A et al. J Abnorm Child Psychol. 2017 Apr;45(3):501-7.

The highly anticipated Alzheimer’s drug lecanemab was granted accelerated approval status on Jan. 6 by the FDA, offering hope where there has been little for patients and their families affected by the devastating disease.

More than 6 million people in the United States live with Alzheimer’s.

It’s not a cure, but the drug, given intravenously every 2 weeks, has shown moderate positive effects in clinical trials in slowing early-stage disease.

But many are wary. As explained in an editorial in the journal The Lancet, “The Alzheimer’s disease community has become accustomed to false hope, disappointment, and controversy.”

Some worry about lecanemab’s safety as some people in clinical trials experienced serious side effects of bleeding and swelling in the brain. Scientists recently attributed a third death to lecanemab, brand name Leqembi, though the drugmaker disputed the medication was the cause.

So what should patients and their families make of this news? Here we answer some of the top questions surrounding the drug.
 

What does the FDA action mean?

The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing the progression of early-stage disease.

The FDA can grant accelerated approval for drugs that treat serious conditions and fill an unmet medical need while drugs continue to be studied in larger trials.

With the FDA approval in hand, doctors can now prescribe the medication.

Rebecca Edelmayer, PhD, the Alzheimer’s Association senior director of scientific engagement, says that with the FDA’s move, ramping up manufacturing – and eventually nationwide distribution and implementation – will take some time.

“Ask your doctor about availability,” she says. “The main issue is that, without insurance and Medicare coverage of this class of treatments, access for those who could benefit from the newly approved treatment will only be available to those who can pay out-of-pocket. Without coverage, people simply won’t be able to get the treatment.”

The Washington Post reports that with accelerated approval, drugmaker Eisai is expected to immediately apply for full FDA approval, which wouldn’t be likely to come before later this year. Full approval could help clear the path for Medicare coverage of the drug.
 

Potential benefit?

Those who got Leqembi in a clinical trial for 18 months experienced 27% less decline in memory and thinking relative to the group who got a placebo. It also reduced amyloid in the brain, the sticky protein that builds up in the brains of people with Alzheimer’s and is considered a hallmark of the disease.

Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, says, “It’s the first phase 3 study in our field of a disease-modifying drug where the clinical efficacy was very clear.”
 

Concerns about side effects

The drug has raised safety concerns as it has been linked with certain serious adverse events, including brain swelling and bleeding. In the trial, 14% of patients who received the drug experienced side effects that included brain swelling and bleeding, compared with about 11% in the placebo group.

Scientists have reportedly linked three deaths during the clinical trial to lecanemab, though it is unclear whether it caused the deaths.

Dr. Fillit notes that the first two people who died were on blood thinners when they received lecanemab.

“There are things about the use of the drug in the real world that we need to work out, especially in the context of people with comorbidities,” he says.

The third death is a little different, Dr. Fillit says. The patient, who had a stroke, showed signs of vasculitis, or inflammation of the blood vessels.

“We don’t know exactly what happened, but we do know it was very, very rare” among the people involved in the trials, he says.

Dr. Edelmayer says that the most common reported side effects during the trials were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). According to the FDA, these abnormalities “are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur.”

The FDA has added these as warnings to the drug’s label, describing the possible infusion-related reactions as flu-like symptoms, nausea, vomiting, and changes in blood pressure.
 

How much will it cost?

Eisai says that lecanemab will cost $26,500 a year.

In a draft report released in December, the Institute for Clinical and Economic Review said a price ranging from $8,500 to $20,600 a year would make the drug cost-effective. While the group has no authority to set prices, many large health insurers consider its reports when they negotiate prices and some drugmakers take into account ICER’s recommendations when setting prices.

An editorial in The Lancet last month warns that the cost will likely be “prohibitive” for low- and middle-income countries and many health systems don’t have the infrastructure for a widespread rollout.
 

Will Medicare cover it?

The Centers for Medicare & Medicaid Services, which runs Medicare, which covers most people with Alzheimer’s, has indicated it won’t broadly cover amyloid-lowering drugs until the drug gets full U.S. approval based on clinical benefits, as opposed to accelerated approval.

That means people would have to pay thousands out of pocket at first to get it.

The CMS decision effectively denies Medicare coverage of fast-tracked FDA-approved medications for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.

On Dec. 19, the Alzheimer’s Association filed a formal request asking CMS to remove the trial-only requirement and provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.

CMS says in a statement issued after the announcement: “Because Eisai’s product, lecanemab, was granted accelerated approval by the FDA, it falls under CMS’s existing national coverage determination. CMS is examining available information and may reconsider its current coverage based on this review.”

“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage,” the statement says.
 

Who benefits most from this drug?

Lecanemab is a treatment for people with early-stage Alzheimer’s disease who have amyloid in their brain. This means people with other types of dementia, or those in the later stages of Alzheimer’s disease, are not likely to improve with this drug.

Who makes lecanemab?  

Japan-based Eisai is developing the drug, a monoclonal antibody, in collaboration with the U.S. company Biogen.

What’s the Alzheimer’s Association’s view?

The association urged accelerated FDA approval. In a statement, it says it “welcomes and is further encouraged” by the clinical trial results.

It says data published in the New England Journal of Medicine confirms lecanemab “can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease.”

“We are energized at the progress we are seeing in the research pipeline. The science is telling us that although antiamyloid treatments are not a cure – they are not going to be the end of treating Alzheimer’s – they are certainly the beginning,” Dr. Edelmayer says.
 

Are there alternatives?

The FDA gave accelerated approval to Biogen to produce another drug for Alzheimer’s, Aduhelm (aducanemab), in 2021, but the move was controversial as the drug’s effectiveness was widely questioned. It has since largely been pulled from the market.

Aduhelm had been the first approved early-stage Alzheimer’s treatment since 2003.

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

The highly anticipated Alzheimer’s drug lecanemab was granted accelerated approval status on Jan. 6 by the FDA, offering hope where there has been little for patients and their families affected by the devastating disease.

More than 6 million people in the United States live with Alzheimer’s.

It’s not a cure, but the drug, given intravenously every 2 weeks, has shown moderate positive effects in clinical trials in slowing early-stage disease.

But many are wary. As explained in an editorial in the journal The Lancet, “The Alzheimer’s disease community has become accustomed to false hope, disappointment, and controversy.”

Some worry about lecanemab’s safety as some people in clinical trials experienced serious side effects of bleeding and swelling in the brain. Scientists recently attributed a third death to lecanemab, brand name Leqembi, though the drugmaker disputed the medication was the cause.

So what should patients and their families make of this news? Here we answer some of the top questions surrounding the drug.
 

What does the FDA action mean?

The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing the progression of early-stage disease.

The FDA can grant accelerated approval for drugs that treat serious conditions and fill an unmet medical need while drugs continue to be studied in larger trials.

With the FDA approval in hand, doctors can now prescribe the medication.

Rebecca Edelmayer, PhD, the Alzheimer’s Association senior director of scientific engagement, says that with the FDA’s move, ramping up manufacturing – and eventually nationwide distribution and implementation – will take some time.

“Ask your doctor about availability,” she says. “The main issue is that, without insurance and Medicare coverage of this class of treatments, access for those who could benefit from the newly approved treatment will only be available to those who can pay out-of-pocket. Without coverage, people simply won’t be able to get the treatment.”

The Washington Post reports that with accelerated approval, drugmaker Eisai is expected to immediately apply for full FDA approval, which wouldn’t be likely to come before later this year. Full approval could help clear the path for Medicare coverage of the drug.
 

Potential benefit?

Those who got Leqembi in a clinical trial for 18 months experienced 27% less decline in memory and thinking relative to the group who got a placebo. It also reduced amyloid in the brain, the sticky protein that builds up in the brains of people with Alzheimer’s and is considered a hallmark of the disease.

Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, says, “It’s the first phase 3 study in our field of a disease-modifying drug where the clinical efficacy was very clear.”
 

Concerns about side effects

The drug has raised safety concerns as it has been linked with certain serious adverse events, including brain swelling and bleeding. In the trial, 14% of patients who received the drug experienced side effects that included brain swelling and bleeding, compared with about 11% in the placebo group.

Scientists have reportedly linked three deaths during the clinical trial to lecanemab, though it is unclear whether it caused the deaths.

Dr. Fillit notes that the first two people who died were on blood thinners when they received lecanemab.

“There are things about the use of the drug in the real world that we need to work out, especially in the context of people with comorbidities,” he says.

The third death is a little different, Dr. Fillit says. The patient, who had a stroke, showed signs of vasculitis, or inflammation of the blood vessels.

“We don’t know exactly what happened, but we do know it was very, very rare” among the people involved in the trials, he says.

Dr. Edelmayer says that the most common reported side effects during the trials were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). According to the FDA, these abnormalities “are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur.”

The FDA has added these as warnings to the drug’s label, describing the possible infusion-related reactions as flu-like symptoms, nausea, vomiting, and changes in blood pressure.
 

How much will it cost?

Eisai says that lecanemab will cost $26,500 a year.

In a draft report released in December, the Institute for Clinical and Economic Review said a price ranging from $8,500 to $20,600 a year would make the drug cost-effective. While the group has no authority to set prices, many large health insurers consider its reports when they negotiate prices and some drugmakers take into account ICER’s recommendations when setting prices.

An editorial in The Lancet last month warns that the cost will likely be “prohibitive” for low- and middle-income countries and many health systems don’t have the infrastructure for a widespread rollout.
 

Will Medicare cover it?

The Centers for Medicare & Medicaid Services, which runs Medicare, which covers most people with Alzheimer’s, has indicated it won’t broadly cover amyloid-lowering drugs until the drug gets full U.S. approval based on clinical benefits, as opposed to accelerated approval.

That means people would have to pay thousands out of pocket at first to get it.

The CMS decision effectively denies Medicare coverage of fast-tracked FDA-approved medications for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.

On Dec. 19, the Alzheimer’s Association filed a formal request asking CMS to remove the trial-only requirement and provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.

CMS says in a statement issued after the announcement: “Because Eisai’s product, lecanemab, was granted accelerated approval by the FDA, it falls under CMS’s existing national coverage determination. CMS is examining available information and may reconsider its current coverage based on this review.”

“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage,” the statement says.
 

Who benefits most from this drug?

Lecanemab is a treatment for people with early-stage Alzheimer’s disease who have amyloid in their brain. This means people with other types of dementia, or those in the later stages of Alzheimer’s disease, are not likely to improve with this drug.

Who makes lecanemab?  

Japan-based Eisai is developing the drug, a monoclonal antibody, in collaboration with the U.S. company Biogen.

What’s the Alzheimer’s Association’s view?

The association urged accelerated FDA approval. In a statement, it says it “welcomes and is further encouraged” by the clinical trial results.

It says data published in the New England Journal of Medicine confirms lecanemab “can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease.”

“We are energized at the progress we are seeing in the research pipeline. The science is telling us that although antiamyloid treatments are not a cure – they are not going to be the end of treating Alzheimer’s – they are certainly the beginning,” Dr. Edelmayer says.
 

Are there alternatives?

The FDA gave accelerated approval to Biogen to produce another drug for Alzheimer’s, Aduhelm (aducanemab), in 2021, but the move was controversial as the drug’s effectiveness was widely questioned. It has since largely been pulled from the market.

Aduhelm had been the first approved early-stage Alzheimer’s treatment since 2003.

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

The highly anticipated Alzheimer’s drug lecanemab was granted accelerated approval status on Jan. 6 by the FDA, offering hope where there has been little for patients and their families affected by the devastating disease.

More than 6 million people in the United States live with Alzheimer’s.

It’s not a cure, but the drug, given intravenously every 2 weeks, has shown moderate positive effects in clinical trials in slowing early-stage disease.

But many are wary. As explained in an editorial in the journal The Lancet, “The Alzheimer’s disease community has become accustomed to false hope, disappointment, and controversy.”

Some worry about lecanemab’s safety as some people in clinical trials experienced serious side effects of bleeding and swelling in the brain. Scientists recently attributed a third death to lecanemab, brand name Leqembi, though the drugmaker disputed the medication was the cause.

So what should patients and their families make of this news? Here we answer some of the top questions surrounding the drug.
 

What does the FDA action mean?

The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing the progression of early-stage disease.

The FDA can grant accelerated approval for drugs that treat serious conditions and fill an unmet medical need while drugs continue to be studied in larger trials.

With the FDA approval in hand, doctors can now prescribe the medication.

Rebecca Edelmayer, PhD, the Alzheimer’s Association senior director of scientific engagement, says that with the FDA’s move, ramping up manufacturing – and eventually nationwide distribution and implementation – will take some time.

“Ask your doctor about availability,” she says. “The main issue is that, without insurance and Medicare coverage of this class of treatments, access for those who could benefit from the newly approved treatment will only be available to those who can pay out-of-pocket. Without coverage, people simply won’t be able to get the treatment.”

The Washington Post reports that with accelerated approval, drugmaker Eisai is expected to immediately apply for full FDA approval, which wouldn’t be likely to come before later this year. Full approval could help clear the path for Medicare coverage of the drug.
 

Potential benefit?

Those who got Leqembi in a clinical trial for 18 months experienced 27% less decline in memory and thinking relative to the group who got a placebo. It also reduced amyloid in the brain, the sticky protein that builds up in the brains of people with Alzheimer’s and is considered a hallmark of the disease.

Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, says, “It’s the first phase 3 study in our field of a disease-modifying drug where the clinical efficacy was very clear.”
 

Concerns about side effects

The drug has raised safety concerns as it has been linked with certain serious adverse events, including brain swelling and bleeding. In the trial, 14% of patients who received the drug experienced side effects that included brain swelling and bleeding, compared with about 11% in the placebo group.

Scientists have reportedly linked three deaths during the clinical trial to lecanemab, though it is unclear whether it caused the deaths.

Dr. Fillit notes that the first two people who died were on blood thinners when they received lecanemab.

“There are things about the use of the drug in the real world that we need to work out, especially in the context of people with comorbidities,” he says.

The third death is a little different, Dr. Fillit says. The patient, who had a stroke, showed signs of vasculitis, or inflammation of the blood vessels.

“We don’t know exactly what happened, but we do know it was very, very rare” among the people involved in the trials, he says.

Dr. Edelmayer says that the most common reported side effects during the trials were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). According to the FDA, these abnormalities “are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur.”

The FDA has added these as warnings to the drug’s label, describing the possible infusion-related reactions as flu-like symptoms, nausea, vomiting, and changes in blood pressure.
 

How much will it cost?

Eisai says that lecanemab will cost $26,500 a year.

In a draft report released in December, the Institute for Clinical and Economic Review said a price ranging from $8,500 to $20,600 a year would make the drug cost-effective. While the group has no authority to set prices, many large health insurers consider its reports when they negotiate prices and some drugmakers take into account ICER’s recommendations when setting prices.

An editorial in The Lancet last month warns that the cost will likely be “prohibitive” for low- and middle-income countries and many health systems don’t have the infrastructure for a widespread rollout.
 

Will Medicare cover it?

The Centers for Medicare & Medicaid Services, which runs Medicare, which covers most people with Alzheimer’s, has indicated it won’t broadly cover amyloid-lowering drugs until the drug gets full U.S. approval based on clinical benefits, as opposed to accelerated approval.

That means people would have to pay thousands out of pocket at first to get it.

The CMS decision effectively denies Medicare coverage of fast-tracked FDA-approved medications for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.

On Dec. 19, the Alzheimer’s Association filed a formal request asking CMS to remove the trial-only requirement and provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.

CMS says in a statement issued after the announcement: “Because Eisai’s product, lecanemab, was granted accelerated approval by the FDA, it falls under CMS’s existing national coverage determination. CMS is examining available information and may reconsider its current coverage based on this review.”

“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage,” the statement says.
 

Who benefits most from this drug?

Lecanemab is a treatment for people with early-stage Alzheimer’s disease who have amyloid in their brain. This means people with other types of dementia, or those in the later stages of Alzheimer’s disease, are not likely to improve with this drug.

Who makes lecanemab?  

Japan-based Eisai is developing the drug, a monoclonal antibody, in collaboration with the U.S. company Biogen.

What’s the Alzheimer’s Association’s view?

The association urged accelerated FDA approval. In a statement, it says it “welcomes and is further encouraged” by the clinical trial results.

It says data published in the New England Journal of Medicine confirms lecanemab “can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease.”

“We are energized at the progress we are seeing in the research pipeline. The science is telling us that although antiamyloid treatments are not a cure – they are not going to be the end of treating Alzheimer’s – they are certainly the beginning,” Dr. Edelmayer says.
 

Are there alternatives?

The FDA gave accelerated approval to Biogen to produce another drug for Alzheimer’s, Aduhelm (aducanemab), in 2021, but the move was controversial as the drug’s effectiveness was widely questioned. It has since largely been pulled from the market.

Aduhelm had been the first approved early-stage Alzheimer’s treatment since 2003.

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

During the initial stage of the COVID-19 pandemic U.S. medical students were suspended from in-person clinical interaction. This decision was based on specific guidance from the Association of American Medical Colleges and subsequently implemented in medical schools across the United States.¹ Our research project addressed students’ stress level before and after clinical in-person suspension and assessed medical students perceived COVID-19–related risk level. We were particularly curious to learn about students’ emotional struggles as they navigated the initial pedagogical uncertainty associated with the pandemic.

Our study showed that students had a significantly higher stress level after the clinical suspension of in-person clinical interaction as compared with the time before the suspension of clinical in-person interaction. It is likely that heightened stress was greater than before and the rationale was likely multifactorial in nature.²

One key stressor U.S. medical students faced was the negative impacts of COVID-19 on medical education. U.S. Medical Licensing Examination exam-taking was severely impacted, and some students needed to reschedule their test dates because of increased restrictions at testing centers. Third-year medical students in particular were worried about how COVID-19 would influence their residency application; for example, in-person residency interviews and away rotations as fourth-year medical students. Another concern was not being able to be involved in clinical work during the direst stage of this public health emergency because of personal protective equipment shortages and attempts to reduce community spread of COVID-19.

Our study also showed that students had a relatively lower perceived risk level when it comes to COVID-19 than health care workers in the 2003 SARS epidemic, which we suspect is mostly attributable to the suspension of clinical in-person interaction. We also found that female gender and self-reported mental illness diagnosis were two risk factors for perceived stress level, consistent with our current literature.

The reality of clinical in-person inaction caused by PPE shortage and limited telehealth options, together with social isolation and uncertainty regarding future education opportunities, appear to have had a detrimental effect on medical students’ psychological wellbeing. This did not have to be the case. Some medical students found innovative ways to stay involved.

For example, in 2020 some of Dr. Zhang’s classmates helped proctor virtual group therapy sessions held by the local National Alliance on Mental Illness chapter. Medical students at the Icahn School of Medicine at Mount Sinai, New York were not only able to engage in telehealth but also join other task forces, such as PPE supply, distribution, and coordination, morale promotion, and administrative services.³ Finally, many medical students in New York volunteered in providing child care for frontline doctors to help relieve their burden.⁴ These actions, if implemented more widely, may have had a protective effect on the stress and well-being of medical students at that time.

While our study focused on the academic side of things, the personal impacts from COVID-19 need to be acknowledged – sickness from COVID-19 and its sequelae, family loss fromCOVID-19, financial struggle, and racial targeting of Asians to name a few. COVID-19 has influenced many families’ livelihood and changed our understanding of ourselves, others, and the world in unprecedented ways.

Fast forward to today – medical students are used to learning and living in a world with an ongoing pandemic, and medical education and residency application process have adapted to this new normal. The once-crippling uncertainty surrounding COVID-19 and disastrous PPE shortages have passed. Yet, COVID-19 continues to be a stressor. In fact, burnout related to “COVID-19 fatigue” has been on the rise and one recent national survey shows one in five physicians intends to leave practice within 2 years.⁵

Meanwhile, uncertainty continued to persist, as in August 2022 monkeypox was declared a public health emergency in the United States.⁶ What Dr. Zhang learned as a medical student during the initial months of COVID-19 continues to be relevant: connect with loved ones, understand the changing reality, process the emotions, recognize what is under one’s control, have a solution-oriented mindset, and be forgiving and patient with oneself and others.

Dr. Zhang is a second-year psychiatry resident physician at Saint Elizabeth’s Hospital/DC DBH, Washington. Dr. Himelhoch serves as professor and chair of the department of psychiatry at the University of Kentucky, Lexington. His research focuses on developing and studying the efficacy of innovative strategies aimed at improving the health and welfare among people with co-occurring psychiatric and substance use disorders.

References

1. Association of American Medical Colleges. Important Guidance for Medical Students on Clinical Rotations During the Coronavirus (COVID-19) Outbreak. 2020 Mar 17.

2. Zhang Y et al. Psychiatry Res. 2022;313:114595. doi: 10.1016/j.psychres.2022.114595.

3. Bahethi RR et al. Acad Med. 2021 Jun 1;96(6):859-63. doi: 10.1097/ACM.0000000000003863.

4. Krieger P and Goodnough A. Medical Students, Sidelined for Now, Find New Ways to Fight Coronavirus. The New York Times. 2020 Mar 23.

5. Abbasi J. JAMA. 2022 Apr 19;327(15):1435-7. doi: 10.1001/jama.2022.5074.

6. Department of Health & Human Services. Biden-Harris Administration Bolsters Monkeypox Response; HHS Secretary Becerra Declares Public Health Emergency. 2022 Aug 4.

During the initial stage of the COVID-19 pandemic U.S. medical students were suspended from in-person clinical interaction. This decision was based on specific guidance from the Association of American Medical Colleges and subsequently implemented in medical schools across the United States.¹ Our research project addressed students’ stress level before and after clinical in-person suspension and assessed medical students perceived COVID-19–related risk level. We were particularly curious to learn about students’ emotional struggles as they navigated the initial pedagogical uncertainty associated with the pandemic.

Our study showed that students had a significantly higher stress level after the clinical suspension of in-person clinical interaction as compared with the time before the suspension of clinical in-person interaction. It is likely that heightened stress was greater than before and the rationale was likely multifactorial in nature.²

One key stressor U.S. medical students faced was the negative impacts of COVID-19 on medical education. U.S. Medical Licensing Examination exam-taking was severely impacted, and some students needed to reschedule their test dates because of increased restrictions at testing centers. Third-year medical students in particular were worried about how COVID-19 would influence their residency application; for example, in-person residency interviews and away rotations as fourth-year medical students. Another concern was not being able to be involved in clinical work during the direst stage of this public health emergency because of personal protective equipment shortages and attempts to reduce community spread of COVID-19.

Our study also showed that students had a relatively lower perceived risk level when it comes to COVID-19 than health care workers in the 2003 SARS epidemic, which we suspect is mostly attributable to the suspension of clinical in-person interaction. We also found that female gender and self-reported mental illness diagnosis were two risk factors for perceived stress level, consistent with our current literature.

The reality of clinical in-person inaction caused by PPE shortage and limited telehealth options, together with social isolation and uncertainty regarding future education opportunities, appear to have had a detrimental effect on medical students’ psychological wellbeing. This did not have to be the case. Some medical students found innovative ways to stay involved.

For example, in 2020 some of Dr. Zhang’s classmates helped proctor virtual group therapy sessions held by the local National Alliance on Mental Illness chapter. Medical students at the Icahn School of Medicine at Mount Sinai, New York were not only able to engage in telehealth but also join other task forces, such as PPE supply, distribution, and coordination, morale promotion, and administrative services.³ Finally, many medical students in New York volunteered in providing child care for frontline doctors to help relieve their burden.⁴ These actions, if implemented more widely, may have had a protective effect on the stress and well-being of medical students at that time.

While our study focused on the academic side of things, the personal impacts from COVID-19 need to be acknowledged – sickness from COVID-19 and its sequelae, family loss fromCOVID-19, financial struggle, and racial targeting of Asians to name a few. COVID-19 has influenced many families’ livelihood and changed our understanding of ourselves, others, and the world in unprecedented ways.

Fast forward to today – medical students are used to learning and living in a world with an ongoing pandemic, and medical education and residency application process have adapted to this new normal. The once-crippling uncertainty surrounding COVID-19 and disastrous PPE shortages have passed. Yet, COVID-19 continues to be a stressor. In fact, burnout related to “COVID-19 fatigue” has been on the rise and one recent national survey shows one in five physicians intends to leave practice within 2 years.⁵

Meanwhile, uncertainty continued to persist, as in August 2022 monkeypox was declared a public health emergency in the United States.⁶ What Dr. Zhang learned as a medical student during the initial months of COVID-19 continues to be relevant: connect with loved ones, understand the changing reality, process the emotions, recognize what is under one’s control, have a solution-oriented mindset, and be forgiving and patient with oneself and others.

Dr. Zhang is a second-year psychiatry resident physician at Saint Elizabeth’s Hospital/DC DBH, Washington. Dr. Himelhoch serves as professor and chair of the department of psychiatry at the University of Kentucky, Lexington. His research focuses on developing and studying the efficacy of innovative strategies aimed at improving the health and welfare among people with co-occurring psychiatric and substance use disorders.

References

1. Association of American Medical Colleges. Important Guidance for Medical Students on Clinical Rotations During the Coronavirus (COVID-19) Outbreak. 2020 Mar 17.

2. Zhang Y et al. Psychiatry Res. 2022;313:114595. doi: 10.1016/j.psychres.2022.114595.

3. Bahethi RR et al. Acad Med. 2021 Jun 1;96(6):859-63. doi: 10.1097/ACM.0000000000003863.

4. Krieger P and Goodnough A. Medical Students, Sidelined for Now, Find New Ways to Fight Coronavirus. The New York Times. 2020 Mar 23.

5. Abbasi J. JAMA. 2022 Apr 19;327(15):1435-7. doi: 10.1001/jama.2022.5074.

6. Department of Health & Human Services. Biden-Harris Administration Bolsters Monkeypox Response; HHS Secretary Becerra Declares Public Health Emergency. 2022 Aug 4.

During the initial stage of the COVID-19 pandemic U.S. medical students were suspended from in-person clinical interaction. This decision was based on specific guidance from the Association of American Medical Colleges and subsequently implemented in medical schools across the United States.¹ Our research project addressed students’ stress level before and after clinical in-person suspension and assessed medical students perceived COVID-19–related risk level. We were particularly curious to learn about students’ emotional struggles as they navigated the initial pedagogical uncertainty associated with the pandemic.

Our study showed that students had a significantly higher stress level after the clinical suspension of in-person clinical interaction as compared with the time before the suspension of clinical in-person interaction. It is likely that heightened stress was greater than before and the rationale was likely multifactorial in nature.²

One key stressor U.S. medical students faced was the negative impacts of COVID-19 on medical education. U.S. Medical Licensing Examination exam-taking was severely impacted, and some students needed to reschedule their test dates because of increased restrictions at testing centers. Third-year medical students in particular were worried about how COVID-19 would influence their residency application; for example, in-person residency interviews and away rotations as fourth-year medical students. Another concern was not being able to be involved in clinical work during the direst stage of this public health emergency because of personal protective equipment shortages and attempts to reduce community spread of COVID-19.

Our study also showed that students had a relatively lower perceived risk level when it comes to COVID-19 than health care workers in the 2003 SARS epidemic, which we suspect is mostly attributable to the suspension of clinical in-person interaction. We also found that female gender and self-reported mental illness diagnosis were two risk factors for perceived stress level, consistent with our current literature.

The reality of clinical in-person inaction caused by PPE shortage and limited telehealth options, together with social isolation and uncertainty regarding future education opportunities, appear to have had a detrimental effect on medical students’ psychological wellbeing. This did not have to be the case. Some medical students found innovative ways to stay involved.

For example, in 2020 some of Dr. Zhang’s classmates helped proctor virtual group therapy sessions held by the local National Alliance on Mental Illness chapter. Medical students at the Icahn School of Medicine at Mount Sinai, New York were not only able to engage in telehealth but also join other task forces, such as PPE supply, distribution, and coordination, morale promotion, and administrative services.³ Finally, many medical students in New York volunteered in providing child care for frontline doctors to help relieve their burden.⁴ These actions, if implemented more widely, may have had a protective effect on the stress and well-being of medical students at that time.

While our study focused on the academic side of things, the personal impacts from COVID-19 need to be acknowledged – sickness from COVID-19 and its sequelae, family loss fromCOVID-19, financial struggle, and racial targeting of Asians to name a few. COVID-19 has influenced many families’ livelihood and changed our understanding of ourselves, others, and the world in unprecedented ways.

Fast forward to today – medical students are used to learning and living in a world with an ongoing pandemic, and medical education and residency application process have adapted to this new normal. The once-crippling uncertainty surrounding COVID-19 and disastrous PPE shortages have passed. Yet, COVID-19 continues to be a stressor. In fact, burnout related to “COVID-19 fatigue” has been on the rise and one recent national survey shows one in five physicians intends to leave practice within 2 years.⁵

Meanwhile, uncertainty continued to persist, as in August 2022 monkeypox was declared a public health emergency in the United States.⁶ What Dr. Zhang learned as a medical student during the initial months of COVID-19 continues to be relevant: connect with loved ones, understand the changing reality, process the emotions, recognize what is under one’s control, have a solution-oriented mindset, and be forgiving and patient with oneself and others.

Dr. Zhang is a second-year psychiatry resident physician at Saint Elizabeth’s Hospital/DC DBH, Washington. Dr. Himelhoch serves as professor and chair of the department of psychiatry at the University of Kentucky, Lexington. His research focuses on developing and studying the efficacy of innovative strategies aimed at improving the health and welfare among people with co-occurring psychiatric and substance use disorders.

References

1. Association of American Medical Colleges. Important Guidance for Medical Students on Clinical Rotations During the Coronavirus (COVID-19) Outbreak. 2020 Mar 17.

2. Zhang Y et al. Psychiatry Res. 2022;313:114595. doi: 10.1016/j.psychres.2022.114595.

3. Bahethi RR et al. Acad Med. 2021 Jun 1;96(6):859-63. doi: 10.1097/ACM.0000000000003863.

4. Krieger P and Goodnough A. Medical Students, Sidelined for Now, Find New Ways to Fight Coronavirus. The New York Times. 2020 Mar 23.

5. Abbasi J. JAMA. 2022 Apr 19;327(15):1435-7. doi: 10.1001/jama.2022.5074.

6. Department of Health & Human Services. Biden-Harris Administration Bolsters Monkeypox Response; HHS Secretary Becerra Declares Public Health Emergency. 2022 Aug 4.

If you smoke, vape, or ingest cannabis, your anesthesiologist should know before you undergo a surgical procedure, according to new medical guidelines.

All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.

One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.

The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
 

Possible interactions

Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.

“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.

“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.

Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
 

Risks for vomiting, heart attack

The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.

Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.

The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.

Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.

Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.

The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.

Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.

“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.

For one, it can interact with numerous other drugs, including warfarin.

Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.

Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.

“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.

Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.

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

If you smoke, vape, or ingest cannabis, your anesthesiologist should know before you undergo a surgical procedure, according to new medical guidelines.

All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.

One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.

The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
 

Possible interactions

Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.

“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.

“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.

Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
 

Risks for vomiting, heart attack

The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.

Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.

The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.

Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.

Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.

The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.

Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.

“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.

For one, it can interact with numerous other drugs, including warfarin.

Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.

Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.

“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.

Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.

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

If you smoke, vape, or ingest cannabis, your anesthesiologist should know before you undergo a surgical procedure, according to new medical guidelines.

All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.

One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.

The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
 

Possible interactions

Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.

“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.

“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.

Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
 

Risks for vomiting, heart attack

The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.

Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.

The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.

Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.

Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.

The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.

Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.

“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.

For one, it can interact with numerous other drugs, including warfarin.

Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.

Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.

“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.

Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.

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