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Why it’s important to offer cosmeceuticals in a cosmetic practice
SAN DIEGO – , advised Ava Shamban, MD.
It’s important to provide patients with high-quality products to take home with them and cosmeceuticals contain biologically active ingredients that enhance skin care efficacy, Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “You can do all the lasers, injectables, and peels that you want, but if you’re not giving your patients high-quality products to take home with them, you’re not doing your job,” she commented.
“Look for brands that are formulated and tested for effectiveness,” she added. “In my office, we like to have products that are designed for specific issues to accompany prescription products, everything from rosacea, acne, melasma, and eczema to psoriasis.”
Dr. Shamban, author of the 2011 book, “Heal Your Skin: The Breakthrough Plan for Renewal,” recommends that dermatologists devise a questionnaire for patients asking them to list their skin-related concerns and use the responses to create a list of products for them to use at home. Provide clear instructions on use, including proper layering of products, how often to use them, and the correct amount to apply. “If you’re not going to do this, someone else will,” she said. Next, instruct them that cosmeceuticals must be used routinely to achieve optimal benefit. “Nothing happens overnight, and be wary of anyone that promises you otherwise,” Dr. Shamban said. “Offering cosmeceuticals helps bridge the gap between at-home routines and in-office treatments. If in-office procedures are a marathon, view the consistent use of the right products at home as your training.”
During her presentation, she showed a photo of the “beauty bar,” the dedicated space with a counter and shelves for displaying skin care products in her Santa Monica office. “It’s good to set something up like this in your office, even if it’s just a little corner, because it gives it authority,” Dr. Shamban said. “Encourage clients to explore the beauty bar after their appointment with you.” She emphasized the importance of offering a wide range of products to accommodate different lifestyles, budgets, skin types, ages, and specific skin concerns, and training staff about the products. “There is never a one-size-fits-all approach to skincare; it’s all about the individual,” she said. “It’s never about pushing product; it’s always about educating patients.”
Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.
SAN DIEGO – , advised Ava Shamban, MD.
It’s important to provide patients with high-quality products to take home with them and cosmeceuticals contain biologically active ingredients that enhance skin care efficacy, Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “You can do all the lasers, injectables, and peels that you want, but if you’re not giving your patients high-quality products to take home with them, you’re not doing your job,” she commented.
“Look for brands that are formulated and tested for effectiveness,” she added. “In my office, we like to have products that are designed for specific issues to accompany prescription products, everything from rosacea, acne, melasma, and eczema to psoriasis.”
Dr. Shamban, author of the 2011 book, “Heal Your Skin: The Breakthrough Plan for Renewal,” recommends that dermatologists devise a questionnaire for patients asking them to list their skin-related concerns and use the responses to create a list of products for them to use at home. Provide clear instructions on use, including proper layering of products, how often to use them, and the correct amount to apply. “If you’re not going to do this, someone else will,” she said. Next, instruct them that cosmeceuticals must be used routinely to achieve optimal benefit. “Nothing happens overnight, and be wary of anyone that promises you otherwise,” Dr. Shamban said. “Offering cosmeceuticals helps bridge the gap between at-home routines and in-office treatments. If in-office procedures are a marathon, view the consistent use of the right products at home as your training.”
During her presentation, she showed a photo of the “beauty bar,” the dedicated space with a counter and shelves for displaying skin care products in her Santa Monica office. “It’s good to set something up like this in your office, even if it’s just a little corner, because it gives it authority,” Dr. Shamban said. “Encourage clients to explore the beauty bar after their appointment with you.” She emphasized the importance of offering a wide range of products to accommodate different lifestyles, budgets, skin types, ages, and specific skin concerns, and training staff about the products. “There is never a one-size-fits-all approach to skincare; it’s all about the individual,” she said. “It’s never about pushing product; it’s always about educating patients.”
Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.
SAN DIEGO – , advised Ava Shamban, MD.
It’s important to provide patients with high-quality products to take home with them and cosmeceuticals contain biologically active ingredients that enhance skin care efficacy, Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “You can do all the lasers, injectables, and peels that you want, but if you’re not giving your patients high-quality products to take home with them, you’re not doing your job,” she commented.
“Look for brands that are formulated and tested for effectiveness,” she added. “In my office, we like to have products that are designed for specific issues to accompany prescription products, everything from rosacea, acne, melasma, and eczema to psoriasis.”
Dr. Shamban, author of the 2011 book, “Heal Your Skin: The Breakthrough Plan for Renewal,” recommends that dermatologists devise a questionnaire for patients asking them to list their skin-related concerns and use the responses to create a list of products for them to use at home. Provide clear instructions on use, including proper layering of products, how often to use them, and the correct amount to apply. “If you’re not going to do this, someone else will,” she said. Next, instruct them that cosmeceuticals must be used routinely to achieve optimal benefit. “Nothing happens overnight, and be wary of anyone that promises you otherwise,” Dr. Shamban said. “Offering cosmeceuticals helps bridge the gap between at-home routines and in-office treatments. If in-office procedures are a marathon, view the consistent use of the right products at home as your training.”
During her presentation, she showed a photo of the “beauty bar,” the dedicated space with a counter and shelves for displaying skin care products in her Santa Monica office. “It’s good to set something up like this in your office, even if it’s just a little corner, because it gives it authority,” Dr. Shamban said. “Encourage clients to explore the beauty bar after their appointment with you.” She emphasized the importance of offering a wide range of products to accommodate different lifestyles, budgets, skin types, ages, and specific skin concerns, and training staff about the products. “There is never a one-size-fits-all approach to skincare; it’s all about the individual,” she said. “It’s never about pushing product; it’s always about educating patients.”
Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.
AT MOAS 2022
STEMI times to treatment usually miss established goals
Therapy initiated within national treatment-time goals set a decade ago for patients with ST-segment elevation myocardial infarction (STEMI) remains associated with improved survival in recent years. But for many such patients, time from first symptoms to initiation of reperfusion therapy still fails to meet those goals, suggests a cross-sectional registry analysis.
For example, patients initially transported to centers with percutaneous coronary intervention (PCI) capability had a median treatment time of 148 minutes, in the analysis spanning the second quarter (Q2) of 2018 to the third quarter (Q3) of 2021. But the goal for centers called for treatment initiation within 90 minutes for at least 75% of such STEMI patients.
Moreover, overall STEMI treatment times and in-hospital mortality rose in tandem significantly from Q2 2018 through the first quarter (Q1) of 2021, which included the first year of the COVID-19 pandemic. Median time to treatment went from 86 minutes to 91 minutes during that period. Meanwhile, in-hospital mortality went from 5.6% to 8.7%, report the study authors led by James G. Jollis, MD, Duke University, Durham, N.C.
Their report, based on 114,871 STEMI patients at 601 US hospitals contributing to the Get With The Guidelines – Coronary Artery Disease registry, was published online in JAMA.
Of those patients, 25,085 had been transferred from non-PCI hospitals, 32,483 were walk-ins, and 57,303 arrived via emergency medical services (EMS). Their median times from symptom onset to PCI were 240, 195, and 148 minutes, respectively.
In-hospital mortality was significantly reduced in an adjusted analysis for patients treated within target times, compared with those whose treatment missed the time goals, regardless of whether they were transported by EMS, walked into a hospital with on-site PCI, or were transferred from a non-PCI center (Table 1).
Regardless of mode of patient presentation, treatment time goals were not met most of the time, the group reports. Patients who required interhospital transfer experienced the longest system delays; only 17% were treated within 120 minutes.
Among patients who received primary PCI, 20% had a registry-defined hospital-specified reason for delay, including cardiac arrest and/or need for intubation in 6.8%, “difficulty crossing the culprit lesion” in 3.8%, and “other reasons” in 5.8%, the group reports.
“In 2020, a new reason for delay was added to the registry, ‘need for additional personal protective equipment for suspected/confirmed infectious disease.’ This reason was most commonly used in the second quarter of 2020 (6%) and then declined over time to 1% in the final 2 quarters,” they write.
“Thus, active SARS-CoV-2 infection appeared to have a smaller direct role in longer treatment times or worse outcomes.” Rather, they continue, “the pandemic potentially had a significant indirect role as hospitals were overwhelmed with patients, EMS and hospitals were challenged in maintaining paramedic and nurse staffing and intensive care bed availability, and patients experienced delayed care due to barriers to access or perceived fear of becoming entangled in an overwhelmed medical system.”
Still an important quality metric
STEMI treatment times remain an important quality metric to which hospitals should continue to pay attention because shorter times improve patient care, Deepak Bhatt, MD, MPH, told this news organization.
“Having said that, as with all metrics, one needs to be thoughtful and realize that a difference of a couple of minutes is probably not a crucial thing,” said Dr. Bhatt, Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not involved with the current study.
Interhospital transfers indeed involve longer delays, he observed, suggesting that regional integrated health systems should develop methods for optimizing STEMI care – even, for example, if they involve bypassing non-PCI centers or stopping patients briefly for stabilization followed by rapid transport to a PCI-capable facility.
“That, of course, requires cooperation among hospitals. Sometimes that requires hospitals putting aside economic considerations and just focusing on doing the right thing for that individual patient,” Dr. Bhatt said.
Transfer delays are common for patients presenting with STEMI at hospitals without PCI capability, he noted. “Having clear protocols in place that expedite that type of transfer, I think, could go a long way in reducing the time to treatment in patients that are presenting to the hospital without cath labs. That’s an important message that these data provide.”
The onset of COVID-19 led to widespread delays in STEMI time to treatment early in the pandemic. There were concerns about exposing cath lab personnel to SARS-CoV-2 and potential adverse consequences of sick personnel being unable to provide patient care in the subsequent weeks and months, Dr. Bhatt observed.
However, “All of that seems to have quieted down, and I don’t think COVID is impacting time to treatment right now.”
‘Suboptimal compliance’ with standards
The current findings of “suboptimal compliance with national targets underscore why reassessing quality metrics, in light of changing practice patterns and other secular trends, is critical,” write Andrew S. Oseran, MD, MBA, and Robert W. Yeh, MD, both of Harvard Medical School, in an accompanying editorial.
“While the importance of coordinated and expeditious care for this high-risk patient population is undeniable, the specific actions that hospitals can – or should – take to further improve overall STEMI outcomes are less clear,” they say.
“As physicians contemplate the optimal path forward in managing the care of STEMI patients, they must recognize the clinical and operational nuance that exists in caring for this diverse population and acknowledge the trade-offs associated with uniform quality metrics,” write the editorialists.
“Global reductions in time to treatment for STEMI patients has been one of health care’s great success stories. As we move forward, it may be time to consider whether efforts to achieve additional improvement in target treatment times will result in substantive benefits, or whether we have reached the point of diminishing returns.”
A version of this article first appeared on Medscape.com.
Therapy initiated within national treatment-time goals set a decade ago for patients with ST-segment elevation myocardial infarction (STEMI) remains associated with improved survival in recent years. But for many such patients, time from first symptoms to initiation of reperfusion therapy still fails to meet those goals, suggests a cross-sectional registry analysis.
For example, patients initially transported to centers with percutaneous coronary intervention (PCI) capability had a median treatment time of 148 minutes, in the analysis spanning the second quarter (Q2) of 2018 to the third quarter (Q3) of 2021. But the goal for centers called for treatment initiation within 90 minutes for at least 75% of such STEMI patients.
Moreover, overall STEMI treatment times and in-hospital mortality rose in tandem significantly from Q2 2018 through the first quarter (Q1) of 2021, which included the first year of the COVID-19 pandemic. Median time to treatment went from 86 minutes to 91 minutes during that period. Meanwhile, in-hospital mortality went from 5.6% to 8.7%, report the study authors led by James G. Jollis, MD, Duke University, Durham, N.C.
Their report, based on 114,871 STEMI patients at 601 US hospitals contributing to the Get With The Guidelines – Coronary Artery Disease registry, was published online in JAMA.
Of those patients, 25,085 had been transferred from non-PCI hospitals, 32,483 were walk-ins, and 57,303 arrived via emergency medical services (EMS). Their median times from symptom onset to PCI were 240, 195, and 148 minutes, respectively.
In-hospital mortality was significantly reduced in an adjusted analysis for patients treated within target times, compared with those whose treatment missed the time goals, regardless of whether they were transported by EMS, walked into a hospital with on-site PCI, or were transferred from a non-PCI center (Table 1).
Regardless of mode of patient presentation, treatment time goals were not met most of the time, the group reports. Patients who required interhospital transfer experienced the longest system delays; only 17% were treated within 120 minutes.
Among patients who received primary PCI, 20% had a registry-defined hospital-specified reason for delay, including cardiac arrest and/or need for intubation in 6.8%, “difficulty crossing the culprit lesion” in 3.8%, and “other reasons” in 5.8%, the group reports.
“In 2020, a new reason for delay was added to the registry, ‘need for additional personal protective equipment for suspected/confirmed infectious disease.’ This reason was most commonly used in the second quarter of 2020 (6%) and then declined over time to 1% in the final 2 quarters,” they write.
“Thus, active SARS-CoV-2 infection appeared to have a smaller direct role in longer treatment times or worse outcomes.” Rather, they continue, “the pandemic potentially had a significant indirect role as hospitals were overwhelmed with patients, EMS and hospitals were challenged in maintaining paramedic and nurse staffing and intensive care bed availability, and patients experienced delayed care due to barriers to access or perceived fear of becoming entangled in an overwhelmed medical system.”
Still an important quality metric
STEMI treatment times remain an important quality metric to which hospitals should continue to pay attention because shorter times improve patient care, Deepak Bhatt, MD, MPH, told this news organization.
“Having said that, as with all metrics, one needs to be thoughtful and realize that a difference of a couple of minutes is probably not a crucial thing,” said Dr. Bhatt, Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not involved with the current study.
Interhospital transfers indeed involve longer delays, he observed, suggesting that regional integrated health systems should develop methods for optimizing STEMI care – even, for example, if they involve bypassing non-PCI centers or stopping patients briefly for stabilization followed by rapid transport to a PCI-capable facility.
“That, of course, requires cooperation among hospitals. Sometimes that requires hospitals putting aside economic considerations and just focusing on doing the right thing for that individual patient,” Dr. Bhatt said.
Transfer delays are common for patients presenting with STEMI at hospitals without PCI capability, he noted. “Having clear protocols in place that expedite that type of transfer, I think, could go a long way in reducing the time to treatment in patients that are presenting to the hospital without cath labs. That’s an important message that these data provide.”
The onset of COVID-19 led to widespread delays in STEMI time to treatment early in the pandemic. There were concerns about exposing cath lab personnel to SARS-CoV-2 and potential adverse consequences of sick personnel being unable to provide patient care in the subsequent weeks and months, Dr. Bhatt observed.
However, “All of that seems to have quieted down, and I don’t think COVID is impacting time to treatment right now.”
‘Suboptimal compliance’ with standards
The current findings of “suboptimal compliance with national targets underscore why reassessing quality metrics, in light of changing practice patterns and other secular trends, is critical,” write Andrew S. Oseran, MD, MBA, and Robert W. Yeh, MD, both of Harvard Medical School, in an accompanying editorial.
“While the importance of coordinated and expeditious care for this high-risk patient population is undeniable, the specific actions that hospitals can – or should – take to further improve overall STEMI outcomes are less clear,” they say.
“As physicians contemplate the optimal path forward in managing the care of STEMI patients, they must recognize the clinical and operational nuance that exists in caring for this diverse population and acknowledge the trade-offs associated with uniform quality metrics,” write the editorialists.
“Global reductions in time to treatment for STEMI patients has been one of health care’s great success stories. As we move forward, it may be time to consider whether efforts to achieve additional improvement in target treatment times will result in substantive benefits, or whether we have reached the point of diminishing returns.”
A version of this article first appeared on Medscape.com.
Therapy initiated within national treatment-time goals set a decade ago for patients with ST-segment elevation myocardial infarction (STEMI) remains associated with improved survival in recent years. But for many such patients, time from first symptoms to initiation of reperfusion therapy still fails to meet those goals, suggests a cross-sectional registry analysis.
For example, patients initially transported to centers with percutaneous coronary intervention (PCI) capability had a median treatment time of 148 minutes, in the analysis spanning the second quarter (Q2) of 2018 to the third quarter (Q3) of 2021. But the goal for centers called for treatment initiation within 90 minutes for at least 75% of such STEMI patients.
Moreover, overall STEMI treatment times and in-hospital mortality rose in tandem significantly from Q2 2018 through the first quarter (Q1) of 2021, which included the first year of the COVID-19 pandemic. Median time to treatment went from 86 minutes to 91 minutes during that period. Meanwhile, in-hospital mortality went from 5.6% to 8.7%, report the study authors led by James G. Jollis, MD, Duke University, Durham, N.C.
Their report, based on 114,871 STEMI patients at 601 US hospitals contributing to the Get With The Guidelines – Coronary Artery Disease registry, was published online in JAMA.
Of those patients, 25,085 had been transferred from non-PCI hospitals, 32,483 were walk-ins, and 57,303 arrived via emergency medical services (EMS). Their median times from symptom onset to PCI were 240, 195, and 148 minutes, respectively.
In-hospital mortality was significantly reduced in an adjusted analysis for patients treated within target times, compared with those whose treatment missed the time goals, regardless of whether they were transported by EMS, walked into a hospital with on-site PCI, or were transferred from a non-PCI center (Table 1).
Regardless of mode of patient presentation, treatment time goals were not met most of the time, the group reports. Patients who required interhospital transfer experienced the longest system delays; only 17% were treated within 120 minutes.
Among patients who received primary PCI, 20% had a registry-defined hospital-specified reason for delay, including cardiac arrest and/or need for intubation in 6.8%, “difficulty crossing the culprit lesion” in 3.8%, and “other reasons” in 5.8%, the group reports.
“In 2020, a new reason for delay was added to the registry, ‘need for additional personal protective equipment for suspected/confirmed infectious disease.’ This reason was most commonly used in the second quarter of 2020 (6%) and then declined over time to 1% in the final 2 quarters,” they write.
“Thus, active SARS-CoV-2 infection appeared to have a smaller direct role in longer treatment times or worse outcomes.” Rather, they continue, “the pandemic potentially had a significant indirect role as hospitals were overwhelmed with patients, EMS and hospitals were challenged in maintaining paramedic and nurse staffing and intensive care bed availability, and patients experienced delayed care due to barriers to access or perceived fear of becoming entangled in an overwhelmed medical system.”
Still an important quality metric
STEMI treatment times remain an important quality metric to which hospitals should continue to pay attention because shorter times improve patient care, Deepak Bhatt, MD, MPH, told this news organization.
“Having said that, as with all metrics, one needs to be thoughtful and realize that a difference of a couple of minutes is probably not a crucial thing,” said Dr. Bhatt, Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not involved with the current study.
Interhospital transfers indeed involve longer delays, he observed, suggesting that regional integrated health systems should develop methods for optimizing STEMI care – even, for example, if they involve bypassing non-PCI centers or stopping patients briefly for stabilization followed by rapid transport to a PCI-capable facility.
“That, of course, requires cooperation among hospitals. Sometimes that requires hospitals putting aside economic considerations and just focusing on doing the right thing for that individual patient,” Dr. Bhatt said.
Transfer delays are common for patients presenting with STEMI at hospitals without PCI capability, he noted. “Having clear protocols in place that expedite that type of transfer, I think, could go a long way in reducing the time to treatment in patients that are presenting to the hospital without cath labs. That’s an important message that these data provide.”
The onset of COVID-19 led to widespread delays in STEMI time to treatment early in the pandemic. There were concerns about exposing cath lab personnel to SARS-CoV-2 and potential adverse consequences of sick personnel being unable to provide patient care in the subsequent weeks and months, Dr. Bhatt observed.
However, “All of that seems to have quieted down, and I don’t think COVID is impacting time to treatment right now.”
‘Suboptimal compliance’ with standards
The current findings of “suboptimal compliance with national targets underscore why reassessing quality metrics, in light of changing practice patterns and other secular trends, is critical,” write Andrew S. Oseran, MD, MBA, and Robert W. Yeh, MD, both of Harvard Medical School, in an accompanying editorial.
“While the importance of coordinated and expeditious care for this high-risk patient population is undeniable, the specific actions that hospitals can – or should – take to further improve overall STEMI outcomes are less clear,” they say.
“As physicians contemplate the optimal path forward in managing the care of STEMI patients, they must recognize the clinical and operational nuance that exists in caring for this diverse population and acknowledge the trade-offs associated with uniform quality metrics,” write the editorialists.
“Global reductions in time to treatment for STEMI patients has been one of health care’s great success stories. As we move forward, it may be time to consider whether efforts to achieve additional improvement in target treatment times will result in substantive benefits, or whether we have reached the point of diminishing returns.”
A version of this article first appeared on Medscape.com.
FROM JAMA
Nearly 1,400% rise in young children ingesting cannabis edibles
according to a new analysis of data from poison control centers.
In 2017, centers received 207 reports of children aged 5 years and younger who ingested edible cannabis. In 2021, 3,054 such cases were reported, according to the study, which was published online in Pediatrics.
Many of the children experienced clinical effects, such as depression of the central nervous system, impaired coordination, confusion, agitation, an increase in heart rate, or dilated pupils. No deaths were reported.
“These exposures can cause significant toxicity and are responsible for an increasing number of hospitalizations,” study coauthor Marit S. Tweet, MD, of Southern Illinois University, Springfield, and colleagues wrote.
About 97% of the exposures occurred in residences – 90% at the child’s own home – and about half of the cases involved 2- and 3-year-olds, they noted.
Examining national trends
Twenty-one states have approved recreational cannabis for people aged 21 years and older.
Prior research has shown that calls to poison centers and visits to emergency departments for pediatric cannabis consumption increased in certain states after the drug became legal in those jurisdictions.
To assess national trends, Dr. Tweet’s group analyzed cases in the National Poison Data System, which tracks potentially toxic exposures reported to poison control centers in the United States.
During the 5-year period, they identified 7,043 exposures to edible cannabis by children younger than age 6. In 2.2% of the cases, the drug had a major effect, defined as being either life-threatening or causing residual disability. In 21.9% of cases, the effect was considered to be moderate, with symptoms that were more pronounced, prolonged, or systemic than minor effects.
About 8% of the children were admitted to critical care units; 14.6% were admitted to non–critical care units.
Of 4,827 cases for which there was information about the clinical effects of the exposure and therapies used, 70% involved CNS depression, including 1.9% with “more severe CNS effects, including major CNS depression or coma,” according to the report.
Patients also experienced ataxia (7.4%), agitation (7.1%), confusion (6.1%), tremor (2%), and seizures (1.6%). Other common symptoms included tachycardia (11.4%), vomiting (9.5%), mydriasis (5.9%), and respiratory depression (3.1%).
Treatments for the exposures included intravenous fluids (20.7%), food or snacks (10.3%), and oxygen therapy (4%). Some patients also received naloxone (1.4%) or charcoal (2.1%).
“The total number of children requiring intubation during the study period was 35, or approximately 1 in 140,” the researchers reported. “Although this was a relatively rare occurrence, it is important for clinicians to be aware that life-threatening sequelae can develop and may necessitate invasive supportive care measures.”
Tempting and toxic
For toddlers, edible cannabis may be especially tempting and toxic. Edibles can “resemble common treats such as candies, chocolates, cookies, or other baked goods,” the researchers wrote. Children would not recognize, for example, that one chocolate bar might contain multiple 10-mg servings of tetrahydrocannabinol intended for adults.
Poison centers have been fielding more calls about edible cannabis use by older children, as well.
Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health and Science University, Portland, recently found that many cases of intentional misuse and abuse by adolescents involve edible forms of cannabis.
“While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products,” Dr. Hughes said in an interview.
Measures to keep edibles away from children could include changing how the products are packaged, limiting the maximum dose of drug per package, and educating the public about the risks to children, Dr. Tweet’s group wrote. They highlighted a 2019 position statement from the American College of Medical Toxicology that includes recommendations for responsible storage habits.
Dr. Hughes echoed one suggestion that is mentioned in the position statement: Parents should consider keeping their cannabis products locked up.
The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new analysis of data from poison control centers.
In 2017, centers received 207 reports of children aged 5 years and younger who ingested edible cannabis. In 2021, 3,054 such cases were reported, according to the study, which was published online in Pediatrics.
Many of the children experienced clinical effects, such as depression of the central nervous system, impaired coordination, confusion, agitation, an increase in heart rate, or dilated pupils. No deaths were reported.
“These exposures can cause significant toxicity and are responsible for an increasing number of hospitalizations,” study coauthor Marit S. Tweet, MD, of Southern Illinois University, Springfield, and colleagues wrote.
About 97% of the exposures occurred in residences – 90% at the child’s own home – and about half of the cases involved 2- and 3-year-olds, they noted.
Examining national trends
Twenty-one states have approved recreational cannabis for people aged 21 years and older.
Prior research has shown that calls to poison centers and visits to emergency departments for pediatric cannabis consumption increased in certain states after the drug became legal in those jurisdictions.
To assess national trends, Dr. Tweet’s group analyzed cases in the National Poison Data System, which tracks potentially toxic exposures reported to poison control centers in the United States.
During the 5-year period, they identified 7,043 exposures to edible cannabis by children younger than age 6. In 2.2% of the cases, the drug had a major effect, defined as being either life-threatening or causing residual disability. In 21.9% of cases, the effect was considered to be moderate, with symptoms that were more pronounced, prolonged, or systemic than minor effects.
About 8% of the children were admitted to critical care units; 14.6% were admitted to non–critical care units.
Of 4,827 cases for which there was information about the clinical effects of the exposure and therapies used, 70% involved CNS depression, including 1.9% with “more severe CNS effects, including major CNS depression or coma,” according to the report.
Patients also experienced ataxia (7.4%), agitation (7.1%), confusion (6.1%), tremor (2%), and seizures (1.6%). Other common symptoms included tachycardia (11.4%), vomiting (9.5%), mydriasis (5.9%), and respiratory depression (3.1%).
Treatments for the exposures included intravenous fluids (20.7%), food or snacks (10.3%), and oxygen therapy (4%). Some patients also received naloxone (1.4%) or charcoal (2.1%).
“The total number of children requiring intubation during the study period was 35, or approximately 1 in 140,” the researchers reported. “Although this was a relatively rare occurrence, it is important for clinicians to be aware that life-threatening sequelae can develop and may necessitate invasive supportive care measures.”
Tempting and toxic
For toddlers, edible cannabis may be especially tempting and toxic. Edibles can “resemble common treats such as candies, chocolates, cookies, or other baked goods,” the researchers wrote. Children would not recognize, for example, that one chocolate bar might contain multiple 10-mg servings of tetrahydrocannabinol intended for adults.
Poison centers have been fielding more calls about edible cannabis use by older children, as well.
Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health and Science University, Portland, recently found that many cases of intentional misuse and abuse by adolescents involve edible forms of cannabis.
“While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products,” Dr. Hughes said in an interview.
Measures to keep edibles away from children could include changing how the products are packaged, limiting the maximum dose of drug per package, and educating the public about the risks to children, Dr. Tweet’s group wrote. They highlighted a 2019 position statement from the American College of Medical Toxicology that includes recommendations for responsible storage habits.
Dr. Hughes echoed one suggestion that is mentioned in the position statement: Parents should consider keeping their cannabis products locked up.
The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new analysis of data from poison control centers.
In 2017, centers received 207 reports of children aged 5 years and younger who ingested edible cannabis. In 2021, 3,054 such cases were reported, according to the study, which was published online in Pediatrics.
Many of the children experienced clinical effects, such as depression of the central nervous system, impaired coordination, confusion, agitation, an increase in heart rate, or dilated pupils. No deaths were reported.
“These exposures can cause significant toxicity and are responsible for an increasing number of hospitalizations,” study coauthor Marit S. Tweet, MD, of Southern Illinois University, Springfield, and colleagues wrote.
About 97% of the exposures occurred in residences – 90% at the child’s own home – and about half of the cases involved 2- and 3-year-olds, they noted.
Examining national trends
Twenty-one states have approved recreational cannabis for people aged 21 years and older.
Prior research has shown that calls to poison centers and visits to emergency departments for pediatric cannabis consumption increased in certain states after the drug became legal in those jurisdictions.
To assess national trends, Dr. Tweet’s group analyzed cases in the National Poison Data System, which tracks potentially toxic exposures reported to poison control centers in the United States.
During the 5-year period, they identified 7,043 exposures to edible cannabis by children younger than age 6. In 2.2% of the cases, the drug had a major effect, defined as being either life-threatening or causing residual disability. In 21.9% of cases, the effect was considered to be moderate, with symptoms that were more pronounced, prolonged, or systemic than minor effects.
About 8% of the children were admitted to critical care units; 14.6% were admitted to non–critical care units.
Of 4,827 cases for which there was information about the clinical effects of the exposure and therapies used, 70% involved CNS depression, including 1.9% with “more severe CNS effects, including major CNS depression or coma,” according to the report.
Patients also experienced ataxia (7.4%), agitation (7.1%), confusion (6.1%), tremor (2%), and seizures (1.6%). Other common symptoms included tachycardia (11.4%), vomiting (9.5%), mydriasis (5.9%), and respiratory depression (3.1%).
Treatments for the exposures included intravenous fluids (20.7%), food or snacks (10.3%), and oxygen therapy (4%). Some patients also received naloxone (1.4%) or charcoal (2.1%).
“The total number of children requiring intubation during the study period was 35, or approximately 1 in 140,” the researchers reported. “Although this was a relatively rare occurrence, it is important for clinicians to be aware that life-threatening sequelae can develop and may necessitate invasive supportive care measures.”
Tempting and toxic
For toddlers, edible cannabis may be especially tempting and toxic. Edibles can “resemble common treats such as candies, chocolates, cookies, or other baked goods,” the researchers wrote. Children would not recognize, for example, that one chocolate bar might contain multiple 10-mg servings of tetrahydrocannabinol intended for adults.
Poison centers have been fielding more calls about edible cannabis use by older children, as well.
Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health and Science University, Portland, recently found that many cases of intentional misuse and abuse by adolescents involve edible forms of cannabis.
“While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products,” Dr. Hughes said in an interview.
Measures to keep edibles away from children could include changing how the products are packaged, limiting the maximum dose of drug per package, and educating the public about the risks to children, Dr. Tweet’s group wrote. They highlighted a 2019 position statement from the American College of Medical Toxicology that includes recommendations for responsible storage habits.
Dr. Hughes echoed one suggestion that is mentioned in the position statement: Parents should consider keeping their cannabis products locked up.
The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM PEDIATRICS
Study of beliefs about what causes cancer sparks debate
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
Top cardiology societies call for revamp of clinical trials
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Time for a rest
“More than Jews have kept Shabbat, Shabbat has kept the Jews.” – Ahad Ha’am
You should all be well rested by now. After all, we’ve just come through the festive shutdown of the holiday season where all of your pumpkin/peppermint/marshmallow flavored coffees were sipped while walking around in your jimjams at 10 a.m. It was the time of year for you to take time off to get a proper rest and be energized to get back to work. Yet, I’m not feeling it from you.
So let’s talk about burnout – just kidding, that would only make it worse. “Burned-out’’ is a hackneyed and defective phrase to describe what many of us are feeling. We are not “destroyed, gutted by fire or by overheating.” No, we are, as one of our docs put it to me: “Just tired.” Ah, a much better Old English word! “Tired” captures it. It means to feel “in need of rest.” We are not ruined, we are just depleted. We don’t need discarding. We need some rest.
I asked some docs when they thought this feeling of exhaustion first began. We agreed that the pandemic, doubledemic, tripledemic, backlog have taken a toll. But The consumerization of medicine? All factors, but not the beginning. No, the beginning was before paper charts. Well, actually it was before paper. We have to go back to the 5th or 6th century BCE. That is when scholars believe the book of Genesis originated from the Yahwist source. In it, it is written that the 7th day be set aside as a day of rest from labor. It is not written that burnout would ensue if sabbath wasn’t observed; however, if you failed to keep it, then you might have been killed. They took rest seriously back then.
This innovation of setting aside a day each week to rest, reflect, and worship was such a good idea that it was codified as one of the 10 commandments. It spread widely. Early Christians kept the Jewish tradition of observing Shabbat from Friday sundown to Saturday until the ever practical Romans decided that Sunday would be a better day. Sunday was already the day to worship the sun god. The newly-converted Christian Emperor Constantine issued an edict on March 7th, 321 CE that all “city people and craftsmen shall rest from labor upon the venerable day of the sun.” And so Sunday it was.
Protestant Seventh-day denomination churches later shifted sabbath back to Saturday believing that Sunday must have been the Pope’s idea. The best deal seems to have been around 1273 when the Ethiopian Orthodox leader Ewostatewos decreed that both Saturday AND Sunday would be days of rest. (But when would one go to Costco?!) In Islam, there is Jumu’ah on Friday. Buddhists have Uposatha, a day of rest and observance every 7 or 8 days. Bah’ai keep Friday as a day of rest and worship. So vital are days of respite to the health of our communities that the state has made working on certain days a violation of the law, “blue laws” they are called. We’ve had blue laws on the books since the time of the Jamestown Colony in 1619 where the first Virginia Assembly required taking Sunday off for worship. Most of these laws have been repealed, although a few states, such as Rhode Island, still have blue laws prohibiting retail and grocery stores from opening on Thanksgiving or Christmas. So there – enjoy your two days off this year!
Ironically, this column, like most of mine, comes to you after my having written it on a Saturday and Sunday. I also just logged on to my EMR and checked results, renewed a few prescriptions, and answered a couple messages. If I didn’t, my Monday’s work would be crushingly heavy.
Maybe I need to be more efficient and finish my work during the week. Or maybe I need to realize that work has not let up since about 600 BCE and taking one day off each week to rest is an obligation to myself, my family and my community.
I wonder if I can choose Mondays.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
“More than Jews have kept Shabbat, Shabbat has kept the Jews.” – Ahad Ha’am
You should all be well rested by now. After all, we’ve just come through the festive shutdown of the holiday season where all of your pumpkin/peppermint/marshmallow flavored coffees were sipped while walking around in your jimjams at 10 a.m. It was the time of year for you to take time off to get a proper rest and be energized to get back to work. Yet, I’m not feeling it from you.
So let’s talk about burnout – just kidding, that would only make it worse. “Burned-out’’ is a hackneyed and defective phrase to describe what many of us are feeling. We are not “destroyed, gutted by fire or by overheating.” No, we are, as one of our docs put it to me: “Just tired.” Ah, a much better Old English word! “Tired” captures it. It means to feel “in need of rest.” We are not ruined, we are just depleted. We don’t need discarding. We need some rest.
I asked some docs when they thought this feeling of exhaustion first began. We agreed that the pandemic, doubledemic, tripledemic, backlog have taken a toll. But The consumerization of medicine? All factors, but not the beginning. No, the beginning was before paper charts. Well, actually it was before paper. We have to go back to the 5th or 6th century BCE. That is when scholars believe the book of Genesis originated from the Yahwist source. In it, it is written that the 7th day be set aside as a day of rest from labor. It is not written that burnout would ensue if sabbath wasn’t observed; however, if you failed to keep it, then you might have been killed. They took rest seriously back then.
This innovation of setting aside a day each week to rest, reflect, and worship was such a good idea that it was codified as one of the 10 commandments. It spread widely. Early Christians kept the Jewish tradition of observing Shabbat from Friday sundown to Saturday until the ever practical Romans decided that Sunday would be a better day. Sunday was already the day to worship the sun god. The newly-converted Christian Emperor Constantine issued an edict on March 7th, 321 CE that all “city people and craftsmen shall rest from labor upon the venerable day of the sun.” And so Sunday it was.
Protestant Seventh-day denomination churches later shifted sabbath back to Saturday believing that Sunday must have been the Pope’s idea. The best deal seems to have been around 1273 when the Ethiopian Orthodox leader Ewostatewos decreed that both Saturday AND Sunday would be days of rest. (But when would one go to Costco?!) In Islam, there is Jumu’ah on Friday. Buddhists have Uposatha, a day of rest and observance every 7 or 8 days. Bah’ai keep Friday as a day of rest and worship. So vital are days of respite to the health of our communities that the state has made working on certain days a violation of the law, “blue laws” they are called. We’ve had blue laws on the books since the time of the Jamestown Colony in 1619 where the first Virginia Assembly required taking Sunday off for worship. Most of these laws have been repealed, although a few states, such as Rhode Island, still have blue laws prohibiting retail and grocery stores from opening on Thanksgiving or Christmas. So there – enjoy your two days off this year!
Ironically, this column, like most of mine, comes to you after my having written it on a Saturday and Sunday. I also just logged on to my EMR and checked results, renewed a few prescriptions, and answered a couple messages. If I didn’t, my Monday’s work would be crushingly heavy.
Maybe I need to be more efficient and finish my work during the week. Or maybe I need to realize that work has not let up since about 600 BCE and taking one day off each week to rest is an obligation to myself, my family and my community.
I wonder if I can choose Mondays.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
“More than Jews have kept Shabbat, Shabbat has kept the Jews.” – Ahad Ha’am
You should all be well rested by now. After all, we’ve just come through the festive shutdown of the holiday season where all of your pumpkin/peppermint/marshmallow flavored coffees were sipped while walking around in your jimjams at 10 a.m. It was the time of year for you to take time off to get a proper rest and be energized to get back to work. Yet, I’m not feeling it from you.
So let’s talk about burnout – just kidding, that would only make it worse. “Burned-out’’ is a hackneyed and defective phrase to describe what many of us are feeling. We are not “destroyed, gutted by fire or by overheating.” No, we are, as one of our docs put it to me: “Just tired.” Ah, a much better Old English word! “Tired” captures it. It means to feel “in need of rest.” We are not ruined, we are just depleted. We don’t need discarding. We need some rest.
I asked some docs when they thought this feeling of exhaustion first began. We agreed that the pandemic, doubledemic, tripledemic, backlog have taken a toll. But The consumerization of medicine? All factors, but not the beginning. No, the beginning was before paper charts. Well, actually it was before paper. We have to go back to the 5th or 6th century BCE. That is when scholars believe the book of Genesis originated from the Yahwist source. In it, it is written that the 7th day be set aside as a day of rest from labor. It is not written that burnout would ensue if sabbath wasn’t observed; however, if you failed to keep it, then you might have been killed. They took rest seriously back then.
This innovation of setting aside a day each week to rest, reflect, and worship was such a good idea that it was codified as one of the 10 commandments. It spread widely. Early Christians kept the Jewish tradition of observing Shabbat from Friday sundown to Saturday until the ever practical Romans decided that Sunday would be a better day. Sunday was already the day to worship the sun god. The newly-converted Christian Emperor Constantine issued an edict on March 7th, 321 CE that all “city people and craftsmen shall rest from labor upon the venerable day of the sun.” And so Sunday it was.
Protestant Seventh-day denomination churches later shifted sabbath back to Saturday believing that Sunday must have been the Pope’s idea. The best deal seems to have been around 1273 when the Ethiopian Orthodox leader Ewostatewos decreed that both Saturday AND Sunday would be days of rest. (But when would one go to Costco?!) In Islam, there is Jumu’ah on Friday. Buddhists have Uposatha, a day of rest and observance every 7 or 8 days. Bah’ai keep Friday as a day of rest and worship. So vital are days of respite to the health of our communities that the state has made working on certain days a violation of the law, “blue laws” they are called. We’ve had blue laws on the books since the time of the Jamestown Colony in 1619 where the first Virginia Assembly required taking Sunday off for worship. Most of these laws have been repealed, although a few states, such as Rhode Island, still have blue laws prohibiting retail and grocery stores from opening on Thanksgiving or Christmas. So there – enjoy your two days off this year!
Ironically, this column, like most of mine, comes to you after my having written it on a Saturday and Sunday. I also just logged on to my EMR and checked results, renewed a few prescriptions, and answered a couple messages. If I didn’t, my Monday’s work would be crushingly heavy.
Maybe I need to be more efficient and finish my work during the week. Or maybe I need to realize that work has not let up since about 600 BCE and taking one day off each week to rest is an obligation to myself, my family and my community.
I wonder if I can choose Mondays.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Nursing exam failure rates spark review of test results
Nursing oversight groups in the United States and Canada are holding the line on testing standards as more would-be nurses fail entry exams. As a result, pressure is growing to make tests easier to pass given widespread nursing shortages, and some critics wonder whether the exams accurately assess students’ true abilities.
When it comes to training more nurses to keep up with growing demand, the U.S. organization that oversees the main licensing exams for nurses decided earlier this month not to change the passing standards for entry-level tests. Meanwhile,
A similar scenario also is unfolding in Quebec, where the agency overseeing nurse licensing exams announced last month it is holding the line on its passing rates despite an outcry from nurses after more than half of those taking the exam in September failed. Quebec’s commissioner for professional admissions is investigating dozens of complaints from nurses about the failure rate. Nurses who failed the test can sign up to retake it in March.
Joseph Oujeil, DESS, DEF, has been teaching in Canada for 4 years, now at two Quebec nursing schools. “This is surprising and very shocking to our students as well as nurses from outside Quebec who were [completing] an integration program to adjust their practice to Quebec guidelines,” Mr. Oujeil told this news organization. Students from outside the province failed the licensing exam at a higher rate than their Quebec-native peers, he explained.
Quebec’s professional Order of Nurses of Quebec (OIIQ) responded to the nurses’ outcry in a press release last month, saying that the pandemic may be partly to blame for the lower passing rate because it made it more difficult to access internships, labs, and face-to-face teaching. Some students weren’t able to demonstrate their ability to practice during the exam as in previous years, OIIQ reported.
Mr. Oujeil agreed. “I’m sure the pandemic has an impact on the situation as well as some students did less training in hospitals” because of restrictions caused by the pandemic, he said. But students also told Mr. Oujeil some questions seemed ambiguous.
OIIQ stated in its release that it doesn’t want to lower the standard. The goal is to protect the public “by and with nurses,” to “ensure the competence and integrity of nurses in Quebec,” and “promote quality nursing practice,” the release noted.
Similarly in the United States, the National Council of State Boards of Nursing (NCSBN) announced Dec. 8 that it would uphold the current passing standards for its entry-level NCLEX tests for registered nurses and practical nurses. NCSBN analyzes the passing standard every 3 years “to keep the test plan and passing standard current,” a press release explains.
NCLEX pass rates have dropped from about 73% for all candidates and 88% for first-time U.S.-educated candidates to 69% and 82% respectively in 2021, the last full year for which results are available, NCSBN spokesperson Dawn Kappel told this news organization.
Over the past 3 years, including during the pandemic, the board decided “that the current passing standard is appropriate as a measure of safe and effective entry-level nurse practice,” after reviewing national nurse surveys and the findings of panels of nurses representing NCSBN’s geographic areas in the United States and Canada, board president Jay Douglas, MSM, RN, CSAC, said in a press release.
Still, NCSBN is not blind to the larger issues facing nursing, Ms. Kappel told this news organization. “There is a huge nursing shortage in the U.S. and Canada. We want as many nurses in the workforce as possible, but we want to ensure safe practice,” she said.
“Everyone has access to the same test, regardless of which state, province, or country they take it in,” she said. Some international students may not perform as well as U.S.-educated students because of their command of English and the nursing education standards in their home countries, Ms. Kappel added.
“Obviously COVID and the challenge of education in general” affected the results, she said.
Mr. Oujeil, the nursing school professor, said he is frustrated by the test results because the majority of students who failed maintained good grades and passed all of their trainings. Yet they scored just below the passing rate of 55%. He said students are proposing the passing rate be lowered to 50%. The current test doesn’t reflect what students are learning in the classroom or during clinical trainings, Mr. Oujeil added. “I don’t know of any students who scored more than 60%.”
He said he understands that the mission of the OIIQ is protecting the population, but he doesn’t believe lowering the passing rate to 50% will put the population at risk – and it will help offset the staffing shortage.
“I’m especially frustrated by those who were doing integration programs – mothers and fathers with children with family lives and financial responsibilities. Many of them are good, hard workers and were shocked they should have to pass the exam another time.”
Since 2018, the pass rate on the first attempt at the Quebec test has generally been between 71% and 96%, compared with 51.4% during the exam in September, according to the OIIQ press release. Meanwhile, graduates from 30 of the 55 schools and universities in Quebec teaching nurses performed above the average on the recent professional exam, OIIQ reported.
The professional licensing organization pointed out that nursing candidates have three attempts to pass their exam. “In order to better prepare for their next attempt, all those who failed received an individual response detailing the difficulties encountered. The OIIQ offers all the tools necessary to pass the exam; a detailed guide and preparatory workshops are available online.
“In the run up to the next exams, we will continue to support students by working with educational institutions to provide the optimal conditions for passing the exam. This exam is usually successful and we are convinced that the return to face-to-face teaching, as well as support for students, will be factors of success,” OIIQ President Luc Mathieu said in a press release.
Nursing candidates “who have not passed the exam will be put to work in the network, with the possibility of practicing under the supervision of a nurse. ... In addition, we will contact health establishments in order to support them in their supervision activities” of the candidates, he said.
A version of this article first appeared on Medscape.com.
Nursing oversight groups in the United States and Canada are holding the line on testing standards as more would-be nurses fail entry exams. As a result, pressure is growing to make tests easier to pass given widespread nursing shortages, and some critics wonder whether the exams accurately assess students’ true abilities.
When it comes to training more nurses to keep up with growing demand, the U.S. organization that oversees the main licensing exams for nurses decided earlier this month not to change the passing standards for entry-level tests. Meanwhile,
A similar scenario also is unfolding in Quebec, where the agency overseeing nurse licensing exams announced last month it is holding the line on its passing rates despite an outcry from nurses after more than half of those taking the exam in September failed. Quebec’s commissioner for professional admissions is investigating dozens of complaints from nurses about the failure rate. Nurses who failed the test can sign up to retake it in March.
Joseph Oujeil, DESS, DEF, has been teaching in Canada for 4 years, now at two Quebec nursing schools. “This is surprising and very shocking to our students as well as nurses from outside Quebec who were [completing] an integration program to adjust their practice to Quebec guidelines,” Mr. Oujeil told this news organization. Students from outside the province failed the licensing exam at a higher rate than their Quebec-native peers, he explained.
Quebec’s professional Order of Nurses of Quebec (OIIQ) responded to the nurses’ outcry in a press release last month, saying that the pandemic may be partly to blame for the lower passing rate because it made it more difficult to access internships, labs, and face-to-face teaching. Some students weren’t able to demonstrate their ability to practice during the exam as in previous years, OIIQ reported.
Mr. Oujeil agreed. “I’m sure the pandemic has an impact on the situation as well as some students did less training in hospitals” because of restrictions caused by the pandemic, he said. But students also told Mr. Oujeil some questions seemed ambiguous.
OIIQ stated in its release that it doesn’t want to lower the standard. The goal is to protect the public “by and with nurses,” to “ensure the competence and integrity of nurses in Quebec,” and “promote quality nursing practice,” the release noted.
Similarly in the United States, the National Council of State Boards of Nursing (NCSBN) announced Dec. 8 that it would uphold the current passing standards for its entry-level NCLEX tests for registered nurses and practical nurses. NCSBN analyzes the passing standard every 3 years “to keep the test plan and passing standard current,” a press release explains.
NCLEX pass rates have dropped from about 73% for all candidates and 88% for first-time U.S.-educated candidates to 69% and 82% respectively in 2021, the last full year for which results are available, NCSBN spokesperson Dawn Kappel told this news organization.
Over the past 3 years, including during the pandemic, the board decided “that the current passing standard is appropriate as a measure of safe and effective entry-level nurse practice,” after reviewing national nurse surveys and the findings of panels of nurses representing NCSBN’s geographic areas in the United States and Canada, board president Jay Douglas, MSM, RN, CSAC, said in a press release.
Still, NCSBN is not blind to the larger issues facing nursing, Ms. Kappel told this news organization. “There is a huge nursing shortage in the U.S. and Canada. We want as many nurses in the workforce as possible, but we want to ensure safe practice,” she said.
“Everyone has access to the same test, regardless of which state, province, or country they take it in,” she said. Some international students may not perform as well as U.S.-educated students because of their command of English and the nursing education standards in their home countries, Ms. Kappel added.
“Obviously COVID and the challenge of education in general” affected the results, she said.
Mr. Oujeil, the nursing school professor, said he is frustrated by the test results because the majority of students who failed maintained good grades and passed all of their trainings. Yet they scored just below the passing rate of 55%. He said students are proposing the passing rate be lowered to 50%. The current test doesn’t reflect what students are learning in the classroom or during clinical trainings, Mr. Oujeil added. “I don’t know of any students who scored more than 60%.”
He said he understands that the mission of the OIIQ is protecting the population, but he doesn’t believe lowering the passing rate to 50% will put the population at risk – and it will help offset the staffing shortage.
“I’m especially frustrated by those who were doing integration programs – mothers and fathers with children with family lives and financial responsibilities. Many of them are good, hard workers and were shocked they should have to pass the exam another time.”
Since 2018, the pass rate on the first attempt at the Quebec test has generally been between 71% and 96%, compared with 51.4% during the exam in September, according to the OIIQ press release. Meanwhile, graduates from 30 of the 55 schools and universities in Quebec teaching nurses performed above the average on the recent professional exam, OIIQ reported.
The professional licensing organization pointed out that nursing candidates have three attempts to pass their exam. “In order to better prepare for their next attempt, all those who failed received an individual response detailing the difficulties encountered. The OIIQ offers all the tools necessary to pass the exam; a detailed guide and preparatory workshops are available online.
“In the run up to the next exams, we will continue to support students by working with educational institutions to provide the optimal conditions for passing the exam. This exam is usually successful and we are convinced that the return to face-to-face teaching, as well as support for students, will be factors of success,” OIIQ President Luc Mathieu said in a press release.
Nursing candidates “who have not passed the exam will be put to work in the network, with the possibility of practicing under the supervision of a nurse. ... In addition, we will contact health establishments in order to support them in their supervision activities” of the candidates, he said.
A version of this article first appeared on Medscape.com.
Nursing oversight groups in the United States and Canada are holding the line on testing standards as more would-be nurses fail entry exams. As a result, pressure is growing to make tests easier to pass given widespread nursing shortages, and some critics wonder whether the exams accurately assess students’ true abilities.
When it comes to training more nurses to keep up with growing demand, the U.S. organization that oversees the main licensing exams for nurses decided earlier this month not to change the passing standards for entry-level tests. Meanwhile,
A similar scenario also is unfolding in Quebec, where the agency overseeing nurse licensing exams announced last month it is holding the line on its passing rates despite an outcry from nurses after more than half of those taking the exam in September failed. Quebec’s commissioner for professional admissions is investigating dozens of complaints from nurses about the failure rate. Nurses who failed the test can sign up to retake it in March.
Joseph Oujeil, DESS, DEF, has been teaching in Canada for 4 years, now at two Quebec nursing schools. “This is surprising and very shocking to our students as well as nurses from outside Quebec who were [completing] an integration program to adjust their practice to Quebec guidelines,” Mr. Oujeil told this news organization. Students from outside the province failed the licensing exam at a higher rate than their Quebec-native peers, he explained.
Quebec’s professional Order of Nurses of Quebec (OIIQ) responded to the nurses’ outcry in a press release last month, saying that the pandemic may be partly to blame for the lower passing rate because it made it more difficult to access internships, labs, and face-to-face teaching. Some students weren’t able to demonstrate their ability to practice during the exam as in previous years, OIIQ reported.
Mr. Oujeil agreed. “I’m sure the pandemic has an impact on the situation as well as some students did less training in hospitals” because of restrictions caused by the pandemic, he said. But students also told Mr. Oujeil some questions seemed ambiguous.
OIIQ stated in its release that it doesn’t want to lower the standard. The goal is to protect the public “by and with nurses,” to “ensure the competence and integrity of nurses in Quebec,” and “promote quality nursing practice,” the release noted.
Similarly in the United States, the National Council of State Boards of Nursing (NCSBN) announced Dec. 8 that it would uphold the current passing standards for its entry-level NCLEX tests for registered nurses and practical nurses. NCSBN analyzes the passing standard every 3 years “to keep the test plan and passing standard current,” a press release explains.
NCLEX pass rates have dropped from about 73% for all candidates and 88% for first-time U.S.-educated candidates to 69% and 82% respectively in 2021, the last full year for which results are available, NCSBN spokesperson Dawn Kappel told this news organization.
Over the past 3 years, including during the pandemic, the board decided “that the current passing standard is appropriate as a measure of safe and effective entry-level nurse practice,” after reviewing national nurse surveys and the findings of panels of nurses representing NCSBN’s geographic areas in the United States and Canada, board president Jay Douglas, MSM, RN, CSAC, said in a press release.
Still, NCSBN is not blind to the larger issues facing nursing, Ms. Kappel told this news organization. “There is a huge nursing shortage in the U.S. and Canada. We want as many nurses in the workforce as possible, but we want to ensure safe practice,” she said.
“Everyone has access to the same test, regardless of which state, province, or country they take it in,” she said. Some international students may not perform as well as U.S.-educated students because of their command of English and the nursing education standards in their home countries, Ms. Kappel added.
“Obviously COVID and the challenge of education in general” affected the results, she said.
Mr. Oujeil, the nursing school professor, said he is frustrated by the test results because the majority of students who failed maintained good grades and passed all of their trainings. Yet they scored just below the passing rate of 55%. He said students are proposing the passing rate be lowered to 50%. The current test doesn’t reflect what students are learning in the classroom or during clinical trainings, Mr. Oujeil added. “I don’t know of any students who scored more than 60%.”
He said he understands that the mission of the OIIQ is protecting the population, but he doesn’t believe lowering the passing rate to 50% will put the population at risk – and it will help offset the staffing shortage.
“I’m especially frustrated by those who were doing integration programs – mothers and fathers with children with family lives and financial responsibilities. Many of them are good, hard workers and were shocked they should have to pass the exam another time.”
Since 2018, the pass rate on the first attempt at the Quebec test has generally been between 71% and 96%, compared with 51.4% during the exam in September, according to the OIIQ press release. Meanwhile, graduates from 30 of the 55 schools and universities in Quebec teaching nurses performed above the average on the recent professional exam, OIIQ reported.
The professional licensing organization pointed out that nursing candidates have three attempts to pass their exam. “In order to better prepare for their next attempt, all those who failed received an individual response detailing the difficulties encountered. The OIIQ offers all the tools necessary to pass the exam; a detailed guide and preparatory workshops are available online.
“In the run up to the next exams, we will continue to support students by working with educational institutions to provide the optimal conditions for passing the exam. This exam is usually successful and we are convinced that the return to face-to-face teaching, as well as support for students, will be factors of success,” OIIQ President Luc Mathieu said in a press release.
Nursing candidates “who have not passed the exam will be put to work in the network, with the possibility of practicing under the supervision of a nurse. ... In addition, we will contact health establishments in order to support them in their supervision activities” of the candidates, he said.
A version of this article first appeared on Medscape.com.
Medicare pay cuts partly averted in massive budget bill
Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.
The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.
The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.
Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.
These reductions will hit as many clinicians face the toll on rising costs for running their practices, as , the AMA said.
“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.
While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.
“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
New health care policies in omnibus
Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.
House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:
- Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
- Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
- Guarantee 12 months of continuous Medicaid coverage for 40 million children
- Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
- Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
- Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.
FDA’s accelerated approval
The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.
The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.
Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.
Mr. Pallone said the omnibus contains provisions that:
- Require the FDA to specify conditions for required post-approval studies
- Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
- Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.
Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.
The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.
Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.
“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.
A version of this article first appeared on Medscape.com.
Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.
The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.
The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.
Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.
These reductions will hit as many clinicians face the toll on rising costs for running their practices, as , the AMA said.
“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.
While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.
“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
New health care policies in omnibus
Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.
House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:
- Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
- Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
- Guarantee 12 months of continuous Medicaid coverage for 40 million children
- Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
- Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
- Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.
FDA’s accelerated approval
The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.
The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.
Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.
Mr. Pallone said the omnibus contains provisions that:
- Require the FDA to specify conditions for required post-approval studies
- Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
- Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.
Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.
The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.
Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.
“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.
A version of this article first appeared on Medscape.com.
Congress averted bigger reductions in Medicare’s future payments for clinicians in its massive, year-end spending bill, but physicians will still see a 2% cut in a key payment variable in 2023.
The bill also authorizes new policies regarding accelerated drug approvals and substance use disorder treatment.
The House voted 225-201 to clear a wide-ranging legislative package, known as an omnibus, for President Joe Biden’s signature. The Senate voted 68-29 to approve the measure.
Clinicians had been facing as much as 8.5% in cuts to certain factors that set their Medicare payment. The American Medical Association credited an advocacy campaign it joined with more than 150 organizations with fending off the much-feared reimbursement cuts. The 2% trim for 2023 will decline to 1.25% for 2024.
These reductions will hit as many clinicians face the toll on rising costs for running their practices, as , the AMA said.
“Congress must immediately begin the work of long-overdue Medicare physician payment reform that will lead to the program stability that beneficiaries and physicians need,” AMA President Jack Resneck, MD, said in a statement.
While the omnibus bill blocks 6.5% of Medicare payment cuts originally slated to take effect in 2023, it still puts “untenable strain” on primary care clinicians, said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians, in a statement.
“However, we’re pleased to see several provisions that will improve access to care, including bolstering mental health services, extending telehealth, and expanding Medicaid and CHIP coverage,” Dr. Iroku-Malize added.
New health care policies in omnibus
Lawmakers adopted many health care policy changes in the omnibus package, which contained 12 overdue spending bills for fiscal year 2023. (Much of the federal government has been funded through stop-gap measures since this budget year began on Oct. 1.) The final measure runs to more than 4,100 pages in PDF form.
House Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said the health care provisions will:
- Expand patient access to opioid addiction treatment by making it easier for clinicians to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment
- Require health care providers to complete a training requirement on identifying and treating patients with substance use disorders
- Guarantee 12 months of continuous Medicaid coverage for 40 million children
- Provide 2 years of additional Children’s Health Insurance Program (CHIP) funding
- Permanently extend the option for states to offer 12 months of Medicaid coverage to new mothers
- Continue Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities through Dec. 31, 2024.
FDA’s accelerated approval
The omnibus also will shorten the period of uncertainty patients and clinicians face with medicines cleared under the accelerated approval pathway.
The Food and Drug Administration uses accelerated approvals to give conditional clearances to medicines for fatal and serious conditions based on limited evidence signaling a potential benefit. Companies are expected to continue research needed to prove whether promising signals, such as stemming tumor growth, benefits patients.
Concerns have mounted when companies delay confirmatory trials or try to maintain accelerated approvals for drugs that fail those trials.
Mr. Pallone said the omnibus contains provisions that:
- Require the FDA to specify conditions for required post-approval studies
- Authorize the FDA to require post-approval studies to be underway at the time of approval or within a specified time period following approval.
- Clarify and streamline current FDA authority to withdraw approvals when sponsors fail to conduct studies with due diligence.
Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the Doctors for America’s FDA Task Force, told this news organization that she was pleased to see these provisions pass. She had been disappointed they were not included earlier this year in the latest Prescription Drug User Fee Act reauthorization.
The provisions in the omnibus make “clear what steps the FDA can take to remove an unproven drug off the market should manufacturers fail to complete these studies or demonstrate meaningful clinical benefit,” Dr. Ramachandran wrote in an email.
Dr. Ramachandran said she hopes lawmakers build on these steps in the future. She suggested Congress add a mandate to require drug labels to clearly state when the FDA is still waiting for evidence needed to confirm benefits of medicines cleared by accelerated approval.
“Nevertheless, Congress in including and, hopefully, passing these reforms has made it clear that drug companies need to provide meaningful evidence that their accelerated approval drugs work in patients and FDA can take action to protect patients should this not occur,” Dr. Ramachandran wrote.
A version of this article first appeared on Medscape.com.
Problematic alcohol use on the rise among physicians?
However, good data on exactly how common this is and on salient risk factors are lacking.
In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.
However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.
“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.
The findings were published online in JAMA Network Open.
Serious concern
The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.
Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.
To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.
In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.
“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.
Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.
The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
True prevalence unknown
“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.
The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.
True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.
They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.
The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.
The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
However, good data on exactly how common this is and on salient risk factors are lacking.
In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.
However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.
“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.
The findings were published online in JAMA Network Open.
Serious concern
The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.
Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.
To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.
In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.
“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.
Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.
The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
True prevalence unknown
“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.
The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.
True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.
They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.
The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.
The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
However, good data on exactly how common this is and on salient risk factors are lacking.
In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.
However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.
“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.
The findings were published online in JAMA Network Open.
Serious concern
The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.
Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.
To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.
In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.
“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.
Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.
The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
True prevalence unknown
“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.
The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.
True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.
They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.
The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.
The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Alzheimer’s Association to CMS: Ditch restraints on amyloid drugs
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.
Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.
The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.
The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.
“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
‘No time to waste’
“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.
“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.
The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.
A version of this article first appeared on Medscape.com.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.
Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.
The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.
The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.
“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
‘No time to waste’
“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.
“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.
The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.
A version of this article first appeared on Medscape.com.
In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.
Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.
The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.
The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.
“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
‘No time to waste’
“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.
“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.
The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.
“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.
A version of this article first appeared on Medscape.com.