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B-ALL: New Findings Confirm Efficacy of CAR T Product
These findings also highlight the favorable impact of CAR T persistence on treatment outcomes, and suggest that consolidative stem cell transplant (SCT) in R/R B-ALL patients treated with obe-cel does not improve outcomes, Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.
The overall complete remission or complete remission with incomplete count recovery rate was 78% among 127 patients enrolled in the open-label, single-arm study and infused with obe-cel. Among the 99 patients who responded, 18 proceeded to consolidative SCT while in remission, Dr. Jabbour said, noting that all 18 who received SCT were in minimal residual disease (MRD)–negative remission at the time of transplant.
Of those 18 patients, 10 had ongoing CAR T persistence prior to transplant, he said.
At median follow-up of 21.5 months, 40% of responders were in ongoing remission without the need for subsequent consolidation with SCT or other therapy, whereas SCT did not appear to improve outcomes.
The median event-free survival (EFS) after censoring for transplant was 11.9 months, and the 12-month EFS rate was 49.5%. Without censoring for transplant, the EFS and 12-month EFS rate were 9.0 months and 44%, respectively.
“I would like to highlight that the time to transplant was 100 days, and of those 18 patients, all in MRD-negative status ... 80% relapsed or died from transplant-related complications,” Dr. Jabbour said.
Median overall survival (OS) without censoring for transplant was 15.6 months, and the 12-month OS rate was 61.1%. After censoring for transplant, the median OS and 12-month OS rate 23.8 months 63.7%, respectively. The survival curves were fully overlapping, indicating that transplant did not improve OS outcomes.
“Furthermore, when you look at the EFS and [OS], both show a potential plateau for a long-term outcome, and this trend is similar to what was reported in a phase 1 trial with 2 years of follow up and more,” Dr. Jabbour said.
The investigators also assessed the impact of loss of CAR T-cell persistence and loss of B-cell aplasia and found that “both ongoing CAR T-cell persistence and ongoing B-cell aplasia, were correlated with better event-free survival,” he noted, explaining that the risk of relapse was 2.7 times greater in those who lost versus maintained CAR T-cell persistence, and 1.7 times greater in those who lost versus maintained B-cell aplasia.
Among those with ongoing remission at 6 months, median EFS was 15.1 months in those who lost CAR T-cell persistence, whereas the median EFS was not reached in those who maintained CAR T-cell persistence.
Obe-cel is an autologous CAR T-cell product with a fast off-rate CD19 binder designed to mitigate immunotoxicity and improve CAR T-cell expansion and persistence, Dr. Jabbour said, noting that pooled efficacy and safety results from the FELIX phase 1b and 2 trials of heavily pretreated patients have previously been reported.
The findings support the use of obe-cel as a standard treatment in this patient population, and demonstrate that ongoing CAR T-cell persistence and B-cell aplasia are associated with improved EFS — without further consolidation therapy after treatment, he concluded.
This study was funded by Autolus Therapeutics. Dr. Jabbour disclosed ties with Abbvie, Ascentage Pharma, Adaptive Biotechnologies, Amgen, Astellas Pharma, Bristol-Myers Squibb, Genentech, Incyte, Pfizer, and Takeda.
These findings also highlight the favorable impact of CAR T persistence on treatment outcomes, and suggest that consolidative stem cell transplant (SCT) in R/R B-ALL patients treated with obe-cel does not improve outcomes, Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.
The overall complete remission or complete remission with incomplete count recovery rate was 78% among 127 patients enrolled in the open-label, single-arm study and infused with obe-cel. Among the 99 patients who responded, 18 proceeded to consolidative SCT while in remission, Dr. Jabbour said, noting that all 18 who received SCT were in minimal residual disease (MRD)–negative remission at the time of transplant.
Of those 18 patients, 10 had ongoing CAR T persistence prior to transplant, he said.
At median follow-up of 21.5 months, 40% of responders were in ongoing remission without the need for subsequent consolidation with SCT or other therapy, whereas SCT did not appear to improve outcomes.
The median event-free survival (EFS) after censoring for transplant was 11.9 months, and the 12-month EFS rate was 49.5%. Without censoring for transplant, the EFS and 12-month EFS rate were 9.0 months and 44%, respectively.
“I would like to highlight that the time to transplant was 100 days, and of those 18 patients, all in MRD-negative status ... 80% relapsed or died from transplant-related complications,” Dr. Jabbour said.
Median overall survival (OS) without censoring for transplant was 15.6 months, and the 12-month OS rate was 61.1%. After censoring for transplant, the median OS and 12-month OS rate 23.8 months 63.7%, respectively. The survival curves were fully overlapping, indicating that transplant did not improve OS outcomes.
“Furthermore, when you look at the EFS and [OS], both show a potential plateau for a long-term outcome, and this trend is similar to what was reported in a phase 1 trial with 2 years of follow up and more,” Dr. Jabbour said.
The investigators also assessed the impact of loss of CAR T-cell persistence and loss of B-cell aplasia and found that “both ongoing CAR T-cell persistence and ongoing B-cell aplasia, were correlated with better event-free survival,” he noted, explaining that the risk of relapse was 2.7 times greater in those who lost versus maintained CAR T-cell persistence, and 1.7 times greater in those who lost versus maintained B-cell aplasia.
Among those with ongoing remission at 6 months, median EFS was 15.1 months in those who lost CAR T-cell persistence, whereas the median EFS was not reached in those who maintained CAR T-cell persistence.
Obe-cel is an autologous CAR T-cell product with a fast off-rate CD19 binder designed to mitigate immunotoxicity and improve CAR T-cell expansion and persistence, Dr. Jabbour said, noting that pooled efficacy and safety results from the FELIX phase 1b and 2 trials of heavily pretreated patients have previously been reported.
The findings support the use of obe-cel as a standard treatment in this patient population, and demonstrate that ongoing CAR T-cell persistence and B-cell aplasia are associated with improved EFS — without further consolidation therapy after treatment, he concluded.
This study was funded by Autolus Therapeutics. Dr. Jabbour disclosed ties with Abbvie, Ascentage Pharma, Adaptive Biotechnologies, Amgen, Astellas Pharma, Bristol-Myers Squibb, Genentech, Incyte, Pfizer, and Takeda.
These findings also highlight the favorable impact of CAR T persistence on treatment outcomes, and suggest that consolidative stem cell transplant (SCT) in R/R B-ALL patients treated with obe-cel does not improve outcomes, Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.
The overall complete remission or complete remission with incomplete count recovery rate was 78% among 127 patients enrolled in the open-label, single-arm study and infused with obe-cel. Among the 99 patients who responded, 18 proceeded to consolidative SCT while in remission, Dr. Jabbour said, noting that all 18 who received SCT were in minimal residual disease (MRD)–negative remission at the time of transplant.
Of those 18 patients, 10 had ongoing CAR T persistence prior to transplant, he said.
At median follow-up of 21.5 months, 40% of responders were in ongoing remission without the need for subsequent consolidation with SCT or other therapy, whereas SCT did not appear to improve outcomes.
The median event-free survival (EFS) after censoring for transplant was 11.9 months, and the 12-month EFS rate was 49.5%. Without censoring for transplant, the EFS and 12-month EFS rate were 9.0 months and 44%, respectively.
“I would like to highlight that the time to transplant was 100 days, and of those 18 patients, all in MRD-negative status ... 80% relapsed or died from transplant-related complications,” Dr. Jabbour said.
Median overall survival (OS) without censoring for transplant was 15.6 months, and the 12-month OS rate was 61.1%. After censoring for transplant, the median OS and 12-month OS rate 23.8 months 63.7%, respectively. The survival curves were fully overlapping, indicating that transplant did not improve OS outcomes.
“Furthermore, when you look at the EFS and [OS], both show a potential plateau for a long-term outcome, and this trend is similar to what was reported in a phase 1 trial with 2 years of follow up and more,” Dr. Jabbour said.
The investigators also assessed the impact of loss of CAR T-cell persistence and loss of B-cell aplasia and found that “both ongoing CAR T-cell persistence and ongoing B-cell aplasia, were correlated with better event-free survival,” he noted, explaining that the risk of relapse was 2.7 times greater in those who lost versus maintained CAR T-cell persistence, and 1.7 times greater in those who lost versus maintained B-cell aplasia.
Among those with ongoing remission at 6 months, median EFS was 15.1 months in those who lost CAR T-cell persistence, whereas the median EFS was not reached in those who maintained CAR T-cell persistence.
Obe-cel is an autologous CAR T-cell product with a fast off-rate CD19 binder designed to mitigate immunotoxicity and improve CAR T-cell expansion and persistence, Dr. Jabbour said, noting that pooled efficacy and safety results from the FELIX phase 1b and 2 trials of heavily pretreated patients have previously been reported.
The findings support the use of obe-cel as a standard treatment in this patient population, and demonstrate that ongoing CAR T-cell persistence and B-cell aplasia are associated with improved EFS — without further consolidation therapy after treatment, he concluded.
This study was funded by Autolus Therapeutics. Dr. Jabbour disclosed ties with Abbvie, Ascentage Pharma, Adaptive Biotechnologies, Amgen, Astellas Pharma, Bristol-Myers Squibb, Genentech, Incyte, Pfizer, and Takeda.
FROM ASCO 2024
Similar Outcomes With Labetalol, Nifedipine for Chronic Hypertension in Pregnancy
Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.
The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.
Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
Three Comparisons
Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.
The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.
Among the results were the following:
- The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
- Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
- There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.
Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.
“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.
The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.
Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.
Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.
The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.
Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
Three Comparisons
Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.
The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.
Among the results were the following:
- The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
- Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
- There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.
Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.
“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.
The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.
Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.
Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.
The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.
Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
Three Comparisons
Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.
The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.
Among the results were the following:
- The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
- Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
- There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.
Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.
“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.
The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.
Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.
FROM OBSTETRICS & GYNECOLOGY
How Well Do Clinicians Support Patients’ Sexual Health?
From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.
Question: Regarding young individuals, what about sex education in schools?
Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.
In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.
Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].
Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?
Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.
Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.
Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.
Question: More and more young people identify as asexual. What do you think of this?
Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.
I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining.
Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?
Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.
Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge.
Question: What about sexual violence in children? What are the consequences?
Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different.
Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?
Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.
Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!
Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?
Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability.
A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.
Question: But aging itself brings challenges in terms of sexuality.
Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.
Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.
Question: Therefore, is it important to question men past the age of 50 years?
Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.
Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.
After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.
Question: On their side, are women better cared for at menopause?
Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.
Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.
It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.
Question: So we must not forget men or women.
Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.
Question: Sexual medicine is essential, yet it seems inaccessible.
Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?
If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.
Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.
Dr. Burté has no conflicts of interest related to the subject.
This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.
Question: Regarding young individuals, what about sex education in schools?
Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.
In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.
Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].
Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?
Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.
Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.
Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.
Question: More and more young people identify as asexual. What do you think of this?
Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.
I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining.
Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?
Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.
Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge.
Question: What about sexual violence in children? What are the consequences?
Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different.
Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?
Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.
Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!
Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?
Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability.
A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.
Question: But aging itself brings challenges in terms of sexuality.
Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.
Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.
Question: Therefore, is it important to question men past the age of 50 years?
Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.
Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.
After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.
Question: On their side, are women better cared for at menopause?
Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.
Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.
It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.
Question: So we must not forget men or women.
Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.
Question: Sexual medicine is essential, yet it seems inaccessible.
Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?
If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.
Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.
Dr. Burté has no conflicts of interest related to the subject.
This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.
Question: Regarding young individuals, what about sex education in schools?
Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.
In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.
Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].
Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?
Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.
Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.
Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.
Question: More and more young people identify as asexual. What do you think of this?
Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.
I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining.
Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?
Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.
Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge.
Question: What about sexual violence in children? What are the consequences?
Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different.
Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?
Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.
Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!
Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?
Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability.
A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.
Question: But aging itself brings challenges in terms of sexuality.
Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.
Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.
Question: Therefore, is it important to question men past the age of 50 years?
Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.
Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.
After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.
Question: On their side, are women better cared for at menopause?
Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.
Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.
It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.
Question: So we must not forget men or women.
Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.
Question: Sexual medicine is essential, yet it seems inaccessible.
Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?
If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.
Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.
Dr. Burté has no conflicts of interest related to the subject.
This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
FDA Approves Epcoritamab for R/R Follicular Lymphoma
This marks the second indication for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large B-cell lymphoma in adults.
The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.
After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.
Efficacy was similar in the 86 patients who received a three step-up dosing schedule.
Labeling carries a black box warning of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.
Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.
Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.
The price is $16,282.52 for 48 mg/0.8 mL, according to drugs.com.
A version of this article appeared on Medscape.com.
This marks the second indication for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large B-cell lymphoma in adults.
The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.
After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.
Efficacy was similar in the 86 patients who received a three step-up dosing schedule.
Labeling carries a black box warning of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.
Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.
Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.
The price is $16,282.52 for 48 mg/0.8 mL, according to drugs.com.
A version of this article appeared on Medscape.com.
This marks the second indication for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large B-cell lymphoma in adults.
The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.
After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.
Efficacy was similar in the 86 patients who received a three step-up dosing schedule.
Labeling carries a black box warning of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.
Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.
Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.
The price is $16,282.52 for 48 mg/0.8 mL, according to drugs.com.
A version of this article appeared on Medscape.com.
Primary Care: Try These Steps to Boost Lung Cancer Screens
A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.
But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.
Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.
“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”
Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.
Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
Increasing Uptake
The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.
But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.
The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.
Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.
The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.
Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
Patient Navigators to the Rescue?
About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.
“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.
He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.
Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.
The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.
The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.
“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.
The navigator program, however, stopped when the funding for the study ended.
But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.
Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.
“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.
St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.
Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.
To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.
Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.
“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.
Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.
“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”
Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.
A version of this article first appeared on Medscape.com.
A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.
But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.
Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.
“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”
Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.
Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
Increasing Uptake
The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.
But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.
The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.
Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.
The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.
Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
Patient Navigators to the Rescue?
About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.
“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.
He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.
Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.
The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.
The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.
“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.
The navigator program, however, stopped when the funding for the study ended.
But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.
Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.
“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.
St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.
Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.
To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.
Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.
“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.
Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.
“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”
Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.
A version of this article first appeared on Medscape.com.
A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.
But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.
Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.
“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”
Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.
Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
Increasing Uptake
The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.
But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.
The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.
Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.
The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.
Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
Patient Navigators to the Rescue?
About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.
“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.
He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.
Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.
The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.
The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.
“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.
The navigator program, however, stopped when the funding for the study ended.
But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.
Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.
“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.
St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.
Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.
To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.
Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.
“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.
Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.
“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”
Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.
A version of this article first appeared on Medscape.com.
Dengue Surge in US Cases This Year
Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.
The global incidence of dengue in 2024 is the highest on record, reported the agency.
In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.
The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.
Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.
The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
Monitoring for Dengue
With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:
- Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
- Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
- Ensure timely reporting of dengue cases to public health authorities.
- Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.
Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.
Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
Disease Progression
Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.
One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.
Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.
“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.
The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.
The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.
A version of this article first appeared on Medscape.com.
Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.
The global incidence of dengue in 2024 is the highest on record, reported the agency.
In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.
The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.
Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.
The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
Monitoring for Dengue
With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:
- Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
- Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
- Ensure timely reporting of dengue cases to public health authorities.
- Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.
Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.
Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
Disease Progression
Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.
One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.
Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.
“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.
The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.
The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.
A version of this article first appeared on Medscape.com.
Federal health officials with the US Centers for Disease Control and Prevention (CDC) have issued an alert, warning health professionals and the public about an increased risk for dengue virus infections in the United States.
The global incidence of dengue in 2024 is the highest on record, reported the agency.
In the United States, Puerto Rico has declared a public health emergency, with 1498 dengue cases reported so far and a “higher-than-expected” number of dengue cases having been identified among US travelers in the first half of this year at 745 cases, according to the alert.
The CDC reports 197 dengue cases in Florida, 134 in New York, 50 in Massachusetts, 40 in California, 14 in Colorado, nine in Arizona, and eight in the District of Columbia, among others.
Transmitted by infected Aedes genus mosquitoes, dengue is the most common arboviral disease globally and is a nationally notifiable disease in the United States.
The six US territories and freely associated states with frequent or continuous dengue transmission are Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
Monitoring for Dengue
With rising global and domestic cases of dengue, the CDC urges healthcare providers to monitor for dengue:
- Maintain a high index of suspicion in patients with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset.
- Order diagnostic tests for acute dengue infection such as reverse transcription polymerase chain reaction and immunoglobulin M (IgM) antibody tests or nonstructural protein 1 antigen tests and IgM antibody tests.
- Ensure timely reporting of dengue cases to public health authorities.
- Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission.
Roughly one in four dengue virus infections are symptomatic and can be mild or severe. Symptoms begin after an incubation period of about 5-7 days.
Symptoms include fever accompanied by nonspecific signs and symptoms such as nausea, vomiting, rash, muscle aches, joint pain, bone pain, pain behind the eyes, headache, or low white blood cell counts.
Disease Progression
Warning signs that may predict progression to severe disease include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and progressive increase in hematocrit or liver enlargement.
One in 20 people with symptomatic dengue will develop severe disease, with bleeding, shock, or respiratory distress caused by plasma leakage or end-organ impairment.
Infants aged a year or younger, pregnant people, adults aged 65 years or older, people with certain medical conditions, and those with previous dengue infections are at increased risk for severe dengue.
“Healthcare providers should be prepared to recognize, diagnose, manage, and report dengue cases to health authorities; public health partners should investigate cases and disseminate clear prevention messages to the public,” the alert stated.
The CDC is actively implementing several strategies to address the increase in cases of dengue in the United States. In early April, the agency launched a program-led emergency response and is providing monthly situational updates on dengue to partners, stakeholders, and jurisdictions.
The CDC is also expanding laboratory capacity to improve laboratory testing approaches; collaborating with state, tribal, local, and territorial health departments to strengthen dengue surveillance and recommend prevention strategies; and working to educate the public on dengue prevention.
A version of this article first appeared on Medscape.com.
Scope of Practice Concerns Lead to Hospital’s Temp Ban on CRNAs
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
More Evidence PTSD Tied to Obstructive Sleep Apnea Risk
Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.
“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”
The study was published online in JAMA Network Open.
A More Rigorous Evaluation
“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.
The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.
PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.
The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO2 less than 90% was 8.9%.
In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO2 less than 90%.
A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).
The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.
“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
Questions Remain
In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”
However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.
Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.
“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.
“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.
In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.
“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.
The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.
“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”
The study was published online in JAMA Network Open.
A More Rigorous Evaluation
“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.
The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.
PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.
The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO2 less than 90% was 8.9%.
In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO2 less than 90%.
A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).
The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.
“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
Questions Remain
In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”
However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.
Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.
“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.
“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.
In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.
“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.
The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.
“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”
The study was published online in JAMA Network Open.
A More Rigorous Evaluation
“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.
The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.
PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.
The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO2 less than 90% was 8.9%.
In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO2 less than 90%.
A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).
The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.
“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
Questions Remain
In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”
However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.
Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.
“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.
“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.
In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.
“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.
The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
New Insight Into CVD, Stroke Risk in Migraine
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM AHS 2024
Frequent or Severe Flares Linked to Increased Atopic Dermatitis Severity
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source