Marcia Frellick

Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.

Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.

In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.

Large Dataset From United States and Canada

Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.

Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.

The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).

“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
 

Provider Endorsement in Some Cases

Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).

She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”

The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.

Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”

Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.

Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”

Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.

Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.

Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.

In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.

Large Dataset From United States and Canada

Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.

Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.

The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).

“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
 

Provider Endorsement in Some Cases

Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).

She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”

The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.

Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”

Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.

Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”

Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.

Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.

Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.

In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.

Large Dataset From United States and Canada

Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.

Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.

The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).

“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
 

Provider Endorsement in Some Cases

Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).

She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”

The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.

Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”

Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.

Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”

Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Most young people, ages 10-24 years old, who die by suicide have no previously documented mental health diagnosis, according to a large analysis of Centers for Disease Control and Prevention data.

Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
 

Gaps by Race, Sex and Age

The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).

The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.

“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”

Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote. 

In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.

The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
 

Intervention Recommendations

The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.

A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).

They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.

They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.

The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.

Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.

Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.

“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.

A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.

Most young people, ages 10-24 years old, who die by suicide have no previously documented mental health diagnosis, according to a large analysis of Centers for Disease Control and Prevention data.

Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
 

Gaps by Race, Sex and Age

The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).

The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.

“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”

Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote. 

In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.

The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
 

Intervention Recommendations

The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.

A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).

They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.

They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.

The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.

Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.

Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.

“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.

A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.

Most young people, ages 10-24 years old, who die by suicide have no previously documented mental health diagnosis, according to a large analysis of Centers for Disease Control and Prevention data.

Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
 

Gaps by Race, Sex and Age

The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).

The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.

“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”

Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote. 

In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.

The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
 

Intervention Recommendations

The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.

A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).

They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.

They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.

The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.

Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.

Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.

“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.

A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.

Geographic spread of the ticks that most often cause Lyme disease in the United States and a rise in incidence of bites, resulting in 476,000 new US cases a year, have increased the chances that physicians who have never encountered a patient with Lyme disease will see their first cases.

“It’s increasing in areas where it was not seen before,” Steven E. Schutzer, MD, with the Department of Medicine, Rutgers New Jersey Medical School, Newark, said in an interview. Dr. Schutzer coauthored a report on diagnosing and treating Lyme disease with Patricia K. Coyle, MD, Department of Neurology, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York.

The report, a Curbside Consult published in New England Journal of Medicine Evidence, comes amid high season for Lyme disease. Bites from an ixodid (hard shield) tick — almost always the source of the disease in the United States — are most common from April through October.

Identifying the Bite

About 70%-90% of the time, Lyme disease will be signaled by erythema migrans (EM) or lesion expanding from the tick bite site, the authors wrote. The “classic” presentation looks like a bullseye, but most of the time the skin will show a variation of that, the authors noted.

“The presence of EM is considered the best clinical diagnostic marker for Lyme disease,” they wrote.

Other dermatologic conditions, however, can complicate diagnosis: “EM mimickers include contact dermatitis, other arthropod bites, fixed drug eruptions, granuloma annulare, cellulitis, dermatophytosis, and systemic lupus erythematosus,” they wrote.
 

Testing Steps

“The current recommendation is to do two-step testing almost simultaneously,” Dr. Schutzer said in an interview. The first, he said, is an ELISA (enzyme-linked immunosorbent assay)-type test and the second one, used for years, has been a pictoral view of a Western immunoblot showing which antigens of the Lyme bacteria, Borrelia burgdorferi, the antibodies are reacting to.

However, the pictoral view is subjective and some of the antigens could be cross-reactive. So the U.S. Food and Drug Administration (FDA) “has been allowing newer substitutes like a second ELISA-like assay that often uses more recombinant, less cross-reactive antigen targets,” he said. The authors advised that, “The second-tier test should not be performed alone without the first tier.”

Dr. Schutzer advised physicians to check with the lab they plan to use before sending samples.

“If you’re a practicing physician and you know you’re using a particular laboratory, you should familiarize yourself with them, talking to one of the clinical pathologists involved in advance to know what the limitations are.” Take the time to talk with the person overseeing the test and get tips on how they want the sample transported and how the cases should be reported, he said.

If the patient has neurological symptoms, he said, before treating talk with a neurologist who can advise whether, for instance, a spinal tap is in order or whether an emergency department visit is appropriate.

“If you just start proceeding you may mess up the diagnostic signs that could show up in a lab test. Don’t be hesitant to ask for extra input from colleagues,” Dr. Schutzer said.
 

Suspicion in Endemic Areas

On Long Island, New York, where Lyme disease is endemic, internist Ian Storch, DO, said he sees “a few cases a season.

“We have a lot of people over the summer going to the Hamptons and areas out east for the weekend and tick bites are not uncommon,” he said. “People panic.”

He said one thing it’s important to tell patients is that the tick has to be on the skin for 48-72 hours to transmit the disease. If individuals were in a wooded area and were fine before they got there and the tick was attached for less than 2 days, “they’re usually fine.”

Another issue, Dr. Storch said, is patients sometimes want to get tested for Lyme disease immediately after a tick bite. But the antibody test doesn’t turn positive for weeks, he noted, and you can get a false-negative result. “If you’re worried and you really want to test, you need to wait 6 weeks to do the blood test.”

In his region, he said that although a tick bite is a red flag, he may also suspect Lyme disease when a patient presents with otherwise unexplained joint pain, weakness, lethargy, or fever. “In our area, those are things that would make you test for Lyme.”

He also urged consideration of Lyme in this new age of long COVID. Weakness, fatigue, and lethargy are also classic symptoms of long COVID, he noted. “Keep Lyme disease in your differential because there is a lot of overlap with chronic Lyme disease,” Dr. Storch said.

Discerning Lyme from Southern Tick–Associated Rash Illness

Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic in Texas, where Lyme disease is not endemic, said Lyme disease “will not and should not be on the initial differential diagnosis for those residing in nonendemic areas unless a history of travel to an endemic area is obtained.”

She noted the typical EM rash may not be as distinct or easy to discern on black and brown skin. In addition, she said, EM may have many variations in presentation, such as a crusted center or faint borders, which could lead to a delay in diagnosis and treatment. She suggested consulting the CDC guidance on Lyme disease rashes.

Another challenge in diagnosis, she said, is the patient who presents with what appears to be a classic EM lesion but does not live in a Lyme-endemic area. In Texas, Southern Tick–Associated Rash Illness (STARI) may present with a similar lesion, she said.

“It is transmitted by the Lone Star Tick, which is found in the southeast and south-central US,” Dr. Word said. “However, its habitat is moving northward and westerly,” she said.

Adding Lyme disease to the differential diagnosis is reasonable, she said, if a patient presents with neurologic symptoms “such as a facial palsy, meningitis, radiculitis, and carditis if in addition to their symptoms there is evidence of an epidemiologic link to a Lyme-endemic region.”

She noted that a detailed travel history is important as “Lyme is also endemic in Eastern Canada, Europe, states of the former Soviet Union, China, Mongolia, and Japan.”

Primary care physicians play a critical role in evaluating, diagnosing, and treating most cases of early Lyme disease, thus limiting the number of people who will develop disseminated or late Lyme disease, she said. “The two latter manifestations are most often treated by infectious disease, neurology, or rheumatology specialists.”

Treatment* 

Treatment is tailored to the clinical situation, Dr. Schutzer and Dr. Coyle write. A watch-and-wait approach may be appropriate in an asymptomatic but concerned person, even in an endemic area if the person has no known tick bite and no EM lesion.

If there is high risk of an infected ixodid tick bite in a high-incidence area and the tick was attached for at least 36 hours but less than 72 hours, one dose of doxycycline has been recommended as prophylaxis.

When a diagnosis of early nondisseminated Lyme disease is made after observation  of an EM lesion, oral antibiotics are typically used to treat for 10 to 14 days. Suggested oral antibiotics and doses are 100 mg of doxycycline twice a day, 500 mg of amoxicillin three times a day, or 500 mg of cefuroxime twice a day, the authors write.

Dr. Schutzer said he hopes the paper serves as a refresher for those physicians who regularly see Lyme disease cases and also helps those newly included in the disease’s spreading regions.

“The earlier you diagnose it, the earlier you can treat it and the better the chance for a favorable outcome,” he said.

Dr. Schutzer, Dr. Coyle, Dr. Storch, and Dr. Word reported no relevant financial relationships.

*This story was updated on August, 2, 2024.

Geographic spread of the ticks that most often cause Lyme disease in the United States and a rise in incidence of bites, resulting in 476,000 new US cases a year, have increased the chances that physicians who have never encountered a patient with Lyme disease will see their first cases.

“It’s increasing in areas where it was not seen before,” Steven E. Schutzer, MD, with the Department of Medicine, Rutgers New Jersey Medical School, Newark, said in an interview. Dr. Schutzer coauthored a report on diagnosing and treating Lyme disease with Patricia K. Coyle, MD, Department of Neurology, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York.

The report, a Curbside Consult published in New England Journal of Medicine Evidence, comes amid high season for Lyme disease. Bites from an ixodid (hard shield) tick — almost always the source of the disease in the United States — are most common from April through October.

Identifying the Bite

About 70%-90% of the time, Lyme disease will be signaled by erythema migrans (EM) or lesion expanding from the tick bite site, the authors wrote. The “classic” presentation looks like a bullseye, but most of the time the skin will show a variation of that, the authors noted.

“The presence of EM is considered the best clinical diagnostic marker for Lyme disease,” they wrote.

Other dermatologic conditions, however, can complicate diagnosis: “EM mimickers include contact dermatitis, other arthropod bites, fixed drug eruptions, granuloma annulare, cellulitis, dermatophytosis, and systemic lupus erythematosus,” they wrote.
 

Testing Steps

“The current recommendation is to do two-step testing almost simultaneously,” Dr. Schutzer said in an interview. The first, he said, is an ELISA (enzyme-linked immunosorbent assay)-type test and the second one, used for years, has been a pictoral view of a Western immunoblot showing which antigens of the Lyme bacteria, Borrelia burgdorferi, the antibodies are reacting to.

However, the pictoral view is subjective and some of the antigens could be cross-reactive. So the U.S. Food and Drug Administration (FDA) “has been allowing newer substitutes like a second ELISA-like assay that often uses more recombinant, less cross-reactive antigen targets,” he said. The authors advised that, “The second-tier test should not be performed alone without the first tier.”

Dr. Schutzer advised physicians to check with the lab they plan to use before sending samples.

“If you’re a practicing physician and you know you’re using a particular laboratory, you should familiarize yourself with them, talking to one of the clinical pathologists involved in advance to know what the limitations are.” Take the time to talk with the person overseeing the test and get tips on how they want the sample transported and how the cases should be reported, he said.

If the patient has neurological symptoms, he said, before treating talk with a neurologist who can advise whether, for instance, a spinal tap is in order or whether an emergency department visit is appropriate.

“If you just start proceeding you may mess up the diagnostic signs that could show up in a lab test. Don’t be hesitant to ask for extra input from colleagues,” Dr. Schutzer said.
 

Suspicion in Endemic Areas

On Long Island, New York, where Lyme disease is endemic, internist Ian Storch, DO, said he sees “a few cases a season.

“We have a lot of people over the summer going to the Hamptons and areas out east for the weekend and tick bites are not uncommon,” he said. “People panic.”

He said one thing it’s important to tell patients is that the tick has to be on the skin for 48-72 hours to transmit the disease. If individuals were in a wooded area and were fine before they got there and the tick was attached for less than 2 days, “they’re usually fine.”

Another issue, Dr. Storch said, is patients sometimes want to get tested for Lyme disease immediately after a tick bite. But the antibody test doesn’t turn positive for weeks, he noted, and you can get a false-negative result. “If you’re worried and you really want to test, you need to wait 6 weeks to do the blood test.”

In his region, he said that although a tick bite is a red flag, he may also suspect Lyme disease when a patient presents with otherwise unexplained joint pain, weakness, lethargy, or fever. “In our area, those are things that would make you test for Lyme.”

He also urged consideration of Lyme in this new age of long COVID. Weakness, fatigue, and lethargy are also classic symptoms of long COVID, he noted. “Keep Lyme disease in your differential because there is a lot of overlap with chronic Lyme disease,” Dr. Storch said.

Discerning Lyme from Southern Tick–Associated Rash Illness

Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic in Texas, where Lyme disease is not endemic, said Lyme disease “will not and should not be on the initial differential diagnosis for those residing in nonendemic areas unless a history of travel to an endemic area is obtained.”

She noted the typical EM rash may not be as distinct or easy to discern on black and brown skin. In addition, she said, EM may have many variations in presentation, such as a crusted center or faint borders, which could lead to a delay in diagnosis and treatment. She suggested consulting the CDC guidance on Lyme disease rashes.

Another challenge in diagnosis, she said, is the patient who presents with what appears to be a classic EM lesion but does not live in a Lyme-endemic area. In Texas, Southern Tick–Associated Rash Illness (STARI) may present with a similar lesion, she said.

“It is transmitted by the Lone Star Tick, which is found in the southeast and south-central US,” Dr. Word said. “However, its habitat is moving northward and westerly,” she said.

Adding Lyme disease to the differential diagnosis is reasonable, she said, if a patient presents with neurologic symptoms “such as a facial palsy, meningitis, radiculitis, and carditis if in addition to their symptoms there is evidence of an epidemiologic link to a Lyme-endemic region.”

She noted that a detailed travel history is important as “Lyme is also endemic in Eastern Canada, Europe, states of the former Soviet Union, China, Mongolia, and Japan.”

Primary care physicians play a critical role in evaluating, diagnosing, and treating most cases of early Lyme disease, thus limiting the number of people who will develop disseminated or late Lyme disease, she said. “The two latter manifestations are most often treated by infectious disease, neurology, or rheumatology specialists.”

Treatment* 

Treatment is tailored to the clinical situation, Dr. Schutzer and Dr. Coyle write. A watch-and-wait approach may be appropriate in an asymptomatic but concerned person, even in an endemic area if the person has no known tick bite and no EM lesion.

If there is high risk of an infected ixodid tick bite in a high-incidence area and the tick was attached for at least 36 hours but less than 72 hours, one dose of doxycycline has been recommended as prophylaxis.

When a diagnosis of early nondisseminated Lyme disease is made after observation  of an EM lesion, oral antibiotics are typically used to treat for 10 to 14 days. Suggested oral antibiotics and doses are 100 mg of doxycycline twice a day, 500 mg of amoxicillin three times a day, or 500 mg of cefuroxime twice a day, the authors write.

Dr. Schutzer said he hopes the paper serves as a refresher for those physicians who regularly see Lyme disease cases and also helps those newly included in the disease’s spreading regions.

“The earlier you diagnose it, the earlier you can treat it and the better the chance for a favorable outcome,” he said.

Dr. Schutzer, Dr. Coyle, Dr. Storch, and Dr. Word reported no relevant financial relationships.

*This story was updated on August, 2, 2024.

Geographic spread of the ticks that most often cause Lyme disease in the United States and a rise in incidence of bites, resulting in 476,000 new US cases a year, have increased the chances that physicians who have never encountered a patient with Lyme disease will see their first cases.

“It’s increasing in areas where it was not seen before,” Steven E. Schutzer, MD, with the Department of Medicine, Rutgers New Jersey Medical School, Newark, said in an interview. Dr. Schutzer coauthored a report on diagnosing and treating Lyme disease with Patricia K. Coyle, MD, Department of Neurology, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York.

The report, a Curbside Consult published in New England Journal of Medicine Evidence, comes amid high season for Lyme disease. Bites from an ixodid (hard shield) tick — almost always the source of the disease in the United States — are most common from April through October.

Identifying the Bite

About 70%-90% of the time, Lyme disease will be signaled by erythema migrans (EM) or lesion expanding from the tick bite site, the authors wrote. The “classic” presentation looks like a bullseye, but most of the time the skin will show a variation of that, the authors noted.

“The presence of EM is considered the best clinical diagnostic marker for Lyme disease,” they wrote.

Other dermatologic conditions, however, can complicate diagnosis: “EM mimickers include contact dermatitis, other arthropod bites, fixed drug eruptions, granuloma annulare, cellulitis, dermatophytosis, and systemic lupus erythematosus,” they wrote.
 

Testing Steps

“The current recommendation is to do two-step testing almost simultaneously,” Dr. Schutzer said in an interview. The first, he said, is an ELISA (enzyme-linked immunosorbent assay)-type test and the second one, used for years, has been a pictoral view of a Western immunoblot showing which antigens of the Lyme bacteria, Borrelia burgdorferi, the antibodies are reacting to.

However, the pictoral view is subjective and some of the antigens could be cross-reactive. So the U.S. Food and Drug Administration (FDA) “has been allowing newer substitutes like a second ELISA-like assay that often uses more recombinant, less cross-reactive antigen targets,” he said. The authors advised that, “The second-tier test should not be performed alone without the first tier.”

Dr. Schutzer advised physicians to check with the lab they plan to use before sending samples.

“If you’re a practicing physician and you know you’re using a particular laboratory, you should familiarize yourself with them, talking to one of the clinical pathologists involved in advance to know what the limitations are.” Take the time to talk with the person overseeing the test and get tips on how they want the sample transported and how the cases should be reported, he said.

If the patient has neurological symptoms, he said, before treating talk with a neurologist who can advise whether, for instance, a spinal tap is in order or whether an emergency department visit is appropriate.

“If you just start proceeding you may mess up the diagnostic signs that could show up in a lab test. Don’t be hesitant to ask for extra input from colleagues,” Dr. Schutzer said.
 

Suspicion in Endemic Areas

On Long Island, New York, where Lyme disease is endemic, internist Ian Storch, DO, said he sees “a few cases a season.

“We have a lot of people over the summer going to the Hamptons and areas out east for the weekend and tick bites are not uncommon,” he said. “People panic.”

He said one thing it’s important to tell patients is that the tick has to be on the skin for 48-72 hours to transmit the disease. If individuals were in a wooded area and were fine before they got there and the tick was attached for less than 2 days, “they’re usually fine.”

Another issue, Dr. Storch said, is patients sometimes want to get tested for Lyme disease immediately after a tick bite. But the antibody test doesn’t turn positive for weeks, he noted, and you can get a false-negative result. “If you’re worried and you really want to test, you need to wait 6 weeks to do the blood test.”

In his region, he said that although a tick bite is a red flag, he may also suspect Lyme disease when a patient presents with otherwise unexplained joint pain, weakness, lethargy, or fever. “In our area, those are things that would make you test for Lyme.”

He also urged consideration of Lyme in this new age of long COVID. Weakness, fatigue, and lethargy are also classic symptoms of long COVID, he noted. “Keep Lyme disease in your differential because there is a lot of overlap with chronic Lyme disease,” Dr. Storch said.

Discerning Lyme from Southern Tick–Associated Rash Illness

Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic in Texas, where Lyme disease is not endemic, said Lyme disease “will not and should not be on the initial differential diagnosis for those residing in nonendemic areas unless a history of travel to an endemic area is obtained.”

She noted the typical EM rash may not be as distinct or easy to discern on black and brown skin. In addition, she said, EM may have many variations in presentation, such as a crusted center or faint borders, which could lead to a delay in diagnosis and treatment. She suggested consulting the CDC guidance on Lyme disease rashes.

Another challenge in diagnosis, she said, is the patient who presents with what appears to be a classic EM lesion but does not live in a Lyme-endemic area. In Texas, Southern Tick–Associated Rash Illness (STARI) may present with a similar lesion, she said.

“It is transmitted by the Lone Star Tick, which is found in the southeast and south-central US,” Dr. Word said. “However, its habitat is moving northward and westerly,” she said.

Adding Lyme disease to the differential diagnosis is reasonable, she said, if a patient presents with neurologic symptoms “such as a facial palsy, meningitis, radiculitis, and carditis if in addition to their symptoms there is evidence of an epidemiologic link to a Lyme-endemic region.”

She noted that a detailed travel history is important as “Lyme is also endemic in Eastern Canada, Europe, states of the former Soviet Union, China, Mongolia, and Japan.”

Primary care physicians play a critical role in evaluating, diagnosing, and treating most cases of early Lyme disease, thus limiting the number of people who will develop disseminated or late Lyme disease, she said. “The two latter manifestations are most often treated by infectious disease, neurology, or rheumatology specialists.”

Treatment* 

Treatment is tailored to the clinical situation, Dr. Schutzer and Dr. Coyle write. A watch-and-wait approach may be appropriate in an asymptomatic but concerned person, even in an endemic area if the person has no known tick bite and no EM lesion.

If there is high risk of an infected ixodid tick bite in a high-incidence area and the tick was attached for at least 36 hours but less than 72 hours, one dose of doxycycline has been recommended as prophylaxis.

When a diagnosis of early nondisseminated Lyme disease is made after observation  of an EM lesion, oral antibiotics are typically used to treat for 10 to 14 days. Suggested oral antibiotics and doses are 100 mg of doxycycline twice a day, 500 mg of amoxicillin three times a day, or 500 mg of cefuroxime twice a day, the authors write.

Dr. Schutzer said he hopes the paper serves as a refresher for those physicians who regularly see Lyme disease cases and also helps those newly included in the disease’s spreading regions.

“The earlier you diagnose it, the earlier you can treat it and the better the chance for a favorable outcome,” he said.

Dr. Schutzer, Dr. Coyle, Dr. Storch, and Dr. Word reported no relevant financial relationships.

*This story was updated on August, 2, 2024.

Newborn screening for neonatal vitamin B12 deficiency may lead to a fourfold reduction in chances of developing symptomatic vitamin B12 in the first year of life compared with infants without newborn screening, a hospital-based surveillance study in Germany indicates.

Vitamin B12 deficiency can impede development in infants, but the true impact of newborn screening versus no screening had not been known in Germany. Early treatment had been shown to be linked with normal development in infants who got newborn screening, but left unclear was how many who had newborn screening would have progressed to symptomatic vitamin B12 deficiency without treatment. Thus formal evidence for the benefit of the screening was lacking.

The nationwide surveillance study, led by Ulrike Mütze, MD, with the Heidelberg University Center for Child and Adolescent Medicine, was published online in Pediatrics. It used prospectively collected data from incident cases of infants under 12 months of age with vitamin B12 deficiency from 2021 to 2022.

The researchers analyzed 61 cases of vitamin B12 deficiency reported to the German Pediatric Surveillance Unit. They were either identified by newborn screening (n = 31) or diagnosed after the onset of suggestive symptoms (non-newborn screening; n = 30).

At a median 4 months of age, the great majority (90%) of the infants identified by newborn screening were still asymptomatic, while the non-newborn screening cohort presented with muscular hypotonia (68%), anemia (58%), developmental delay (44%), microcephalia (30%), and seizures (12%).

Symptomatically diagnosed vitamin B12 deficiency in the baby’s first year was reported four times more frequently in infants who did not receive newborn screening for neonatal vitamin B12 deficiency compared with those screened for vitamin B12 as newborns (Fisher’s Exact Test; odds ratio, 4.12 [95% confidence interval, 1.29-17.18], P = .008).

Clinical presentation of vitamin B12 deficiency in infants usually starts in the first months and reportedly includes, in addition to developmental delay, feeding difficulties, muscular hypotonia and weakness, severe failure to thrive, irritability, lethargy, and (as late symptoms) megaloblastic anemia and brain atrophy.

The current study confirmed these reports and highlighted that the most common presentations in symptomatic infantile vitamin B12 deficiency were muscular hypotonia, anemia, developmental delay, malnutrition or failure to thrive, and microcephalia, brain atrophy, or delayed myelination.

Stephen Walker, MD, a pediatric neurologist at University of Alabama, Birmingham, who was not involved with the study, said newborn screening for vitamin B12 deficiency is routine in the United States.

“In Alabama, we’re generally the last to adopt any of these newborn screenings ... and we’ve been doing it for several years,” he said. Vitamin B12 deficiency is one of 59 conditions included in the state’s newborn blood spot screening. In the United States, he added, when deficiencies are identified, cases are quickly referred to genetic or nutritional specialists.

In the Mütze et al. study, the authors conclude, “The incidence of symptomatic vitamin B12 deficiency accounts for about half of the estimated incidence of the vitamin B12 deficiency identified by newborn screening [NBS]. This supports the notion that not all newborns identified will develop a symptomatic infantile vitamin B12 deficiency but at the same time [this study demonstrates] the high beneficial potential of NBS for vitamin B12 deficiency.”

Dr. Mütze received a research grant from the Medical Faculty of Heidelberg University, Germany. Dr. Kölker, Dr. Hoffmann, and Dr. Mütze received research grants for their work on newborn screening from the Dietmar Hopp Foundation, St. Leon-Rot, Germany. Dr. Hoffmann, Dr. Janzen, and Dr. Röschinger are principal investigators for newborn screening pilot studies including neonatal vitamin B12 deficiency. The other authors have no relevant disclosures. Dr. Walker reports no relevant financial relationships.

Newborn screening for neonatal vitamin B12 deficiency may lead to a fourfold reduction in chances of developing symptomatic vitamin B12 in the first year of life compared with infants without newborn screening, a hospital-based surveillance study in Germany indicates.

Vitamin B12 deficiency can impede development in infants, but the true impact of newborn screening versus no screening had not been known in Germany. Early treatment had been shown to be linked with normal development in infants who got newborn screening, but left unclear was how many who had newborn screening would have progressed to symptomatic vitamin B12 deficiency without treatment. Thus formal evidence for the benefit of the screening was lacking.

The nationwide surveillance study, led by Ulrike Mütze, MD, with the Heidelberg University Center for Child and Adolescent Medicine, was published online in Pediatrics. It used prospectively collected data from incident cases of infants under 12 months of age with vitamin B12 deficiency from 2021 to 2022.

The researchers analyzed 61 cases of vitamin B12 deficiency reported to the German Pediatric Surveillance Unit. They were either identified by newborn screening (n = 31) or diagnosed after the onset of suggestive symptoms (non-newborn screening; n = 30).

At a median 4 months of age, the great majority (90%) of the infants identified by newborn screening were still asymptomatic, while the non-newborn screening cohort presented with muscular hypotonia (68%), anemia (58%), developmental delay (44%), microcephalia (30%), and seizures (12%).

Symptomatically diagnosed vitamin B12 deficiency in the baby’s first year was reported four times more frequently in infants who did not receive newborn screening for neonatal vitamin B12 deficiency compared with those screened for vitamin B12 as newborns (Fisher’s Exact Test; odds ratio, 4.12 [95% confidence interval, 1.29-17.18], P = .008).

Clinical presentation of vitamin B12 deficiency in infants usually starts in the first months and reportedly includes, in addition to developmental delay, feeding difficulties, muscular hypotonia and weakness, severe failure to thrive, irritability, lethargy, and (as late symptoms) megaloblastic anemia and brain atrophy.

The current study confirmed these reports and highlighted that the most common presentations in symptomatic infantile vitamin B12 deficiency were muscular hypotonia, anemia, developmental delay, malnutrition or failure to thrive, and microcephalia, brain atrophy, or delayed myelination.

Stephen Walker, MD, a pediatric neurologist at University of Alabama, Birmingham, who was not involved with the study, said newborn screening for vitamin B12 deficiency is routine in the United States.

“In Alabama, we’re generally the last to adopt any of these newborn screenings ... and we’ve been doing it for several years,” he said. Vitamin B12 deficiency is one of 59 conditions included in the state’s newborn blood spot screening. In the United States, he added, when deficiencies are identified, cases are quickly referred to genetic or nutritional specialists.

In the Mütze et al. study, the authors conclude, “The incidence of symptomatic vitamin B12 deficiency accounts for about half of the estimated incidence of the vitamin B12 deficiency identified by newborn screening [NBS]. This supports the notion that not all newborns identified will develop a symptomatic infantile vitamin B12 deficiency but at the same time [this study demonstrates] the high beneficial potential of NBS for vitamin B12 deficiency.”

Dr. Mütze received a research grant from the Medical Faculty of Heidelberg University, Germany. Dr. Kölker, Dr. Hoffmann, and Dr. Mütze received research grants for their work on newborn screening from the Dietmar Hopp Foundation, St. Leon-Rot, Germany. Dr. Hoffmann, Dr. Janzen, and Dr. Röschinger are principal investigators for newborn screening pilot studies including neonatal vitamin B12 deficiency. The other authors have no relevant disclosures. Dr. Walker reports no relevant financial relationships.

Newborn screening for neonatal vitamin B12 deficiency may lead to a fourfold reduction in chances of developing symptomatic vitamin B12 in the first year of life compared with infants without newborn screening, a hospital-based surveillance study in Germany indicates.

Vitamin B12 deficiency can impede development in infants, but the true impact of newborn screening versus no screening had not been known in Germany. Early treatment had been shown to be linked with normal development in infants who got newborn screening, but left unclear was how many who had newborn screening would have progressed to symptomatic vitamin B12 deficiency without treatment. Thus formal evidence for the benefit of the screening was lacking.

The nationwide surveillance study, led by Ulrike Mütze, MD, with the Heidelberg University Center for Child and Adolescent Medicine, was published online in Pediatrics. It used prospectively collected data from incident cases of infants under 12 months of age with vitamin B12 deficiency from 2021 to 2022.

The researchers analyzed 61 cases of vitamin B12 deficiency reported to the German Pediatric Surveillance Unit. They were either identified by newborn screening (n = 31) or diagnosed after the onset of suggestive symptoms (non-newborn screening; n = 30).

At a median 4 months of age, the great majority (90%) of the infants identified by newborn screening were still asymptomatic, while the non-newborn screening cohort presented with muscular hypotonia (68%), anemia (58%), developmental delay (44%), microcephalia (30%), and seizures (12%).

Symptomatically diagnosed vitamin B12 deficiency in the baby’s first year was reported four times more frequently in infants who did not receive newborn screening for neonatal vitamin B12 deficiency compared with those screened for vitamin B12 as newborns (Fisher’s Exact Test; odds ratio, 4.12 [95% confidence interval, 1.29-17.18], P = .008).

Clinical presentation of vitamin B12 deficiency in infants usually starts in the first months and reportedly includes, in addition to developmental delay, feeding difficulties, muscular hypotonia and weakness, severe failure to thrive, irritability, lethargy, and (as late symptoms) megaloblastic anemia and brain atrophy.

The current study confirmed these reports and highlighted that the most common presentations in symptomatic infantile vitamin B12 deficiency were muscular hypotonia, anemia, developmental delay, malnutrition or failure to thrive, and microcephalia, brain atrophy, or delayed myelination.

Stephen Walker, MD, a pediatric neurologist at University of Alabama, Birmingham, who was not involved with the study, said newborn screening for vitamin B12 deficiency is routine in the United States.

“In Alabama, we’re generally the last to adopt any of these newborn screenings ... and we’ve been doing it for several years,” he said. Vitamin B12 deficiency is one of 59 conditions included in the state’s newborn blood spot screening. In the United States, he added, when deficiencies are identified, cases are quickly referred to genetic or nutritional specialists.

In the Mütze et al. study, the authors conclude, “The incidence of symptomatic vitamin B12 deficiency accounts for about half of the estimated incidence of the vitamin B12 deficiency identified by newborn screening [NBS]. This supports the notion that not all newborns identified will develop a symptomatic infantile vitamin B12 deficiency but at the same time [this study demonstrates] the high beneficial potential of NBS for vitamin B12 deficiency.”

Dr. Mütze received a research grant from the Medical Faculty of Heidelberg University, Germany. Dr. Kölker, Dr. Hoffmann, and Dr. Mütze received research grants for their work on newborn screening from the Dietmar Hopp Foundation, St. Leon-Rot, Germany. Dr. Hoffmann, Dr. Janzen, and Dr. Röschinger are principal investigators for newborn screening pilot studies including neonatal vitamin B12 deficiency. The other authors have no relevant disclosures. Dr. Walker reports no relevant financial relationships.

In the last 10 years, clinical outcomes have improved for patients with unresectable hepatocellular carcinoma (uHCC). The cancer generally comes with chronic liver inflammation, and liver cirrhosis is present in up to 80% of cases. The level of liver dysfunction helps determine the prognosis, but it also may affect the safety of delivering anticancer treatment.

Clinical trials that have tested systemic immunotherapies have excluded patients who don’t fall into the Child-Pugh class A criteria (CP-A) for liver disease, which is the least severe of the Child-Pugh classes A-C. Therefore, there has been much debate about whether patients who have more liver disease (moderate liver dysfunction) and fit under CP-B criteria, instead of CP-A, should be treated with immune checkpoint inhibitor (ICI) therapy or best supportive care (BSC).

A new study, led by Claudia Angela Maria Fulgenzi, MD, with the Department of Surgery and Cancer at the Imperial College London, England, published in JAMA Oncology on July 18, uses an alternative way to compare outcomes following two different paths of care for uHCC patients with moderate liver dysfunction.
 

How was the study done and what did the investigators find?

Researchers performed a retrospective, multicenter, international clinical case series of patients treated in routine practice in tertiary care centers across Europe, the United States, and Asia. They compared data from uHCC patients with CP-B who were receiving first-line ICI-based treatment regimens (n = 187) with a cohort of matched patients with CP-B receiving BSC (n = 156). The first-line immunotherapies were the monotherapy nivolumab or the combination (atezolizumab plus bevacizumab).

Immunotherapy was linked with significantly lower risk of death, compared with best supportive care.

ICI exposure was associated with a reduction of about 50% in the risk of death (hazard ratio, 0.55; 95% CI, 0.35-0.86; P < .001).
 

Is immunotherapy or best supportive care the superior treatment?

The authors wrote that the results point to “improved survival in association with ICI treatment, compared with BSC in patients with uHCC with CP-B liver dysfunction.”

According to the study’s senior author David Pinato, MD, PhD, “this is the first study to suggest that there might be an advantage [of treatment with immunotherapy] in a proportion of people with Child-Pugh B liver dysfunction and particularly so in those patients with more limited disease and portal vein tumor thrombosis.”
 

Will the findings of this study make treatment allocation for patients with uHCC and moderate liver dysfunction (CP-B) less controversial?

Because it is a retrospective study, Dr. Pinato said in an interview, that the findings are not definitive, but can be used to inform future randomized controlled trials.

Dr. Pinato, who is also with the Imperial College London, added that the findings may also introduce a new question.

Although the study was not powered to look at survival differences across the two immunotherapy options given to the patients, there did not seem to be a striking difference between using one immunotherapy (nivolumab) or a combination (atezolizumab plus bevacizumab), he said.

“This is quite important because we know that combinations are significantly superior to monotherapy in patients with normal liver function but based on our study we might say that this provides preliminary evidence that [superiority of combination therapy] might not be true if the liver function is worse.”
 

What do these findings add to the literature about how best to treat patients with uHCC and suboptimal liver function?

Without evidence of efficacy and safety for the group in previous studies, the widespread recommendation for those with moderate dysfunction has been BSC.

These findings “pave the way to select potential patient subgroups in clinical practice,” Dr. Pinato said. It also suggests that the safety level of immunotherapy treatments is acceptable in this patient population, so they are not necessarily disadvantaged compared to patients with more preserved liver function.

“This is the best level of evidence currently available to guide treatment decisions in patients with Child-Pugh B who have been universally excluded by prospective clinical trials and for whom there is no randomized comparison,” Dr. Pinato said.

Dr. Pinato reported personal fees from Roche, AstraZeneca, Eisai, Mina Therapeutics, Starpharma, Lift Biosciences, Boston Scientific, and Avammune, and grants from GSK, MSD, and BMS outside the submitted work. Dr. Fulgenzi has no disclosures. Other authors of the new research have multiple ties with pharmaceutical companies. Complete disclosures are available with the full text of the journal article.

In the last 10 years, clinical outcomes have improved for patients with unresectable hepatocellular carcinoma (uHCC). The cancer generally comes with chronic liver inflammation, and liver cirrhosis is present in up to 80% of cases. The level of liver dysfunction helps determine the prognosis, but it also may affect the safety of delivering anticancer treatment.

Clinical trials that have tested systemic immunotherapies have excluded patients who don’t fall into the Child-Pugh class A criteria (CP-A) for liver disease, which is the least severe of the Child-Pugh classes A-C. Therefore, there has been much debate about whether patients who have more liver disease (moderate liver dysfunction) and fit under CP-B criteria, instead of CP-A, should be treated with immune checkpoint inhibitor (ICI) therapy or best supportive care (BSC).

A new study, led by Claudia Angela Maria Fulgenzi, MD, with the Department of Surgery and Cancer at the Imperial College London, England, published in JAMA Oncology on July 18, uses an alternative way to compare outcomes following two different paths of care for uHCC patients with moderate liver dysfunction.
 

How was the study done and what did the investigators find?

Researchers performed a retrospective, multicenter, international clinical case series of patients treated in routine practice in tertiary care centers across Europe, the United States, and Asia. They compared data from uHCC patients with CP-B who were receiving first-line ICI-based treatment regimens (n = 187) with a cohort of matched patients with CP-B receiving BSC (n = 156). The first-line immunotherapies were the monotherapy nivolumab or the combination (atezolizumab plus bevacizumab).

Immunotherapy was linked with significantly lower risk of death, compared with best supportive care.

ICI exposure was associated with a reduction of about 50% in the risk of death (hazard ratio, 0.55; 95% CI, 0.35-0.86; P < .001).
 

Is immunotherapy or best supportive care the superior treatment?

The authors wrote that the results point to “improved survival in association with ICI treatment, compared with BSC in patients with uHCC with CP-B liver dysfunction.”

According to the study’s senior author David Pinato, MD, PhD, “this is the first study to suggest that there might be an advantage [of treatment with immunotherapy] in a proportion of people with Child-Pugh B liver dysfunction and particularly so in those patients with more limited disease and portal vein tumor thrombosis.”
 

Will the findings of this study make treatment allocation for patients with uHCC and moderate liver dysfunction (CP-B) less controversial?

Because it is a retrospective study, Dr. Pinato said in an interview, that the findings are not definitive, but can be used to inform future randomized controlled trials.

Dr. Pinato, who is also with the Imperial College London, added that the findings may also introduce a new question.

Although the study was not powered to look at survival differences across the two immunotherapy options given to the patients, there did not seem to be a striking difference between using one immunotherapy (nivolumab) or a combination (atezolizumab plus bevacizumab), he said.

“This is quite important because we know that combinations are significantly superior to monotherapy in patients with normal liver function but based on our study we might say that this provides preliminary evidence that [superiority of combination therapy] might not be true if the liver function is worse.”
 

What do these findings add to the literature about how best to treat patients with uHCC and suboptimal liver function?

Without evidence of efficacy and safety for the group in previous studies, the widespread recommendation for those with moderate dysfunction has been BSC.

These findings “pave the way to select potential patient subgroups in clinical practice,” Dr. Pinato said. It also suggests that the safety level of immunotherapy treatments is acceptable in this patient population, so they are not necessarily disadvantaged compared to patients with more preserved liver function.

“This is the best level of evidence currently available to guide treatment decisions in patients with Child-Pugh B who have been universally excluded by prospective clinical trials and for whom there is no randomized comparison,” Dr. Pinato said.

Dr. Pinato reported personal fees from Roche, AstraZeneca, Eisai, Mina Therapeutics, Starpharma, Lift Biosciences, Boston Scientific, and Avammune, and grants from GSK, MSD, and BMS outside the submitted work. Dr. Fulgenzi has no disclosures. Other authors of the new research have multiple ties with pharmaceutical companies. Complete disclosures are available with the full text of the journal article.

In the last 10 years, clinical outcomes have improved for patients with unresectable hepatocellular carcinoma (uHCC). The cancer generally comes with chronic liver inflammation, and liver cirrhosis is present in up to 80% of cases. The level of liver dysfunction helps determine the prognosis, but it also may affect the safety of delivering anticancer treatment.

Clinical trials that have tested systemic immunotherapies have excluded patients who don’t fall into the Child-Pugh class A criteria (CP-A) for liver disease, which is the least severe of the Child-Pugh classes A-C. Therefore, there has been much debate about whether patients who have more liver disease (moderate liver dysfunction) and fit under CP-B criteria, instead of CP-A, should be treated with immune checkpoint inhibitor (ICI) therapy or best supportive care (BSC).

A new study, led by Claudia Angela Maria Fulgenzi, MD, with the Department of Surgery and Cancer at the Imperial College London, England, published in JAMA Oncology on July 18, uses an alternative way to compare outcomes following two different paths of care for uHCC patients with moderate liver dysfunction.
 

How was the study done and what did the investigators find?

Researchers performed a retrospective, multicenter, international clinical case series of patients treated in routine practice in tertiary care centers across Europe, the United States, and Asia. They compared data from uHCC patients with CP-B who were receiving first-line ICI-based treatment regimens (n = 187) with a cohort of matched patients with CP-B receiving BSC (n = 156). The first-line immunotherapies were the monotherapy nivolumab or the combination (atezolizumab plus bevacizumab).

Immunotherapy was linked with significantly lower risk of death, compared with best supportive care.

ICI exposure was associated with a reduction of about 50% in the risk of death (hazard ratio, 0.55; 95% CI, 0.35-0.86; P < .001).
 

Is immunotherapy or best supportive care the superior treatment?

The authors wrote that the results point to “improved survival in association with ICI treatment, compared with BSC in patients with uHCC with CP-B liver dysfunction.”

According to the study’s senior author David Pinato, MD, PhD, “this is the first study to suggest that there might be an advantage [of treatment with immunotherapy] in a proportion of people with Child-Pugh B liver dysfunction and particularly so in those patients with more limited disease and portal vein tumor thrombosis.”
 

Will the findings of this study make treatment allocation for patients with uHCC and moderate liver dysfunction (CP-B) less controversial?

Because it is a retrospective study, Dr. Pinato said in an interview, that the findings are not definitive, but can be used to inform future randomized controlled trials.

Dr. Pinato, who is also with the Imperial College London, added that the findings may also introduce a new question.

Although the study was not powered to look at survival differences across the two immunotherapy options given to the patients, there did not seem to be a striking difference between using one immunotherapy (nivolumab) or a combination (atezolizumab plus bevacizumab), he said.

“This is quite important because we know that combinations are significantly superior to monotherapy in patients with normal liver function but based on our study we might say that this provides preliminary evidence that [superiority of combination therapy] might not be true if the liver function is worse.”
 

What do these findings add to the literature about how best to treat patients with uHCC and suboptimal liver function?

Without evidence of efficacy and safety for the group in previous studies, the widespread recommendation for those with moderate dysfunction has been BSC.

These findings “pave the way to select potential patient subgroups in clinical practice,” Dr. Pinato said. It also suggests that the safety level of immunotherapy treatments is acceptable in this patient population, so they are not necessarily disadvantaged compared to patients with more preserved liver function.

“This is the best level of evidence currently available to guide treatment decisions in patients with Child-Pugh B who have been universally excluded by prospective clinical trials and for whom there is no randomized comparison,” Dr. Pinato said.

Dr. Pinato reported personal fees from Roche, AstraZeneca, Eisai, Mina Therapeutics, Starpharma, Lift Biosciences, Boston Scientific, and Avammune, and grants from GSK, MSD, and BMS outside the submitted work. Dr. Fulgenzi has no disclosures. Other authors of the new research have multiple ties with pharmaceutical companies. Complete disclosures are available with the full text of the journal article.

A relatively low-resource behavioral intervention may help postpartum women transition to engagement with primary care, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.

Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.

Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
 

Intervention vs Control Group

The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.

For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”

Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.

Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).

Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”

“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”

The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.

Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”

“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
 

Still, Only 40% Used Primary Care

She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.

Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.

Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.

A relatively low-resource behavioral intervention may help postpartum women transition to engagement with primary care, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.

Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.

Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
 

Intervention vs Control Group

The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.

For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”

Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.

Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).

Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”

“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”

The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.

Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”

“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
 

Still, Only 40% Used Primary Care

She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.

Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.

Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.

A relatively low-resource behavioral intervention may help postpartum women transition to engagement with primary care, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.

Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.

Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
 

Intervention vs Control Group

The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.

For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”

Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.

Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).

Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”

“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”

The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.

Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”

“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
 

Still, Only 40% Used Primary Care

She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.

Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.

Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.

One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.

When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found.

The researchers, led by Sally Ozonoff, PhD, Department of Psychiatry and Behavioral Sciences at University of California Davis Health in Sacramento, analyzed data from 1,605 infants who had an older sibling with ASD using data from the global Baby Siblings Research Consortium.

They calculated that the rate of autism recurrence is seven times higher in families who already have one autistic child than in the general population, which points to the importance of close developmental observance in infants born in families with autistic children, particularly male infants in those families. This study replicated a 2011 study, also led by Dr. Ozonoff, which found a similar rate of familial recurrence.
 

Differences by Sex and Race

Dr. Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs. 13.1%).

Additionally, ASD recurrence in White families was 17.8% while across other races collectively the recurrence rate was 25%.
 

Links with Maternal Education

Differences by maternal education were also striking. Recurrence was 32.6% when mothers had a high school or less education; 25.5% with some college; 19.7 with a college degree; and 16.9% with a graduate degree. The parental education revealed a significant effect only for mothers (P < .01); paternal education was not significant (P = .09).

Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the study, praised the study for following babies over time, “doing serial evaluation using two very standard tools in diagnosing autism and developmental delay.”

The babies were evaluated as early as 6 months of age, for up to seven visits. A final assessment was made at 36 months.

Dr. Rybczynski said it was interesting to see that, although ASD prevalence has increased substantially from the 2011 study (0.9%-2.8%), the findings regarding the sibling link have been consistent (18.7% in the 2011 study to 20.2% now).
 

Eliminating Biases

Dr. Rybczynski noted the current study also used diagnoses only from autism experts, which strengthened the findings, noting the potential for overdiagnosis when interviews are with the parents. “This really eliminates those biases.”

The authors explained the factors driving the need to update recurrence rate studies, including the growth in the prevalence of ASD in the last decade to 1 in 36. That may be caused partly by “greater awareness and identification of autistic females and cognitively able, verbal children.”

Also, new diagnostic criteria have been published, with different diagnostic thresholds since the last study. This study, they noted, had a sample size twice as large and more diverse than the 2011 sample.

The size and the diversity are particularly important, Dr. Rybczynski said, as it helps support more recent findings that ASD is not as heavily centered in White males as previously thought.

“We need to make sure we’re monitoring all children, especially from groups where there’s at least one older sibling or multiple siblings with autism or a sister with autism,” she said. The findings of this study are important not just for pediatricians but for families and all who have professional interactions with children.

Dr. Ozonoff reports travel reimbursements and honoraria from Autism Speaks and the Autism Science Foundation and book royalties from Guilford Press. One coauthor has served as a paid consultant to F. Hoffmann–La Roche and Servier and has received royalties from Sage Publications and Guilford Publications. Another is supported by the Stollery Children’s Hospital Foundation Chair in Autism. One coauthor reported a consulting agreement with EarliTec Diagnostics and book royalties from Wiley. A fourth coauthor has received funding from the Simons Foundation and consults for the Beasley Law Firm and Linus Technology. Dr. Rybczynski reported no relevant financial relationships.

One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.

When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found.

The researchers, led by Sally Ozonoff, PhD, Department of Psychiatry and Behavioral Sciences at University of California Davis Health in Sacramento, analyzed data from 1,605 infants who had an older sibling with ASD using data from the global Baby Siblings Research Consortium.

They calculated that the rate of autism recurrence is seven times higher in families who already have one autistic child than in the general population, which points to the importance of close developmental observance in infants born in families with autistic children, particularly male infants in those families. This study replicated a 2011 study, also led by Dr. Ozonoff, which found a similar rate of familial recurrence.
 

Differences by Sex and Race

Dr. Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs. 13.1%).

Additionally, ASD recurrence in White families was 17.8% while across other races collectively the recurrence rate was 25%.
 

Links with Maternal Education

Differences by maternal education were also striking. Recurrence was 32.6% when mothers had a high school or less education; 25.5% with some college; 19.7 with a college degree; and 16.9% with a graduate degree. The parental education revealed a significant effect only for mothers (P < .01); paternal education was not significant (P = .09).

Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the study, praised the study for following babies over time, “doing serial evaluation using two very standard tools in diagnosing autism and developmental delay.”

The babies were evaluated as early as 6 months of age, for up to seven visits. A final assessment was made at 36 months.

Dr. Rybczynski said it was interesting to see that, although ASD prevalence has increased substantially from the 2011 study (0.9%-2.8%), the findings regarding the sibling link have been consistent (18.7% in the 2011 study to 20.2% now).
 

Eliminating Biases

Dr. Rybczynski noted the current study also used diagnoses only from autism experts, which strengthened the findings, noting the potential for overdiagnosis when interviews are with the parents. “This really eliminates those biases.”

The authors explained the factors driving the need to update recurrence rate studies, including the growth in the prevalence of ASD in the last decade to 1 in 36. That may be caused partly by “greater awareness and identification of autistic females and cognitively able, verbal children.”

Also, new diagnostic criteria have been published, with different diagnostic thresholds since the last study. This study, they noted, had a sample size twice as large and more diverse than the 2011 sample.

The size and the diversity are particularly important, Dr. Rybczynski said, as it helps support more recent findings that ASD is not as heavily centered in White males as previously thought.

“We need to make sure we’re monitoring all children, especially from groups where there’s at least one older sibling or multiple siblings with autism or a sister with autism,” she said. The findings of this study are important not just for pediatricians but for families and all who have professional interactions with children.

Dr. Ozonoff reports travel reimbursements and honoraria from Autism Speaks and the Autism Science Foundation and book royalties from Guilford Press. One coauthor has served as a paid consultant to F. Hoffmann–La Roche and Servier and has received royalties from Sage Publications and Guilford Publications. Another is supported by the Stollery Children’s Hospital Foundation Chair in Autism. One coauthor reported a consulting agreement with EarliTec Diagnostics and book royalties from Wiley. A fourth coauthor has received funding from the Simons Foundation and consults for the Beasley Law Firm and Linus Technology. Dr. Rybczynski reported no relevant financial relationships.

One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.

When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found.

The researchers, led by Sally Ozonoff, PhD, Department of Psychiatry and Behavioral Sciences at University of California Davis Health in Sacramento, analyzed data from 1,605 infants who had an older sibling with ASD using data from the global Baby Siblings Research Consortium.

They calculated that the rate of autism recurrence is seven times higher in families who already have one autistic child than in the general population, which points to the importance of close developmental observance in infants born in families with autistic children, particularly male infants in those families. This study replicated a 2011 study, also led by Dr. Ozonoff, which found a similar rate of familial recurrence.
 

Differences by Sex and Race

Dr. Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs. 13.1%).

Additionally, ASD recurrence in White families was 17.8% while across other races collectively the recurrence rate was 25%.
 

Links with Maternal Education

Differences by maternal education were also striking. Recurrence was 32.6% when mothers had a high school or less education; 25.5% with some college; 19.7 with a college degree; and 16.9% with a graduate degree. The parental education revealed a significant effect only for mothers (P < .01); paternal education was not significant (P = .09).

Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the study, praised the study for following babies over time, “doing serial evaluation using two very standard tools in diagnosing autism and developmental delay.”

The babies were evaluated as early as 6 months of age, for up to seven visits. A final assessment was made at 36 months.

Dr. Rybczynski said it was interesting to see that, although ASD prevalence has increased substantially from the 2011 study (0.9%-2.8%), the findings regarding the sibling link have been consistent (18.7% in the 2011 study to 20.2% now).
 

Eliminating Biases

Dr. Rybczynski noted the current study also used diagnoses only from autism experts, which strengthened the findings, noting the potential for overdiagnosis when interviews are with the parents. “This really eliminates those biases.”

The authors explained the factors driving the need to update recurrence rate studies, including the growth in the prevalence of ASD in the last decade to 1 in 36. That may be caused partly by “greater awareness and identification of autistic females and cognitively able, verbal children.”

Also, new diagnostic criteria have been published, with different diagnostic thresholds since the last study. This study, they noted, had a sample size twice as large and more diverse than the 2011 sample.

The size and the diversity are particularly important, Dr. Rybczynski said, as it helps support more recent findings that ASD is not as heavily centered in White males as previously thought.

“We need to make sure we’re monitoring all children, especially from groups where there’s at least one older sibling or multiple siblings with autism or a sister with autism,” she said. The findings of this study are important not just for pediatricians but for families and all who have professional interactions with children.

Dr. Ozonoff reports travel reimbursements and honoraria from Autism Speaks and the Autism Science Foundation and book royalties from Guilford Press. One coauthor has served as a paid consultant to F. Hoffmann–La Roche and Servier and has received royalties from Sage Publications and Guilford Publications. Another is supported by the Stollery Children’s Hospital Foundation Chair in Autism. One coauthor reported a consulting agreement with EarliTec Diagnostics and book royalties from Wiley. A fourth coauthor has received funding from the Simons Foundation and consults for the Beasley Law Firm and Linus Technology. Dr. Rybczynski reported no relevant financial relationships.

Most women (72%) are not aware they are at risk for developing uterine fibroids, though up to 77% of women will develop them in their lifetime, results of a new survey indicate.

Data from The Harris Poll, conducted on behalf of the Society of Interventional Radiology, also found that 17% of women mistakenly think a hysterectomy is the only treatment option, including more than one in four women (27%) who are between the ages of 18 and 34. Results were shared in a press release. The survey included 1,122 US women, some who have been diagnosed with uterine fibroids.

Fibroids may not cause symptoms for some, but some women may have heavy, prolonged, debilitating bleeding. Some women experience pelvic pain, a diminished sex life, and declining energy. However, the growths do not spread to other body regions and typically are not dangerous.
 

Hysterectomy Is Only One Option

Among the women in the survey who had been diagnosed with fibroids, 53% were presented the option of hysterectomy and 20% were told about other, less-invasive options, including over-the-counter NSAIDs (19%); uterine fibroid embolization (UFE) (17%); oral contraceptives (17%); and endometrial ablation (17%).

“Women need to be informed about the complete range of options available for treating their uterine fibroids, not just the surgical options as is most commonly done by gynecologists,” John C. Lipman, MD, founder and medical director of the Atlanta Fibroid Center in Smyrna, Georgia, said in the press release.

The survey also found that:

• More than half of women ages 18-34 (56%) and women ages 35-44 (51%) were either not familiar with uterine fibroids or never heard of them.
• Awareness was particularly low among Hispanic women, as 50% of Hispanic women say they’ve never heard of or aren’t familiar with the condition, compared with 37% of Black women who answered that way.
• More than one third (36%) of Black women and 22% of Hispanic women mistakenly think they are not at risk for developing fibroids, yet research has shown that uterine fibroids are three times more common in Black women and two times more common in Hispanic women than in White women.

For this study, the full sample data is accurate to within +/– 3.2 percentage points using a 95% confidence level. The data are part of the report “The Fibroid Fix: What Women Need to Know,” published on July 9 by the Society of Interventional Radiology.

Linda Fan, MD, chief of gynecology at Yale University in New Haven, Connecticut, said she is not surprised by those numbers. She says many patients are referred to her department who have not been given the full array of medical options for their fibroids or have not had thorough discussions with their providers, such as whether they want to preserve their fertility, or how they feel about an incision, undergoing anesthesia, or having their uterus removed.

Sometimes the hysterectomy choice is clear, she said — for instance, if there are indications of the rare cancer leiomyosarcoma, or if a postmenopausal woman has rapid growth of fibroids or heavy bleeding. Fibroids should not start growing after menopause, she said.

Additional options include radiofrequency ablation, performed while a patient is under anesthesia, by laparoscopy or hysteroscopy. The procedure uses ultrasound to watch a probe as it shrinks the fibroids with heat.

Currently, if a woman wants large fibroids removed and wants to keep her fertility options open, Dr. Fan says, myomectomy or medication are best “because we have the most information or data on (those options).”

When treating patients who don’t prioritize fertility, she said, UFE is a good option that doesn’t need incisions or anesthesia. But patients sometimes require a lot of pain medication afterward, Dr. Fan said. With radiofrequency ablation, specifically the Acessa and Sonata procedures, she said, “patients don’t experience a lot of pain after the procedure because the shrinking happens when they’re asleep under anesthesia.”
 

Uterine Fibroid Embolization a Nonsurgical Option

The report describes how UFE works but the Harris Poll showed that 60% of women who have heard of UFE did not hear about it first from a healthcare provider.

“UFE is a nonsurgical treatment, performed by interventional radiologists, that has been proven to significantly reduce heavy menstrual bleeding, relieve uterine pain, and improve energy levels,” the authors write. “Through a tiny incision in the wrist or thigh, a catheter is guided via imaging to the vessels leading to the fibroids. Through this catheter, small clear particles are injected to block the blood flow leading to the fibroids causing them to shrink and disappear.”

After UFE, most women leave the hospital the day of or the day after treatment, according to the report authors, who add that many patients also report they can resume normal activity in about 2 weeks, more quickly than with surgical treatments.

In some cases, watchful waiting will be the best option, the report notes, and that may require repeated checkups and scans.

Dr. Lipman is an adviser on The Fibroid Fix report.

Most women (72%) are not aware they are at risk for developing uterine fibroids, though up to 77% of women will develop them in their lifetime, results of a new survey indicate.

Data from The Harris Poll, conducted on behalf of the Society of Interventional Radiology, also found that 17% of women mistakenly think a hysterectomy is the only treatment option, including more than one in four women (27%) who are between the ages of 18 and 34. Results were shared in a press release. The survey included 1,122 US women, some who have been diagnosed with uterine fibroids.

Fibroids may not cause symptoms for some, but some women may have heavy, prolonged, debilitating bleeding. Some women experience pelvic pain, a diminished sex life, and declining energy. However, the growths do not spread to other body regions and typically are not dangerous.
 

Hysterectomy Is Only One Option

Among the women in the survey who had been diagnosed with fibroids, 53% were presented the option of hysterectomy and 20% were told about other, less-invasive options, including over-the-counter NSAIDs (19%); uterine fibroid embolization (UFE) (17%); oral contraceptives (17%); and endometrial ablation (17%).

“Women need to be informed about the complete range of options available for treating their uterine fibroids, not just the surgical options as is most commonly done by gynecologists,” John C. Lipman, MD, founder and medical director of the Atlanta Fibroid Center in Smyrna, Georgia, said in the press release.

The survey also found that:

• More than half of women ages 18-34 (56%) and women ages 35-44 (51%) were either not familiar with uterine fibroids or never heard of them.
• Awareness was particularly low among Hispanic women, as 50% of Hispanic women say they’ve never heard of or aren’t familiar with the condition, compared with 37% of Black women who answered that way.
• More than one third (36%) of Black women and 22% of Hispanic women mistakenly think they are not at risk for developing fibroids, yet research has shown that uterine fibroids are three times more common in Black women and two times more common in Hispanic women than in White women.

For this study, the full sample data is accurate to within +/– 3.2 percentage points using a 95% confidence level. The data are part of the report “The Fibroid Fix: What Women Need to Know,” published on July 9 by the Society of Interventional Radiology.

Linda Fan, MD, chief of gynecology at Yale University in New Haven, Connecticut, said she is not surprised by those numbers. She says many patients are referred to her department who have not been given the full array of medical options for their fibroids or have not had thorough discussions with their providers, such as whether they want to preserve their fertility, or how they feel about an incision, undergoing anesthesia, or having their uterus removed.

Sometimes the hysterectomy choice is clear, she said — for instance, if there are indications of the rare cancer leiomyosarcoma, or if a postmenopausal woman has rapid growth of fibroids or heavy bleeding. Fibroids should not start growing after menopause, she said.

Additional options include radiofrequency ablation, performed while a patient is under anesthesia, by laparoscopy or hysteroscopy. The procedure uses ultrasound to watch a probe as it shrinks the fibroids with heat.

Currently, if a woman wants large fibroids removed and wants to keep her fertility options open, Dr. Fan says, myomectomy or medication are best “because we have the most information or data on (those options).”

When treating patients who don’t prioritize fertility, she said, UFE is a good option that doesn’t need incisions or anesthesia. But patients sometimes require a lot of pain medication afterward, Dr. Fan said. With radiofrequency ablation, specifically the Acessa and Sonata procedures, she said, “patients don’t experience a lot of pain after the procedure because the shrinking happens when they’re asleep under anesthesia.”
 

Uterine Fibroid Embolization a Nonsurgical Option

The report describes how UFE works but the Harris Poll showed that 60% of women who have heard of UFE did not hear about it first from a healthcare provider.

“UFE is a nonsurgical treatment, performed by interventional radiologists, that has been proven to significantly reduce heavy menstrual bleeding, relieve uterine pain, and improve energy levels,” the authors write. “Through a tiny incision in the wrist or thigh, a catheter is guided via imaging to the vessels leading to the fibroids. Through this catheter, small clear particles are injected to block the blood flow leading to the fibroids causing them to shrink and disappear.”

After UFE, most women leave the hospital the day of or the day after treatment, according to the report authors, who add that many patients also report they can resume normal activity in about 2 weeks, more quickly than with surgical treatments.

In some cases, watchful waiting will be the best option, the report notes, and that may require repeated checkups and scans.

Dr. Lipman is an adviser on The Fibroid Fix report.

Most women (72%) are not aware they are at risk for developing uterine fibroids, though up to 77% of women will develop them in their lifetime, results of a new survey indicate.

Data from The Harris Poll, conducted on behalf of the Society of Interventional Radiology, also found that 17% of women mistakenly think a hysterectomy is the only treatment option, including more than one in four women (27%) who are between the ages of 18 and 34. Results were shared in a press release. The survey included 1,122 US women, some who have been diagnosed with uterine fibroids.

Fibroids may not cause symptoms for some, but some women may have heavy, prolonged, debilitating bleeding. Some women experience pelvic pain, a diminished sex life, and declining energy. However, the growths do not spread to other body regions and typically are not dangerous.
 

Hysterectomy Is Only One Option

Among the women in the survey who had been diagnosed with fibroids, 53% were presented the option of hysterectomy and 20% were told about other, less-invasive options, including over-the-counter NSAIDs (19%); uterine fibroid embolization (UFE) (17%); oral contraceptives (17%); and endometrial ablation (17%).

“Women need to be informed about the complete range of options available for treating their uterine fibroids, not just the surgical options as is most commonly done by gynecologists,” John C. Lipman, MD, founder and medical director of the Atlanta Fibroid Center in Smyrna, Georgia, said in the press release.

The survey also found that:

• More than half of women ages 18-34 (56%) and women ages 35-44 (51%) were either not familiar with uterine fibroids or never heard of them.
• Awareness was particularly low among Hispanic women, as 50% of Hispanic women say they’ve never heard of or aren’t familiar with the condition, compared with 37% of Black women who answered that way.
• More than one third (36%) of Black women and 22% of Hispanic women mistakenly think they are not at risk for developing fibroids, yet research has shown that uterine fibroids are three times more common in Black women and two times more common in Hispanic women than in White women.

For this study, the full sample data is accurate to within +/– 3.2 percentage points using a 95% confidence level. The data are part of the report “The Fibroid Fix: What Women Need to Know,” published on July 9 by the Society of Interventional Radiology.

Linda Fan, MD, chief of gynecology at Yale University in New Haven, Connecticut, said she is not surprised by those numbers. She says many patients are referred to her department who have not been given the full array of medical options for their fibroids or have not had thorough discussions with their providers, such as whether they want to preserve their fertility, or how they feel about an incision, undergoing anesthesia, or having their uterus removed.

Sometimes the hysterectomy choice is clear, she said — for instance, if there are indications of the rare cancer leiomyosarcoma, or if a postmenopausal woman has rapid growth of fibroids or heavy bleeding. Fibroids should not start growing after menopause, she said.

Additional options include radiofrequency ablation, performed while a patient is under anesthesia, by laparoscopy or hysteroscopy. The procedure uses ultrasound to watch a probe as it shrinks the fibroids with heat.

Currently, if a woman wants large fibroids removed and wants to keep her fertility options open, Dr. Fan says, myomectomy or medication are best “because we have the most information or data on (those options).”

When treating patients who don’t prioritize fertility, she said, UFE is a good option that doesn’t need incisions or anesthesia. But patients sometimes require a lot of pain medication afterward, Dr. Fan said. With radiofrequency ablation, specifically the Acessa and Sonata procedures, she said, “patients don’t experience a lot of pain after the procedure because the shrinking happens when they’re asleep under anesthesia.”
 

Uterine Fibroid Embolization a Nonsurgical Option

The report describes how UFE works but the Harris Poll showed that 60% of women who have heard of UFE did not hear about it first from a healthcare provider.

“UFE is a nonsurgical treatment, performed by interventional radiologists, that has been proven to significantly reduce heavy menstrual bleeding, relieve uterine pain, and improve energy levels,” the authors write. “Through a tiny incision in the wrist or thigh, a catheter is guided via imaging to the vessels leading to the fibroids. Through this catheter, small clear particles are injected to block the blood flow leading to the fibroids causing them to shrink and disappear.”

After UFE, most women leave the hospital the day of or the day after treatment, according to the report authors, who add that many patients also report they can resume normal activity in about 2 weeks, more quickly than with surgical treatments.

In some cases, watchful waiting will be the best option, the report notes, and that may require repeated checkups and scans.

Dr. Lipman is an adviser on The Fibroid Fix report.

Nearly half (46%) of ob.gyn.s, and physicians generally, said in a new survey their employers were not paying enough attention to the extent of burnout among their physicians.

Findings of the survey were reported in Medscape’s Ob/Gyn Practice Issues Report 2024.

“It’s a big problem,” said Nigel Girgrah, MD, PhD, chief wellness officer at Ochsner Health in New Orleans, Louisiana. But he added he expects that 46% level to drop in the next few years.

“There’s an increasing awareness among executives in healthcare that well-being is a leading quality indicator, if not the indicator, of favorable outcomes in patient care, staff turnover, and other vital areas,” he said.

However, there are structural barriers that threaten work-life balance, says Eve Espey, MD, MPH, chair of the Department of Obstetrics and Gynecology at the University of New Mexico in Albuquerque. In a specialty made up mostly of women, she notes, there is no federal policy on paid medical leave, leading to women ob.gyn.s pulling double duty at work and at home.

“To me, the most important way to engage on burnout is not offering yoga lessons; it’s dealing with these big structural issues,” she said.
 

What’s Driving the Burnout

Ob.gyn. survey respondents said the top two reasons for burnout are too many bureaucratic tasks, such as paperwork and charting, (cited by 62%) and too many hours at work (cited by 53%).

More than half (55%) said the paperwork burden had increased in the past year; 34% said it stayed the same; and 11% said it had decreased.

“I think the regulatory burden has gotten higher for most of my colleagues,” Dr. Espey, said. “Coding and billing rules are pretty opaque to most ob.gyn.s and a lot of the tasks that used to be done by medical assistants are now done by physicians.”
 

‘Big Hope’ Is AI

“The big hope on the horizon is AI and programs that do basically what scribes do,” Dr. Espey said. “People feel like that will be a game-changer when it comes to paperwork.”

She said the root problem is that EHRs are used mostly for billing, not for communication. Two thirds of the respondents said they sometimes or always copy and paste from charts, which can lead to note bloat.

“You can’t write concise notes in EHRs,” Dr. Espey said. “I think this is an area where the promise of AI would be very helpful.”

Nearly 40% of ob.gyn.s were enthusiastic about the potential for AI in the survey; 43% were neutral on the subject; and the remainder were apprehensive. Asked about how their practices have most commonly used AI so far, 23% said it was used for researching conditions. The next highest usage was for help in diagnosing conditions (mentioned by 13%).

More than half (53%) of the ob.gyn.s said they thought AI would free up more time for patient conversations and care while only 38% of doctors generally thought it would.
 

Hard to Spend More Time With One Patient

Nearly three in 10 ob.gyn.s said they have a patient quota at their workplace, compared with one in four for physicians generally.

“Clearly, there can be thresholds (for ob.gyn.s) in the office and ambulatory care settings,” said Catherine Cansino, MD, MPH, a Sacramento ob.gyn. affiliated with University of California–Davis Medical Center. She added that on the inpatient side, patient quotas come from the allotted time an ob.gyn. can spend with a patient. “There are definitely hoops to jump through when we want to spend more time with a patient, and it can be tough for them to get a follow-up appointment.”

Most ob.gyn.s (62%) in the survey would give their employer good ratings for offering an engaging and welcoming atmosphere. But nearly 40% said their employer emphasizes patient quotas and CPT codes more than care quality.

Data for this report were drawn from several Medscape surveys performed between March and October of 2023.
 

Nearly half (46%) of ob.gyn.s, and physicians generally, said in a new survey their employers were not paying enough attention to the extent of burnout among their physicians.

Findings of the survey were reported in Medscape’s Ob/Gyn Practice Issues Report 2024.

“It’s a big problem,” said Nigel Girgrah, MD, PhD, chief wellness officer at Ochsner Health in New Orleans, Louisiana. But he added he expects that 46% level to drop in the next few years.

“There’s an increasing awareness among executives in healthcare that well-being is a leading quality indicator, if not the indicator, of favorable outcomes in patient care, staff turnover, and other vital areas,” he said.

However, there are structural barriers that threaten work-life balance, says Eve Espey, MD, MPH, chair of the Department of Obstetrics and Gynecology at the University of New Mexico in Albuquerque. In a specialty made up mostly of women, she notes, there is no federal policy on paid medical leave, leading to women ob.gyn.s pulling double duty at work and at home.

“To me, the most important way to engage on burnout is not offering yoga lessons; it’s dealing with these big structural issues,” she said.
 

What’s Driving the Burnout

Ob.gyn. survey respondents said the top two reasons for burnout are too many bureaucratic tasks, such as paperwork and charting, (cited by 62%) and too many hours at work (cited by 53%).

More than half (55%) said the paperwork burden had increased in the past year; 34% said it stayed the same; and 11% said it had decreased.

“I think the regulatory burden has gotten higher for most of my colleagues,” Dr. Espey, said. “Coding and billing rules are pretty opaque to most ob.gyn.s and a lot of the tasks that used to be done by medical assistants are now done by physicians.”
 

‘Big Hope’ Is AI

“The big hope on the horizon is AI and programs that do basically what scribes do,” Dr. Espey said. “People feel like that will be a game-changer when it comes to paperwork.”

She said the root problem is that EHRs are used mostly for billing, not for communication. Two thirds of the respondents said they sometimes or always copy and paste from charts, which can lead to note bloat.

“You can’t write concise notes in EHRs,” Dr. Espey said. “I think this is an area where the promise of AI would be very helpful.”

Nearly 40% of ob.gyn.s were enthusiastic about the potential for AI in the survey; 43% were neutral on the subject; and the remainder were apprehensive. Asked about how their practices have most commonly used AI so far, 23% said it was used for researching conditions. The next highest usage was for help in diagnosing conditions (mentioned by 13%).

More than half (53%) of the ob.gyn.s said they thought AI would free up more time for patient conversations and care while only 38% of doctors generally thought it would.
 

Hard to Spend More Time With One Patient

Nearly three in 10 ob.gyn.s said they have a patient quota at their workplace, compared with one in four for physicians generally.

“Clearly, there can be thresholds (for ob.gyn.s) in the office and ambulatory care settings,” said Catherine Cansino, MD, MPH, a Sacramento ob.gyn. affiliated with University of California–Davis Medical Center. She added that on the inpatient side, patient quotas come from the allotted time an ob.gyn. can spend with a patient. “There are definitely hoops to jump through when we want to spend more time with a patient, and it can be tough for them to get a follow-up appointment.”

Most ob.gyn.s (62%) in the survey would give their employer good ratings for offering an engaging and welcoming atmosphere. But nearly 40% said their employer emphasizes patient quotas and CPT codes more than care quality.

Data for this report were drawn from several Medscape surveys performed between March and October of 2023.
 

Nearly half (46%) of ob.gyn.s, and physicians generally, said in a new survey their employers were not paying enough attention to the extent of burnout among their physicians.

Findings of the survey were reported in Medscape’s Ob/Gyn Practice Issues Report 2024.

“It’s a big problem,” said Nigel Girgrah, MD, PhD, chief wellness officer at Ochsner Health in New Orleans, Louisiana. But he added he expects that 46% level to drop in the next few years.

“There’s an increasing awareness among executives in healthcare that well-being is a leading quality indicator, if not the indicator, of favorable outcomes in patient care, staff turnover, and other vital areas,” he said.

However, there are structural barriers that threaten work-life balance, says Eve Espey, MD, MPH, chair of the Department of Obstetrics and Gynecology at the University of New Mexico in Albuquerque. In a specialty made up mostly of women, she notes, there is no federal policy on paid medical leave, leading to women ob.gyn.s pulling double duty at work and at home.

“To me, the most important way to engage on burnout is not offering yoga lessons; it’s dealing with these big structural issues,” she said.
 

What’s Driving the Burnout

Ob.gyn. survey respondents said the top two reasons for burnout are too many bureaucratic tasks, such as paperwork and charting, (cited by 62%) and too many hours at work (cited by 53%).

More than half (55%) said the paperwork burden had increased in the past year; 34% said it stayed the same; and 11% said it had decreased.

“I think the regulatory burden has gotten higher for most of my colleagues,” Dr. Espey, said. “Coding and billing rules are pretty opaque to most ob.gyn.s and a lot of the tasks that used to be done by medical assistants are now done by physicians.”
 

‘Big Hope’ Is AI

“The big hope on the horizon is AI and programs that do basically what scribes do,” Dr. Espey said. “People feel like that will be a game-changer when it comes to paperwork.”

She said the root problem is that EHRs are used mostly for billing, not for communication. Two thirds of the respondents said they sometimes or always copy and paste from charts, which can lead to note bloat.

“You can’t write concise notes in EHRs,” Dr. Espey said. “I think this is an area where the promise of AI would be very helpful.”

Nearly 40% of ob.gyn.s were enthusiastic about the potential for AI in the survey; 43% were neutral on the subject; and the remainder were apprehensive. Asked about how their practices have most commonly used AI so far, 23% said it was used for researching conditions. The next highest usage was for help in diagnosing conditions (mentioned by 13%).

More than half (53%) of the ob.gyn.s said they thought AI would free up more time for patient conversations and care while only 38% of doctors generally thought it would.
 

Hard to Spend More Time With One Patient

Nearly three in 10 ob.gyn.s said they have a patient quota at their workplace, compared with one in four for physicians generally.

“Clearly, there can be thresholds (for ob.gyn.s) in the office and ambulatory care settings,” said Catherine Cansino, MD, MPH, a Sacramento ob.gyn. affiliated with University of California–Davis Medical Center. She added that on the inpatient side, patient quotas come from the allotted time an ob.gyn. can spend with a patient. “There are definitely hoops to jump through when we want to spend more time with a patient, and it can be tough for them to get a follow-up appointment.”

Most ob.gyn.s (62%) in the survey would give their employer good ratings for offering an engaging and welcoming atmosphere. But nearly 40% said their employer emphasizes patient quotas and CPT codes more than care quality.

Data for this report were drawn from several Medscape surveys performed between March and October of 2023.