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Survey asks adults: How likely are you to develop dementia?
Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.
More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.
Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.
The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.
A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.
People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.
“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”
Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).
Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.
“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.
Dr. Maust had no financial disclosures.
SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946
I do not find it surprising that older adults fear dementia. Since they correctly perceive that there is no disease-modifying therapy (and maybe also that “getting caught with memory loss” would lead to a loss of driving privileges and other restrictions), they may be trying not to focus on it. As for asking about strategies to “prevent” dementia, that question implies unwarranted optimism about the effectiveness of any such strategy, especially in an older adult. I think we can say that a lifetime of healthy habits (regular physical exercise and careful control of any chronic conditions like diabetes being particularly important) may reduce our risk of dementia a bit, but the idea that anything a 75-year-old does is going to prevent it at that point is probably wishful thinking. Supplements and the like seem to have their own followers. It amazes me how many people suspect what they are taking probably does no good but they do it anyway out of blind hope. Sometimes we can talk them out of spending their money on such things – but not always.
Richard Caselli, MD, is associate director and clinical core director of the Alzheimer’s Disease Center at the Mayo Clinic in Scottsdale, Ariz.
I do not find it surprising that older adults fear dementia. Since they correctly perceive that there is no disease-modifying therapy (and maybe also that “getting caught with memory loss” would lead to a loss of driving privileges and other restrictions), they may be trying not to focus on it. As for asking about strategies to “prevent” dementia, that question implies unwarranted optimism about the effectiveness of any such strategy, especially in an older adult. I think we can say that a lifetime of healthy habits (regular physical exercise and careful control of any chronic conditions like diabetes being particularly important) may reduce our risk of dementia a bit, but the idea that anything a 75-year-old does is going to prevent it at that point is probably wishful thinking. Supplements and the like seem to have their own followers. It amazes me how many people suspect what they are taking probably does no good but they do it anyway out of blind hope. Sometimes we can talk them out of spending their money on such things – but not always.
Richard Caselli, MD, is associate director and clinical core director of the Alzheimer’s Disease Center at the Mayo Clinic in Scottsdale, Ariz.
I do not find it surprising that older adults fear dementia. Since they correctly perceive that there is no disease-modifying therapy (and maybe also that “getting caught with memory loss” would lead to a loss of driving privileges and other restrictions), they may be trying not to focus on it. As for asking about strategies to “prevent” dementia, that question implies unwarranted optimism about the effectiveness of any such strategy, especially in an older adult. I think we can say that a lifetime of healthy habits (regular physical exercise and careful control of any chronic conditions like diabetes being particularly important) may reduce our risk of dementia a bit, but the idea that anything a 75-year-old does is going to prevent it at that point is probably wishful thinking. Supplements and the like seem to have their own followers. It amazes me how many people suspect what they are taking probably does no good but they do it anyway out of blind hope. Sometimes we can talk them out of spending their money on such things – but not always.
Richard Caselli, MD, is associate director and clinical core director of the Alzheimer’s Disease Center at the Mayo Clinic in Scottsdale, Ariz.
Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.
More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.
Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.
The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.
A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.
People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.
“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”
Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).
Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.
“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.
Dr. Maust had no financial disclosures.
SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946
Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.
More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.
Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.
The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.
A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.
People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.
“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”
Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).
Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.
“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.
Dr. Maust had no financial disclosures.
SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946
FROM JAMA NEUROLOGY
Will paying patients to take oral antipsychotics boost adherence?
COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.
He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.
This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.
If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.
The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.
“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.
In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.
“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.
Dr. Guinart reported having no financial conflicts of interest regarding his presentation.
COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.
He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.
This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.
If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.
The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.
“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.
In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.
“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.
Dr. Guinart reported having no financial conflicts of interest regarding his presentation.
COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.
He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.
This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.
If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.
The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.
“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.
In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.
“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.
Dr. Guinart reported having no financial conflicts of interest regarding his presentation.
REPORTING FROM ECNP 2019
Bariatric Surgery Improves Long-Term Health—but Not Long-Term Health Care Costs
Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?
Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.
Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.
Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.
The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.
Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.
The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”
Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?
Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.
Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.
Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.
The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.
Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.
The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”
Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?
Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.
Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.
Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.
The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.
Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.
The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”
FDA approves Brukinsa for relapsed, refractory MCL
The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.
The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.
Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.
The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.
“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.
The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.
The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.
Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.
The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.
“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.
The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.
The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.
Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.
The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.
“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.
PREVENT trial shows benefits of secukinumab for nonradiographic axSpA
ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.
For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.
“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.
Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.
The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.
At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).
Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).
Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and –1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).
Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.
There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.
Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”
When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.
“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.
The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.
SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.
ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.
For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.
“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.
Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.
The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.
At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).
Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).
Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and –1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).
Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.
There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.
Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”
When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.
“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.
The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.
SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.
ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.
For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.
“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.
Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.
The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.
At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).
Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).
Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and –1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).
Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.
There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.
Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”
When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.
“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.
The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.
SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.
REPORTING FROM ACR 2019
PHM19: Mitigating the harm we cause learners in medical education
PHM19 session
Mitigating the harm we cause learners in medical education
Presenters
Benjamin Kinnear, MD, MEd
Andrew Olson, MD
Matthew Kelleher, MD, MEd
Session summary
Dr. Kinnear, Dr. Olson, and Dr. Kelleher expertly led this TED-Talk style session at Pediatric Hospital Medicine 2019, convincing the audience that medical educators persistently harm the learners under their supervision.
Dr. Kinnear, of Cincinnati Children’s Hospital, opened the session noting that the path through medical school presently has a perverse focus on grades as a necessary achievement. As an expert in competency-based assessment, he asserted that the current learner assessment strategy is neither valid nor robust enough to indicate actual competence. Summary assessments presented throughout medical school are lacking continuous constructive feedback, leaving early residents in a state of shock when receiving corrective or negative assessments. He also noted that structurally many rotations create both team and patient discontinuity, leaving the learner with a feeling of detachment and limited ownership of the human patient under his/her/their care.
Dr. Olson of the University of Minnesota next described the need for the USMLE STEP 1 exam to be transitioned to a pass/fail endeavor. He cited the error of measurement of 24 points (i.e., the same test taker could have a 220 one day and a 244 the next) and the potential loss of valuable rotation experiences during the several-month period of intense study. He challenged audience members to complete an esoteric exam question to prove his point and asserted that many learners are lacking in humility, communication skills, and professionalism, and seek only the honors designation on rotations. He likened the experience of medical students on rotation and residents on service weeks to a series of first dates and affirmed the value of longitudinal learner-educator relationships.
Further, he outlined the detachment of learners from patient outcomes, demonstrated by frequent hand-offs and rotation transitions. Dr Olson also cited medical pedagogy as failing to meet the known needs of adult learners to engage in deliberate progressive practice, reflective practice, or to use concepts such as spacing or interleaving to reinforce knowledge.
Dr. Kelleher, also of Cincinnati Children’s Hospital, ended the session by taking those in attendance on an imagined “what-if” journey where each of the wrongs currently done to early learners in medical education were corrected. This included engagement in daily reflection (5 minutes at a time), reporting system issues on rounds that had failed the patient, presenting learners with a CV of attending failures to reinforce the imperfection that is a reality in medicine, praising learners when they admit “they don’t know the answer” to a question posed on rounds, completing assessments in real time in the learner’s presence, rounding until specific feedback can be identified for each learner on the team, having a kiosk on each floor where ANY team member could provide feedback to learners, using cognitive science on rounds for teaching (i.e., Socratic) rather than pimping, modeling interprofessional teamwork daily using a culture of vulnerability rather than infallibility (i.e., airline culture), and by encouraging the attending to care for patients or complete tasks independently, showing the value of education over service and model ideal family-centered communication with the team.
One might wonder, if all of the above were accomplished at the request of our talented presenters, would a pass/fail USMLE world where medical education was learner centered and filled with longitudinal relationships with teams and patients, and outcomes were connected to education produce more engaged, knowledgeable, and holistic physicians? According to this team of presenters, yes.
Key takeaways
• Current processes in medical education are harming today’s adult learner.
• Harms include reliance on numerical rather than competency-based assessment, fragmented learning environments, focus on perfection rather than improvement, ignorance of updates in cognitive science for instructional methodology, and individualist rather than team-based learning.
• Reforms are needed to remedy harms in health professional education, including making USMLE pass/fail, creating a learning-centered rather than service-centered residency environment, encouraging longitudinal relationships between teacher and learner, and connecting education to clinical outcomes.
Dr. King is associate program director, University of Minnesota Pediatric Residency Program, Minneapolis.
PHM19 session
Mitigating the harm we cause learners in medical education
Presenters
Benjamin Kinnear, MD, MEd
Andrew Olson, MD
Matthew Kelleher, MD, MEd
Session summary
Dr. Kinnear, Dr. Olson, and Dr. Kelleher expertly led this TED-Talk style session at Pediatric Hospital Medicine 2019, convincing the audience that medical educators persistently harm the learners under their supervision.
Dr. Kinnear, of Cincinnati Children’s Hospital, opened the session noting that the path through medical school presently has a perverse focus on grades as a necessary achievement. As an expert in competency-based assessment, he asserted that the current learner assessment strategy is neither valid nor robust enough to indicate actual competence. Summary assessments presented throughout medical school are lacking continuous constructive feedback, leaving early residents in a state of shock when receiving corrective or negative assessments. He also noted that structurally many rotations create both team and patient discontinuity, leaving the learner with a feeling of detachment and limited ownership of the human patient under his/her/their care.
Dr. Olson of the University of Minnesota next described the need for the USMLE STEP 1 exam to be transitioned to a pass/fail endeavor. He cited the error of measurement of 24 points (i.e., the same test taker could have a 220 one day and a 244 the next) and the potential loss of valuable rotation experiences during the several-month period of intense study. He challenged audience members to complete an esoteric exam question to prove his point and asserted that many learners are lacking in humility, communication skills, and professionalism, and seek only the honors designation on rotations. He likened the experience of medical students on rotation and residents on service weeks to a series of first dates and affirmed the value of longitudinal learner-educator relationships.
Further, he outlined the detachment of learners from patient outcomes, demonstrated by frequent hand-offs and rotation transitions. Dr Olson also cited medical pedagogy as failing to meet the known needs of adult learners to engage in deliberate progressive practice, reflective practice, or to use concepts such as spacing or interleaving to reinforce knowledge.
Dr. Kelleher, also of Cincinnati Children’s Hospital, ended the session by taking those in attendance on an imagined “what-if” journey where each of the wrongs currently done to early learners in medical education were corrected. This included engagement in daily reflection (5 minutes at a time), reporting system issues on rounds that had failed the patient, presenting learners with a CV of attending failures to reinforce the imperfection that is a reality in medicine, praising learners when they admit “they don’t know the answer” to a question posed on rounds, completing assessments in real time in the learner’s presence, rounding until specific feedback can be identified for each learner on the team, having a kiosk on each floor where ANY team member could provide feedback to learners, using cognitive science on rounds for teaching (i.e., Socratic) rather than pimping, modeling interprofessional teamwork daily using a culture of vulnerability rather than infallibility (i.e., airline culture), and by encouraging the attending to care for patients or complete tasks independently, showing the value of education over service and model ideal family-centered communication with the team.
One might wonder, if all of the above were accomplished at the request of our talented presenters, would a pass/fail USMLE world where medical education was learner centered and filled with longitudinal relationships with teams and patients, and outcomes were connected to education produce more engaged, knowledgeable, and holistic physicians? According to this team of presenters, yes.
Key takeaways
• Current processes in medical education are harming today’s adult learner.
• Harms include reliance on numerical rather than competency-based assessment, fragmented learning environments, focus on perfection rather than improvement, ignorance of updates in cognitive science for instructional methodology, and individualist rather than team-based learning.
• Reforms are needed to remedy harms in health professional education, including making USMLE pass/fail, creating a learning-centered rather than service-centered residency environment, encouraging longitudinal relationships between teacher and learner, and connecting education to clinical outcomes.
Dr. King is associate program director, University of Minnesota Pediatric Residency Program, Minneapolis.
PHM19 session
Mitigating the harm we cause learners in medical education
Presenters
Benjamin Kinnear, MD, MEd
Andrew Olson, MD
Matthew Kelleher, MD, MEd
Session summary
Dr. Kinnear, Dr. Olson, and Dr. Kelleher expertly led this TED-Talk style session at Pediatric Hospital Medicine 2019, convincing the audience that medical educators persistently harm the learners under their supervision.
Dr. Kinnear, of Cincinnati Children’s Hospital, opened the session noting that the path through medical school presently has a perverse focus on grades as a necessary achievement. As an expert in competency-based assessment, he asserted that the current learner assessment strategy is neither valid nor robust enough to indicate actual competence. Summary assessments presented throughout medical school are lacking continuous constructive feedback, leaving early residents in a state of shock when receiving corrective or negative assessments. He also noted that structurally many rotations create both team and patient discontinuity, leaving the learner with a feeling of detachment and limited ownership of the human patient under his/her/their care.
Dr. Olson of the University of Minnesota next described the need for the USMLE STEP 1 exam to be transitioned to a pass/fail endeavor. He cited the error of measurement of 24 points (i.e., the same test taker could have a 220 one day and a 244 the next) and the potential loss of valuable rotation experiences during the several-month period of intense study. He challenged audience members to complete an esoteric exam question to prove his point and asserted that many learners are lacking in humility, communication skills, and professionalism, and seek only the honors designation on rotations. He likened the experience of medical students on rotation and residents on service weeks to a series of first dates and affirmed the value of longitudinal learner-educator relationships.
Further, he outlined the detachment of learners from patient outcomes, demonstrated by frequent hand-offs and rotation transitions. Dr Olson also cited medical pedagogy as failing to meet the known needs of adult learners to engage in deliberate progressive practice, reflective practice, or to use concepts such as spacing or interleaving to reinforce knowledge.
Dr. Kelleher, also of Cincinnati Children’s Hospital, ended the session by taking those in attendance on an imagined “what-if” journey where each of the wrongs currently done to early learners in medical education were corrected. This included engagement in daily reflection (5 minutes at a time), reporting system issues on rounds that had failed the patient, presenting learners with a CV of attending failures to reinforce the imperfection that is a reality in medicine, praising learners when they admit “they don’t know the answer” to a question posed on rounds, completing assessments in real time in the learner’s presence, rounding until specific feedback can be identified for each learner on the team, having a kiosk on each floor where ANY team member could provide feedback to learners, using cognitive science on rounds for teaching (i.e., Socratic) rather than pimping, modeling interprofessional teamwork daily using a culture of vulnerability rather than infallibility (i.e., airline culture), and by encouraging the attending to care for patients or complete tasks independently, showing the value of education over service and model ideal family-centered communication with the team.
One might wonder, if all of the above were accomplished at the request of our talented presenters, would a pass/fail USMLE world where medical education was learner centered and filled with longitudinal relationships with teams and patients, and outcomes were connected to education produce more engaged, knowledgeable, and holistic physicians? According to this team of presenters, yes.
Key takeaways
• Current processes in medical education are harming today’s adult learner.
• Harms include reliance on numerical rather than competency-based assessment, fragmented learning environments, focus on perfection rather than improvement, ignorance of updates in cognitive science for instructional methodology, and individualist rather than team-based learning.
• Reforms are needed to remedy harms in health professional education, including making USMLE pass/fail, creating a learning-centered rather than service-centered residency environment, encouraging longitudinal relationships between teacher and learner, and connecting education to clinical outcomes.
Dr. King is associate program director, University of Minnesota Pediatric Residency Program, Minneapolis.
Support for medical marijuana transcends political affiliation
There is not much common ground between Republicans and Democrats these days, but both sides strongly supported the use of medical marijuana in a recent survey by the American Society of Clinical Oncology.
Overall support of medical marijuana among all 4,001 respondents was higher (84%) for use among cancer patients, but 76% also supported its use for any medical reason, according to data from the survey conducted for ASCO by the Harris Poll.
The differences in support between Republicans and Democrats were significant, but both parties were over 80% for marijuana use by cancer patients and over 70% for use for any medical reason. In both cases, the independents in between mirrored the overall population, with support at 84% and 76%, respectively, ASCO said.
Support for medical marijuana also was consistent based on the respondents’ cancer experience. For use by cancer patients, those who were current or previous patients were at 84%, caregivers (those providing unpaid care to an immediate family member or loved one with cancer) and other family members/loved ones were both at 87%, and those with no cancer experiences were at 82%, the survey results showed.
Use of marijuana for any medical reason was supported by 72% of current/previous patients, 79% of family members and loved ones, 80% of caregivers, and 74% of those with no cancer experience, ASCO reported.
In a question asked only of current or previous patients, 62% said that they are/were open to use of marijuana to alleviate cancer-related pain, nausea, or other symptoms, and 60% said that they wished they had more information about the benefits of medical marijuana use, according to the results of the survey, which was conducted online from July 9 to Aug. 10, 2019.
There is not much common ground between Republicans and Democrats these days, but both sides strongly supported the use of medical marijuana in a recent survey by the American Society of Clinical Oncology.
Overall support of medical marijuana among all 4,001 respondents was higher (84%) for use among cancer patients, but 76% also supported its use for any medical reason, according to data from the survey conducted for ASCO by the Harris Poll.
The differences in support between Republicans and Democrats were significant, but both parties were over 80% for marijuana use by cancer patients and over 70% for use for any medical reason. In both cases, the independents in between mirrored the overall population, with support at 84% and 76%, respectively, ASCO said.
Support for medical marijuana also was consistent based on the respondents’ cancer experience. For use by cancer patients, those who were current or previous patients were at 84%, caregivers (those providing unpaid care to an immediate family member or loved one with cancer) and other family members/loved ones were both at 87%, and those with no cancer experiences were at 82%, the survey results showed.
Use of marijuana for any medical reason was supported by 72% of current/previous patients, 79% of family members and loved ones, 80% of caregivers, and 74% of those with no cancer experience, ASCO reported.
In a question asked only of current or previous patients, 62% said that they are/were open to use of marijuana to alleviate cancer-related pain, nausea, or other symptoms, and 60% said that they wished they had more information about the benefits of medical marijuana use, according to the results of the survey, which was conducted online from July 9 to Aug. 10, 2019.
There is not much common ground between Republicans and Democrats these days, but both sides strongly supported the use of medical marijuana in a recent survey by the American Society of Clinical Oncology.
Overall support of medical marijuana among all 4,001 respondents was higher (84%) for use among cancer patients, but 76% also supported its use for any medical reason, according to data from the survey conducted for ASCO by the Harris Poll.
The differences in support between Republicans and Democrats were significant, but both parties were over 80% for marijuana use by cancer patients and over 70% for use for any medical reason. In both cases, the independents in between mirrored the overall population, with support at 84% and 76%, respectively, ASCO said.
Support for medical marijuana also was consistent based on the respondents’ cancer experience. For use by cancer patients, those who were current or previous patients were at 84%, caregivers (those providing unpaid care to an immediate family member or loved one with cancer) and other family members/loved ones were both at 87%, and those with no cancer experiences were at 82%, the survey results showed.
Use of marijuana for any medical reason was supported by 72% of current/previous patients, 79% of family members and loved ones, 80% of caregivers, and 74% of those with no cancer experience, ASCO reported.
In a question asked only of current or previous patients, 62% said that they are/were open to use of marijuana to alleviate cancer-related pain, nausea, or other symptoms, and 60% said that they wished they had more information about the benefits of medical marijuana use, according to the results of the survey, which was conducted online from July 9 to Aug. 10, 2019.
Researchers seek a way to predict cognitive deficits in children treated for ALL
Researchers are attempting to determine, early in the treatment process, which children with acute lymphoblastic leukemia (ALL) have an increased risk of neurocognitive deficits after chemotherapy.
The goal of the researchers’ project (5R01CA220568-02) is to determine if gene variants and biomarkers associated with oxidative stress, neuroinflammation, and folate physiology correlate with cognitive decline during and after chemotherapy. Ideally, certain variants and biomarkers will reveal patients who might benefit from interventions to prevent or even reverse cognitive deficits.
Peter D. Cole, MD, of Rutgers Cancer Institute, New Brunswick, N.J., and colleagues are conducting this research in patients from the DFCI-16-001 trial (NCT03020030). This multicenter, phase 3 study is enrolling patients (aged 1-21 years) with B- or T-cell ALL who then receive a multidrug chemotherapy regimen.
Dr. Cole and colleagues are analyzing a subset of patients from the trial, looking for relationships between chemotherapy-induced neurocognitive changes, gene variants, and changes in biomarkers detected in cerebrospinal fluid (CSF).
“We’re looking at a broad panel of target gene variants that are associated with either drug metabolism, defenses against oxidative stress, neuroinflammation, or folate physiology,” Dr. Cole said in an interview.
This includes variants Dr. Cole and colleagues identified in a previous, retrospective study of ALL survivors. The researchers found that survivors who were homozygous for NOS3 894T, had a variant SLCO2A1 G allele, or had at least one GSTP1 T allele were more likely to exhibit cognitive deficits (J Clin Oncol. 2015 Jul 1;33[19]:2205-11).
The researchers are also analyzing CSF samples, looking for changes in tau protein, homocysteine, homocysteic acid, the adenosylmethionine to adenosylhomocysteine ratio, and other biomarkers of oxidative stress, neuroinflammation, and folate physiology. The CSF is collected at five time points: the start of chemotherapy, day 18, the start of first consolidation, the end of first consolidation, and 7 weeks later in second consolidation.
Cognitive testing
While Dr. Cole is leading the genetic and biomarker analyses, Stephen A. Sands, PsyD, of Memorial Sloan Kettering Cancer Center in New York, is leading the cognitive testing.
The researchers are evaluating patients for cognitive decline using computerized tests from a company called Cogstate. The tests are designed to assess functions such as processing speed, attention, visual learning, and working memory. The tests are administered on an iPad and involve tasks like identifying features of playing cards and finding the correct way through a maze.
The patients – aged 3 years and older – undergo cognitive testing at six time points: baseline, which is any time between days 8 and 32 of induction (except within 72 hours after sedation or anesthesia); at first consolidation; the end of central nervous system therapy; 1 year into chemotherapy; the end of chemotherapy; and 1 year after chemotherapy ends.
In a prior study, Cogstate testing proved reliable for detecting neurocognitive changes in patients undergoing treatment for ALL (Support Care Cancer. 2017;25[2]:449-57). In the current study, the researchers are supplementing Cogstate test results with Wechsler IQ tests administered 1 year after patients complete chemotherapy.
Dr. Sands noted that Cogstate tests provide benefits over the Wechsler “paper-and-pencil” tests. One benefit is that Cogstate tests can be given more often without inducing practice effects (J Clin Exp Neuropsychol. 2006 Oct;28[7]:1095-112). Another is that Cogstate tests can be administered by anyone with a bachelor’s degree who has undergone the appropriate training, while Wechsler IQ tests must be given by psychologists.
Preliminary results
This research is ongoing, so it’s too early to announce any discoveries, but the study is moving along as planned.
“The preliminary data we have so far are demonstrating the validity of the study,” Dr. Cole said. “Things are going well. We’re able to do the cognitive testing and collect the samples that we need and ship them without losing the integrity of the samples.”
Dr. Sands noted that enrollment has been encouraging. As this is a substudy of DFCI-16-001, the researchers must obtain consent separately from the main study. Dr. Sands said about 89% of parents involved in the main study have agreed to enroll their children in the substudy.
Dr. Sands also said that early results from Cogstate testing have revealed patients who are experiencing cognitive decline during treatment. The researchers still have to determine if these results correlate with any biomarkers or gene variants.
Potential interventions
If the researchers can pinpoint patients at risk for cognitive deficits, the next step will be to investigate pharmacologic and behavioral interventions.
Dr. Cole said he is particularly interested in treatments that reduce oxidative stress, such as dextromethorphan and memantine. Dextromethorphan has been shown to resolve symptoms of methotrexate-induced neurotoxicity in patients (Pediatr Hematol Oncol. 2002 Jul-Aug;19[5]:319-27), and memantine reduced memory deficits in animals treated with methotrexate (Clin Cancer Res. 2013 Aug 15;19[16]:4446-54).
“Memantine hasn’t been used in kids with leukemia yet, but it’s something that I’d like to see brought to a clinical trial,” Dr. Cole said.
Dr. Sands pointed to other potential pharmacologic interventions, including the stimulants methylphenidate and modafinil. Both drugs have been shown to improve cognitive deficits in cancer survivors (J Clin Oncol. 2001 Mar 15;19[6]:1802-8; Cancer. 2009 Jun 15; 115[12]: 2605-16).
Computer-based cognitive training tools may be another option. One such tool, Lumosity, improved executive functions in a study of breast cancer survivors (Clin Breast Cancer. 2013 Aug;13[4]:299-306). Another tool, CogMed, improved working memory in survivors of brain tumors and ALL (Psychooncology. 2013 Aug; 22[8]: 1856-65).
Other behavioral interventions might include sleep hygiene and exercise. Sleep hygiene has been shown to improve cognitive function in childhood cancer survivors (Cancer. 2011 Jun 1;117[11]:2559-68), and a recent study revealed an association between exercise intolerance and negative neurocognitive outcomes in ALL survivors (Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510).
“What we need to figure out is which children will respond to which interventions,” Dr. Sands said, adding that interventions will likely need to be combined.
“It’s not going to be one thing that will work for everybody,” he said. “It’s going to be: What packages of things will work for different people?”
Dr. Sands and Dr. Cole reported having no relevant financial disclosures.
Researchers are attempting to determine, early in the treatment process, which children with acute lymphoblastic leukemia (ALL) have an increased risk of neurocognitive deficits after chemotherapy.
The goal of the researchers’ project (5R01CA220568-02) is to determine if gene variants and biomarkers associated with oxidative stress, neuroinflammation, and folate physiology correlate with cognitive decline during and after chemotherapy. Ideally, certain variants and biomarkers will reveal patients who might benefit from interventions to prevent or even reverse cognitive deficits.
Peter D. Cole, MD, of Rutgers Cancer Institute, New Brunswick, N.J., and colleagues are conducting this research in patients from the DFCI-16-001 trial (NCT03020030). This multicenter, phase 3 study is enrolling patients (aged 1-21 years) with B- or T-cell ALL who then receive a multidrug chemotherapy regimen.
Dr. Cole and colleagues are analyzing a subset of patients from the trial, looking for relationships between chemotherapy-induced neurocognitive changes, gene variants, and changes in biomarkers detected in cerebrospinal fluid (CSF).
“We’re looking at a broad panel of target gene variants that are associated with either drug metabolism, defenses against oxidative stress, neuroinflammation, or folate physiology,” Dr. Cole said in an interview.
This includes variants Dr. Cole and colleagues identified in a previous, retrospective study of ALL survivors. The researchers found that survivors who were homozygous for NOS3 894T, had a variant SLCO2A1 G allele, or had at least one GSTP1 T allele were more likely to exhibit cognitive deficits (J Clin Oncol. 2015 Jul 1;33[19]:2205-11).
The researchers are also analyzing CSF samples, looking for changes in tau protein, homocysteine, homocysteic acid, the adenosylmethionine to adenosylhomocysteine ratio, and other biomarkers of oxidative stress, neuroinflammation, and folate physiology. The CSF is collected at five time points: the start of chemotherapy, day 18, the start of first consolidation, the end of first consolidation, and 7 weeks later in second consolidation.
Cognitive testing
While Dr. Cole is leading the genetic and biomarker analyses, Stephen A. Sands, PsyD, of Memorial Sloan Kettering Cancer Center in New York, is leading the cognitive testing.
The researchers are evaluating patients for cognitive decline using computerized tests from a company called Cogstate. The tests are designed to assess functions such as processing speed, attention, visual learning, and working memory. The tests are administered on an iPad and involve tasks like identifying features of playing cards and finding the correct way through a maze.
The patients – aged 3 years and older – undergo cognitive testing at six time points: baseline, which is any time between days 8 and 32 of induction (except within 72 hours after sedation or anesthesia); at first consolidation; the end of central nervous system therapy; 1 year into chemotherapy; the end of chemotherapy; and 1 year after chemotherapy ends.
In a prior study, Cogstate testing proved reliable for detecting neurocognitive changes in patients undergoing treatment for ALL (Support Care Cancer. 2017;25[2]:449-57). In the current study, the researchers are supplementing Cogstate test results with Wechsler IQ tests administered 1 year after patients complete chemotherapy.
Dr. Sands noted that Cogstate tests provide benefits over the Wechsler “paper-and-pencil” tests. One benefit is that Cogstate tests can be given more often without inducing practice effects (J Clin Exp Neuropsychol. 2006 Oct;28[7]:1095-112). Another is that Cogstate tests can be administered by anyone with a bachelor’s degree who has undergone the appropriate training, while Wechsler IQ tests must be given by psychologists.
Preliminary results
This research is ongoing, so it’s too early to announce any discoveries, but the study is moving along as planned.
“The preliminary data we have so far are demonstrating the validity of the study,” Dr. Cole said. “Things are going well. We’re able to do the cognitive testing and collect the samples that we need and ship them without losing the integrity of the samples.”
Dr. Sands noted that enrollment has been encouraging. As this is a substudy of DFCI-16-001, the researchers must obtain consent separately from the main study. Dr. Sands said about 89% of parents involved in the main study have agreed to enroll their children in the substudy.
Dr. Sands also said that early results from Cogstate testing have revealed patients who are experiencing cognitive decline during treatment. The researchers still have to determine if these results correlate with any biomarkers or gene variants.
Potential interventions
If the researchers can pinpoint patients at risk for cognitive deficits, the next step will be to investigate pharmacologic and behavioral interventions.
Dr. Cole said he is particularly interested in treatments that reduce oxidative stress, such as dextromethorphan and memantine. Dextromethorphan has been shown to resolve symptoms of methotrexate-induced neurotoxicity in patients (Pediatr Hematol Oncol. 2002 Jul-Aug;19[5]:319-27), and memantine reduced memory deficits in animals treated with methotrexate (Clin Cancer Res. 2013 Aug 15;19[16]:4446-54).
“Memantine hasn’t been used in kids with leukemia yet, but it’s something that I’d like to see brought to a clinical trial,” Dr. Cole said.
Dr. Sands pointed to other potential pharmacologic interventions, including the stimulants methylphenidate and modafinil. Both drugs have been shown to improve cognitive deficits in cancer survivors (J Clin Oncol. 2001 Mar 15;19[6]:1802-8; Cancer. 2009 Jun 15; 115[12]: 2605-16).
Computer-based cognitive training tools may be another option. One such tool, Lumosity, improved executive functions in a study of breast cancer survivors (Clin Breast Cancer. 2013 Aug;13[4]:299-306). Another tool, CogMed, improved working memory in survivors of brain tumors and ALL (Psychooncology. 2013 Aug; 22[8]: 1856-65).
Other behavioral interventions might include sleep hygiene and exercise. Sleep hygiene has been shown to improve cognitive function in childhood cancer survivors (Cancer. 2011 Jun 1;117[11]:2559-68), and a recent study revealed an association between exercise intolerance and negative neurocognitive outcomes in ALL survivors (Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510).
“What we need to figure out is which children will respond to which interventions,” Dr. Sands said, adding that interventions will likely need to be combined.
“It’s not going to be one thing that will work for everybody,” he said. “It’s going to be: What packages of things will work for different people?”
Dr. Sands and Dr. Cole reported having no relevant financial disclosures.
Researchers are attempting to determine, early in the treatment process, which children with acute lymphoblastic leukemia (ALL) have an increased risk of neurocognitive deficits after chemotherapy.
The goal of the researchers’ project (5R01CA220568-02) is to determine if gene variants and biomarkers associated with oxidative stress, neuroinflammation, and folate physiology correlate with cognitive decline during and after chemotherapy. Ideally, certain variants and biomarkers will reveal patients who might benefit from interventions to prevent or even reverse cognitive deficits.
Peter D. Cole, MD, of Rutgers Cancer Institute, New Brunswick, N.J., and colleagues are conducting this research in patients from the DFCI-16-001 trial (NCT03020030). This multicenter, phase 3 study is enrolling patients (aged 1-21 years) with B- or T-cell ALL who then receive a multidrug chemotherapy regimen.
Dr. Cole and colleagues are analyzing a subset of patients from the trial, looking for relationships between chemotherapy-induced neurocognitive changes, gene variants, and changes in biomarkers detected in cerebrospinal fluid (CSF).
“We’re looking at a broad panel of target gene variants that are associated with either drug metabolism, defenses against oxidative stress, neuroinflammation, or folate physiology,” Dr. Cole said in an interview.
This includes variants Dr. Cole and colleagues identified in a previous, retrospective study of ALL survivors. The researchers found that survivors who were homozygous for NOS3 894T, had a variant SLCO2A1 G allele, or had at least one GSTP1 T allele were more likely to exhibit cognitive deficits (J Clin Oncol. 2015 Jul 1;33[19]:2205-11).
The researchers are also analyzing CSF samples, looking for changes in tau protein, homocysteine, homocysteic acid, the adenosylmethionine to adenosylhomocysteine ratio, and other biomarkers of oxidative stress, neuroinflammation, and folate physiology. The CSF is collected at five time points: the start of chemotherapy, day 18, the start of first consolidation, the end of first consolidation, and 7 weeks later in second consolidation.
Cognitive testing
While Dr. Cole is leading the genetic and biomarker analyses, Stephen A. Sands, PsyD, of Memorial Sloan Kettering Cancer Center in New York, is leading the cognitive testing.
The researchers are evaluating patients for cognitive decline using computerized tests from a company called Cogstate. The tests are designed to assess functions such as processing speed, attention, visual learning, and working memory. The tests are administered on an iPad and involve tasks like identifying features of playing cards and finding the correct way through a maze.
The patients – aged 3 years and older – undergo cognitive testing at six time points: baseline, which is any time between days 8 and 32 of induction (except within 72 hours after sedation or anesthesia); at first consolidation; the end of central nervous system therapy; 1 year into chemotherapy; the end of chemotherapy; and 1 year after chemotherapy ends.
In a prior study, Cogstate testing proved reliable for detecting neurocognitive changes in patients undergoing treatment for ALL (Support Care Cancer. 2017;25[2]:449-57). In the current study, the researchers are supplementing Cogstate test results with Wechsler IQ tests administered 1 year after patients complete chemotherapy.
Dr. Sands noted that Cogstate tests provide benefits over the Wechsler “paper-and-pencil” tests. One benefit is that Cogstate tests can be given more often without inducing practice effects (J Clin Exp Neuropsychol. 2006 Oct;28[7]:1095-112). Another is that Cogstate tests can be administered by anyone with a bachelor’s degree who has undergone the appropriate training, while Wechsler IQ tests must be given by psychologists.
Preliminary results
This research is ongoing, so it’s too early to announce any discoveries, but the study is moving along as planned.
“The preliminary data we have so far are demonstrating the validity of the study,” Dr. Cole said. “Things are going well. We’re able to do the cognitive testing and collect the samples that we need and ship them without losing the integrity of the samples.”
Dr. Sands noted that enrollment has been encouraging. As this is a substudy of DFCI-16-001, the researchers must obtain consent separately from the main study. Dr. Sands said about 89% of parents involved in the main study have agreed to enroll their children in the substudy.
Dr. Sands also said that early results from Cogstate testing have revealed patients who are experiencing cognitive decline during treatment. The researchers still have to determine if these results correlate with any biomarkers or gene variants.
Potential interventions
If the researchers can pinpoint patients at risk for cognitive deficits, the next step will be to investigate pharmacologic and behavioral interventions.
Dr. Cole said he is particularly interested in treatments that reduce oxidative stress, such as dextromethorphan and memantine. Dextromethorphan has been shown to resolve symptoms of methotrexate-induced neurotoxicity in patients (Pediatr Hematol Oncol. 2002 Jul-Aug;19[5]:319-27), and memantine reduced memory deficits in animals treated with methotrexate (Clin Cancer Res. 2013 Aug 15;19[16]:4446-54).
“Memantine hasn’t been used in kids with leukemia yet, but it’s something that I’d like to see brought to a clinical trial,” Dr. Cole said.
Dr. Sands pointed to other potential pharmacologic interventions, including the stimulants methylphenidate and modafinil. Both drugs have been shown to improve cognitive deficits in cancer survivors (J Clin Oncol. 2001 Mar 15;19[6]:1802-8; Cancer. 2009 Jun 15; 115[12]: 2605-16).
Computer-based cognitive training tools may be another option. One such tool, Lumosity, improved executive functions in a study of breast cancer survivors (Clin Breast Cancer. 2013 Aug;13[4]:299-306). Another tool, CogMed, improved working memory in survivors of brain tumors and ALL (Psychooncology. 2013 Aug; 22[8]: 1856-65).
Other behavioral interventions might include sleep hygiene and exercise. Sleep hygiene has been shown to improve cognitive function in childhood cancer survivors (Cancer. 2011 Jun 1;117[11]:2559-68), and a recent study revealed an association between exercise intolerance and negative neurocognitive outcomes in ALL survivors (Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510).
“What we need to figure out is which children will respond to which interventions,” Dr. Sands said, adding that interventions will likely need to be combined.
“It’s not going to be one thing that will work for everybody,” he said. “It’s going to be: What packages of things will work for different people?”
Dr. Sands and Dr. Cole reported having no relevant financial disclosures.
Football for the young
A few weeks ago I was at a Friday-night football game, but not to watch the game. I’ve been there and done that too many times when I used to be the team physician. I was there to listen to my granddaughter drumming in the pep band. And there was a lot of drumming because her high school’s team is having a hot year and outscoring opponents by three and four touchdowns every week.
At half time, the field was swarmed by 45-50 early grade schoolers looking like bobblehead dolls in their oversize helmets and surprisingly professional-appearing miniature football outfits. Under the lights, on the local college’s turf field, they were in football heaven. The pep band got into it and there was more drumming as the few kids who had a clue what football was about were scampering over and around their teammates and opponents who were roughhousing with each other, rolling around on the turf having a grand time, blissfully unimpressed by such trivial concepts as the line of scrimmage or the difference between blocking and tackling or even offense and defense.
Despite all the alarming articles both lay and professional that you and I see, this was an evening on which no one seemed particularly concerned about sports-related concussions. This is class B football in Maine, not a state well known as an incubator of Division I college football players. While there were a few scrawny kids with some speed,
Watching 4- and 5-year-olds in their football uniforms seemed to me to be a rather harmless exercise and certainly a more positive investment in their time on a Friday night than sitting on the couch with an electronic device clutched in their little hands. A recent report in JAMA Pediatrics suggests that my lack of concern has some validity (“Consensus statement on sports-related concussions in youth sports using a modified delphi approach.” JAMA Pediatr. 2019 Nov 11. doi: 10.1001/jamapediatrics.2019.4006). Eleven experts in sports-related injuries were surveyed with multiple rounds of questionnaires. Their anonymous responses were aggregated and shared with the group after each round until a consensus could be arrived on for each of seven broad questions about sports-related concussions. It is a paper worth reading and like most good literature surveys determined that in many situations more study needs to be done.
Among the many findings that impressed me was the group’s failure to find an “association between repetitive head impact exposure in youth and long-term neurocognitive outcomes.” In addition, “there is little evidence that age at first exposure repetitive head impacts in sports is independently associated with neurodegenerative changes.” The experts also could find “no evidence that growth or development affect the risk of sports-related concussions.”
The problem with youth football is that it is the portal that can lead to college and professional football, in which large bodies are allowed to collide after accelerating at speeds we mortals only can achieve behind the wheel of our motor vehicles. Rules to minimize those collisions do exist, but lax enforcement has failed to prevent their cumulative damage.
Whether the culture of big-time football is going to change to a point at which a conscientious parent could encourage his or her child to play after adolescence remains to be seen. However, the evidence seems to suggest that allowing young children to bang themselves around imitating the big guys seems to be reasonably safe. At least as safe as what kids used to do to each other before we adults invented television and video games.
When my son was 3 or 4 years old, he played on a hockey team he thought was called the Toronto Make-Believes (Maple Leafs). Maybe we should be telling parents it’s safe for their children to play make-believe contact sports. The challenge comes after those kids reach puberty and want to start playing the real thing.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
A few weeks ago I was at a Friday-night football game, but not to watch the game. I’ve been there and done that too many times when I used to be the team physician. I was there to listen to my granddaughter drumming in the pep band. And there was a lot of drumming because her high school’s team is having a hot year and outscoring opponents by three and four touchdowns every week.
At half time, the field was swarmed by 45-50 early grade schoolers looking like bobblehead dolls in their oversize helmets and surprisingly professional-appearing miniature football outfits. Under the lights, on the local college’s turf field, they were in football heaven. The pep band got into it and there was more drumming as the few kids who had a clue what football was about were scampering over and around their teammates and opponents who were roughhousing with each other, rolling around on the turf having a grand time, blissfully unimpressed by such trivial concepts as the line of scrimmage or the difference between blocking and tackling or even offense and defense.
Despite all the alarming articles both lay and professional that you and I see, this was an evening on which no one seemed particularly concerned about sports-related concussions. This is class B football in Maine, not a state well known as an incubator of Division I college football players. While there were a few scrawny kids with some speed,
Watching 4- and 5-year-olds in their football uniforms seemed to me to be a rather harmless exercise and certainly a more positive investment in their time on a Friday night than sitting on the couch with an electronic device clutched in their little hands. A recent report in JAMA Pediatrics suggests that my lack of concern has some validity (“Consensus statement on sports-related concussions in youth sports using a modified delphi approach.” JAMA Pediatr. 2019 Nov 11. doi: 10.1001/jamapediatrics.2019.4006). Eleven experts in sports-related injuries were surveyed with multiple rounds of questionnaires. Their anonymous responses were aggregated and shared with the group after each round until a consensus could be arrived on for each of seven broad questions about sports-related concussions. It is a paper worth reading and like most good literature surveys determined that in many situations more study needs to be done.
Among the many findings that impressed me was the group’s failure to find an “association between repetitive head impact exposure in youth and long-term neurocognitive outcomes.” In addition, “there is little evidence that age at first exposure repetitive head impacts in sports is independently associated with neurodegenerative changes.” The experts also could find “no evidence that growth or development affect the risk of sports-related concussions.”
The problem with youth football is that it is the portal that can lead to college and professional football, in which large bodies are allowed to collide after accelerating at speeds we mortals only can achieve behind the wheel of our motor vehicles. Rules to minimize those collisions do exist, but lax enforcement has failed to prevent their cumulative damage.
Whether the culture of big-time football is going to change to a point at which a conscientious parent could encourage his or her child to play after adolescence remains to be seen. However, the evidence seems to suggest that allowing young children to bang themselves around imitating the big guys seems to be reasonably safe. At least as safe as what kids used to do to each other before we adults invented television and video games.
When my son was 3 or 4 years old, he played on a hockey team he thought was called the Toronto Make-Believes (Maple Leafs). Maybe we should be telling parents it’s safe for their children to play make-believe contact sports. The challenge comes after those kids reach puberty and want to start playing the real thing.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
A few weeks ago I was at a Friday-night football game, but not to watch the game. I’ve been there and done that too many times when I used to be the team physician. I was there to listen to my granddaughter drumming in the pep band. And there was a lot of drumming because her high school’s team is having a hot year and outscoring opponents by three and four touchdowns every week.
At half time, the field was swarmed by 45-50 early grade schoolers looking like bobblehead dolls in their oversize helmets and surprisingly professional-appearing miniature football outfits. Under the lights, on the local college’s turf field, they were in football heaven. The pep band got into it and there was more drumming as the few kids who had a clue what football was about were scampering over and around their teammates and opponents who were roughhousing with each other, rolling around on the turf having a grand time, blissfully unimpressed by such trivial concepts as the line of scrimmage or the difference between blocking and tackling or even offense and defense.
Despite all the alarming articles both lay and professional that you and I see, this was an evening on which no one seemed particularly concerned about sports-related concussions. This is class B football in Maine, not a state well known as an incubator of Division I college football players. While there were a few scrawny kids with some speed,
Watching 4- and 5-year-olds in their football uniforms seemed to me to be a rather harmless exercise and certainly a more positive investment in their time on a Friday night than sitting on the couch with an electronic device clutched in their little hands. A recent report in JAMA Pediatrics suggests that my lack of concern has some validity (“Consensus statement on sports-related concussions in youth sports using a modified delphi approach.” JAMA Pediatr. 2019 Nov 11. doi: 10.1001/jamapediatrics.2019.4006). Eleven experts in sports-related injuries were surveyed with multiple rounds of questionnaires. Their anonymous responses were aggregated and shared with the group after each round until a consensus could be arrived on for each of seven broad questions about sports-related concussions. It is a paper worth reading and like most good literature surveys determined that in many situations more study needs to be done.
Among the many findings that impressed me was the group’s failure to find an “association between repetitive head impact exposure in youth and long-term neurocognitive outcomes.” In addition, “there is little evidence that age at first exposure repetitive head impacts in sports is independently associated with neurodegenerative changes.” The experts also could find “no evidence that growth or development affect the risk of sports-related concussions.”
The problem with youth football is that it is the portal that can lead to college and professional football, in which large bodies are allowed to collide after accelerating at speeds we mortals only can achieve behind the wheel of our motor vehicles. Rules to minimize those collisions do exist, but lax enforcement has failed to prevent their cumulative damage.
Whether the culture of big-time football is going to change to a point at which a conscientious parent could encourage his or her child to play after adolescence remains to be seen. However, the evidence seems to suggest that allowing young children to bang themselves around imitating the big guys seems to be reasonably safe. At least as safe as what kids used to do to each other before we adults invented television and video games.
When my son was 3 or 4 years old, he played on a hockey team he thought was called the Toronto Make-Believes (Maple Leafs). Maybe we should be telling parents it’s safe for their children to play make-believe contact sports. The challenge comes after those kids reach puberty and want to start playing the real thing.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
FDA noncommittal on e-cigarette action
on when the agency would act and what actions it was planning on taking.
“I was actually shocked that, in a hearing that is focused in part on the youth vaping epidemic [that] your testimony, both written and oral here, made no mention of the administration’s Sept. 11 announcement that it intended to clear the market of all unauthorized non–tobacco-flavored vaping products,” said Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions Committee, during a Nov. 13 hearing to Mitchell Zeller, director of the FDA’s Center for Tobacco Products. “Why is that not included in your testimony?”
Director Zeller would only offer a vague response, testifying that the agency is “committed to doing everything that we can to prevent kids from using any tobacco product, including e-cigarettes, and that we are continuing to develop a policy approach that aligns with that concern.”
When Sen. Murray pressed further, Director Zeller deflected: “I think that any questions that the committee has about the announcement that the White House and anything related to what remains a deliberative process on policy is best referred to the White House itself.”
He would not even offer any perspective on when the FDA might take actual regulatory action when asked about it by Sen. Murray.
“I can’t give you a specific timeline, Senator, other than to say that the deliberative process continues,” Director Zeller responded, telling her that “I really would refer you and the committee to the White House to ask specific questions about where we are.”
The hearing, called to examine the response to lung illnesses and rising youth e-cigarette usage, shed no new light on the issue. And while Director Zeller outlined the numerous educational campaigns being aimed at convincing youth to not use e-cigarettes, Committee Chairman Lamar Alexander (R-Tenn.) questioned whether the FDA was doing an adequate job.
The FDA, from late 2017 to the end of 2020, “will wind up investing about $150 million in a massive, multimedia public education campaign to get the word out to kids” on the dangers of vaping, Director Zeller said, adding that the agency is “aggressively enforcing” youth access restrictions in targeting sellers of e-cigarette products to minors.
“Well, obviously we are not making much progress with youth use ... if one in four of American high schoolers, according to your statistics, are using e-cigarettes,” Sen. Alexander said.
While most on the committee were focused on the rising numbers of youth vaping and e-cigarette usage, Sen. Rand Paul (R-Ky.) cautioned that any regulatory action, particularly a ban on all flavored e-cigarette products, would adversely affect adults, particularly those who are turning to e-cigarettes as a smoking cessation tool.
His solution, noting that it is already illegal for kids to be purchasing vaping and e-cigarette products, was to increase the penalties for those found selling to minors, adding that “most adults are using the flavors as well” and it could lead them back to combustible tobacco products if they are prevented from accessing flavored e-cigarettes.
on when the agency would act and what actions it was planning on taking.
“I was actually shocked that, in a hearing that is focused in part on the youth vaping epidemic [that] your testimony, both written and oral here, made no mention of the administration’s Sept. 11 announcement that it intended to clear the market of all unauthorized non–tobacco-flavored vaping products,” said Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions Committee, during a Nov. 13 hearing to Mitchell Zeller, director of the FDA’s Center for Tobacco Products. “Why is that not included in your testimony?”
Director Zeller would only offer a vague response, testifying that the agency is “committed to doing everything that we can to prevent kids from using any tobacco product, including e-cigarettes, and that we are continuing to develop a policy approach that aligns with that concern.”
When Sen. Murray pressed further, Director Zeller deflected: “I think that any questions that the committee has about the announcement that the White House and anything related to what remains a deliberative process on policy is best referred to the White House itself.”
He would not even offer any perspective on when the FDA might take actual regulatory action when asked about it by Sen. Murray.
“I can’t give you a specific timeline, Senator, other than to say that the deliberative process continues,” Director Zeller responded, telling her that “I really would refer you and the committee to the White House to ask specific questions about where we are.”
The hearing, called to examine the response to lung illnesses and rising youth e-cigarette usage, shed no new light on the issue. And while Director Zeller outlined the numerous educational campaigns being aimed at convincing youth to not use e-cigarettes, Committee Chairman Lamar Alexander (R-Tenn.) questioned whether the FDA was doing an adequate job.
The FDA, from late 2017 to the end of 2020, “will wind up investing about $150 million in a massive, multimedia public education campaign to get the word out to kids” on the dangers of vaping, Director Zeller said, adding that the agency is “aggressively enforcing” youth access restrictions in targeting sellers of e-cigarette products to minors.
“Well, obviously we are not making much progress with youth use ... if one in four of American high schoolers, according to your statistics, are using e-cigarettes,” Sen. Alexander said.
While most on the committee were focused on the rising numbers of youth vaping and e-cigarette usage, Sen. Rand Paul (R-Ky.) cautioned that any regulatory action, particularly a ban on all flavored e-cigarette products, would adversely affect adults, particularly those who are turning to e-cigarettes as a smoking cessation tool.
His solution, noting that it is already illegal for kids to be purchasing vaping and e-cigarette products, was to increase the penalties for those found selling to minors, adding that “most adults are using the flavors as well” and it could lead them back to combustible tobacco products if they are prevented from accessing flavored e-cigarettes.
on when the agency would act and what actions it was planning on taking.
“I was actually shocked that, in a hearing that is focused in part on the youth vaping epidemic [that] your testimony, both written and oral here, made no mention of the administration’s Sept. 11 announcement that it intended to clear the market of all unauthorized non–tobacco-flavored vaping products,” said Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions Committee, during a Nov. 13 hearing to Mitchell Zeller, director of the FDA’s Center for Tobacco Products. “Why is that not included in your testimony?”
Director Zeller would only offer a vague response, testifying that the agency is “committed to doing everything that we can to prevent kids from using any tobacco product, including e-cigarettes, and that we are continuing to develop a policy approach that aligns with that concern.”
When Sen. Murray pressed further, Director Zeller deflected: “I think that any questions that the committee has about the announcement that the White House and anything related to what remains a deliberative process on policy is best referred to the White House itself.”
He would not even offer any perspective on when the FDA might take actual regulatory action when asked about it by Sen. Murray.
“I can’t give you a specific timeline, Senator, other than to say that the deliberative process continues,” Director Zeller responded, telling her that “I really would refer you and the committee to the White House to ask specific questions about where we are.”
The hearing, called to examine the response to lung illnesses and rising youth e-cigarette usage, shed no new light on the issue. And while Director Zeller outlined the numerous educational campaigns being aimed at convincing youth to not use e-cigarettes, Committee Chairman Lamar Alexander (R-Tenn.) questioned whether the FDA was doing an adequate job.
The FDA, from late 2017 to the end of 2020, “will wind up investing about $150 million in a massive, multimedia public education campaign to get the word out to kids” on the dangers of vaping, Director Zeller said, adding that the agency is “aggressively enforcing” youth access restrictions in targeting sellers of e-cigarette products to minors.
“Well, obviously we are not making much progress with youth use ... if one in four of American high schoolers, according to your statistics, are using e-cigarettes,” Sen. Alexander said.
While most on the committee were focused on the rising numbers of youth vaping and e-cigarette usage, Sen. Rand Paul (R-Ky.) cautioned that any regulatory action, particularly a ban on all flavored e-cigarette products, would adversely affect adults, particularly those who are turning to e-cigarettes as a smoking cessation tool.
His solution, noting that it is already illegal for kids to be purchasing vaping and e-cigarette products, was to increase the penalties for those found selling to minors, adding that “most adults are using the flavors as well” and it could lead them back to combustible tobacco products if they are prevented from accessing flavored e-cigarettes.
REPORTING FROM A SENATE HELP COMMITTEE HEARING