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OTC cannabidiol products tied to improved pain, sleep, anxiety
Interim findings from Advancing CBD Education and Science, a 100% virtual, open label, randomized, controlled trial, show study participants experienced various degrees of “clinically meaningful” improvements in sleep quality, anxiety, and pain.
“ACES is the largest clinical trial ever conducted on commercially available CBD products and provides first-of-its-kind real world evidence into what conditions users may experience benefit from CBD usage, whether these benefits are clinically meaningful, what attributes of CBD products may impact health outcomes, and what side effects may occur,” study coinvestigator Jessica Saleska, PhD, MPH, director of research at Radicle Science, the company that conducted the study, told this news organization.
Scant evidence
Despite the growing market size of commercially available CBD products “there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed, and scale limitations of the current approach to scientific research,” Jeff Chen, MD, MBA, cofounder and CEO of Radicle Science, told this news organization.
One of the study’s goals, said Ethan Russo, MD, a neurologist, founder/CEO of CReDO Science, and scientific adviser for Radicle, is to help consumers make informed decisions before purchasing and using commercially available oral CBD products.
Designed to eliminate all physical infrastructure, which minimizes costs and facilitates faster execution, ACES was conducted much like a phase 4 clinical trial, collating real-world data gathered over 4 weeks.
“The process that Radicle scientists [have] advanced is sort of a crowdsourcing approach to doing clinical science,” Dr. Russo said. “Hopefully, there is going to be a considerable amount of data generated that [will] affect people’s buying options.”
The study also aimed to evaluate product attributes, including composition, mode of use, dosage, dosage timing and frequency, and their correlation to degrees of outcomes.
Dr. Russo explained why product composition is an important factor, especially when dealing with CBD. “What happens with any given [CBD] preparation is going to be totally a function of other components, if any.
“For example, there’s this mistaken notion that cannabidiol is sedating; it is not. Pure cannabidiol is stimulating in low and moderate amounts. Where the confusion has arisen is that the early chemovars containing cannabidiol were also predominant in myrcene, the sedating terpene, [thereby] creating this misimpression that it is good for sleep,” he added.
However, CBD might also affect sleep by reducing anxiety that interferes with it. “What’s clear is that cannabidiol is an antianxiety agent, if you have a sufficient dose,” Dr. Russo said.
The 4-week study included 2,704 participants aged 21 years and older, self-reporting anxiety, chronic pain, or sleep disturbances as a primary reason for taking CBD. Study participants were randomly assigned to receive 1 of 13 commercially available oral CBD extracts.
Participants were allocated to 1 of 14 cohorts, comprising 13 treatment groups with 208 participants each who received a single CBD product, or a wait-list control group of 296 participants who received product at the study’s end.
The primary outcome focused on “clinically meaningful” changes, which were defined as “distinct and palpable improvements in quality of life through improvements in respective health outcomes.”
Secondary outcomes included changes in sleep, anxiety, and pain based on several validated indices, including the PROMIS (Patient-Reported Outcome Measurement Information System) Sleep Short Form; the PROMIS Anxiety Scale; the Patient Global Impression of Change; the Pain, Enjoyment, General Activity scale; and the General Anxiety Disorder–7 scale.
The interim study results are promising, with participants reporting, on average, a 71% improvement in well-being. Additionally, 63% reported clinically meaningful improvements in anxiety, and 61% in sleep quality. The CBD products provided smaller benefits in pain management, with less than half (47%) experiencing meaningful improvements.
In addition to improvement in sleep, pain, and anxiety, these data highlight how rapidly benefits occurred; most were realized during the first week of the study, with up to 61% of treatment group participants reporting a therapeutic effect within 1-4 hours of taking their assigned product.
Overcoming the placebo effect
Commenting on the research, Justin Strickland, PhD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, who was not involved in the research, said without knowing a lot about the pharmacology of the products being tested, early dramatic improvements in these measures, such as sleep impairment, are common.
“There are some data to suggest that there is an expectancy effect when we talk about the therapeutic benefit of cannabinoid products, (i.e., when someone has the expectation that they are going to experience a stronger effect) but this is true of any drug in an open label trial,” Dr. Strickland added.
Dr. Russo took the point a step further. “It’s getting near impossible to look at cannabinoid compounds, even with randomized, controlled trials because of the burgeoning placebo responses. When you couple it with the fact that consumers have the mistaken notion that cannabis-based drugs are miraculous, the expectations are so high that everyone thinks that they’re on the real stuff, even if it’s a placebo group.”
Still, both Dr. Strickland and Dr. Russo highlighted the fact that ACES mirrors real-world experience, which will they hope will inform the use of CBD and CBD-based preparations moving forward. By removing certain barriers like institutional bureaucracy or federal funding restrictions inherent to more traditional randomized controlled trial design, ACES might provide data that bridge the gap between efficacy and effectiveness.
ACES was funded by Radicle Science. Dr. Chen is cofounder and CEO of Radicle Science. Dr. Russo and Dr. Strickland disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Interim findings from Advancing CBD Education and Science, a 100% virtual, open label, randomized, controlled trial, show study participants experienced various degrees of “clinically meaningful” improvements in sleep quality, anxiety, and pain.
“ACES is the largest clinical trial ever conducted on commercially available CBD products and provides first-of-its-kind real world evidence into what conditions users may experience benefit from CBD usage, whether these benefits are clinically meaningful, what attributes of CBD products may impact health outcomes, and what side effects may occur,” study coinvestigator Jessica Saleska, PhD, MPH, director of research at Radicle Science, the company that conducted the study, told this news organization.
Scant evidence
Despite the growing market size of commercially available CBD products “there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed, and scale limitations of the current approach to scientific research,” Jeff Chen, MD, MBA, cofounder and CEO of Radicle Science, told this news organization.
One of the study’s goals, said Ethan Russo, MD, a neurologist, founder/CEO of CReDO Science, and scientific adviser for Radicle, is to help consumers make informed decisions before purchasing and using commercially available oral CBD products.
Designed to eliminate all physical infrastructure, which minimizes costs and facilitates faster execution, ACES was conducted much like a phase 4 clinical trial, collating real-world data gathered over 4 weeks.
“The process that Radicle scientists [have] advanced is sort of a crowdsourcing approach to doing clinical science,” Dr. Russo said. “Hopefully, there is going to be a considerable amount of data generated that [will] affect people’s buying options.”
The study also aimed to evaluate product attributes, including composition, mode of use, dosage, dosage timing and frequency, and their correlation to degrees of outcomes.
Dr. Russo explained why product composition is an important factor, especially when dealing with CBD. “What happens with any given [CBD] preparation is going to be totally a function of other components, if any.
“For example, there’s this mistaken notion that cannabidiol is sedating; it is not. Pure cannabidiol is stimulating in low and moderate amounts. Where the confusion has arisen is that the early chemovars containing cannabidiol were also predominant in myrcene, the sedating terpene, [thereby] creating this misimpression that it is good for sleep,” he added.
However, CBD might also affect sleep by reducing anxiety that interferes with it. “What’s clear is that cannabidiol is an antianxiety agent, if you have a sufficient dose,” Dr. Russo said.
The 4-week study included 2,704 participants aged 21 years and older, self-reporting anxiety, chronic pain, or sleep disturbances as a primary reason for taking CBD. Study participants were randomly assigned to receive 1 of 13 commercially available oral CBD extracts.
Participants were allocated to 1 of 14 cohorts, comprising 13 treatment groups with 208 participants each who received a single CBD product, or a wait-list control group of 296 participants who received product at the study’s end.
The primary outcome focused on “clinically meaningful” changes, which were defined as “distinct and palpable improvements in quality of life through improvements in respective health outcomes.”
Secondary outcomes included changes in sleep, anxiety, and pain based on several validated indices, including the PROMIS (Patient-Reported Outcome Measurement Information System) Sleep Short Form; the PROMIS Anxiety Scale; the Patient Global Impression of Change; the Pain, Enjoyment, General Activity scale; and the General Anxiety Disorder–7 scale.
The interim study results are promising, with participants reporting, on average, a 71% improvement in well-being. Additionally, 63% reported clinically meaningful improvements in anxiety, and 61% in sleep quality. The CBD products provided smaller benefits in pain management, with less than half (47%) experiencing meaningful improvements.
In addition to improvement in sleep, pain, and anxiety, these data highlight how rapidly benefits occurred; most were realized during the first week of the study, with up to 61% of treatment group participants reporting a therapeutic effect within 1-4 hours of taking their assigned product.
Overcoming the placebo effect
Commenting on the research, Justin Strickland, PhD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, who was not involved in the research, said without knowing a lot about the pharmacology of the products being tested, early dramatic improvements in these measures, such as sleep impairment, are common.
“There are some data to suggest that there is an expectancy effect when we talk about the therapeutic benefit of cannabinoid products, (i.e., when someone has the expectation that they are going to experience a stronger effect) but this is true of any drug in an open label trial,” Dr. Strickland added.
Dr. Russo took the point a step further. “It’s getting near impossible to look at cannabinoid compounds, even with randomized, controlled trials because of the burgeoning placebo responses. When you couple it with the fact that consumers have the mistaken notion that cannabis-based drugs are miraculous, the expectations are so high that everyone thinks that they’re on the real stuff, even if it’s a placebo group.”
Still, both Dr. Strickland and Dr. Russo highlighted the fact that ACES mirrors real-world experience, which will they hope will inform the use of CBD and CBD-based preparations moving forward. By removing certain barriers like institutional bureaucracy or federal funding restrictions inherent to more traditional randomized controlled trial design, ACES might provide data that bridge the gap between efficacy and effectiveness.
ACES was funded by Radicle Science. Dr. Chen is cofounder and CEO of Radicle Science. Dr. Russo and Dr. Strickland disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Interim findings from Advancing CBD Education and Science, a 100% virtual, open label, randomized, controlled trial, show study participants experienced various degrees of “clinically meaningful” improvements in sleep quality, anxiety, and pain.
“ACES is the largest clinical trial ever conducted on commercially available CBD products and provides first-of-its-kind real world evidence into what conditions users may experience benefit from CBD usage, whether these benefits are clinically meaningful, what attributes of CBD products may impact health outcomes, and what side effects may occur,” study coinvestigator Jessica Saleska, PhD, MPH, director of research at Radicle Science, the company that conducted the study, told this news organization.
Scant evidence
Despite the growing market size of commercially available CBD products “there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed, and scale limitations of the current approach to scientific research,” Jeff Chen, MD, MBA, cofounder and CEO of Radicle Science, told this news organization.
One of the study’s goals, said Ethan Russo, MD, a neurologist, founder/CEO of CReDO Science, and scientific adviser for Radicle, is to help consumers make informed decisions before purchasing and using commercially available oral CBD products.
Designed to eliminate all physical infrastructure, which minimizes costs and facilitates faster execution, ACES was conducted much like a phase 4 clinical trial, collating real-world data gathered over 4 weeks.
“The process that Radicle scientists [have] advanced is sort of a crowdsourcing approach to doing clinical science,” Dr. Russo said. “Hopefully, there is going to be a considerable amount of data generated that [will] affect people’s buying options.”
The study also aimed to evaluate product attributes, including composition, mode of use, dosage, dosage timing and frequency, and their correlation to degrees of outcomes.
Dr. Russo explained why product composition is an important factor, especially when dealing with CBD. “What happens with any given [CBD] preparation is going to be totally a function of other components, if any.
“For example, there’s this mistaken notion that cannabidiol is sedating; it is not. Pure cannabidiol is stimulating in low and moderate amounts. Where the confusion has arisen is that the early chemovars containing cannabidiol were also predominant in myrcene, the sedating terpene, [thereby] creating this misimpression that it is good for sleep,” he added.
However, CBD might also affect sleep by reducing anxiety that interferes with it. “What’s clear is that cannabidiol is an antianxiety agent, if you have a sufficient dose,” Dr. Russo said.
The 4-week study included 2,704 participants aged 21 years and older, self-reporting anxiety, chronic pain, or sleep disturbances as a primary reason for taking CBD. Study participants were randomly assigned to receive 1 of 13 commercially available oral CBD extracts.
Participants were allocated to 1 of 14 cohorts, comprising 13 treatment groups with 208 participants each who received a single CBD product, or a wait-list control group of 296 participants who received product at the study’s end.
The primary outcome focused on “clinically meaningful” changes, which were defined as “distinct and palpable improvements in quality of life through improvements in respective health outcomes.”
Secondary outcomes included changes in sleep, anxiety, and pain based on several validated indices, including the PROMIS (Patient-Reported Outcome Measurement Information System) Sleep Short Form; the PROMIS Anxiety Scale; the Patient Global Impression of Change; the Pain, Enjoyment, General Activity scale; and the General Anxiety Disorder–7 scale.
The interim study results are promising, with participants reporting, on average, a 71% improvement in well-being. Additionally, 63% reported clinically meaningful improvements in anxiety, and 61% in sleep quality. The CBD products provided smaller benefits in pain management, with less than half (47%) experiencing meaningful improvements.
In addition to improvement in sleep, pain, and anxiety, these data highlight how rapidly benefits occurred; most were realized during the first week of the study, with up to 61% of treatment group participants reporting a therapeutic effect within 1-4 hours of taking their assigned product.
Overcoming the placebo effect
Commenting on the research, Justin Strickland, PhD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, who was not involved in the research, said without knowing a lot about the pharmacology of the products being tested, early dramatic improvements in these measures, such as sleep impairment, are common.
“There are some data to suggest that there is an expectancy effect when we talk about the therapeutic benefit of cannabinoid products, (i.e., when someone has the expectation that they are going to experience a stronger effect) but this is true of any drug in an open label trial,” Dr. Strickland added.
Dr. Russo took the point a step further. “It’s getting near impossible to look at cannabinoid compounds, even with randomized, controlled trials because of the burgeoning placebo responses. When you couple it with the fact that consumers have the mistaken notion that cannabis-based drugs are miraculous, the expectations are so high that everyone thinks that they’re on the real stuff, even if it’s a placebo group.”
Still, both Dr. Strickland and Dr. Russo highlighted the fact that ACES mirrors real-world experience, which will they hope will inform the use of CBD and CBD-based preparations moving forward. By removing certain barriers like institutional bureaucracy or federal funding restrictions inherent to more traditional randomized controlled trial design, ACES might provide data that bridge the gap between efficacy and effectiveness.
ACES was funded by Radicle Science. Dr. Chen is cofounder and CEO of Radicle Science. Dr. Russo and Dr. Strickland disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Oral penicillin advised for high-risk rheumatic heart disease
Some patients with rheumatic heart disease who are thought to have an allergic response to injectable penicillin may actually be experiencing a cardiac reaction to the injection, new information suggests.
This has resulted in new advice from the American Heart Association suggesting that oral penicillin may be a safer option for people with rheumatic heart disease who are at high risk of a cardiac reaction.
Those at high risk of a cardiac reaction include those with rheumatic heart disease and severe valvular heart disease with or without reduced ventricular function, those with aortic insufficiency or decreased left ventricular systolic function, and those who have active symptoms of rheumatic heart disease.
This new guidance is the subject of an AHA “presidential advisory” published online in the Journal of the American Heart Association on Jan. 20, 2022.
The advisory notes that more than 39 million people worldwide have rheumatic heart disease, a condition in which the heart’s valves are permanently damaged by rheumatic fever, which can occur if a strep throat infection or scarlet fever is untreated or inadequately treated.
Most cases of rheumatic heart disease occur in people living in low- and middle-income countries, where the condition is often diagnosed after severe valvular heart disease or other cardiovascular complications have already developed, leading to higher rates of death and lower life expectancy.
The recommended treatment for rheumatic heart disease is an intramuscular injection of benzathine penicillin G (BPG) given every 3-4 weeks for many years or even lifelong. Treatment with BPG for rheumatic heart disease has been limited in part because of patients’ and clinicians’ fears of anaphylaxis.
However, a growing number of reports of BPG-related deaths have not shown the features of classic anaphylaxis and instead point to a cardiovascular reaction, specifically, a vasovagal episode, the advisory states.
Signs of a vasovagal episode often occur immediately after administration of BPG, sometimes even during injection, and include low blood pressure, which can improve if patients are put into a supine position, slow heart rate, and fainting, all of which may lead to low blood flow to the heart, irregular heart rhythm, and sudden cardiac death.
On the other hand, signs of anaphylaxis after BPG injection are usually slightly delayed after the injection, even up to an hour later, and include coughing, respiratory distress, rapid heart rate, low blood pressure that doesn’t respond to position change, fainting, itching and redness at the injection site, the document notes.
The risks of a cardiovascular reaction to BPG are highest among individuals with severe mitral stenosis, aortic stenosis, aortic insufficiency or decreased left ventricular systolic function (ejection fraction <50%), and those who have active symptoms of rheumatic heart disease. For these patients, treatment with oral penicillin should be strongly considered.
People with rheumatic heart disease who are at low risk of this cardiovascular reaction and who do not have a history of being allergic to penicillin or anaphylaxis can still be prescribed BPG for treatment and prevention of rheumatic heart disease, which has been proven to be the best treatment for prevention of recurrent rheumatic fever.
The advisory recommended the following standard practices for all patients receiving BPG for rheumatic heart disease:
- Reducing injection pain and patient anxiety, both of which are known risk factors for injection-related fainting. Methods for pain reduction include applying firm pressure to the site for 10 seconds or application of an ice pack or the use of analgesics (such as acetaminophen, ibuprofen, or other NSAIDs).
- Patients should be well hydrated prior to injection and should drink at least 500 mL of water before injection to prevent reflexive fainting.
- Eating a small amount of solid food within the hour before injection.
- Receiving the injection while lying down, which may reduce the risk of blood pooling in the extremities.
- Providers who administer BPG should be taught how to recognize and quickly treat symptoms such as low blood pressure, low heart rate, or fainting.
A version of this article first appeared on Medscape.com.
Some patients with rheumatic heart disease who are thought to have an allergic response to injectable penicillin may actually be experiencing a cardiac reaction to the injection, new information suggests.
This has resulted in new advice from the American Heart Association suggesting that oral penicillin may be a safer option for people with rheumatic heart disease who are at high risk of a cardiac reaction.
Those at high risk of a cardiac reaction include those with rheumatic heart disease and severe valvular heart disease with or without reduced ventricular function, those with aortic insufficiency or decreased left ventricular systolic function, and those who have active symptoms of rheumatic heart disease.
This new guidance is the subject of an AHA “presidential advisory” published online in the Journal of the American Heart Association on Jan. 20, 2022.
The advisory notes that more than 39 million people worldwide have rheumatic heart disease, a condition in which the heart’s valves are permanently damaged by rheumatic fever, which can occur if a strep throat infection or scarlet fever is untreated or inadequately treated.
Most cases of rheumatic heart disease occur in people living in low- and middle-income countries, where the condition is often diagnosed after severe valvular heart disease or other cardiovascular complications have already developed, leading to higher rates of death and lower life expectancy.
The recommended treatment for rheumatic heart disease is an intramuscular injection of benzathine penicillin G (BPG) given every 3-4 weeks for many years or even lifelong. Treatment with BPG for rheumatic heart disease has been limited in part because of patients’ and clinicians’ fears of anaphylaxis.
However, a growing number of reports of BPG-related deaths have not shown the features of classic anaphylaxis and instead point to a cardiovascular reaction, specifically, a vasovagal episode, the advisory states.
Signs of a vasovagal episode often occur immediately after administration of BPG, sometimes even during injection, and include low blood pressure, which can improve if patients are put into a supine position, slow heart rate, and fainting, all of which may lead to low blood flow to the heart, irregular heart rhythm, and sudden cardiac death.
On the other hand, signs of anaphylaxis after BPG injection are usually slightly delayed after the injection, even up to an hour later, and include coughing, respiratory distress, rapid heart rate, low blood pressure that doesn’t respond to position change, fainting, itching and redness at the injection site, the document notes.
The risks of a cardiovascular reaction to BPG are highest among individuals with severe mitral stenosis, aortic stenosis, aortic insufficiency or decreased left ventricular systolic function (ejection fraction <50%), and those who have active symptoms of rheumatic heart disease. For these patients, treatment with oral penicillin should be strongly considered.
People with rheumatic heart disease who are at low risk of this cardiovascular reaction and who do not have a history of being allergic to penicillin or anaphylaxis can still be prescribed BPG for treatment and prevention of rheumatic heart disease, which has been proven to be the best treatment for prevention of recurrent rheumatic fever.
The advisory recommended the following standard practices for all patients receiving BPG for rheumatic heart disease:
- Reducing injection pain and patient anxiety, both of which are known risk factors for injection-related fainting. Methods for pain reduction include applying firm pressure to the site for 10 seconds or application of an ice pack or the use of analgesics (such as acetaminophen, ibuprofen, or other NSAIDs).
- Patients should be well hydrated prior to injection and should drink at least 500 mL of water before injection to prevent reflexive fainting.
- Eating a small amount of solid food within the hour before injection.
- Receiving the injection while lying down, which may reduce the risk of blood pooling in the extremities.
- Providers who administer BPG should be taught how to recognize and quickly treat symptoms such as low blood pressure, low heart rate, or fainting.
A version of this article first appeared on Medscape.com.
Some patients with rheumatic heart disease who are thought to have an allergic response to injectable penicillin may actually be experiencing a cardiac reaction to the injection, new information suggests.
This has resulted in new advice from the American Heart Association suggesting that oral penicillin may be a safer option for people with rheumatic heart disease who are at high risk of a cardiac reaction.
Those at high risk of a cardiac reaction include those with rheumatic heart disease and severe valvular heart disease with or without reduced ventricular function, those with aortic insufficiency or decreased left ventricular systolic function, and those who have active symptoms of rheumatic heart disease.
This new guidance is the subject of an AHA “presidential advisory” published online in the Journal of the American Heart Association on Jan. 20, 2022.
The advisory notes that more than 39 million people worldwide have rheumatic heart disease, a condition in which the heart’s valves are permanently damaged by rheumatic fever, which can occur if a strep throat infection or scarlet fever is untreated or inadequately treated.
Most cases of rheumatic heart disease occur in people living in low- and middle-income countries, where the condition is often diagnosed after severe valvular heart disease or other cardiovascular complications have already developed, leading to higher rates of death and lower life expectancy.
The recommended treatment for rheumatic heart disease is an intramuscular injection of benzathine penicillin G (BPG) given every 3-4 weeks for many years or even lifelong. Treatment with BPG for rheumatic heart disease has been limited in part because of patients’ and clinicians’ fears of anaphylaxis.
However, a growing number of reports of BPG-related deaths have not shown the features of classic anaphylaxis and instead point to a cardiovascular reaction, specifically, a vasovagal episode, the advisory states.
Signs of a vasovagal episode often occur immediately after administration of BPG, sometimes even during injection, and include low blood pressure, which can improve if patients are put into a supine position, slow heart rate, and fainting, all of which may lead to low blood flow to the heart, irregular heart rhythm, and sudden cardiac death.
On the other hand, signs of anaphylaxis after BPG injection are usually slightly delayed after the injection, even up to an hour later, and include coughing, respiratory distress, rapid heart rate, low blood pressure that doesn’t respond to position change, fainting, itching and redness at the injection site, the document notes.
The risks of a cardiovascular reaction to BPG are highest among individuals with severe mitral stenosis, aortic stenosis, aortic insufficiency or decreased left ventricular systolic function (ejection fraction <50%), and those who have active symptoms of rheumatic heart disease. For these patients, treatment with oral penicillin should be strongly considered.
People with rheumatic heart disease who are at low risk of this cardiovascular reaction and who do not have a history of being allergic to penicillin or anaphylaxis can still be prescribed BPG for treatment and prevention of rheumatic heart disease, which has been proven to be the best treatment for prevention of recurrent rheumatic fever.
The advisory recommended the following standard practices for all patients receiving BPG for rheumatic heart disease:
- Reducing injection pain and patient anxiety, both of which are known risk factors for injection-related fainting. Methods for pain reduction include applying firm pressure to the site for 10 seconds or application of an ice pack or the use of analgesics (such as acetaminophen, ibuprofen, or other NSAIDs).
- Patients should be well hydrated prior to injection and should drink at least 500 mL of water before injection to prevent reflexive fainting.
- Eating a small amount of solid food within the hour before injection.
- Receiving the injection while lying down, which may reduce the risk of blood pooling in the extremities.
- Providers who administer BPG should be taught how to recognize and quickly treat symptoms such as low blood pressure, low heart rate, or fainting.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Delays in NSTEMI hospitalization linked to lower survival
Patients who do not receive care for non–ST-segment elevation myocardial infarction (NSTEMI) within 24 hours have a substantially increased risk of mortality 3 years later when compared with those receiving earlier intervention, according to a population-based study evaluating more than 6,000 patients.
The characteristics of patients receiving NSTEMI care more than 24 hours after symptom onset were different from those treated earlier, but understanding these differences might provide clues for improved pathways to care, according to the investigators of this study, published in the Journal of the American College of Cardiology.
In a study of 6,544 NSTEMI patients in the Korea Acute Myocardial Infarction Registry, 1,827 (27%) were evaluated and treated 24 hours or more after symptom onset. When compared with the group with a shorter symptom-to-door time, outcomes at a median follow-up of 1,098 days were substantially worse.
Most importantly, this included a more than 50% absolute unadjusted increase in death from any cause (17.0% vs. 10.5%). On a 3-year adjusted multivariate hazard ratio, the increase was 35% (HR, 1.35; 95% confidence interval, 1.17-1.56; P < .001)
The absolute relative increase in cardiac death was similar in the delayed treatment group (10.8% vs. 6.4%) with a 37% increase in the 3-year multivariate adjustment (HR, 1.37; 95% CI 1.14-1.65; P < .001).
Delay raises composite adverse outcome >50%
On a composite of events that included mortality, recurrent MI, or hospitalization for heart failure, the rates climbed from 15.7% in the group treated within 24 hours to 23.3% (P < .001) when treatment was delayed. Heart failure, which was not significantly increased when evaluated separately, was not a major contributor to adverse outcomes, but those with delayed treatment did have more recurrent MIs (5.3% vs. 3.7%; P = .02).
Among a long list of differences between groups, those with delayed care had higher rates of atypical chest pain (25.1% vs. 14.8%; P < .001) and dyspnea (32.6% vs. 23.4%; P < .001). Expressed in odds ratios, they were also significantly more likely to be female (OR, 1.23), be aged 75 years or older (OR, 1.44), have diabetes (OR, 1.31), and to arrive at the hospital without aid from emergency medical services (OR, 3.44).
NSTEMI patients with delayed symptom-to-door time were also less likely to have hypertension (54.8% vs. 59.1%; P < .001), chronic kidney disease (20.8% vs. 25.5%), or a family history of cardiovascular disease (4.7% vs. 7.4%; P < .001). They were more likely to have left main and multivessel disease (57.1% vs. 50.5%; P < .001).
The value of early treatment has already been demonstrated for STEMI, which is reflected in guidelines, most of which now emphasize minimizing the door-to-balloon angioplasty time in order to more rapidly restore perfusion, thereby preserving more functional cardiac tissue. This study suggests that benefit from early intervention is also true of NSTEMI.
Reducing prehospital delay in care “should be emphasized as a crucial factor that increases the risk of all-cause mortality in NSTEMI patients,” reported the authors, led by Jung-Joon Cha, MD, PhD, division of cardiology, Korea University Anam Hospital, Seoul.
Public health campaigns needed
When asked about the take-home message, Dr. Cha, along with the senior author, Tae Hoon Ahn, MD, PhD, contend that delays can be addressed by educating both the public and clinicians.
“We would like to emphasize the need for public health campaigns to make patients more aware of atypical symptoms,” Dr. Cha said in an interview.
Dr. Ahn also believes that there is not enough current emphasis within medical systems to recognize and urgently treat NSTEMI patients with a nontraditional profile.
“Atypical symptoms in NSTEMI patients may lead physicians to underestimate the disease severity,” according to Dr. Ahn, who participated in an interview on the significance of these results. He said that atypical symptoms should induce clinicians to exercise “more caution rather than to neglect them.”
For understanding the value of prompt care in NSTEMI patients, this is important information. However, the importance of the 24-hour threshold as a discriminator of long-term risk was questioned by José A. Barrabés, MD, PhD, head of the acute cardiac care unit, University Hospital Vall d’Hebron, Barcelona.
The cutoff in this study was 24 hours, but Dr. Barrabés in an accompanying editorial pointed out that the median delay in those with a symptom-to-door time of at least 24 hours was in fact 72.0 hours.
Intermediate delay effect unknown
“This time lag is unusual and reduces the generalizability of the results,” according to Dr. Barrabés. He suggested that the exceptional delay increases the likelihood that the characteristics of the patients, such as more comorbidities or lower socioeconomic status, might have played a role in the differences in outcomes.
Asked to elaborate, Dr. Barrabés explained that delays in treatment, such as antithrombotic therapy, are plausible explanations for the worse outcomes at 3 years, but it is unclear from this data whether the risk starts at a delay of 24 hours.
“It is certainly plausible that intermediate delays are also associated with a worse prognosis,” Dr. Barrabés said in an interview, but “the risk associated with an intermediate delay in symptom-to-door time cannot be quantified with the data collected in this study.”
Dr. Cha and coinvestigators reported no potential conflicts of interest for this study. Dr. Barrabés has financial relationship with AstraZeneca, Novo Nordisk, and Rovi.
Patients who do not receive care for non–ST-segment elevation myocardial infarction (NSTEMI) within 24 hours have a substantially increased risk of mortality 3 years later when compared with those receiving earlier intervention, according to a population-based study evaluating more than 6,000 patients.
The characteristics of patients receiving NSTEMI care more than 24 hours after symptom onset were different from those treated earlier, but understanding these differences might provide clues for improved pathways to care, according to the investigators of this study, published in the Journal of the American College of Cardiology.
In a study of 6,544 NSTEMI patients in the Korea Acute Myocardial Infarction Registry, 1,827 (27%) were evaluated and treated 24 hours or more after symptom onset. When compared with the group with a shorter symptom-to-door time, outcomes at a median follow-up of 1,098 days were substantially worse.
Most importantly, this included a more than 50% absolute unadjusted increase in death from any cause (17.0% vs. 10.5%). On a 3-year adjusted multivariate hazard ratio, the increase was 35% (HR, 1.35; 95% confidence interval, 1.17-1.56; P < .001)
The absolute relative increase in cardiac death was similar in the delayed treatment group (10.8% vs. 6.4%) with a 37% increase in the 3-year multivariate adjustment (HR, 1.37; 95% CI 1.14-1.65; P < .001).
Delay raises composite adverse outcome >50%
On a composite of events that included mortality, recurrent MI, or hospitalization for heart failure, the rates climbed from 15.7% in the group treated within 24 hours to 23.3% (P < .001) when treatment was delayed. Heart failure, which was not significantly increased when evaluated separately, was not a major contributor to adverse outcomes, but those with delayed treatment did have more recurrent MIs (5.3% vs. 3.7%; P = .02).
Among a long list of differences between groups, those with delayed care had higher rates of atypical chest pain (25.1% vs. 14.8%; P < .001) and dyspnea (32.6% vs. 23.4%; P < .001). Expressed in odds ratios, they were also significantly more likely to be female (OR, 1.23), be aged 75 years or older (OR, 1.44), have diabetes (OR, 1.31), and to arrive at the hospital without aid from emergency medical services (OR, 3.44).
NSTEMI patients with delayed symptom-to-door time were also less likely to have hypertension (54.8% vs. 59.1%; P < .001), chronic kidney disease (20.8% vs. 25.5%), or a family history of cardiovascular disease (4.7% vs. 7.4%; P < .001). They were more likely to have left main and multivessel disease (57.1% vs. 50.5%; P < .001).
The value of early treatment has already been demonstrated for STEMI, which is reflected in guidelines, most of which now emphasize minimizing the door-to-balloon angioplasty time in order to more rapidly restore perfusion, thereby preserving more functional cardiac tissue. This study suggests that benefit from early intervention is also true of NSTEMI.
Reducing prehospital delay in care “should be emphasized as a crucial factor that increases the risk of all-cause mortality in NSTEMI patients,” reported the authors, led by Jung-Joon Cha, MD, PhD, division of cardiology, Korea University Anam Hospital, Seoul.
Public health campaigns needed
When asked about the take-home message, Dr. Cha, along with the senior author, Tae Hoon Ahn, MD, PhD, contend that delays can be addressed by educating both the public and clinicians.
“We would like to emphasize the need for public health campaigns to make patients more aware of atypical symptoms,” Dr. Cha said in an interview.
Dr. Ahn also believes that there is not enough current emphasis within medical systems to recognize and urgently treat NSTEMI patients with a nontraditional profile.
“Atypical symptoms in NSTEMI patients may lead physicians to underestimate the disease severity,” according to Dr. Ahn, who participated in an interview on the significance of these results. He said that atypical symptoms should induce clinicians to exercise “more caution rather than to neglect them.”
For understanding the value of prompt care in NSTEMI patients, this is important information. However, the importance of the 24-hour threshold as a discriminator of long-term risk was questioned by José A. Barrabés, MD, PhD, head of the acute cardiac care unit, University Hospital Vall d’Hebron, Barcelona.
The cutoff in this study was 24 hours, but Dr. Barrabés in an accompanying editorial pointed out that the median delay in those with a symptom-to-door time of at least 24 hours was in fact 72.0 hours.
Intermediate delay effect unknown
“This time lag is unusual and reduces the generalizability of the results,” according to Dr. Barrabés. He suggested that the exceptional delay increases the likelihood that the characteristics of the patients, such as more comorbidities or lower socioeconomic status, might have played a role in the differences in outcomes.
Asked to elaborate, Dr. Barrabés explained that delays in treatment, such as antithrombotic therapy, are plausible explanations for the worse outcomes at 3 years, but it is unclear from this data whether the risk starts at a delay of 24 hours.
“It is certainly plausible that intermediate delays are also associated with a worse prognosis,” Dr. Barrabés said in an interview, but “the risk associated with an intermediate delay in symptom-to-door time cannot be quantified with the data collected in this study.”
Dr. Cha and coinvestigators reported no potential conflicts of interest for this study. Dr. Barrabés has financial relationship with AstraZeneca, Novo Nordisk, and Rovi.
Patients who do not receive care for non–ST-segment elevation myocardial infarction (NSTEMI) within 24 hours have a substantially increased risk of mortality 3 years later when compared with those receiving earlier intervention, according to a population-based study evaluating more than 6,000 patients.
The characteristics of patients receiving NSTEMI care more than 24 hours after symptom onset were different from those treated earlier, but understanding these differences might provide clues for improved pathways to care, according to the investigators of this study, published in the Journal of the American College of Cardiology.
In a study of 6,544 NSTEMI patients in the Korea Acute Myocardial Infarction Registry, 1,827 (27%) were evaluated and treated 24 hours or more after symptom onset. When compared with the group with a shorter symptom-to-door time, outcomes at a median follow-up of 1,098 days were substantially worse.
Most importantly, this included a more than 50% absolute unadjusted increase in death from any cause (17.0% vs. 10.5%). On a 3-year adjusted multivariate hazard ratio, the increase was 35% (HR, 1.35; 95% confidence interval, 1.17-1.56; P < .001)
The absolute relative increase in cardiac death was similar in the delayed treatment group (10.8% vs. 6.4%) with a 37% increase in the 3-year multivariate adjustment (HR, 1.37; 95% CI 1.14-1.65; P < .001).
Delay raises composite adverse outcome >50%
On a composite of events that included mortality, recurrent MI, or hospitalization for heart failure, the rates climbed from 15.7% in the group treated within 24 hours to 23.3% (P < .001) when treatment was delayed. Heart failure, which was not significantly increased when evaluated separately, was not a major contributor to adverse outcomes, but those with delayed treatment did have more recurrent MIs (5.3% vs. 3.7%; P = .02).
Among a long list of differences between groups, those with delayed care had higher rates of atypical chest pain (25.1% vs. 14.8%; P < .001) and dyspnea (32.6% vs. 23.4%; P < .001). Expressed in odds ratios, they were also significantly more likely to be female (OR, 1.23), be aged 75 years or older (OR, 1.44), have diabetes (OR, 1.31), and to arrive at the hospital without aid from emergency medical services (OR, 3.44).
NSTEMI patients with delayed symptom-to-door time were also less likely to have hypertension (54.8% vs. 59.1%; P < .001), chronic kidney disease (20.8% vs. 25.5%), or a family history of cardiovascular disease (4.7% vs. 7.4%; P < .001). They were more likely to have left main and multivessel disease (57.1% vs. 50.5%; P < .001).
The value of early treatment has already been demonstrated for STEMI, which is reflected in guidelines, most of which now emphasize minimizing the door-to-balloon angioplasty time in order to more rapidly restore perfusion, thereby preserving more functional cardiac tissue. This study suggests that benefit from early intervention is also true of NSTEMI.
Reducing prehospital delay in care “should be emphasized as a crucial factor that increases the risk of all-cause mortality in NSTEMI patients,” reported the authors, led by Jung-Joon Cha, MD, PhD, division of cardiology, Korea University Anam Hospital, Seoul.
Public health campaigns needed
When asked about the take-home message, Dr. Cha, along with the senior author, Tae Hoon Ahn, MD, PhD, contend that delays can be addressed by educating both the public and clinicians.
“We would like to emphasize the need for public health campaigns to make patients more aware of atypical symptoms,” Dr. Cha said in an interview.
Dr. Ahn also believes that there is not enough current emphasis within medical systems to recognize and urgently treat NSTEMI patients with a nontraditional profile.
“Atypical symptoms in NSTEMI patients may lead physicians to underestimate the disease severity,” according to Dr. Ahn, who participated in an interview on the significance of these results. He said that atypical symptoms should induce clinicians to exercise “more caution rather than to neglect them.”
For understanding the value of prompt care in NSTEMI patients, this is important information. However, the importance of the 24-hour threshold as a discriminator of long-term risk was questioned by José A. Barrabés, MD, PhD, head of the acute cardiac care unit, University Hospital Vall d’Hebron, Barcelona.
The cutoff in this study was 24 hours, but Dr. Barrabés in an accompanying editorial pointed out that the median delay in those with a symptom-to-door time of at least 24 hours was in fact 72.0 hours.
Intermediate delay effect unknown
“This time lag is unusual and reduces the generalizability of the results,” according to Dr. Barrabés. He suggested that the exceptional delay increases the likelihood that the characteristics of the patients, such as more comorbidities or lower socioeconomic status, might have played a role in the differences in outcomes.
Asked to elaborate, Dr. Barrabés explained that delays in treatment, such as antithrombotic therapy, are plausible explanations for the worse outcomes at 3 years, but it is unclear from this data whether the risk starts at a delay of 24 hours.
“It is certainly plausible that intermediate delays are also associated with a worse prognosis,” Dr. Barrabés said in an interview, but “the risk associated with an intermediate delay in symptom-to-door time cannot be quantified with the data collected in this study.”
Dr. Cha and coinvestigators reported no potential conflicts of interest for this study. Dr. Barrabés has financial relationship with AstraZeneca, Novo Nordisk, and Rovi.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Clinical Edge Journal Scan Commentary: Prenatal Testing February 2022
Prenatal ultrasound detects structural fetal abnormalities in about 3% of pregnancies. When structural fetal abnormalities are found on prenatal ultrasound, diagnostic genetic testing with either CVS or amniocentesis are recommended. Classically, this has meant fetal karyotype and chromosomal microarray testing (CMA). Recently, a new type of genetic testing has become available on fetal samples, whole-exome sequencing (WES). Smogavec et al. assesses this new technology and its ability to detect fetal genetic abnormalities. They retrospectively studied 90 fetuses with abnormalities detected on prenatal ultrasound that had normal CMA results and negative fluorescence in situ hybridization analysis testing for aneuploidy. They found WES testing added a 34.4% increased rate of detection of fetal genetic abnormalities. WES is a powerful tool for genetic diagnosis in fetuses with structural anomalies and should be considered anytime a karyotype or CMA is normal in a fetus with structural anomalies.
Lastly, prenatal genetic diagnosis at an early gestational age is critical for medical management of fetuses with anomalies. In a cohort study, Chen et al. assess the simultaneous combined use of CNV-seq and WES on testing turnaround time. They found by running the testing simultaneously, rather than sequentially, this would decrease testing time from over a month to less than 2 weeks. This strategy of testing could potentially decrease the time from detection of a fetal anomaly on ultrasound to a genetic diagnosis allowing for earlier counseling and medical guidance.
Prenatal ultrasound detects structural fetal abnormalities in about 3% of pregnancies. When structural fetal abnormalities are found on prenatal ultrasound, diagnostic genetic testing with either CVS or amniocentesis are recommended. Classically, this has meant fetal karyotype and chromosomal microarray testing (CMA). Recently, a new type of genetic testing has become available on fetal samples, whole-exome sequencing (WES). Smogavec et al. assesses this new technology and its ability to detect fetal genetic abnormalities. They retrospectively studied 90 fetuses with abnormalities detected on prenatal ultrasound that had normal CMA results and negative fluorescence in situ hybridization analysis testing for aneuploidy. They found WES testing added a 34.4% increased rate of detection of fetal genetic abnormalities. WES is a powerful tool for genetic diagnosis in fetuses with structural anomalies and should be considered anytime a karyotype or CMA is normal in a fetus with structural anomalies.
Lastly, prenatal genetic diagnosis at an early gestational age is critical for medical management of fetuses with anomalies. In a cohort study, Chen et al. assess the simultaneous combined use of CNV-seq and WES on testing turnaround time. They found by running the testing simultaneously, rather than sequentially, this would decrease testing time from over a month to less than 2 weeks. This strategy of testing could potentially decrease the time from detection of a fetal anomaly on ultrasound to a genetic diagnosis allowing for earlier counseling and medical guidance.
Prenatal ultrasound detects structural fetal abnormalities in about 3% of pregnancies. When structural fetal abnormalities are found on prenatal ultrasound, diagnostic genetic testing with either CVS or amniocentesis are recommended. Classically, this has meant fetal karyotype and chromosomal microarray testing (CMA). Recently, a new type of genetic testing has become available on fetal samples, whole-exome sequencing (WES). Smogavec et al. assesses this new technology and its ability to detect fetal genetic abnormalities. They retrospectively studied 90 fetuses with abnormalities detected on prenatal ultrasound that had normal CMA results and negative fluorescence in situ hybridization analysis testing for aneuploidy. They found WES testing added a 34.4% increased rate of detection of fetal genetic abnormalities. WES is a powerful tool for genetic diagnosis in fetuses with structural anomalies and should be considered anytime a karyotype or CMA is normal in a fetus with structural anomalies.
Lastly, prenatal genetic diagnosis at an early gestational age is critical for medical management of fetuses with anomalies. In a cohort study, Chen et al. assess the simultaneous combined use of CNV-seq and WES on testing turnaround time. They found by running the testing simultaneously, rather than sequentially, this would decrease testing time from over a month to less than 2 weeks. This strategy of testing could potentially decrease the time from detection of a fetal anomaly on ultrasound to a genetic diagnosis allowing for earlier counseling and medical guidance.
Physician burnout, depression compounded by COVID: Survey
In 2020, it was hard to imagine that the situation could get worse for doctors.
But 2021 presented a new set of challenges. As quarantines lifted and physicians tried to get back to work, they were forced to deal with reduced staff, continuing COVID stress, and pandemic-related anxieties about family and loved ones.
Medscape’s National Burnout and Depression Report 2022 asked more than 13,000 physicians from 29 specialties to share details about their lives and struggles with burnout and depression in 2021. The results paint a picture of physicians trying to fulfill their mission to care for patients, but struggling to maintain their own well-being amid a global pandemic.
Burnout bump
In 2021’s report, 42% of physicians said they were burned out. In 2022, that number increased to 47%. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, increasing from 43% to 60%. Critical care (56%), ob.gyn. (53%), and infectious disease and family medicine (both at 51%) rounded out the top five specialties with doctors experiencing burnout in 2021.
Burnout has typically been a greater problem for women than men physicians, and the pandemic hasn’t changed that. “There’s no question that women have reported far more role strain during the pandemic than men,” says Carol A. Bernstein, MD, psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at the Albert Einstein College of Medicine, both in New York. And indeed, 56% of women and 41% of men reported burnout in the 2022 survey.
The causes, however, weren’t especially pandemic related – or at least not directly. As in previous surveys, the major contributing factor to burnout was too much paperwork (60%), such as charting and other bureaucratic tasks. Treating COVID-19 patients was cited as the major source of stress by 10% of respondents. About 34% said too many hours at work was the biggest contributing factor to burnout.
The nature of the beast
What is burnout like for these doctors? One described the conditions that lead to burnout like this: “I barely spend enough time with most patients, just running from one to the next; and then after work, I spend hours documenting, charting, dealing with reports. I feel like an overpaid clerk.” Another said: “Where’s the relationships with patients that used to make this worthwhile?” Others fingered staffing shortages at work or an overwhelming home life: “Staff calls in sick; we’re all running around trying to find things and get things done. It never ends.”
Of those who do experience burnout, the problem reaches beyond the workplace, with 54% saying that their burnout has a strong/severe impact on life and 68% reporting that burnout affects their relationships. One respondent said: “I’m always tired; I have trouble concentrating, no time for the children, more arguments with my hubby.” Another put it this way: “Home is just as busy and chaotic as work. I can never relax.”
It doesn’t help matters that physicians are likely to think they’re the only professionals experiencing job burnout. For example, only 36% of respondents believe teachers experience comparable burnout, yet more than 41% of teachers leave the profession within 5 years of starting – often because of burnout.
When it comes to methods for coping with burnout, exercise is the clear favorite, with 63% of respondents saying exercise helps maintain their mental health. About 41% talk with family members or close friends. However, less healthy coping mechanisms were cited as well, such as isolating themselves from others (45%), sleeping (41%), and eating junk food (35%) or drinking alcohol (24%).
When it comes to trying to alleviate burnout, 29% have tried meditation or similar stress-reduction techniques, while others have reduced their work hours (29%) or changed their work settings (19%).
‘Now I feel like there’s no hope’
About a fifth of physicians (21%) said they suffered from clinical depression, and 64% reported feeling “blue, down, or sad.” One physician characterized their depression this way: “I used to think my life would be great. Now I feel like there’s no hope, this will never get better, I’ll never be happy.”
Of doctors reporting depression, 53% said their illness did not affect their interactions with patients, while 34% said depression caused them to be more easily exasperated by patients.
When asked about seeking help for depression, about half (49%) said they believed they could deal with emotional stress on their own. Unfortunately, fear of medical boards finding out keeps 43% of physicians from reaching out for help, according to the survey.
A version of this article first appeared on Medscape.com.
In 2020, it was hard to imagine that the situation could get worse for doctors.
But 2021 presented a new set of challenges. As quarantines lifted and physicians tried to get back to work, they were forced to deal with reduced staff, continuing COVID stress, and pandemic-related anxieties about family and loved ones.
Medscape’s National Burnout and Depression Report 2022 asked more than 13,000 physicians from 29 specialties to share details about their lives and struggles with burnout and depression in 2021. The results paint a picture of physicians trying to fulfill their mission to care for patients, but struggling to maintain their own well-being amid a global pandemic.
Burnout bump
In 2021’s report, 42% of physicians said they were burned out. In 2022, that number increased to 47%. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, increasing from 43% to 60%. Critical care (56%), ob.gyn. (53%), and infectious disease and family medicine (both at 51%) rounded out the top five specialties with doctors experiencing burnout in 2021.
Burnout has typically been a greater problem for women than men physicians, and the pandemic hasn’t changed that. “There’s no question that women have reported far more role strain during the pandemic than men,” says Carol A. Bernstein, MD, psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at the Albert Einstein College of Medicine, both in New York. And indeed, 56% of women and 41% of men reported burnout in the 2022 survey.
The causes, however, weren’t especially pandemic related – or at least not directly. As in previous surveys, the major contributing factor to burnout was too much paperwork (60%), such as charting and other bureaucratic tasks. Treating COVID-19 patients was cited as the major source of stress by 10% of respondents. About 34% said too many hours at work was the biggest contributing factor to burnout.
The nature of the beast
What is burnout like for these doctors? One described the conditions that lead to burnout like this: “I barely spend enough time with most patients, just running from one to the next; and then after work, I spend hours documenting, charting, dealing with reports. I feel like an overpaid clerk.” Another said: “Where’s the relationships with patients that used to make this worthwhile?” Others fingered staffing shortages at work or an overwhelming home life: “Staff calls in sick; we’re all running around trying to find things and get things done. It never ends.”
Of those who do experience burnout, the problem reaches beyond the workplace, with 54% saying that their burnout has a strong/severe impact on life and 68% reporting that burnout affects their relationships. One respondent said: “I’m always tired; I have trouble concentrating, no time for the children, more arguments with my hubby.” Another put it this way: “Home is just as busy and chaotic as work. I can never relax.”
It doesn’t help matters that physicians are likely to think they’re the only professionals experiencing job burnout. For example, only 36% of respondents believe teachers experience comparable burnout, yet more than 41% of teachers leave the profession within 5 years of starting – often because of burnout.
When it comes to methods for coping with burnout, exercise is the clear favorite, with 63% of respondents saying exercise helps maintain their mental health. About 41% talk with family members or close friends. However, less healthy coping mechanisms were cited as well, such as isolating themselves from others (45%), sleeping (41%), and eating junk food (35%) or drinking alcohol (24%).
When it comes to trying to alleviate burnout, 29% have tried meditation or similar stress-reduction techniques, while others have reduced their work hours (29%) or changed their work settings (19%).
‘Now I feel like there’s no hope’
About a fifth of physicians (21%) said they suffered from clinical depression, and 64% reported feeling “blue, down, or sad.” One physician characterized their depression this way: “I used to think my life would be great. Now I feel like there’s no hope, this will never get better, I’ll never be happy.”
Of doctors reporting depression, 53% said their illness did not affect their interactions with patients, while 34% said depression caused them to be more easily exasperated by patients.
When asked about seeking help for depression, about half (49%) said they believed they could deal with emotional stress on their own. Unfortunately, fear of medical boards finding out keeps 43% of physicians from reaching out for help, according to the survey.
A version of this article first appeared on Medscape.com.
In 2020, it was hard to imagine that the situation could get worse for doctors.
But 2021 presented a new set of challenges. As quarantines lifted and physicians tried to get back to work, they were forced to deal with reduced staff, continuing COVID stress, and pandemic-related anxieties about family and loved ones.
Medscape’s National Burnout and Depression Report 2022 asked more than 13,000 physicians from 29 specialties to share details about their lives and struggles with burnout and depression in 2021. The results paint a picture of physicians trying to fulfill their mission to care for patients, but struggling to maintain their own well-being amid a global pandemic.
Burnout bump
In 2021’s report, 42% of physicians said they were burned out. In 2022, that number increased to 47%. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, increasing from 43% to 60%. Critical care (56%), ob.gyn. (53%), and infectious disease and family medicine (both at 51%) rounded out the top five specialties with doctors experiencing burnout in 2021.
Burnout has typically been a greater problem for women than men physicians, and the pandemic hasn’t changed that. “There’s no question that women have reported far more role strain during the pandemic than men,” says Carol A. Bernstein, MD, psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at the Albert Einstein College of Medicine, both in New York. And indeed, 56% of women and 41% of men reported burnout in the 2022 survey.
The causes, however, weren’t especially pandemic related – or at least not directly. As in previous surveys, the major contributing factor to burnout was too much paperwork (60%), such as charting and other bureaucratic tasks. Treating COVID-19 patients was cited as the major source of stress by 10% of respondents. About 34% said too many hours at work was the biggest contributing factor to burnout.
The nature of the beast
What is burnout like for these doctors? One described the conditions that lead to burnout like this: “I barely spend enough time with most patients, just running from one to the next; and then after work, I spend hours documenting, charting, dealing with reports. I feel like an overpaid clerk.” Another said: “Where’s the relationships with patients that used to make this worthwhile?” Others fingered staffing shortages at work or an overwhelming home life: “Staff calls in sick; we’re all running around trying to find things and get things done. It never ends.”
Of those who do experience burnout, the problem reaches beyond the workplace, with 54% saying that their burnout has a strong/severe impact on life and 68% reporting that burnout affects their relationships. One respondent said: “I’m always tired; I have trouble concentrating, no time for the children, more arguments with my hubby.” Another put it this way: “Home is just as busy and chaotic as work. I can never relax.”
It doesn’t help matters that physicians are likely to think they’re the only professionals experiencing job burnout. For example, only 36% of respondents believe teachers experience comparable burnout, yet more than 41% of teachers leave the profession within 5 years of starting – often because of burnout.
When it comes to methods for coping with burnout, exercise is the clear favorite, with 63% of respondents saying exercise helps maintain their mental health. About 41% talk with family members or close friends. However, less healthy coping mechanisms were cited as well, such as isolating themselves from others (45%), sleeping (41%), and eating junk food (35%) or drinking alcohol (24%).
When it comes to trying to alleviate burnout, 29% have tried meditation or similar stress-reduction techniques, while others have reduced their work hours (29%) or changed their work settings (19%).
‘Now I feel like there’s no hope’
About a fifth of physicians (21%) said they suffered from clinical depression, and 64% reported feeling “blue, down, or sad.” One physician characterized their depression this way: “I used to think my life would be great. Now I feel like there’s no hope, this will never get better, I’ll never be happy.”
Of doctors reporting depression, 53% said their illness did not affect their interactions with patients, while 34% said depression caused them to be more easily exasperated by patients.
When asked about seeking help for depression, about half (49%) said they believed they could deal with emotional stress on their own. Unfortunately, fear of medical boards finding out keeps 43% of physicians from reaching out for help, according to the survey.
A version of this article first appeared on Medscape.com.
Expert views diverge on adding chemotherapy to EGFR TKIs in EGFR-mutant NSCLC
One affirms single-agent EGFR TKI treatment, such as with osimertinib, as the current standard of care for first-line advanced metastatic EGFR-positive mNSCLC, and the other affirms clear benefits for first-generation EGFR TKIs combined with either chemotherapy or VEGF monoclonal antibodies.
In the analysis supporting combination therapy for mNSCLC, Sara Moore, MD, and Paul Wheatley-Price MD, wrote that while targeted therapy with EGFR TKIs is highly effective initially, resistance inevitably develops.
Recent data, they stated, have demonstrated that combination strategies can delay development of resistance and improve outcomes for mNSCLC populations. Combining first-generation EGFR TKIs with either chemotherapy or VEGF monoclonal antibodies has led to consistent improvement in progression-free survival (PFS) and overall survival (OS) in some cases. In the NEJ009 trial, the combination of chemotherapy (carboplatin and pemetrexed, with pemetrexed maintenance) plus gefitinib versus gefitinib alone improved response rate (84% vs. 67%, P < 0.001), PFS (median, 20.9 months vs. 11.2 months; P < .001), and OS (median, 50.9 months vs. 38.8 months; P = .021). An increase in adverse events in the chemotherapy arm led to a decrease in quality of life.
Another clinical trial (by Noronha and colleagues) conducted in India of the same combination found benefit for combination therapy in response rate (75% vs. 63%), PFS (median, 16 months vs. 8 months), and OS (not reached vs. 17 months). Grade 3 or higher adverse event rates were higher with the combination (51% vs. 25%) with quality of life was not yet reported.
While both trials have been criticized owing to a lack of standard T790M resistance testing and low use of osimertinib in subsequent lines of therapy, Dr. Moore and Dr. Wheatley-Price pointed out: “Even with the use of first-line osimertinib monotherapy, patients may still be exposed to chemotherapy with later lines of treatment. Therefore, combination therapy does not expose patients to new toxicity, it simply changes when they will be exposed to that toxicity during their treatment course.”
The importance of using combination therapy in the first-line setting, they stated, is underscored by the consistent drop-off in patients who receive second-line combination therapy. In the phase 3 FLAURA trial of first-line osimertinib monotherapy, of the patients who discontinued osimertinib, the most common reason for not receiving subsequent therapy was death (60% went on to receive further systemic therapy). This highlights the need to use the most effective treatments up front, Dr. Moore and Dr. Wheatley-Price wrote.
The four large trials of VEGF-targeted therapy with either monoclonal antibodies or TKIs added to first-generation EGFR TKIs have consistently shown improved PFS. Increased toxicities led to discontinuation of VEGF-targeted therapy in 20%-30%.
In the RELAY trial, however, despite more toxicities, quality of life was not diminished. In general, the authors concluded that long-term detriments to quality of life have not been demonstrated. Ongoing studies of osimertinib in combination with VEGF inhibition include a phase 1/2 trial with bevacizumab in previously untreated patients showing an 80% response rate (median PFS, 18.4 months) with no unexpected toxicity.
Chemotherapy-based treatment for mNSCLC with third-generation EGFR TKIs, in appropriately selected patients, the authors concluded, “can offer an additional standard-of-care option as first-line treatment of EGFR-mutant lung cancer.”
Since the introduction of EGFR TKIs, Sophie Stock-Martineau, MD and Frances A. Shepherd, MD noted in their analysis, researchers have aimed to improve their efficacy through combining them with other agents. The authors review research on the addition of chemo- or immunotherapy and agents targeting major resistance mechanisms such as MET. Their review of the same NEJ009 trial focuses, however, on the 65.3% (EGFR TKI plus chemotherapy) versus 31.0% (gefitinib alone) grade 3 adverse event rate, and the 51% versus 25% grade 3 adverse event rate in a similar trial by Noronha and colleagues. The review by Dr. Stock-Martineau and Dr. Shepherd further found that, while adding antiangiogenic agents to an EGFR TKI “mildly” prolongs PFS, survival benefits have not been demonstrated. The added costs, not just in toxicity, were a “far from negligible” $120,000 above the cost of bevacizumab alone for 16 treatments. Data from trials of immune checkpoint inhibitors added to EGFR TKIs reveal heightened toxicities and limited efficacy. Trials of EGFR monoclonal antibodies with an EGFR TKI showed no PFS or OS benefit and were terminated early. Similarly, evidence to date shows no benefit beyond that shown for EGFR TKI monotherapy with the addition of a MET inhibitor.
“Adding virtually all agents to EGFR TKIs has been associated with more toxicity to patients and a significant financial burden to the health care system,” Dr. Stock-Martineau and Dr. Shepherd concluded, further observing that combinations, given their heightened toxicity profiles, could potentially also worsen quality of life.
No conflicts of interest were reported by the authors of either study.
One affirms single-agent EGFR TKI treatment, such as with osimertinib, as the current standard of care for first-line advanced metastatic EGFR-positive mNSCLC, and the other affirms clear benefits for first-generation EGFR TKIs combined with either chemotherapy or VEGF monoclonal antibodies.
In the analysis supporting combination therapy for mNSCLC, Sara Moore, MD, and Paul Wheatley-Price MD, wrote that while targeted therapy with EGFR TKIs is highly effective initially, resistance inevitably develops.
Recent data, they stated, have demonstrated that combination strategies can delay development of resistance and improve outcomes for mNSCLC populations. Combining first-generation EGFR TKIs with either chemotherapy or VEGF monoclonal antibodies has led to consistent improvement in progression-free survival (PFS) and overall survival (OS) in some cases. In the NEJ009 trial, the combination of chemotherapy (carboplatin and pemetrexed, with pemetrexed maintenance) plus gefitinib versus gefitinib alone improved response rate (84% vs. 67%, P < 0.001), PFS (median, 20.9 months vs. 11.2 months; P < .001), and OS (median, 50.9 months vs. 38.8 months; P = .021). An increase in adverse events in the chemotherapy arm led to a decrease in quality of life.
Another clinical trial (by Noronha and colleagues) conducted in India of the same combination found benefit for combination therapy in response rate (75% vs. 63%), PFS (median, 16 months vs. 8 months), and OS (not reached vs. 17 months). Grade 3 or higher adverse event rates were higher with the combination (51% vs. 25%) with quality of life was not yet reported.
While both trials have been criticized owing to a lack of standard T790M resistance testing and low use of osimertinib in subsequent lines of therapy, Dr. Moore and Dr. Wheatley-Price pointed out: “Even with the use of first-line osimertinib monotherapy, patients may still be exposed to chemotherapy with later lines of treatment. Therefore, combination therapy does not expose patients to new toxicity, it simply changes when they will be exposed to that toxicity during their treatment course.”
The importance of using combination therapy in the first-line setting, they stated, is underscored by the consistent drop-off in patients who receive second-line combination therapy. In the phase 3 FLAURA trial of first-line osimertinib monotherapy, of the patients who discontinued osimertinib, the most common reason for not receiving subsequent therapy was death (60% went on to receive further systemic therapy). This highlights the need to use the most effective treatments up front, Dr. Moore and Dr. Wheatley-Price wrote.
The four large trials of VEGF-targeted therapy with either monoclonal antibodies or TKIs added to first-generation EGFR TKIs have consistently shown improved PFS. Increased toxicities led to discontinuation of VEGF-targeted therapy in 20%-30%.
In the RELAY trial, however, despite more toxicities, quality of life was not diminished. In general, the authors concluded that long-term detriments to quality of life have not been demonstrated. Ongoing studies of osimertinib in combination with VEGF inhibition include a phase 1/2 trial with bevacizumab in previously untreated patients showing an 80% response rate (median PFS, 18.4 months) with no unexpected toxicity.
Chemotherapy-based treatment for mNSCLC with third-generation EGFR TKIs, in appropriately selected patients, the authors concluded, “can offer an additional standard-of-care option as first-line treatment of EGFR-mutant lung cancer.”
Since the introduction of EGFR TKIs, Sophie Stock-Martineau, MD and Frances A. Shepherd, MD noted in their analysis, researchers have aimed to improve their efficacy through combining them with other agents. The authors review research on the addition of chemo- or immunotherapy and agents targeting major resistance mechanisms such as MET. Their review of the same NEJ009 trial focuses, however, on the 65.3% (EGFR TKI plus chemotherapy) versus 31.0% (gefitinib alone) grade 3 adverse event rate, and the 51% versus 25% grade 3 adverse event rate in a similar trial by Noronha and colleagues. The review by Dr. Stock-Martineau and Dr. Shepherd further found that, while adding antiangiogenic agents to an EGFR TKI “mildly” prolongs PFS, survival benefits have not been demonstrated. The added costs, not just in toxicity, were a “far from negligible” $120,000 above the cost of bevacizumab alone for 16 treatments. Data from trials of immune checkpoint inhibitors added to EGFR TKIs reveal heightened toxicities and limited efficacy. Trials of EGFR monoclonal antibodies with an EGFR TKI showed no PFS or OS benefit and were terminated early. Similarly, evidence to date shows no benefit beyond that shown for EGFR TKI monotherapy with the addition of a MET inhibitor.
“Adding virtually all agents to EGFR TKIs has been associated with more toxicity to patients and a significant financial burden to the health care system,” Dr. Stock-Martineau and Dr. Shepherd concluded, further observing that combinations, given their heightened toxicity profiles, could potentially also worsen quality of life.
No conflicts of interest were reported by the authors of either study.
One affirms single-agent EGFR TKI treatment, such as with osimertinib, as the current standard of care for first-line advanced metastatic EGFR-positive mNSCLC, and the other affirms clear benefits for first-generation EGFR TKIs combined with either chemotherapy or VEGF monoclonal antibodies.
In the analysis supporting combination therapy for mNSCLC, Sara Moore, MD, and Paul Wheatley-Price MD, wrote that while targeted therapy with EGFR TKIs is highly effective initially, resistance inevitably develops.
Recent data, they stated, have demonstrated that combination strategies can delay development of resistance and improve outcomes for mNSCLC populations. Combining first-generation EGFR TKIs with either chemotherapy or VEGF monoclonal antibodies has led to consistent improvement in progression-free survival (PFS) and overall survival (OS) in some cases. In the NEJ009 trial, the combination of chemotherapy (carboplatin and pemetrexed, with pemetrexed maintenance) plus gefitinib versus gefitinib alone improved response rate (84% vs. 67%, P < 0.001), PFS (median, 20.9 months vs. 11.2 months; P < .001), and OS (median, 50.9 months vs. 38.8 months; P = .021). An increase in adverse events in the chemotherapy arm led to a decrease in quality of life.
Another clinical trial (by Noronha and colleagues) conducted in India of the same combination found benefit for combination therapy in response rate (75% vs. 63%), PFS (median, 16 months vs. 8 months), and OS (not reached vs. 17 months). Grade 3 or higher adverse event rates were higher with the combination (51% vs. 25%) with quality of life was not yet reported.
While both trials have been criticized owing to a lack of standard T790M resistance testing and low use of osimertinib in subsequent lines of therapy, Dr. Moore and Dr. Wheatley-Price pointed out: “Even with the use of first-line osimertinib monotherapy, patients may still be exposed to chemotherapy with later lines of treatment. Therefore, combination therapy does not expose patients to new toxicity, it simply changes when they will be exposed to that toxicity during their treatment course.”
The importance of using combination therapy in the first-line setting, they stated, is underscored by the consistent drop-off in patients who receive second-line combination therapy. In the phase 3 FLAURA trial of first-line osimertinib monotherapy, of the patients who discontinued osimertinib, the most common reason for not receiving subsequent therapy was death (60% went on to receive further systemic therapy). This highlights the need to use the most effective treatments up front, Dr. Moore and Dr. Wheatley-Price wrote.
The four large trials of VEGF-targeted therapy with either monoclonal antibodies or TKIs added to first-generation EGFR TKIs have consistently shown improved PFS. Increased toxicities led to discontinuation of VEGF-targeted therapy in 20%-30%.
In the RELAY trial, however, despite more toxicities, quality of life was not diminished. In general, the authors concluded that long-term detriments to quality of life have not been demonstrated. Ongoing studies of osimertinib in combination with VEGF inhibition include a phase 1/2 trial with bevacizumab in previously untreated patients showing an 80% response rate (median PFS, 18.4 months) with no unexpected toxicity.
Chemotherapy-based treatment for mNSCLC with third-generation EGFR TKIs, in appropriately selected patients, the authors concluded, “can offer an additional standard-of-care option as first-line treatment of EGFR-mutant lung cancer.”
Since the introduction of EGFR TKIs, Sophie Stock-Martineau, MD and Frances A. Shepherd, MD noted in their analysis, researchers have aimed to improve their efficacy through combining them with other agents. The authors review research on the addition of chemo- or immunotherapy and agents targeting major resistance mechanisms such as MET. Their review of the same NEJ009 trial focuses, however, on the 65.3% (EGFR TKI plus chemotherapy) versus 31.0% (gefitinib alone) grade 3 adverse event rate, and the 51% versus 25% grade 3 adverse event rate in a similar trial by Noronha and colleagues. The review by Dr. Stock-Martineau and Dr. Shepherd further found that, while adding antiangiogenic agents to an EGFR TKI “mildly” prolongs PFS, survival benefits have not been demonstrated. The added costs, not just in toxicity, were a “far from negligible” $120,000 above the cost of bevacizumab alone for 16 treatments. Data from trials of immune checkpoint inhibitors added to EGFR TKIs reveal heightened toxicities and limited efficacy. Trials of EGFR monoclonal antibodies with an EGFR TKI showed no PFS or OS benefit and were terminated early. Similarly, evidence to date shows no benefit beyond that shown for EGFR TKI monotherapy with the addition of a MET inhibitor.
“Adding virtually all agents to EGFR TKIs has been associated with more toxicity to patients and a significant financial burden to the health care system,” Dr. Stock-Martineau and Dr. Shepherd concluded, further observing that combinations, given their heightened toxicity profiles, could potentially also worsen quality of life.
No conflicts of interest were reported by the authors of either study.
FROM THE JOURNAL OF THORACIC ONCOLOGY
Celebratory binge drinking a potential trigger for new-onset AFib
Emergency department visits for atrial fibrillation (AFib) appear to go up on days around some annual events in the United States that many people commemorate by consuming alcohol in excess – think Christmas, New Year’s Day, and Super Bowl Sunday.
The novel finding seemed especially true for people without a previous AFib diagnosis, suggesting that alcohol intake, and especially binge drinking, “may acutely enhance the risk” of new-onset AFib, propose researchers in their Jan. 12 report for the inaugural issue of Nature Cardiovascular Research.
Leveraging an international database of breathalyzer test results, the group saw jumps in alcohol intake across several days surrounding eight “recurrent, nationally recognized events,” which also included U.S. Independence Day and the FIFA World Cup.
They then compared the timing of those events to ED visits linked to acute alcohol ingestion and, separately, to ED visits coded for AFib in 10 years of data that cover all of California.
Collectively, the eight annual occasions for heavy alcohol use corresponded to spikes in both kinds of ED visit. Their relationship to AFib-related visits overall grew in strength when the analysis was restricted to new AFib diagnoses.
The researchers acknowledge the limitations of their observational study. Still, the findings represent “the first evidence that acute exposure to alcohol can lead to a given atrial fib episode in a short period of time, even among those without an established AFib diagnosis,” senior author Gregory M. Marcus, MD, MAS, University of California, San Francisco, told this news organization.
“The observation that this was detectable in the general population is a warning to those who drink heavily that any one episode of excessive alcohol consumption could land them in the ED with atrial fibrillation,” he said.
It’s “definitely speculation,” but such ED visits could represent an opportunity for individuals to link their new arrhythmia with a specific episode of excessive drinking, strengthening the message that the two are likely connected, Dr. Marcus observed. The experience could potentially inspire some to “reduce or eliminate” their alcohol intake in an effort to avoid future AFib.
The group obtained data from 2014 to 2016 on more than 1.2 million breath alcohol measurements from about 36,000 people in 59 countries, half residing in the United States, who used commercially available breathalyzer devices from one manufacturer (BACtrack).
The 8 days marking recurrent nationally recognized events, and the days before and after them, were associated with mean blood-alcohol concentrations in the top fifth percentile for the year.
The same eight occasions marked significant bumps in ED visits related to acute alcohol ingestion in records from the California Office of Statewide Health Planning and Development (OSHPD), which documented almost 1.2 million such visits from 2005 to 2015.
Collectively in adjusted analysis, the eight nationally recognized events, compared with other days of the year, accounted for 2,640 excess alcohol-related ED visits per 100,000 person-years across all of California (P < .001).
Separately, ED visits coded for a diagnosis of AFib concentrated significantly around those same 8 days, on which there was an excess of 719 such AFib-related visits per 100,000 person-years (P = .008).
The analysis was replicated after exclusion of OSHPD records from anyone with a previous AFib-related ED visit or hospitalization, or previous outpatient procedure related to AFib, such as ablation or cardioversion. It saw 1,757 excess ED visits per 100,000 person-years (P < .001) for what was considered new-onset AFib in association with the eight nationally recognized events, compared with the rest of the year.
The implication, that a bout of alcohol use leading to an ED visit can acutely raise the risk for a first episode of AFib, was subjected to a “negative control analysis” that focused on ED visits for supraventricular tachycardia. It showed no significant relationships with the eight nationally recognized events.
“We think that helps demonstrate that it’s not just more ED visits, more palpitations, or more heart-related visits per se” associated with acute alcohol use, Dr. Marcus said, “but that it’s something fairly specific to AFib.”
The authors declare no competing interests. Dr. Marcus has previously reported research with Medtronic, Eight Sleep, and Baylis; consulting for InCarda Therapeutics and Johnson & Johnson; and equity in InCarda Therapeutics as cofounder.
A version of this article first appeared on Medscape.com.
Emergency department visits for atrial fibrillation (AFib) appear to go up on days around some annual events in the United States that many people commemorate by consuming alcohol in excess – think Christmas, New Year’s Day, and Super Bowl Sunday.
The novel finding seemed especially true for people without a previous AFib diagnosis, suggesting that alcohol intake, and especially binge drinking, “may acutely enhance the risk” of new-onset AFib, propose researchers in their Jan. 12 report for the inaugural issue of Nature Cardiovascular Research.
Leveraging an international database of breathalyzer test results, the group saw jumps in alcohol intake across several days surrounding eight “recurrent, nationally recognized events,” which also included U.S. Independence Day and the FIFA World Cup.
They then compared the timing of those events to ED visits linked to acute alcohol ingestion and, separately, to ED visits coded for AFib in 10 years of data that cover all of California.
Collectively, the eight annual occasions for heavy alcohol use corresponded to spikes in both kinds of ED visit. Their relationship to AFib-related visits overall grew in strength when the analysis was restricted to new AFib diagnoses.
The researchers acknowledge the limitations of their observational study. Still, the findings represent “the first evidence that acute exposure to alcohol can lead to a given atrial fib episode in a short period of time, even among those without an established AFib diagnosis,” senior author Gregory M. Marcus, MD, MAS, University of California, San Francisco, told this news organization.
“The observation that this was detectable in the general population is a warning to those who drink heavily that any one episode of excessive alcohol consumption could land them in the ED with atrial fibrillation,” he said.
It’s “definitely speculation,” but such ED visits could represent an opportunity for individuals to link their new arrhythmia with a specific episode of excessive drinking, strengthening the message that the two are likely connected, Dr. Marcus observed. The experience could potentially inspire some to “reduce or eliminate” their alcohol intake in an effort to avoid future AFib.
The group obtained data from 2014 to 2016 on more than 1.2 million breath alcohol measurements from about 36,000 people in 59 countries, half residing in the United States, who used commercially available breathalyzer devices from one manufacturer (BACtrack).
The 8 days marking recurrent nationally recognized events, and the days before and after them, were associated with mean blood-alcohol concentrations in the top fifth percentile for the year.
The same eight occasions marked significant bumps in ED visits related to acute alcohol ingestion in records from the California Office of Statewide Health Planning and Development (OSHPD), which documented almost 1.2 million such visits from 2005 to 2015.
Collectively in adjusted analysis, the eight nationally recognized events, compared with other days of the year, accounted for 2,640 excess alcohol-related ED visits per 100,000 person-years across all of California (P < .001).
Separately, ED visits coded for a diagnosis of AFib concentrated significantly around those same 8 days, on which there was an excess of 719 such AFib-related visits per 100,000 person-years (P = .008).
The analysis was replicated after exclusion of OSHPD records from anyone with a previous AFib-related ED visit or hospitalization, or previous outpatient procedure related to AFib, such as ablation or cardioversion. It saw 1,757 excess ED visits per 100,000 person-years (P < .001) for what was considered new-onset AFib in association with the eight nationally recognized events, compared with the rest of the year.
The implication, that a bout of alcohol use leading to an ED visit can acutely raise the risk for a first episode of AFib, was subjected to a “negative control analysis” that focused on ED visits for supraventricular tachycardia. It showed no significant relationships with the eight nationally recognized events.
“We think that helps demonstrate that it’s not just more ED visits, more palpitations, or more heart-related visits per se” associated with acute alcohol use, Dr. Marcus said, “but that it’s something fairly specific to AFib.”
The authors declare no competing interests. Dr. Marcus has previously reported research with Medtronic, Eight Sleep, and Baylis; consulting for InCarda Therapeutics and Johnson & Johnson; and equity in InCarda Therapeutics as cofounder.
A version of this article first appeared on Medscape.com.
Emergency department visits for atrial fibrillation (AFib) appear to go up on days around some annual events in the United States that many people commemorate by consuming alcohol in excess – think Christmas, New Year’s Day, and Super Bowl Sunday.
The novel finding seemed especially true for people without a previous AFib diagnosis, suggesting that alcohol intake, and especially binge drinking, “may acutely enhance the risk” of new-onset AFib, propose researchers in their Jan. 12 report for the inaugural issue of Nature Cardiovascular Research.
Leveraging an international database of breathalyzer test results, the group saw jumps in alcohol intake across several days surrounding eight “recurrent, nationally recognized events,” which also included U.S. Independence Day and the FIFA World Cup.
They then compared the timing of those events to ED visits linked to acute alcohol ingestion and, separately, to ED visits coded for AFib in 10 years of data that cover all of California.
Collectively, the eight annual occasions for heavy alcohol use corresponded to spikes in both kinds of ED visit. Their relationship to AFib-related visits overall grew in strength when the analysis was restricted to new AFib diagnoses.
The researchers acknowledge the limitations of their observational study. Still, the findings represent “the first evidence that acute exposure to alcohol can lead to a given atrial fib episode in a short period of time, even among those without an established AFib diagnosis,” senior author Gregory M. Marcus, MD, MAS, University of California, San Francisco, told this news organization.
“The observation that this was detectable in the general population is a warning to those who drink heavily that any one episode of excessive alcohol consumption could land them in the ED with atrial fibrillation,” he said.
It’s “definitely speculation,” but such ED visits could represent an opportunity for individuals to link their new arrhythmia with a specific episode of excessive drinking, strengthening the message that the two are likely connected, Dr. Marcus observed. The experience could potentially inspire some to “reduce or eliminate” their alcohol intake in an effort to avoid future AFib.
The group obtained data from 2014 to 2016 on more than 1.2 million breath alcohol measurements from about 36,000 people in 59 countries, half residing in the United States, who used commercially available breathalyzer devices from one manufacturer (BACtrack).
The 8 days marking recurrent nationally recognized events, and the days before and after them, were associated with mean blood-alcohol concentrations in the top fifth percentile for the year.
The same eight occasions marked significant bumps in ED visits related to acute alcohol ingestion in records from the California Office of Statewide Health Planning and Development (OSHPD), which documented almost 1.2 million such visits from 2005 to 2015.
Collectively in adjusted analysis, the eight nationally recognized events, compared with other days of the year, accounted for 2,640 excess alcohol-related ED visits per 100,000 person-years across all of California (P < .001).
Separately, ED visits coded for a diagnosis of AFib concentrated significantly around those same 8 days, on which there was an excess of 719 such AFib-related visits per 100,000 person-years (P = .008).
The analysis was replicated after exclusion of OSHPD records from anyone with a previous AFib-related ED visit or hospitalization, or previous outpatient procedure related to AFib, such as ablation or cardioversion. It saw 1,757 excess ED visits per 100,000 person-years (P < .001) for what was considered new-onset AFib in association with the eight nationally recognized events, compared with the rest of the year.
The implication, that a bout of alcohol use leading to an ED visit can acutely raise the risk for a first episode of AFib, was subjected to a “negative control analysis” that focused on ED visits for supraventricular tachycardia. It showed no significant relationships with the eight nationally recognized events.
“We think that helps demonstrate that it’s not just more ED visits, more palpitations, or more heart-related visits per se” associated with acute alcohol use, Dr. Marcus said, “but that it’s something fairly specific to AFib.”
The authors declare no competing interests. Dr. Marcus has previously reported research with Medtronic, Eight Sleep, and Baylis; consulting for InCarda Therapeutics and Johnson & Johnson; and equity in InCarda Therapeutics as cofounder.
A version of this article first appeared on Medscape.com.
‘We just have to keep them alive’: Transitioning youth with type 1 diabetes
“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.
Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.
Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.
“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”
In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”
This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.
Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
Challenges when transitioning from pediatric to adult care
During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.
When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.
The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.
Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.
At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.
“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.
As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
Engage with kid, not disease; don’t palm them off on new recruits
“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”
“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.
Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.
“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.
And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.
Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.
But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”
He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.
This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”
In short, it must be someone experienced who loves working with this age group.
Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”
And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
Preparing for the transition
To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.
This should also include transferring management responsibilities to the young adult rather than their parent.
The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.
And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.
Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.
Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.
“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.
What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
Be a guide, not a gatekeeper
Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”
“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”
Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”
“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’
“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”
Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.
“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”
Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.
While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.
“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.
“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.
One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.
“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.
Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.
As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.
The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.
Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
“This is high priority”
Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.
“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.
“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”
And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”
Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”
Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.
A version of this article first appeared on Medscape.com.
“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.
Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.
Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.
“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”
In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”
This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.
Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
Challenges when transitioning from pediatric to adult care
During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.
When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.
The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.
Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.
At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.
“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.
As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
Engage with kid, not disease; don’t palm them off on new recruits
“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”
“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.
Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.
“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.
And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.
Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.
But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”
He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.
This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”
In short, it must be someone experienced who loves working with this age group.
Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”
And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
Preparing for the transition
To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.
This should also include transferring management responsibilities to the young adult rather than their parent.
The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.
And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.
Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.
Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.
“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.
What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
Be a guide, not a gatekeeper
Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”
“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”
Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”
“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’
“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”
Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.
“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”
Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.
While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.
“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.
“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.
One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.
“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.
Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.
As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.
The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.
Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
“This is high priority”
Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.
“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.
“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”
And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”
Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”
Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.
A version of this article first appeared on Medscape.com.
“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.
Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.
Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.
“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”
In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”
This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.
Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
Challenges when transitioning from pediatric to adult care
During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.
When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.
The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.
Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.
At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.
“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.
As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
Engage with kid, not disease; don’t palm them off on new recruits
“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”
“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.
Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.
“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.
And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.
Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.
But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”
He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.
This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”
In short, it must be someone experienced who loves working with this age group.
Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”
And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
Preparing for the transition
To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.
This should also include transferring management responsibilities to the young adult rather than their parent.
The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.
And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.
Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.
Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.
“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.
What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
Be a guide, not a gatekeeper
Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”
“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”
Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”
“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’
“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”
Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.
“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”
Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.
While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.
“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.
“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.
One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.
“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.
Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.
As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.
The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.
Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
“This is high priority”
Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.
“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.
“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”
And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”
Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”
Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.
A version of this article first appeared on Medscape.com.
Abraxane still in short supply for cancer patients
Abraxane (Bristol-Myers Squibb) is a paclitaxel albumin-bound injectable. It is different from alternative chemotherapy treatments like Taxol (paclitaxel) because it doesn’t use the solvents that can make Taxol difficult to tolerate. It was described as a “next-generation taxane” because it didn’t rely on solvents. It was approved in 2005 for metastatic breast cancer, then in 2012 for advanced non–small cell lung cancer, in 2013 for late-stage pancreatic cancer and in 2019 for people with PD-L1–positive metastatic triple-negative breast cancer.
The shortage, which was announced on Oct. 5, 2021, by the Food and Drug Administration, has led to some difficult decisions for patients and physicians. How long the shortage will last isn’t clear.
“I printed out [an] allotment sheet 2 days ago, and all it says [for Abraxane] is allocated,” said Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, Hammond, La. “Everyone is keeping what they’ve got for their own patients, so there really isn’t anything available.”
The Pontchartrain Cancer Center sent two patients to the University of Texas MD Anderson Cancer Center, Houston, for continued treatment with Abraxane, but that option is costly and time consuming for patients. The two patients had the means to travel, but Ms. Oubre said that many others cannot afford to travel for treatment. “Everyone has patients who are living paycheck to paycheck who certainly couldn’t afford to do that. There are going to be patients across the nation that are not going to be able to have care as a result of these things.”
The supply problems are causing difficult decisions for physicians, who may have to switch a patient from an unavailable drug to an alternative that isn’t as effective, Ms. Oubre said. “I can’t imagine the stress and the sadness that the physicians have to feel when they have to go explain that to a patient. That runs counter to everything they are as physicians.”
Other strategies include chemo holidays and rounding down doses in patients with metastatic cancer, according to Camille Hill, PharmD, vice president of oncology pharmacy services, West Cancer Center, Germantown, Tenn.
Shortages and allocations are growing at an alarming rate, Ms. Oubre said. In her 15 years of working in the industry, “I don’t recall it ever being this challenging.” During a Zoom interview, she held up a lengthy list of drugs on allocation or unavailable that her pharmacy group purchasing organization sent her the previous week. “I don’t ever recall getting this kind of list. Every 3 days, I’m getting this. If it were just that one product, I can live with that. We figure it out. But it’s bigger than that.”
Worker shortages are exacerbating the issue. Ms. Oubre received a letter from a drug company describing its employee issues, which included chemists, plant workers, and loading dock staff. On top of that, delivery companies are experiencing staff shortages, which can result in more delays and complicate matters further. “It’s just compounding. These things can get really difficult very quickly. I don’t want to say we’re in crisis, and we’re not rationing care. We’re not in those buckets yet. But I would say that if these things don’t get better, it’s the first time in my work career that we are having those conversations of: ‘How we are going to plan for that it does come to that?’ ” she said.
“In general, with the pandemic, we have seen all sorts of just disruptions to the supply chain. So, I think you just do your best, you find alternatives for those patients that you can, and you come up with strategies. I don’t know that for Abraxane, or any other product, that I’d be particularly confident that we may not see another shortage,” Dr. Hill said.
Abraxane (Bristol-Myers Squibb) is a paclitaxel albumin-bound injectable. It is different from alternative chemotherapy treatments like Taxol (paclitaxel) because it doesn’t use the solvents that can make Taxol difficult to tolerate. It was described as a “next-generation taxane” because it didn’t rely on solvents. It was approved in 2005 for metastatic breast cancer, then in 2012 for advanced non–small cell lung cancer, in 2013 for late-stage pancreatic cancer and in 2019 for people with PD-L1–positive metastatic triple-negative breast cancer.
The shortage, which was announced on Oct. 5, 2021, by the Food and Drug Administration, has led to some difficult decisions for patients and physicians. How long the shortage will last isn’t clear.
“I printed out [an] allotment sheet 2 days ago, and all it says [for Abraxane] is allocated,” said Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, Hammond, La. “Everyone is keeping what they’ve got for their own patients, so there really isn’t anything available.”
The Pontchartrain Cancer Center sent two patients to the University of Texas MD Anderson Cancer Center, Houston, for continued treatment with Abraxane, but that option is costly and time consuming for patients. The two patients had the means to travel, but Ms. Oubre said that many others cannot afford to travel for treatment. “Everyone has patients who are living paycheck to paycheck who certainly couldn’t afford to do that. There are going to be patients across the nation that are not going to be able to have care as a result of these things.”
The supply problems are causing difficult decisions for physicians, who may have to switch a patient from an unavailable drug to an alternative that isn’t as effective, Ms. Oubre said. “I can’t imagine the stress and the sadness that the physicians have to feel when they have to go explain that to a patient. That runs counter to everything they are as physicians.”
Other strategies include chemo holidays and rounding down doses in patients with metastatic cancer, according to Camille Hill, PharmD, vice president of oncology pharmacy services, West Cancer Center, Germantown, Tenn.
Shortages and allocations are growing at an alarming rate, Ms. Oubre said. In her 15 years of working in the industry, “I don’t recall it ever being this challenging.” During a Zoom interview, she held up a lengthy list of drugs on allocation or unavailable that her pharmacy group purchasing organization sent her the previous week. “I don’t ever recall getting this kind of list. Every 3 days, I’m getting this. If it were just that one product, I can live with that. We figure it out. But it’s bigger than that.”
Worker shortages are exacerbating the issue. Ms. Oubre received a letter from a drug company describing its employee issues, which included chemists, plant workers, and loading dock staff. On top of that, delivery companies are experiencing staff shortages, which can result in more delays and complicate matters further. “It’s just compounding. These things can get really difficult very quickly. I don’t want to say we’re in crisis, and we’re not rationing care. We’re not in those buckets yet. But I would say that if these things don’t get better, it’s the first time in my work career that we are having those conversations of: ‘How we are going to plan for that it does come to that?’ ” she said.
“In general, with the pandemic, we have seen all sorts of just disruptions to the supply chain. So, I think you just do your best, you find alternatives for those patients that you can, and you come up with strategies. I don’t know that for Abraxane, or any other product, that I’d be particularly confident that we may not see another shortage,” Dr. Hill said.
Abraxane (Bristol-Myers Squibb) is a paclitaxel albumin-bound injectable. It is different from alternative chemotherapy treatments like Taxol (paclitaxel) because it doesn’t use the solvents that can make Taxol difficult to tolerate. It was described as a “next-generation taxane” because it didn’t rely on solvents. It was approved in 2005 for metastatic breast cancer, then in 2012 for advanced non–small cell lung cancer, in 2013 for late-stage pancreatic cancer and in 2019 for people with PD-L1–positive metastatic triple-negative breast cancer.
The shortage, which was announced on Oct. 5, 2021, by the Food and Drug Administration, has led to some difficult decisions for patients and physicians. How long the shortage will last isn’t clear.
“I printed out [an] allotment sheet 2 days ago, and all it says [for Abraxane] is allocated,” said Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, Hammond, La. “Everyone is keeping what they’ve got for their own patients, so there really isn’t anything available.”
The Pontchartrain Cancer Center sent two patients to the University of Texas MD Anderson Cancer Center, Houston, for continued treatment with Abraxane, but that option is costly and time consuming for patients. The two patients had the means to travel, but Ms. Oubre said that many others cannot afford to travel for treatment. “Everyone has patients who are living paycheck to paycheck who certainly couldn’t afford to do that. There are going to be patients across the nation that are not going to be able to have care as a result of these things.”
The supply problems are causing difficult decisions for physicians, who may have to switch a patient from an unavailable drug to an alternative that isn’t as effective, Ms. Oubre said. “I can’t imagine the stress and the sadness that the physicians have to feel when they have to go explain that to a patient. That runs counter to everything they are as physicians.”
Other strategies include chemo holidays and rounding down doses in patients with metastatic cancer, according to Camille Hill, PharmD, vice president of oncology pharmacy services, West Cancer Center, Germantown, Tenn.
Shortages and allocations are growing at an alarming rate, Ms. Oubre said. In her 15 years of working in the industry, “I don’t recall it ever being this challenging.” During a Zoom interview, she held up a lengthy list of drugs on allocation or unavailable that her pharmacy group purchasing organization sent her the previous week. “I don’t ever recall getting this kind of list. Every 3 days, I’m getting this. If it were just that one product, I can live with that. We figure it out. But it’s bigger than that.”
Worker shortages are exacerbating the issue. Ms. Oubre received a letter from a drug company describing its employee issues, which included chemists, plant workers, and loading dock staff. On top of that, delivery companies are experiencing staff shortages, which can result in more delays and complicate matters further. “It’s just compounding. These things can get really difficult very quickly. I don’t want to say we’re in crisis, and we’re not rationing care. We’re not in those buckets yet. But I would say that if these things don’t get better, it’s the first time in my work career that we are having those conversations of: ‘How we are going to plan for that it does come to that?’ ” she said.
“In general, with the pandemic, we have seen all sorts of just disruptions to the supply chain. So, I think you just do your best, you find alternatives for those patients that you can, and you come up with strategies. I don’t know that for Abraxane, or any other product, that I’d be particularly confident that we may not see another shortage,” Dr. Hill said.
Doc’s botched surgery leads to incontinence and $10 million judgment; more
Early in December 2021 a jury awarded a couple $10 million in a case involving a hysterectomy that went badly wrong, according to a story in the New York Post, among other news sites.
In October 2018, Michele Nugent, 41, of New York, underwent the procedure at Richmond University Medical Center. After giving birth to four children via cesarean delivery, she had developed scarring and was suffering from excessive and painful uterine bleeding.
A few days after her hysterectomy, however, Ms. Nugent experienced what she described as the worst pain of her life, along with nausea, vomiting, and urinary leakage. She was brought to the hospital emergency department, where she was reportedly told by staff there that her symptoms were normal complications of her surgery and that the treating gynecologist, Eli Serur, MD, would soon be in touch.
Despite these reassurances, Ms. Nugent’s postsurgical issues continued to worsen over the next 10 days. Among other things, she lost almost complete control of her bladder, which required her to wear adult diapers. Still, her doctor’s office told her to put off visiting until her next scheduled appointment.
At that meeting, which took place 13 days after Ms. Nugent’s surgery, Dr. Serur diagnosed a urinary tract infection and placed her on antibiotics. He also encouraged her to return to work the following week.
Ms. Nugent’s problems persisted, however. At an office meeting that included 20 men, she suddenly lost complete control of her bladder, despite going regularly to the bathroom and wearing adult diapers. “Out of nowhere,” she testified at trial, “I urinated all over myself and had to leave.” The experience left her humiliated and embarrassed.
Several weeks later, Ms. Nugent consulted with a urologist, who soon repaired the cause of her urinary problems – a fistula between her vagina and bladder.
Though successful, the procedure still left Ms. Nugent with, what are for now at least, intractable symptoms. At night, she’s forced to make multiple trips to the bathroom, and sex with her husband has become all but impossible because of the pain it elicits.
In reaching its verdict, the jury of four women and two men faulted Dr. Serur for not only performing a faulty surgery but for failing to identify and correct his mistake. In so doing, it concluded, he had departed “from good and accepted medical practice.”
Jurors divided the $10 million judgment against him into two parts: $6.5 million for Ms. Nugent’s past and future suffering, and $3.5 million to her husband for his past and future loss of consortium – that is, his loss of intimacy with his wife.
As for the medical center, the Nugents agreed to dismiss it from the case prior to trial.
Physician accused of gross negligence finally surrenders his license
A California doctor under investigation multiple times during the past 2 decades has surrendered his medical license, as a story reported by Valley Public Radio indicates.
Since 1999, the Medical Board of California has opened three investigations against Bakersfield ob.gyn. Arthur Park, MD, each involving accusations of gross negligence “following the deaths of mothers and/or their babies during childbirth.” In 2000, and again in 2020, the board voted that Dr. Park should lose his license but then suspended its decision, which enabled Dr. Park to continue practicing under probation and on condition that he complete remedial education.
Early in 2021, however, the board filed yet another accusation against him, this one involving the 2019 death of Demi Dominguez and her newborn baby. According to the accusation, Ms. Dominguez died of preeclampsia because Dr. Park and a colleague failed to treat her high blood pressure prior to delivery. While doctors attempted to resuscitate her, Ms. Dominguez’s son was delivered by emergency cesarean but died only a few hours later. The board said that Dr. Park was “grossly negligent in his care and treatment” and that his actions constituted “an extreme departure from the applicable standard of care.”
Early in December 2021, even before the board and attorney general’s office had completed their investigations, Dr. Park agreed to surrender his medical license.
Patient advocates were pleased by the doctor’s decision but also disappointed that he’d no longer be compelled to stand before a judge, as he had been scheduled to do in connection with the Dominguez case.
A review of public records by Valley Public Radio indicates that – between the various board accusations against him and an additional nine lawsuits alleging malpractice and other issues – at least two mothers and five children have died while under Dr. Park’s care. Others whose delivery he oversaw claim their children were permanently injured during childbirth.
Although Dr. Park will be eligible to reapply for his license after 2 years, a representative of his medical office said Dr. Park had decided to retire from practicing medicine.
Delayed cancer diagnosis prompts med-mal suit
An Illinois woman who claims her doctor and his staff failed to follow up on her abnormal Pap smear has filed a malpractice suit against them and their medical group, reports a story in the Madison-St. Clair Record.
In early 2019, Lisa Albright visited the medical group after she had experienced pain during intercourse. A family nurse practitioner at the practice performed a Pap smear, and Ms. Albright was instructed to wait a few days and check her patient portal for the results. In her suit, Ms. Albright claims those results were abnormal. Despite this, neither the nurse practitioner nor anyone else at the practice scheduled a follow-up test or other diagnostic assessment.
Approximately 5 months later, Ms. Albright consulted a new physician, whose follow-up testing indicated that Ms. Albright had a cervical squamous cell carcinoma.
Ms. Albright’s suit alleges that the diagnostic delay has, among other things, caused her to undergo multiple surgical procedures and treatments, face a shorter life expectancy, and endure a loss in the quality of her life.
At press time, Ms. Albright and her legal representative have not yet determined the amount they will ask for – it will be set after the severity and permanency of Ms. Albright’s injuries have been more thoroughly investigated. But it’s expected that they will seek damages, along with all legal and court expenses.
The defendants haven’t responded to the plaintiff’s suit.
A version of this article first appeared on Medscape.com.
Early in December 2021 a jury awarded a couple $10 million in a case involving a hysterectomy that went badly wrong, according to a story in the New York Post, among other news sites.
In October 2018, Michele Nugent, 41, of New York, underwent the procedure at Richmond University Medical Center. After giving birth to four children via cesarean delivery, she had developed scarring and was suffering from excessive and painful uterine bleeding.
A few days after her hysterectomy, however, Ms. Nugent experienced what she described as the worst pain of her life, along with nausea, vomiting, and urinary leakage. She was brought to the hospital emergency department, where she was reportedly told by staff there that her symptoms were normal complications of her surgery and that the treating gynecologist, Eli Serur, MD, would soon be in touch.
Despite these reassurances, Ms. Nugent’s postsurgical issues continued to worsen over the next 10 days. Among other things, she lost almost complete control of her bladder, which required her to wear adult diapers. Still, her doctor’s office told her to put off visiting until her next scheduled appointment.
At that meeting, which took place 13 days after Ms. Nugent’s surgery, Dr. Serur diagnosed a urinary tract infection and placed her on antibiotics. He also encouraged her to return to work the following week.
Ms. Nugent’s problems persisted, however. At an office meeting that included 20 men, she suddenly lost complete control of her bladder, despite going regularly to the bathroom and wearing adult diapers. “Out of nowhere,” she testified at trial, “I urinated all over myself and had to leave.” The experience left her humiliated and embarrassed.
Several weeks later, Ms. Nugent consulted with a urologist, who soon repaired the cause of her urinary problems – a fistula between her vagina and bladder.
Though successful, the procedure still left Ms. Nugent with, what are for now at least, intractable symptoms. At night, she’s forced to make multiple trips to the bathroom, and sex with her husband has become all but impossible because of the pain it elicits.
In reaching its verdict, the jury of four women and two men faulted Dr. Serur for not only performing a faulty surgery but for failing to identify and correct his mistake. In so doing, it concluded, he had departed “from good and accepted medical practice.”
Jurors divided the $10 million judgment against him into two parts: $6.5 million for Ms. Nugent’s past and future suffering, and $3.5 million to her husband for his past and future loss of consortium – that is, his loss of intimacy with his wife.
As for the medical center, the Nugents agreed to dismiss it from the case prior to trial.
Physician accused of gross negligence finally surrenders his license
A California doctor under investigation multiple times during the past 2 decades has surrendered his medical license, as a story reported by Valley Public Radio indicates.
Since 1999, the Medical Board of California has opened three investigations against Bakersfield ob.gyn. Arthur Park, MD, each involving accusations of gross negligence “following the deaths of mothers and/or their babies during childbirth.” In 2000, and again in 2020, the board voted that Dr. Park should lose his license but then suspended its decision, which enabled Dr. Park to continue practicing under probation and on condition that he complete remedial education.
Early in 2021, however, the board filed yet another accusation against him, this one involving the 2019 death of Demi Dominguez and her newborn baby. According to the accusation, Ms. Dominguez died of preeclampsia because Dr. Park and a colleague failed to treat her high blood pressure prior to delivery. While doctors attempted to resuscitate her, Ms. Dominguez’s son was delivered by emergency cesarean but died only a few hours later. The board said that Dr. Park was “grossly negligent in his care and treatment” and that his actions constituted “an extreme departure from the applicable standard of care.”
Early in December 2021, even before the board and attorney general’s office had completed their investigations, Dr. Park agreed to surrender his medical license.
Patient advocates were pleased by the doctor’s decision but also disappointed that he’d no longer be compelled to stand before a judge, as he had been scheduled to do in connection with the Dominguez case.
A review of public records by Valley Public Radio indicates that – between the various board accusations against him and an additional nine lawsuits alleging malpractice and other issues – at least two mothers and five children have died while under Dr. Park’s care. Others whose delivery he oversaw claim their children were permanently injured during childbirth.
Although Dr. Park will be eligible to reapply for his license after 2 years, a representative of his medical office said Dr. Park had decided to retire from practicing medicine.
Delayed cancer diagnosis prompts med-mal suit
An Illinois woman who claims her doctor and his staff failed to follow up on her abnormal Pap smear has filed a malpractice suit against them and their medical group, reports a story in the Madison-St. Clair Record.
In early 2019, Lisa Albright visited the medical group after she had experienced pain during intercourse. A family nurse practitioner at the practice performed a Pap smear, and Ms. Albright was instructed to wait a few days and check her patient portal for the results. In her suit, Ms. Albright claims those results were abnormal. Despite this, neither the nurse practitioner nor anyone else at the practice scheduled a follow-up test or other diagnostic assessment.
Approximately 5 months later, Ms. Albright consulted a new physician, whose follow-up testing indicated that Ms. Albright had a cervical squamous cell carcinoma.
Ms. Albright’s suit alleges that the diagnostic delay has, among other things, caused her to undergo multiple surgical procedures and treatments, face a shorter life expectancy, and endure a loss in the quality of her life.
At press time, Ms. Albright and her legal representative have not yet determined the amount they will ask for – it will be set after the severity and permanency of Ms. Albright’s injuries have been more thoroughly investigated. But it’s expected that they will seek damages, along with all legal and court expenses.
The defendants haven’t responded to the plaintiff’s suit.
A version of this article first appeared on Medscape.com.
Early in December 2021 a jury awarded a couple $10 million in a case involving a hysterectomy that went badly wrong, according to a story in the New York Post, among other news sites.
In October 2018, Michele Nugent, 41, of New York, underwent the procedure at Richmond University Medical Center. After giving birth to four children via cesarean delivery, she had developed scarring and was suffering from excessive and painful uterine bleeding.
A few days after her hysterectomy, however, Ms. Nugent experienced what she described as the worst pain of her life, along with nausea, vomiting, and urinary leakage. She was brought to the hospital emergency department, where she was reportedly told by staff there that her symptoms were normal complications of her surgery and that the treating gynecologist, Eli Serur, MD, would soon be in touch.
Despite these reassurances, Ms. Nugent’s postsurgical issues continued to worsen over the next 10 days. Among other things, she lost almost complete control of her bladder, which required her to wear adult diapers. Still, her doctor’s office told her to put off visiting until her next scheduled appointment.
At that meeting, which took place 13 days after Ms. Nugent’s surgery, Dr. Serur diagnosed a urinary tract infection and placed her on antibiotics. He also encouraged her to return to work the following week.
Ms. Nugent’s problems persisted, however. At an office meeting that included 20 men, she suddenly lost complete control of her bladder, despite going regularly to the bathroom and wearing adult diapers. “Out of nowhere,” she testified at trial, “I urinated all over myself and had to leave.” The experience left her humiliated and embarrassed.
Several weeks later, Ms. Nugent consulted with a urologist, who soon repaired the cause of her urinary problems – a fistula between her vagina and bladder.
Though successful, the procedure still left Ms. Nugent with, what are for now at least, intractable symptoms. At night, she’s forced to make multiple trips to the bathroom, and sex with her husband has become all but impossible because of the pain it elicits.
In reaching its verdict, the jury of four women and two men faulted Dr. Serur for not only performing a faulty surgery but for failing to identify and correct his mistake. In so doing, it concluded, he had departed “from good and accepted medical practice.”
Jurors divided the $10 million judgment against him into two parts: $6.5 million for Ms. Nugent’s past and future suffering, and $3.5 million to her husband for his past and future loss of consortium – that is, his loss of intimacy with his wife.
As for the medical center, the Nugents agreed to dismiss it from the case prior to trial.
Physician accused of gross negligence finally surrenders his license
A California doctor under investigation multiple times during the past 2 decades has surrendered his medical license, as a story reported by Valley Public Radio indicates.
Since 1999, the Medical Board of California has opened three investigations against Bakersfield ob.gyn. Arthur Park, MD, each involving accusations of gross negligence “following the deaths of mothers and/or their babies during childbirth.” In 2000, and again in 2020, the board voted that Dr. Park should lose his license but then suspended its decision, which enabled Dr. Park to continue practicing under probation and on condition that he complete remedial education.
Early in 2021, however, the board filed yet another accusation against him, this one involving the 2019 death of Demi Dominguez and her newborn baby. According to the accusation, Ms. Dominguez died of preeclampsia because Dr. Park and a colleague failed to treat her high blood pressure prior to delivery. While doctors attempted to resuscitate her, Ms. Dominguez’s son was delivered by emergency cesarean but died only a few hours later. The board said that Dr. Park was “grossly negligent in his care and treatment” and that his actions constituted “an extreme departure from the applicable standard of care.”
Early in December 2021, even before the board and attorney general’s office had completed their investigations, Dr. Park agreed to surrender his medical license.
Patient advocates were pleased by the doctor’s decision but also disappointed that he’d no longer be compelled to stand before a judge, as he had been scheduled to do in connection with the Dominguez case.
A review of public records by Valley Public Radio indicates that – between the various board accusations against him and an additional nine lawsuits alleging malpractice and other issues – at least two mothers and five children have died while under Dr. Park’s care. Others whose delivery he oversaw claim their children were permanently injured during childbirth.
Although Dr. Park will be eligible to reapply for his license after 2 years, a representative of his medical office said Dr. Park had decided to retire from practicing medicine.
Delayed cancer diagnosis prompts med-mal suit
An Illinois woman who claims her doctor and his staff failed to follow up on her abnormal Pap smear has filed a malpractice suit against them and their medical group, reports a story in the Madison-St. Clair Record.
In early 2019, Lisa Albright visited the medical group after she had experienced pain during intercourse. A family nurse practitioner at the practice performed a Pap smear, and Ms. Albright was instructed to wait a few days and check her patient portal for the results. In her suit, Ms. Albright claims those results were abnormal. Despite this, neither the nurse practitioner nor anyone else at the practice scheduled a follow-up test or other diagnostic assessment.
Approximately 5 months later, Ms. Albright consulted a new physician, whose follow-up testing indicated that Ms. Albright had a cervical squamous cell carcinoma.
Ms. Albright’s suit alleges that the diagnostic delay has, among other things, caused her to undergo multiple surgical procedures and treatments, face a shorter life expectancy, and endure a loss in the quality of her life.
At press time, Ms. Albright and her legal representative have not yet determined the amount they will ask for – it will be set after the severity and permanency of Ms. Albright’s injuries have been more thoroughly investigated. But it’s expected that they will seek damages, along with all legal and court expenses.
The defendants haven’t responded to the plaintiff’s suit.
A version of this article first appeared on Medscape.com.