Debra Katz, CNM, has noticed a shift in the number of teenagers coming to the teen obstetrics program at St. Joseph’s Medical Center in Paterson, N.J. A decade ago, about 30 adolescents gave birth in a given month; now, that figure is closer to 20, said Ms. Katz, chief of the nurse midwifery service at the center.

Ms. Katz’s observations mirror a national trend: The rate of teen births is falling in the United States, according to a study published in Obstetrics and Gynecology.

But, there’s a catch. The adolescents who are giving birth are more likely to have obesity, mental health problems, asthma, and other conditions that can complicate their pregnancies, the research shows. Rates of delivery complications have also increased in this age group.

Ms. Katz said that, compared with adult patients, teens tend to require longer medical visits. Most patients have limited knowledge of what prenatal care entails.

“Most of these patients have never even had a female [gynecologic] exam before,” Ms. Katz said. “They come in and they’re not used to the equipment. They’re not used to the terminology.”

Also consistent with the national trends, St. Joseph’s younger patients often have mental health problems or obesity. Many also lack stable housing and adequate food.

“Unfortunately, we are seeing a greater number of patients with morbid obesity; there’s a lot of bipolar disease; here’s a lot of depression; there’s a lot of anxiety,” Ms. Katz said. “And we also have a bit of PTSD [post traumatic stress disorder] as well.”

These factors make clinical practice more complex, according to the authors of the new study. “To optimize adolescent pregnancy outcomes, prenatal care will likely need to provide increasingly complex clinical management in addition to addressing outreach challenges of this population,” the authors of the new study write.

At St. Joseph’s, teens receive prenatal care in a group setting with other patients who are due to deliver in the same month. This model, called CenteringPregnancy, can increase self-esteem, build community, and may improve patient outcomes, Ms. Katz said. The program uses a team approach that includes a dietitian and social worker to address social support needs.
 

Shifting health status

To characterize delivery hospitalization trends for patients aged 11-19 years, Anna P. Staniczenko, MD, with Columbia University Irving Medical Center, New York, and her colleagues conducted a cross-sectional analysis of data from the 2000-2018 National Inpatient Sample.

Of more than 73 million estimated delivery hospitalizations during that period, 88,363 occurred in patients aged 11-14 years, and 6,359,331 were among patients aged 15-19 years.

Deliveries among patients aged 11-14 years decreased from 2.1 per 1,000 to 0.4 per 1,000 during the time frame. Deliveries among patients aged 15-19 years decreased from 11.5% of all deliveries to 4.8% over the study period.

Among patients aged 11-19 years, rates of comorbidities significantly increased from 2000 to 2018, the researchers found. The prevalence of obesity increased from 0.2% to 7.2%, asthma increased from 1.6% to 7%, while mental health conditions increased from 0.5% to 7.1%.

Severe maternal morbidity, defined as a patient having at least one of 20 conditions, including stroke, heart failure, and sepsis, increased from 0.5% to 0.7%. The rate of postpartum hemorrhage increased from 2.9% to 4.7%, the rate of cesarean delivery increased from 15.2% to 19.5%, and that of hypertensive disorders of pregnancy increased from 7.5% to 13.7%.
 

An often overlooked group

Adolescent pregnancies are more common in the United States than in other wealthy nations, and about 80% are unintended. In addition to the growth in comorbid conditions, adolescent mothers are at an increased risk of living under the poverty line, and children born to teen moms may be at increased risk for adverse pediatric outcomes.

Still, these pregnancies “may be planned and desired. ... It is unclear that there is an ‘ideal’ rate of pregnancy for this age group,” the study authors write.

Prior research has shown an increase in rates of chronic conditions among adults giving birth, but, “from what I could tell, this is really the first data” on chronic conditions in the pediatric obstetric population, said Lindsay K. Admon, MD, an ob.gyn. at the University of Michigan, Ann Arbor, who wrote an editorial accompanying the journal article.
 

Behind the decline

That there are fewer teen deliveries may be because the adolescent population is savvier about contraceptive methods. In addition, the Affordable Care Act expanded insurance coverage of contraception, said Stephanie Teal, MD, MPH, chair of obstetrics and gynecology and reproductive biology at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland.

Dr. Teal was involved in the Colorado Family Planning Initiative, a state effort that showed that long-acting reversible contraception was effective and acceptable to young people.

“We are definitely seeing more adolescents who use birth control the first time they have sex,” Dr. Teal told this news organization. “When I started in practice, it was fairly uncommon that I would see a teenager who was sexually active who was consistently using a birth control method. And now they just look at me, roll their eyes, and are, like, ‘Duh, of course. He uses condoms, and I have an IUD.’ ”

To the extent that these deliveries include unintended pregnancies, the data may point to a need for clinicians to provide contraceptive education to adolescents with chronic conditions, according to Dr. Admon.
 

Abortion shifts

If U.S. Supreme Court rulings and state laws further limit access to contraception or abortion, the result could lead to more teen deliveries, Dr. Admon said.

While the adolescent birth rate has plummeted, the teen abortion rate has not increased, Dr. Teal said.

“Pregnancy is a time of health risk for women, and it’s getting riskier,” she said. “Our concern is that if people are having to go through a pregnancy that they don’t feel physically or financially or emotionally prepared to go through, that we will see an increase in these kinds of adverse health outcomes with birth.”

One study author has a leadership role on an American College of Obstetricians and Gynecologists safe motherhood initiative that has received unrestricted funding from Merck for Mothers. Another author has ties to Delfina Care, and one is on the board of directors of Planned Parenthood of Greater New York. Dr. Admon receives funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Teal has received grants from Merck, Bayer Healthcare, Sebela, and Medicines360 and personal fees from Merck and from Bayer Healthcare. Ms. Katz has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Debra Katz, CNM, has noticed a shift in the number of teenagers coming to the teen obstetrics program at St. Joseph’s Medical Center in Paterson, N.J. A decade ago, about 30 adolescents gave birth in a given month; now, that figure is closer to 20, said Ms. Katz, chief of the nurse midwifery service at the center.

Ms. Katz’s observations mirror a national trend: The rate of teen births is falling in the United States, according to a study published in Obstetrics and Gynecology.

But, there’s a catch. The adolescents who are giving birth are more likely to have obesity, mental health problems, asthma, and other conditions that can complicate their pregnancies, the research shows. Rates of delivery complications have also increased in this age group.

Ms. Katz said that, compared with adult patients, teens tend to require longer medical visits. Most patients have limited knowledge of what prenatal care entails.

“Most of these patients have never even had a female [gynecologic] exam before,” Ms. Katz said. “They come in and they’re not used to the equipment. They’re not used to the terminology.”

Also consistent with the national trends, St. Joseph’s younger patients often have mental health problems or obesity. Many also lack stable housing and adequate food.

“Unfortunately, we are seeing a greater number of patients with morbid obesity; there’s a lot of bipolar disease; here’s a lot of depression; there’s a lot of anxiety,” Ms. Katz said. “And we also have a bit of PTSD [post traumatic stress disorder] as well.”

These factors make clinical practice more complex, according to the authors of the new study. “To optimize adolescent pregnancy outcomes, prenatal care will likely need to provide increasingly complex clinical management in addition to addressing outreach challenges of this population,” the authors of the new study write.

At St. Joseph’s, teens receive prenatal care in a group setting with other patients who are due to deliver in the same month. This model, called CenteringPregnancy, can increase self-esteem, build community, and may improve patient outcomes, Ms. Katz said. The program uses a team approach that includes a dietitian and social worker to address social support needs.
 

Shifting health status

To characterize delivery hospitalization trends for patients aged 11-19 years, Anna P. Staniczenko, MD, with Columbia University Irving Medical Center, New York, and her colleagues conducted a cross-sectional analysis of data from the 2000-2018 National Inpatient Sample.

Of more than 73 million estimated delivery hospitalizations during that period, 88,363 occurred in patients aged 11-14 years, and 6,359,331 were among patients aged 15-19 years.

Deliveries among patients aged 11-14 years decreased from 2.1 per 1,000 to 0.4 per 1,000 during the time frame. Deliveries among patients aged 15-19 years decreased from 11.5% of all deliveries to 4.8% over the study period.

Among patients aged 11-19 years, rates of comorbidities significantly increased from 2000 to 2018, the researchers found. The prevalence of obesity increased from 0.2% to 7.2%, asthma increased from 1.6% to 7%, while mental health conditions increased from 0.5% to 7.1%.

Severe maternal morbidity, defined as a patient having at least one of 20 conditions, including stroke, heart failure, and sepsis, increased from 0.5% to 0.7%. The rate of postpartum hemorrhage increased from 2.9% to 4.7%, the rate of cesarean delivery increased from 15.2% to 19.5%, and that of hypertensive disorders of pregnancy increased from 7.5% to 13.7%.
 

An often overlooked group

Adolescent pregnancies are more common in the United States than in other wealthy nations, and about 80% are unintended. In addition to the growth in comorbid conditions, adolescent mothers are at an increased risk of living under the poverty line, and children born to teen moms may be at increased risk for adverse pediatric outcomes.

Still, these pregnancies “may be planned and desired. ... It is unclear that there is an ‘ideal’ rate of pregnancy for this age group,” the study authors write.

Prior research has shown an increase in rates of chronic conditions among adults giving birth, but, “from what I could tell, this is really the first data” on chronic conditions in the pediatric obstetric population, said Lindsay K. Admon, MD, an ob.gyn. at the University of Michigan, Ann Arbor, who wrote an editorial accompanying the journal article.
 

Behind the decline

That there are fewer teen deliveries may be because the adolescent population is savvier about contraceptive methods. In addition, the Affordable Care Act expanded insurance coverage of contraception, said Stephanie Teal, MD, MPH, chair of obstetrics and gynecology and reproductive biology at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland.

Dr. Teal was involved in the Colorado Family Planning Initiative, a state effort that showed that long-acting reversible contraception was effective and acceptable to young people.

“We are definitely seeing more adolescents who use birth control the first time they have sex,” Dr. Teal told this news organization. “When I started in practice, it was fairly uncommon that I would see a teenager who was sexually active who was consistently using a birth control method. And now they just look at me, roll their eyes, and are, like, ‘Duh, of course. He uses condoms, and I have an IUD.’ ”

To the extent that these deliveries include unintended pregnancies, the data may point to a need for clinicians to provide contraceptive education to adolescents with chronic conditions, according to Dr. Admon.
 

Abortion shifts

If U.S. Supreme Court rulings and state laws further limit access to contraception or abortion, the result could lead to more teen deliveries, Dr. Admon said.

While the adolescent birth rate has plummeted, the teen abortion rate has not increased, Dr. Teal said.

“Pregnancy is a time of health risk for women, and it’s getting riskier,” she said. “Our concern is that if people are having to go through a pregnancy that they don’t feel physically or financially or emotionally prepared to go through, that we will see an increase in these kinds of adverse health outcomes with birth.”

One study author has a leadership role on an American College of Obstetricians and Gynecologists safe motherhood initiative that has received unrestricted funding from Merck for Mothers. Another author has ties to Delfina Care, and one is on the board of directors of Planned Parenthood of Greater New York. Dr. Admon receives funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Teal has received grants from Merck, Bayer Healthcare, Sebela, and Medicines360 and personal fees from Merck and from Bayer Healthcare. Ms. Katz has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Debra Katz, CNM, has noticed a shift in the number of teenagers coming to the teen obstetrics program at St. Joseph’s Medical Center in Paterson, N.J. A decade ago, about 30 adolescents gave birth in a given month; now, that figure is closer to 20, said Ms. Katz, chief of the nurse midwifery service at the center.

Ms. Katz’s observations mirror a national trend: The rate of teen births is falling in the United States, according to a study published in Obstetrics and Gynecology.

But, there’s a catch. The adolescents who are giving birth are more likely to have obesity, mental health problems, asthma, and other conditions that can complicate their pregnancies, the research shows. Rates of delivery complications have also increased in this age group.

Ms. Katz said that, compared with adult patients, teens tend to require longer medical visits. Most patients have limited knowledge of what prenatal care entails.

“Most of these patients have never even had a female [gynecologic] exam before,” Ms. Katz said. “They come in and they’re not used to the equipment. They’re not used to the terminology.”

Also consistent with the national trends, St. Joseph’s younger patients often have mental health problems or obesity. Many also lack stable housing and adequate food.

“Unfortunately, we are seeing a greater number of patients with morbid obesity; there’s a lot of bipolar disease; here’s a lot of depression; there’s a lot of anxiety,” Ms. Katz said. “And we also have a bit of PTSD [post traumatic stress disorder] as well.”

These factors make clinical practice more complex, according to the authors of the new study. “To optimize adolescent pregnancy outcomes, prenatal care will likely need to provide increasingly complex clinical management in addition to addressing outreach challenges of this population,” the authors of the new study write.

At St. Joseph’s, teens receive prenatal care in a group setting with other patients who are due to deliver in the same month. This model, called CenteringPregnancy, can increase self-esteem, build community, and may improve patient outcomes, Ms. Katz said. The program uses a team approach that includes a dietitian and social worker to address social support needs.
 

Shifting health status

To characterize delivery hospitalization trends for patients aged 11-19 years, Anna P. Staniczenko, MD, with Columbia University Irving Medical Center, New York, and her colleagues conducted a cross-sectional analysis of data from the 2000-2018 National Inpatient Sample.

Of more than 73 million estimated delivery hospitalizations during that period, 88,363 occurred in patients aged 11-14 years, and 6,359,331 were among patients aged 15-19 years.

Deliveries among patients aged 11-14 years decreased from 2.1 per 1,000 to 0.4 per 1,000 during the time frame. Deliveries among patients aged 15-19 years decreased from 11.5% of all deliveries to 4.8% over the study period.

Among patients aged 11-19 years, rates of comorbidities significantly increased from 2000 to 2018, the researchers found. The prevalence of obesity increased from 0.2% to 7.2%, asthma increased from 1.6% to 7%, while mental health conditions increased from 0.5% to 7.1%.

Severe maternal morbidity, defined as a patient having at least one of 20 conditions, including stroke, heart failure, and sepsis, increased from 0.5% to 0.7%. The rate of postpartum hemorrhage increased from 2.9% to 4.7%, the rate of cesarean delivery increased from 15.2% to 19.5%, and that of hypertensive disorders of pregnancy increased from 7.5% to 13.7%.
 

An often overlooked group

Adolescent pregnancies are more common in the United States than in other wealthy nations, and about 80% are unintended. In addition to the growth in comorbid conditions, adolescent mothers are at an increased risk of living under the poverty line, and children born to teen moms may be at increased risk for adverse pediatric outcomes.

Still, these pregnancies “may be planned and desired. ... It is unclear that there is an ‘ideal’ rate of pregnancy for this age group,” the study authors write.

Prior research has shown an increase in rates of chronic conditions among adults giving birth, but, “from what I could tell, this is really the first data” on chronic conditions in the pediatric obstetric population, said Lindsay K. Admon, MD, an ob.gyn. at the University of Michigan, Ann Arbor, who wrote an editorial accompanying the journal article.
 

Behind the decline

That there are fewer teen deliveries may be because the adolescent population is savvier about contraceptive methods. In addition, the Affordable Care Act expanded insurance coverage of contraception, said Stephanie Teal, MD, MPH, chair of obstetrics and gynecology and reproductive biology at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland.

Dr. Teal was involved in the Colorado Family Planning Initiative, a state effort that showed that long-acting reversible contraception was effective and acceptable to young people.

“We are definitely seeing more adolescents who use birth control the first time they have sex,” Dr. Teal told this news organization. “When I started in practice, it was fairly uncommon that I would see a teenager who was sexually active who was consistently using a birth control method. And now they just look at me, roll their eyes, and are, like, ‘Duh, of course. He uses condoms, and I have an IUD.’ ”

To the extent that these deliveries include unintended pregnancies, the data may point to a need for clinicians to provide contraceptive education to adolescents with chronic conditions, according to Dr. Admon.
 

Abortion shifts

If U.S. Supreme Court rulings and state laws further limit access to contraception or abortion, the result could lead to more teen deliveries, Dr. Admon said.

While the adolescent birth rate has plummeted, the teen abortion rate has not increased, Dr. Teal said.

“Pregnancy is a time of health risk for women, and it’s getting riskier,” she said. “Our concern is that if people are having to go through a pregnancy that they don’t feel physically or financially or emotionally prepared to go through, that we will see an increase in these kinds of adverse health outcomes with birth.”

One study author has a leadership role on an American College of Obstetricians and Gynecologists safe motherhood initiative that has received unrestricted funding from Merck for Mothers. Another author has ties to Delfina Care, and one is on the board of directors of Planned Parenthood of Greater New York. Dr. Admon receives funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Teal has received grants from Merck, Bayer Healthcare, Sebela, and Medicines360 and personal fees from Merck and from Bayer Healthcare. Ms. Katz has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.

The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.

Andrew D. Bowser/MDedge News

In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.

The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”

Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.

In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.

The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”

On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”

The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.

“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”

“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.

The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.

The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”

But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.

The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.

Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.

About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.

The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.

Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.

Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.

Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.

A version of this article first appeared on Medscape.com.

A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.

The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.

Andrew D. Bowser/MDedge News

In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.

The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”

Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.

In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.

The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”

On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”

The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.

“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”

“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.

The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.

The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”

But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.

The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.

Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.

About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.

The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.

Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.

Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.

Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.

A version of this article first appeared on Medscape.com.

A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.

The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.

Andrew D. Bowser/MDedge News

In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.

The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”

Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.

In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.

The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”

On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”

The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.

“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”

“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.

The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.

The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”

But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.

The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.

Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.

About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.

The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.

Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.

Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.

Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.

A version of this article first appeared on Medscape.com.

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.¹ In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

CA-125 has Food and Drug Administration approval for use in patients with a current or prior diagnosis of ovarian cancer to monitor treatment response, progression of disease, or disease recurrence.

It is frequently used off label in the workup of adnexal masses, while not FDA approved. CA-125 and other serum biomarkers may help determine the etiology of an adnexal mass; however, they are not diagnostic and should be used thoughtfully. It is important to have conversations with patients before ordering a CA-125 (or other serum biomarkers) about potential results and their effect on diagnosis and treatment. This will lessen some patient anxiety when tests results become available, especially in the setting of autoreleasing results under the Cures Act.

One of the reasons that CA-125 can be difficult to interpret when used as a diagnostic tool is the number of nonmalignant disease processes that can result in CA-125 elevations. CA-125 can be elevated in inflammatory and infectious disease states, including but not limited to, chronic obstructive pulmonary disease, pelvic inflammatory disease, diverticulitis, and pneumonia. Severe/critical COVID-19 infection has recently been found to be associated with increased levels of CA-125.² It is important to obtain a complete medical history and to take specific note of any current or recent flares in inflammatory or infectious processes that could contribute to CA-125 elevations.

Special caution should be taken in premenopausal patients. The sensitivity and specificity of CA-125 are lower in this cohort of patients compared to postmenopausal women. This is multifactorial but in part due to gynecologic conditions that can increase CA-125, such as uterine fibroids and endometriosis, and the higher incidence of nonepithelial ovarian cancers (which frequently have different serum biomarkers) in younger patients. A patient’s gynecologic history, her age, and ultrasound or other imaging findings should help determine what, if any, serum biomarkers are appropriate for workup of an adnexal mass rather than the default ordering of CA-125 to determine need for referral to gynecologic oncology. If the decision has been made to take the patient to the operating room, CA-125 is not approved as a triage tool to guide who best to perform the surgery. In this case, one of two serum tumor marker panel tests that has received FDA approval for triage after the decision for surgery has been made (the multivariate index assay or the risk of ovarian malignancy algorithm) should be used.

When considering its ability to serve as a diagnostic test for ovarian cancer, the sensitivity of CA-125 is affected by the number of patients with epithelial ovarian cancer who have a test result that falls within the normal range (up to 50% of patients with stage I disease).³ The specificity of CA-125 is affected by the large number of nonmalignant conditions that can cause its elevation. Depending on the age of the patient, her menopausal status, comorbid conditions, and reason for obtaining serum biomarkers (e.g., decision for surgery has already been made), CA-125 (or CA-125 alone) may not be the best tool to use in the workup of an adnexal mass and can cause significant patient anxiety. In the setting of acute disease, such as COVID-19 infection, it may be better to delay obtaining serum biomarkers for the work-up of an adnexal mass. If delay is not feasible, then repeat serum biomarkers once the acute phase of illness has passed.

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Thériault C et al. Gynecol Oncol. 2011 Jun 1;121(3):434-43.

2. Wei X et al. J Med Virol. 2020;92(10):2036-41.

3. Zurawski VR Jr et al. Int J Cancer. 1988;42:677-80.

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.¹ In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

CA-125 has Food and Drug Administration approval for use in patients with a current or prior diagnosis of ovarian cancer to monitor treatment response, progression of disease, or disease recurrence.

It is frequently used off label in the workup of adnexal masses, while not FDA approved. CA-125 and other serum biomarkers may help determine the etiology of an adnexal mass; however, they are not diagnostic and should be used thoughtfully. It is important to have conversations with patients before ordering a CA-125 (or other serum biomarkers) about potential results and their effect on diagnosis and treatment. This will lessen some patient anxiety when tests results become available, especially in the setting of autoreleasing results under the Cures Act.

One of the reasons that CA-125 can be difficult to interpret when used as a diagnostic tool is the number of nonmalignant disease processes that can result in CA-125 elevations. CA-125 can be elevated in inflammatory and infectious disease states, including but not limited to, chronic obstructive pulmonary disease, pelvic inflammatory disease, diverticulitis, and pneumonia. Severe/critical COVID-19 infection has recently been found to be associated with increased levels of CA-125.² It is important to obtain a complete medical history and to take specific note of any current or recent flares in inflammatory or infectious processes that could contribute to CA-125 elevations.

Special caution should be taken in premenopausal patients. The sensitivity and specificity of CA-125 are lower in this cohort of patients compared to postmenopausal women. This is multifactorial but in part due to gynecologic conditions that can increase CA-125, such as uterine fibroids and endometriosis, and the higher incidence of nonepithelial ovarian cancers (which frequently have different serum biomarkers) in younger patients. A patient’s gynecologic history, her age, and ultrasound or other imaging findings should help determine what, if any, serum biomarkers are appropriate for workup of an adnexal mass rather than the default ordering of CA-125 to determine need for referral to gynecologic oncology. If the decision has been made to take the patient to the operating room, CA-125 is not approved as a triage tool to guide who best to perform the surgery. In this case, one of two serum tumor marker panel tests that has received FDA approval for triage after the decision for surgery has been made (the multivariate index assay or the risk of ovarian malignancy algorithm) should be used.

When considering its ability to serve as a diagnostic test for ovarian cancer, the sensitivity of CA-125 is affected by the number of patients with epithelial ovarian cancer who have a test result that falls within the normal range (up to 50% of patients with stage I disease).³ The specificity of CA-125 is affected by the large number of nonmalignant conditions that can cause its elevation. Depending on the age of the patient, her menopausal status, comorbid conditions, and reason for obtaining serum biomarkers (e.g., decision for surgery has already been made), CA-125 (or CA-125 alone) may not be the best tool to use in the workup of an adnexal mass and can cause significant patient anxiety. In the setting of acute disease, such as COVID-19 infection, it may be better to delay obtaining serum biomarkers for the work-up of an adnexal mass. If delay is not feasible, then repeat serum biomarkers once the acute phase of illness has passed.

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Thériault C et al. Gynecol Oncol. 2011 Jun 1;121(3):434-43.

2. Wei X et al. J Med Virol. 2020;92(10):2036-41.

3. Zurawski VR Jr et al. Int J Cancer. 1988;42:677-80.

CA-125, or cancer antigen 125, is an epitope (antigen) on the transmembrane glycoprotein MUC16, or mucin 16. This protein is expressed on the surface of tissue derived from embryonic coelomic and Müllerian epithelium including the reproductive tract. CA-125 is also expressed in other tissue such as the pleura, lungs, pericardium, intestines, and kidneys. MUC16 plays an important role in tumor proliferation, invasiveness, and cell motility.¹ In patients with epithelial ovarian cancer (EOC), CA-125 may be found on the surface of ovarian cancer cells. It is shed in the bloodstream and can be quantified using a serum test.

There are a number of CA-125 assays in commercial use, and although none have been deemed to be clinically superior, there can be some differences between assays. It is important, if possible, to use the same assay when following serial CA-125 values. Most frequently, this will mean getting the test through the same laboratory.

CA-125 has Food and Drug Administration approval for use in patients with a current or prior diagnosis of ovarian cancer to monitor treatment response, progression of disease, or disease recurrence.

It is frequently used off label in the workup of adnexal masses, while not FDA approved. CA-125 and other serum biomarkers may help determine the etiology of an adnexal mass; however, they are not diagnostic and should be used thoughtfully. It is important to have conversations with patients before ordering a CA-125 (or other serum biomarkers) about potential results and their effect on diagnosis and treatment. This will lessen some patient anxiety when tests results become available, especially in the setting of autoreleasing results under the Cures Act.

One of the reasons that CA-125 can be difficult to interpret when used as a diagnostic tool is the number of nonmalignant disease processes that can result in CA-125 elevations. CA-125 can be elevated in inflammatory and infectious disease states, including but not limited to, chronic obstructive pulmonary disease, pelvic inflammatory disease, diverticulitis, and pneumonia. Severe/critical COVID-19 infection has recently been found to be associated with increased levels of CA-125.² It is important to obtain a complete medical history and to take specific note of any current or recent flares in inflammatory or infectious processes that could contribute to CA-125 elevations.

Special caution should be taken in premenopausal patients. The sensitivity and specificity of CA-125 are lower in this cohort of patients compared to postmenopausal women. This is multifactorial but in part due to gynecologic conditions that can increase CA-125, such as uterine fibroids and endometriosis, and the higher incidence of nonepithelial ovarian cancers (which frequently have different serum biomarkers) in younger patients. A patient’s gynecologic history, her age, and ultrasound or other imaging findings should help determine what, if any, serum biomarkers are appropriate for workup of an adnexal mass rather than the default ordering of CA-125 to determine need for referral to gynecologic oncology. If the decision has been made to take the patient to the operating room, CA-125 is not approved as a triage tool to guide who best to perform the surgery. In this case, one of two serum tumor marker panel tests that has received FDA approval for triage after the decision for surgery has been made (the multivariate index assay or the risk of ovarian malignancy algorithm) should be used.

When considering its ability to serve as a diagnostic test for ovarian cancer, the sensitivity of CA-125 is affected by the number of patients with epithelial ovarian cancer who have a test result that falls within the normal range (up to 50% of patients with stage I disease).³ The specificity of CA-125 is affected by the large number of nonmalignant conditions that can cause its elevation. Depending on the age of the patient, her menopausal status, comorbid conditions, and reason for obtaining serum biomarkers (e.g., decision for surgery has already been made), CA-125 (or CA-125 alone) may not be the best tool to use in the workup of an adnexal mass and can cause significant patient anxiety. In the setting of acute disease, such as COVID-19 infection, it may be better to delay obtaining serum biomarkers for the work-up of an adnexal mass. If delay is not feasible, then repeat serum biomarkers once the acute phase of illness has passed.

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Thériault C et al. Gynecol Oncol. 2011 Jun 1;121(3):434-43.

2. Wei X et al. J Med Virol. 2020;92(10):2036-41.

3. Zurawski VR Jr et al. Int J Cancer. 1988;42:677-80.

Tirzepatide (Mounjaro) – the new twincretin approved by the Food and Drug Administration for glycemic control in patients with type 2 diabetes – was priced by Lilly, the company that will market the drug, at a list price of $974.33 for four weekly doses regardless of dose size, a cost that adds up to about $12,666 per year, according to a statement made on May 20 by a Lilly spokesperson.

This price puts tirzepatide, which combines the activity of two of the primary human incretins in one molecule, roughly in the same ballpark as what might be its main competitor, semaglutide (Ozempic) for type 2 diabetes, which retails at many U.S. pharmacies for about $925 for four weekly doses, or about $12,025 per year, although Ozempic’s posted retail price is about $100 higher for four doses.

According to the Lilly spokesperson, discount programs could reduce the monthly out-of-pocket cost for patients to as little as $25.

Tirzepatide, which received approval from the FDA on May 13, is a dual glucagonlike peptide–1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, which is indicated as Wegovy for weight loss in patients with obesity regardless of diabetes status.

A version of this article first appeared on Medscape.com.

Tirzepatide (Mounjaro) – the new twincretin approved by the Food and Drug Administration for glycemic control in patients with type 2 diabetes – was priced by Lilly, the company that will market the drug, at a list price of $974.33 for four weekly doses regardless of dose size, a cost that adds up to about $12,666 per year, according to a statement made on May 20 by a Lilly spokesperson.

This price puts tirzepatide, which combines the activity of two of the primary human incretins in one molecule, roughly in the same ballpark as what might be its main competitor, semaglutide (Ozempic) for type 2 diabetes, which retails at many U.S. pharmacies for about $925 for four weekly doses, or about $12,025 per year, although Ozempic’s posted retail price is about $100 higher for four doses.

According to the Lilly spokesperson, discount programs could reduce the monthly out-of-pocket cost for patients to as little as $25.

Tirzepatide, which received approval from the FDA on May 13, is a dual glucagonlike peptide–1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, which is indicated as Wegovy for weight loss in patients with obesity regardless of diabetes status.

A version of this article first appeared on Medscape.com.

Tirzepatide (Mounjaro) – the new twincretin approved by the Food and Drug Administration for glycemic control in patients with type 2 diabetes – was priced by Lilly, the company that will market the drug, at a list price of $974.33 for four weekly doses regardless of dose size, a cost that adds up to about $12,666 per year, according to a statement made on May 20 by a Lilly spokesperson.

This price puts tirzepatide, which combines the activity of two of the primary human incretins in one molecule, roughly in the same ballpark as what might be its main competitor, semaglutide (Ozempic) for type 2 diabetes, which retails at many U.S. pharmacies for about $925 for four weekly doses, or about $12,025 per year, although Ozempic’s posted retail price is about $100 higher for four doses.

According to the Lilly spokesperson, discount programs could reduce the monthly out-of-pocket cost for patients to as little as $25.

Tirzepatide, which received approval from the FDA on May 13, is a dual glucagonlike peptide–1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, which is indicated as Wegovy for weight loss in patients with obesity regardless of diabetes status.

A version of this article first appeared on Medscape.com.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

When Jane Cooke Wright, MD, entered the medical profession in 1945, the notion that toxic drugs could target tumors struck many physicians and patients as outlandish. How could one poison be weaponized against another poison – a cancerous tumor – without creating more havoc? Let alone a combination of two or more chemicals?

Yet by the time Dr. Wright retired in 1987, chemotherapy treatments that she’d helped develop were routinely saving lives. In fact, she’d played key roles in the development of oncology, a new medical specialty, and of its most powerful agent to combat disease and death.

Courtesy of the Wright family

Dr. Wright’s story would be extraordinary enough if she’d looked like most of her colleagues, but this surgeon and researcher stood apart. An African American woman at a time when medicine and science – like politics and law – were almost entirely the domain of White men, Dr. Wright had determination in her blood. Her father, once honored by a crowd of dignitaries that included a First Lady, persevered despite his horrific encounters with racism. She shared her father’s commitment to progress and added her own personal twists. She balanced elegance and beauty with scientific savvy, fierce ambition, and a refusal to be defined by anything other than her accomplishments.

“She didn’t focus on race, not at all,” her daughter Alison Jones, PhD, a psychologist in East Lansing, Mich., said in an interview. “Wherever she was, she wanted to be the best, not the best Black person. It was not about how she performed in a category, and she would get upset if someone said she was good as a Black physician.”

On the road to being the best, Dr. Jones said, her mother set a goal of curing cancer. National Cancer Research Month is a fitting opportunity to look back on a scientist dedicated to bringing humanity closer to that elusive achievement.
 

Medical legacy blazed in toil and trauma

A strong case could be made that Dr. Jane C. Wright and her father Louis Tompkins Wright, MD, are the most accomplished father-and-daughter team in all of medicine.

The elder Dr. Wright, son of a formerly enslaved man turned physician and a stepson of the first African American to graduate from Yale University, New Haven, Conn., himself graduated from Harvard Medical School in 1915. He earned a Purple Heart while serving in World War I, then went on to become the first Black surgeon to join the staff at Harlem Hospital.

Dr. Wright, who had witnessed mob violence and the aftermath of a lynching as a young man, became a supporter of the Harlem Renaissance and a prominent advocate for civil rights and integration. He served as chairman of the National Association for the Advancement of Colored People and was only the second Black member of the American College of Surgeons.

According to the 2009 book “Black Genius: Inspirational Portraits of African American Leaders,” he successfully treated the rare but devastating venereal disease lymphogranuloma venereum with a new antibiotic developed by his former colleague Yellapragada SubbaRow, MD. Dr. Wright even tried the drug himself, “as a lot of doctors in the olden days did,” according to another of his daughters, the late Barbara Wright Pierce, MD, who was quoted in “Black Genius.” She, too, was a physician.

In 1948, Dr. Jane C. Wright joined her father at Harlem Hospital’s Cancer Research Foundation. There the duo explored the cancer-fighting possibilities of a nitrogen mustard–like chemical agent that had been known since World War I to kill white blood cells. Ironically, Dr. Louis Wright himself suffered lifelong health problems because of an attack from the poisonous gas phosgene during his wartime service.

“Remissions were observed in patients with sarcoma, Hodgkin disease, and chronic myelogenous leukemia, mycosis fungoides, and lymphoma,” reported a 2013 obituary in the journal Oncology of the younger Dr. Wright. “They also performed early research into the clinical efficacy and toxicity of folic acid antagonists, documenting responses in 93 patients with various forms of incurable blood cancers and solid tumors.”

This research appears in a study that was authored by three Dr. Wrights – Dr. Louis T. Wright and his daughters Jane and Barbara.

“The elder Dr. Wright died in 1952, just months after 1,000 people – including Eleanor Roosevelt – honored him at a dinner to dedicate a Harlem Hospital library named after him. He was 61.
 

Scientific savvy mixed with modesty and elegance

After her father’s death, Dr. Janet C. Wright became director of the hospital’s cancer foundation. From the 1950s to the 1970s, she “worked out ways to use pieces of a patient’s own tumor, removed by surgery and grown in a nutrient culture medium in the laboratory, as a ‘guinea pig for testing drugs,’ ” according to the 1991 book “Black Scientists.” Previously, researchers had focused on mice as test subjects.

This approach also allowed Dr. Wright to determine if specific drugs such as methotrexate, a folic acid antagonist, would help specific patients. “She was looking for predictive activity for chemotherapeutic efficacy in vitro at a time when no one had good predictive tests,” wrote James F. Holland, MD, the late Mount Sinai School of Medicine oncologist, who was quoted in Dr. Wright’s 2013 Oncology obituary.

“Her strict attention to detail and concern for her patients helped determine effective dosing levels and establish treatment guidelines,” the Oncology obituary reported. “She treated patients that other physicians had given up on, and she was among the first small cadre of researchers to carefully test the effects of drugs against cancer in a clinical trial setting.”

Dr. Wright also focused on developing ways to administer chemotherapy, such using a catheter to reach difficult-to-access organs like the spleen without surgery, according to “Black Scientists.”

Along with her work, Dr. Wright’s appearance set her apart. According to “Black Genius,” a newspaper columnist dubbed her one of the 10 most beautiful Back woman in America, and Ebony Magazine in 1966 honored her as one of the best-dressed women in America. It featured a photograph of her in a stunning ivory and yellow brocade gown, noting that she was “in private life Mrs. David J. Jones.” (She’d married the Harvard University Law School graduate in 1946.)

Dr. Wright had a sense of modesty despite her accomplishments, according to her daughter Alison Jones. She even downplayed her own mental powers in a newspaper interview. “I know I’m a member of two minority groups,” she told The New York Post in 1967, “but I don’t think of myself that way. Sure, a woman has to try twice as hard. But – racial prejudice? I’ve met very little of it. It could be I met it – and wasn’t intelligent enough to recognize it.”

Sharp-eyed readers might have glimpsed her modesty nearly 2 decades later. In a 1984 article for the Journal of the National Medical Association, a society of African American physicians, she wrote about the past, present, and future of chemotherapy without noting her own prominent role in its development.
 

‘Global medical pioneer’ cofounds ASCO – and more

In the 1960s, Dr. Wright joined the influential President’s Commission on Heart Disease, Cancer, and Stroke and was named associate dean at New York Medical College, her alma mater, a first for a black woman at a prominent U.S. medical school. Even more importantly, Dr. Wright was the sole woman among seven physicians who founded the American Society of Clinical Oncology in Chicago in 1964. She served as ASCO’s first Secretary-Treasurer and was honored as its longest surviving founder when she passed away 9 years ago.

“Jane Wright had the vision to see that oncology was an important separate discipline within medicine with far-reaching implications for research and discovery,” Georgetown University Medical Center, Washington, oncologist Sandra M. Swain, MD, a former president of the ASCO and author of the 2013 Oncology obituary of Dr. Wright, said in an interview. “It is truly remarkable that, as a woman and an African American woman, she had a seat at the very small table for the formation of such an important group.”

As her friend and fellow oncologist Edith Mitchell, MD, said in a eulogy, “Dr. Wright led delegations of oncologists to China and the Soviet Union, and countries in Africa and Eastern Europe. She led medical teams providing medical and cancer care and education to other nurses and physicians in Ghana in 1957 and Kenya in 1961. From 1973 to 1984, she served as vice-president of the African Research and Medical foundation.”

Dr. Wright also raised two daughters. A 1968 Ebony article devoted to her career and family declared that neither of her teenagers was interested in medical careers. Their perspectives shifted, however – as had Dr. Wright’s. An undergraduate at Smith College, Dr. Wright majored in art, swam on the varsity team, and had a special affinity for German language studies before she switched to premed.

Like their mother, Dr. Wright’s daughters also changed paths, and they ultimately became the fourth generation of their family to enter the medical field. Dr. Alison Jones, the psychologist, currently works in a prison, while Jane Jones, MD, became a clinical psychiatrist. She’s now retired and lives in Guttenberg, N.J.

Both fondly remember their mother as a supportive force who insisted on excellence. “There couldn’t be any excuses for you not getting where you wanted to go,” Dr. Jane Jones recalled in an interview.

Nevertheless, Dr. Wright was still keenly aware of society’s limits. “She told me I had to be a doctor or lawyer,” Dr. Alison Jones said, “because that’s how you need to survive when you’re Black in America.”

Dr. Wright passed away in 2013 at age 93. “Dr. Jane C. Wright truly has made contributions that have changed the practice of medicine,” noted her friend Dr. Mitchell, an oncologist and a retired brigadier general with the U.S. Air Force who now teaches at Thomas Jefferson University, Philadelphia. “A true pioneer. A concerned mentor. A renowned researcher. A global teacher. A global medical pioneer. A talented researcher, beloved sister, wife, and mother, and a beautiful, kind, and loving human being.”

When Jane Cooke Wright, MD, entered the medical profession in 1945, the notion that toxic drugs could target tumors struck many physicians and patients as outlandish. How could one poison be weaponized against another poison – a cancerous tumor – without creating more havoc? Let alone a combination of two or more chemicals?

Yet by the time Dr. Wright retired in 1987, chemotherapy treatments that she’d helped develop were routinely saving lives. In fact, she’d played key roles in the development of oncology, a new medical specialty, and of its most powerful agent to combat disease and death.

Courtesy of the Wright family

Dr. Wright’s story would be extraordinary enough if she’d looked like most of her colleagues, but this surgeon and researcher stood apart. An African American woman at a time when medicine and science – like politics and law – were almost entirely the domain of White men, Dr. Wright had determination in her blood. Her father, once honored by a crowd of dignitaries that included a First Lady, persevered despite his horrific encounters with racism. She shared her father’s commitment to progress and added her own personal twists. She balanced elegance and beauty with scientific savvy, fierce ambition, and a refusal to be defined by anything other than her accomplishments.

“She didn’t focus on race, not at all,” her daughter Alison Jones, PhD, a psychologist in East Lansing, Mich., said in an interview. “Wherever she was, she wanted to be the best, not the best Black person. It was not about how she performed in a category, and she would get upset if someone said she was good as a Black physician.”

On the road to being the best, Dr. Jones said, her mother set a goal of curing cancer. National Cancer Research Month is a fitting opportunity to look back on a scientist dedicated to bringing humanity closer to that elusive achievement.
 

Medical legacy blazed in toil and trauma

A strong case could be made that Dr. Jane C. Wright and her father Louis Tompkins Wright, MD, are the most accomplished father-and-daughter team in all of medicine.

The elder Dr. Wright, son of a formerly enslaved man turned physician and a stepson of the first African American to graduate from Yale University, New Haven, Conn., himself graduated from Harvard Medical School in 1915. He earned a Purple Heart while serving in World War I, then went on to become the first Black surgeon to join the staff at Harlem Hospital.

Dr. Wright, who had witnessed mob violence and the aftermath of a lynching as a young man, became a supporter of the Harlem Renaissance and a prominent advocate for civil rights and integration. He served as chairman of the National Association for the Advancement of Colored People and was only the second Black member of the American College of Surgeons.

According to the 2009 book “Black Genius: Inspirational Portraits of African American Leaders,” he successfully treated the rare but devastating venereal disease lymphogranuloma venereum with a new antibiotic developed by his former colleague Yellapragada SubbaRow, MD. Dr. Wright even tried the drug himself, “as a lot of doctors in the olden days did,” according to another of his daughters, the late Barbara Wright Pierce, MD, who was quoted in “Black Genius.” She, too, was a physician.

In 1948, Dr. Jane C. Wright joined her father at Harlem Hospital’s Cancer Research Foundation. There the duo explored the cancer-fighting possibilities of a nitrogen mustard–like chemical agent that had been known since World War I to kill white blood cells. Ironically, Dr. Louis Wright himself suffered lifelong health problems because of an attack from the poisonous gas phosgene during his wartime service.

“Remissions were observed in patients with sarcoma, Hodgkin disease, and chronic myelogenous leukemia, mycosis fungoides, and lymphoma,” reported a 2013 obituary in the journal Oncology of the younger Dr. Wright. “They also performed early research into the clinical efficacy and toxicity of folic acid antagonists, documenting responses in 93 patients with various forms of incurable blood cancers and solid tumors.”

This research appears in a study that was authored by three Dr. Wrights – Dr. Louis T. Wright and his daughters Jane and Barbara.

“The elder Dr. Wright died in 1952, just months after 1,000 people – including Eleanor Roosevelt – honored him at a dinner to dedicate a Harlem Hospital library named after him. He was 61.
 

Scientific savvy mixed with modesty and elegance

After her father’s death, Dr. Janet C. Wright became director of the hospital’s cancer foundation. From the 1950s to the 1970s, she “worked out ways to use pieces of a patient’s own tumor, removed by surgery and grown in a nutrient culture medium in the laboratory, as a ‘guinea pig for testing drugs,’ ” according to the 1991 book “Black Scientists.” Previously, researchers had focused on mice as test subjects.

This approach also allowed Dr. Wright to determine if specific drugs such as methotrexate, a folic acid antagonist, would help specific patients. “She was looking for predictive activity for chemotherapeutic efficacy in vitro at a time when no one had good predictive tests,” wrote James F. Holland, MD, the late Mount Sinai School of Medicine oncologist, who was quoted in Dr. Wright’s 2013 Oncology obituary.

“Her strict attention to detail and concern for her patients helped determine effective dosing levels and establish treatment guidelines,” the Oncology obituary reported. “She treated patients that other physicians had given up on, and she was among the first small cadre of researchers to carefully test the effects of drugs against cancer in a clinical trial setting.”

Dr. Wright also focused on developing ways to administer chemotherapy, such using a catheter to reach difficult-to-access organs like the spleen without surgery, according to “Black Scientists.”

Along with her work, Dr. Wright’s appearance set her apart. According to “Black Genius,” a newspaper columnist dubbed her one of the 10 most beautiful Back woman in America, and Ebony Magazine in 1966 honored her as one of the best-dressed women in America. It featured a photograph of her in a stunning ivory and yellow brocade gown, noting that she was “in private life Mrs. David J. Jones.” (She’d married the Harvard University Law School graduate in 1946.)

Dr. Wright had a sense of modesty despite her accomplishments, according to her daughter Alison Jones. She even downplayed her own mental powers in a newspaper interview. “I know I’m a member of two minority groups,” she told The New York Post in 1967, “but I don’t think of myself that way. Sure, a woman has to try twice as hard. But – racial prejudice? I’ve met very little of it. It could be I met it – and wasn’t intelligent enough to recognize it.”

Sharp-eyed readers might have glimpsed her modesty nearly 2 decades later. In a 1984 article for the Journal of the National Medical Association, a society of African American physicians, she wrote about the past, present, and future of chemotherapy without noting her own prominent role in its development.
 

‘Global medical pioneer’ cofounds ASCO – and more

In the 1960s, Dr. Wright joined the influential President’s Commission on Heart Disease, Cancer, and Stroke and was named associate dean at New York Medical College, her alma mater, a first for a black woman at a prominent U.S. medical school. Even more importantly, Dr. Wright was the sole woman among seven physicians who founded the American Society of Clinical Oncology in Chicago in 1964. She served as ASCO’s first Secretary-Treasurer and was honored as its longest surviving founder when she passed away 9 years ago.

“Jane Wright had the vision to see that oncology was an important separate discipline within medicine with far-reaching implications for research and discovery,” Georgetown University Medical Center, Washington, oncologist Sandra M. Swain, MD, a former president of the ASCO and author of the 2013 Oncology obituary of Dr. Wright, said in an interview. “It is truly remarkable that, as a woman and an African American woman, she had a seat at the very small table for the formation of such an important group.”

As her friend and fellow oncologist Edith Mitchell, MD, said in a eulogy, “Dr. Wright led delegations of oncologists to China and the Soviet Union, and countries in Africa and Eastern Europe. She led medical teams providing medical and cancer care and education to other nurses and physicians in Ghana in 1957 and Kenya in 1961. From 1973 to 1984, she served as vice-president of the African Research and Medical foundation.”

Dr. Wright also raised two daughters. A 1968 Ebony article devoted to her career and family declared that neither of her teenagers was interested in medical careers. Their perspectives shifted, however – as had Dr. Wright’s. An undergraduate at Smith College, Dr. Wright majored in art, swam on the varsity team, and had a special affinity for German language studies before she switched to premed.

Like their mother, Dr. Wright’s daughters also changed paths, and they ultimately became the fourth generation of their family to enter the medical field. Dr. Alison Jones, the psychologist, currently works in a prison, while Jane Jones, MD, became a clinical psychiatrist. She’s now retired and lives in Guttenberg, N.J.

Both fondly remember their mother as a supportive force who insisted on excellence. “There couldn’t be any excuses for you not getting where you wanted to go,” Dr. Jane Jones recalled in an interview.

Nevertheless, Dr. Wright was still keenly aware of society’s limits. “She told me I had to be a doctor or lawyer,” Dr. Alison Jones said, “because that’s how you need to survive when you’re Black in America.”

Dr. Wright passed away in 2013 at age 93. “Dr. Jane C. Wright truly has made contributions that have changed the practice of medicine,” noted her friend Dr. Mitchell, an oncologist and a retired brigadier general with the U.S. Air Force who now teaches at Thomas Jefferson University, Philadelphia. “A true pioneer. A concerned mentor. A renowned researcher. A global teacher. A global medical pioneer. A talented researcher, beloved sister, wife, and mother, and a beautiful, kind, and loving human being.”

When Jane Cooke Wright, MD, entered the medical profession in 1945, the notion that toxic drugs could target tumors struck many physicians and patients as outlandish. How could one poison be weaponized against another poison – a cancerous tumor – without creating more havoc? Let alone a combination of two or more chemicals?

Yet by the time Dr. Wright retired in 1987, chemotherapy treatments that she’d helped develop were routinely saving lives. In fact, she’d played key roles in the development of oncology, a new medical specialty, and of its most powerful agent to combat disease and death.

Courtesy of the Wright family

Dr. Wright’s story would be extraordinary enough if she’d looked like most of her colleagues, but this surgeon and researcher stood apart. An African American woman at a time when medicine and science – like politics and law – were almost entirely the domain of White men, Dr. Wright had determination in her blood. Her father, once honored by a crowd of dignitaries that included a First Lady, persevered despite his horrific encounters with racism. She shared her father’s commitment to progress and added her own personal twists. She balanced elegance and beauty with scientific savvy, fierce ambition, and a refusal to be defined by anything other than her accomplishments.

“She didn’t focus on race, not at all,” her daughter Alison Jones, PhD, a psychologist in East Lansing, Mich., said in an interview. “Wherever she was, she wanted to be the best, not the best Black person. It was not about how she performed in a category, and she would get upset if someone said she was good as a Black physician.”

On the road to being the best, Dr. Jones said, her mother set a goal of curing cancer. National Cancer Research Month is a fitting opportunity to look back on a scientist dedicated to bringing humanity closer to that elusive achievement.
 

Medical legacy blazed in toil and trauma

A strong case could be made that Dr. Jane C. Wright and her father Louis Tompkins Wright, MD, are the most accomplished father-and-daughter team in all of medicine.

The elder Dr. Wright, son of a formerly enslaved man turned physician and a stepson of the first African American to graduate from Yale University, New Haven, Conn., himself graduated from Harvard Medical School in 1915. He earned a Purple Heart while serving in World War I, then went on to become the first Black surgeon to join the staff at Harlem Hospital.

Dr. Wright, who had witnessed mob violence and the aftermath of a lynching as a young man, became a supporter of the Harlem Renaissance and a prominent advocate for civil rights and integration. He served as chairman of the National Association for the Advancement of Colored People and was only the second Black member of the American College of Surgeons.

According to the 2009 book “Black Genius: Inspirational Portraits of African American Leaders,” he successfully treated the rare but devastating venereal disease lymphogranuloma venereum with a new antibiotic developed by his former colleague Yellapragada SubbaRow, MD. Dr. Wright even tried the drug himself, “as a lot of doctors in the olden days did,” according to another of his daughters, the late Barbara Wright Pierce, MD, who was quoted in “Black Genius.” She, too, was a physician.

In 1948, Dr. Jane C. Wright joined her father at Harlem Hospital’s Cancer Research Foundation. There the duo explored the cancer-fighting possibilities of a nitrogen mustard–like chemical agent that had been known since World War I to kill white blood cells. Ironically, Dr. Louis Wright himself suffered lifelong health problems because of an attack from the poisonous gas phosgene during his wartime service.

“Remissions were observed in patients with sarcoma, Hodgkin disease, and chronic myelogenous leukemia, mycosis fungoides, and lymphoma,” reported a 2013 obituary in the journal Oncology of the younger Dr. Wright. “They also performed early research into the clinical efficacy and toxicity of folic acid antagonists, documenting responses in 93 patients with various forms of incurable blood cancers and solid tumors.”

This research appears in a study that was authored by three Dr. Wrights – Dr. Louis T. Wright and his daughters Jane and Barbara.

“The elder Dr. Wright died in 1952, just months after 1,000 people – including Eleanor Roosevelt – honored him at a dinner to dedicate a Harlem Hospital library named after him. He was 61.
 

Scientific savvy mixed with modesty and elegance

After her father’s death, Dr. Janet C. Wright became director of the hospital’s cancer foundation. From the 1950s to the 1970s, she “worked out ways to use pieces of a patient’s own tumor, removed by surgery and grown in a nutrient culture medium in the laboratory, as a ‘guinea pig for testing drugs,’ ” according to the 1991 book “Black Scientists.” Previously, researchers had focused on mice as test subjects.

This approach also allowed Dr. Wright to determine if specific drugs such as methotrexate, a folic acid antagonist, would help specific patients. “She was looking for predictive activity for chemotherapeutic efficacy in vitro at a time when no one had good predictive tests,” wrote James F. Holland, MD, the late Mount Sinai School of Medicine oncologist, who was quoted in Dr. Wright’s 2013 Oncology obituary.

“Her strict attention to detail and concern for her patients helped determine effective dosing levels and establish treatment guidelines,” the Oncology obituary reported. “She treated patients that other physicians had given up on, and she was among the first small cadre of researchers to carefully test the effects of drugs against cancer in a clinical trial setting.”

Dr. Wright also focused on developing ways to administer chemotherapy, such using a catheter to reach difficult-to-access organs like the spleen without surgery, according to “Black Scientists.”

Along with her work, Dr. Wright’s appearance set her apart. According to “Black Genius,” a newspaper columnist dubbed her one of the 10 most beautiful Back woman in America, and Ebony Magazine in 1966 honored her as one of the best-dressed women in America. It featured a photograph of her in a stunning ivory and yellow brocade gown, noting that she was “in private life Mrs. David J. Jones.” (She’d married the Harvard University Law School graduate in 1946.)

Dr. Wright had a sense of modesty despite her accomplishments, according to her daughter Alison Jones. She even downplayed her own mental powers in a newspaper interview. “I know I’m a member of two minority groups,” she told The New York Post in 1967, “but I don’t think of myself that way. Sure, a woman has to try twice as hard. But – racial prejudice? I’ve met very little of it. It could be I met it – and wasn’t intelligent enough to recognize it.”

Sharp-eyed readers might have glimpsed her modesty nearly 2 decades later. In a 1984 article for the Journal of the National Medical Association, a society of African American physicians, she wrote about the past, present, and future of chemotherapy without noting her own prominent role in its development.
 

‘Global medical pioneer’ cofounds ASCO – and more

In the 1960s, Dr. Wright joined the influential President’s Commission on Heart Disease, Cancer, and Stroke and was named associate dean at New York Medical College, her alma mater, a first for a black woman at a prominent U.S. medical school. Even more importantly, Dr. Wright was the sole woman among seven physicians who founded the American Society of Clinical Oncology in Chicago in 1964. She served as ASCO’s first Secretary-Treasurer and was honored as its longest surviving founder when she passed away 9 years ago.

“Jane Wright had the vision to see that oncology was an important separate discipline within medicine with far-reaching implications for research and discovery,” Georgetown University Medical Center, Washington, oncologist Sandra M. Swain, MD, a former president of the ASCO and author of the 2013 Oncology obituary of Dr. Wright, said in an interview. “It is truly remarkable that, as a woman and an African American woman, she had a seat at the very small table for the formation of such an important group.”

As her friend and fellow oncologist Edith Mitchell, MD, said in a eulogy, “Dr. Wright led delegations of oncologists to China and the Soviet Union, and countries in Africa and Eastern Europe. She led medical teams providing medical and cancer care and education to other nurses and physicians in Ghana in 1957 and Kenya in 1961. From 1973 to 1984, she served as vice-president of the African Research and Medical foundation.”

Dr. Wright also raised two daughters. A 1968 Ebony article devoted to her career and family declared that neither of her teenagers was interested in medical careers. Their perspectives shifted, however – as had Dr. Wright’s. An undergraduate at Smith College, Dr. Wright majored in art, swam on the varsity team, and had a special affinity for German language studies before she switched to premed.

Like their mother, Dr. Wright’s daughters also changed paths, and they ultimately became the fourth generation of their family to enter the medical field. Dr. Alison Jones, the psychologist, currently works in a prison, while Jane Jones, MD, became a clinical psychiatrist. She’s now retired and lives in Guttenberg, N.J.

Both fondly remember their mother as a supportive force who insisted on excellence. “There couldn’t be any excuses for you not getting where you wanted to go,” Dr. Jane Jones recalled in an interview.

Nevertheless, Dr. Wright was still keenly aware of society’s limits. “She told me I had to be a doctor or lawyer,” Dr. Alison Jones said, “because that’s how you need to survive when you’re Black in America.”

Dr. Wright passed away in 2013 at age 93. “Dr. Jane C. Wright truly has made contributions that have changed the practice of medicine,” noted her friend Dr. Mitchell, an oncologist and a retired brigadier general with the U.S. Air Force who now teaches at Thomas Jefferson University, Philadelphia. “A true pioneer. A concerned mentor. A renowned researcher. A global teacher. A global medical pioneer. A talented researcher, beloved sister, wife, and mother, and a beautiful, kind, and loving human being.”

SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.

The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.

“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”

Dr. Yiannakou presented the finding at the annual Digestive Diseases Week^® (DDW).

Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.

First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.

Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*

Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.

PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.

To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.

The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.

On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.

However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.

There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.

Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.

Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.

“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.

Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”

Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.

*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market. 

SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.

The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.

“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”

Dr. Yiannakou presented the finding at the annual Digestive Diseases Week^® (DDW).

Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.

First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.

Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*

Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.

PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.

To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.

The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.

On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.

However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.

There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.

Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.

Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.

“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.

Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”

Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.

*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market. 

SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.

The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.

“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”

Dr. Yiannakou presented the finding at the annual Digestive Diseases Week^® (DDW).

Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.

First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.

Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*

Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.

PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.

To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.

The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.

On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.

However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.

There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.

Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.

Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.

“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.

Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”

Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.

*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market. 

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

Different psychiatric disorders often share the same genetic architecture, which may help explain why many individuals diagnosed with one psychiatric disorder will be diagnosed with another in their lifetime, new research suggests.

Investigators conducted a genetic analysis of 11 major psychiatric disorders, including schizophrenia and bipolar disorder.

“Our findings confirm that high comorbidity across some disorders in part reflects overlapping pathways of genetic risk,” lead author Andrew Grotzinger, PhD, department of psychology and neuroscience, University of Colorado at Boulder, said in a press release.

The results could lead to the development of treatments that address multiple psychiatric disorders at once and help reshape the way diagnoses are established, the researchers note.

The findings were published online in Nature Genetics.
 

Common genetic patterns

Using the massive UK Biobank and the Psychiatric Genomics Consortium, the researchers applied novel statistical genetic methods to identify common patterns across 11 major psychiatric disorders: schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, anorexia nervosa, obsessive-compulsive disorder (OCD), Tourette syndrome, post traumatic stress disorder, problematic alcohol use, attention deficit hyperactive disorder, and autism. 

The average total sample size per disorder was 156,771 participants, with a range of 9,725 to 802,939 participants.

In all, the investigators identified 152 genetic variants shared across multiple disorders, including those already known to influence certain types of brain cells.

For example, they found that 70% of the genetic signal associated with schizophrenia was also associated with bipolar disorder. 

Results also showed that anorexia nervosa and OCD have a strong, shared genetic architecture and that individuals with a genetic predisposition to low body mass index also tend to have a genetic predisposition to these two disorders.

Not surprisingly, the researchers note, there was a large genetic overlap between anxiety disorder and major depressive disorder.

They also observed that psychiatric disorders that tend to cluster together also tend to share genes that influence how and when individuals are physically active during the day.

For example, patients with internalizing disorders such as anxiety and depression tend to have a genetic architecture associated with low movement throughout the day. On the other hand, those with OCD and anorexia tend to have genes associated with higher movement throughout the day. 

“When you think about it, it makes sense,” said Dr. Grotzinger. Depressed individuals often experience fatigue or low energy while those with compulsive disorders may have a tough time sitting still, he noted.
 

One treatment for multiple disorders?

“Collectively, these results offer key insights into the shared and disorder-specific mechanisms of genetic risk for psychiatric disease,” the investigators write.

Their research is also a first step toward developing therapies that can address multiple disorders with one treatment, they add.

“People are more likely today to be prescribed multiple medications intended to treat multiple diagnoses, and in some instances those medicines can have side effects,” Dr. Grotzinger said.

“By identifying what is shared across these issues, we can hopefully come up with ways to target them in a different way that doesn’t require four separate pills or four separate psychotherapy interventions,” he added.

Dr. Grotzinger noted that, for now, the knowledge that genetics are underlying their disorders may provide comfort to some patients.

“It’s important for people to know that they didn’t just get a terrible roll of the dice in life – that they are not facing multiple different issues but rather one set of risk factors bleeding into them all,” he said.

This research had no commercial funding. Dr. Grotzinger reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Different psychiatric disorders often share the same genetic architecture, which may help explain why many individuals diagnosed with one psychiatric disorder will be diagnosed with another in their lifetime, new research suggests.

Investigators conducted a genetic analysis of 11 major psychiatric disorders, including schizophrenia and bipolar disorder.

“Our findings confirm that high comorbidity across some disorders in part reflects overlapping pathways of genetic risk,” lead author Andrew Grotzinger, PhD, department of psychology and neuroscience, University of Colorado at Boulder, said in a press release.

The results could lead to the development of treatments that address multiple psychiatric disorders at once and help reshape the way diagnoses are established, the researchers note.

The findings were published online in Nature Genetics.
 

Common genetic patterns

Using the massive UK Biobank and the Psychiatric Genomics Consortium, the researchers applied novel statistical genetic methods to identify common patterns across 11 major psychiatric disorders: schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, anorexia nervosa, obsessive-compulsive disorder (OCD), Tourette syndrome, post traumatic stress disorder, problematic alcohol use, attention deficit hyperactive disorder, and autism. 

The average total sample size per disorder was 156,771 participants, with a range of 9,725 to 802,939 participants.

In all, the investigators identified 152 genetic variants shared across multiple disorders, including those already known to influence certain types of brain cells.

For example, they found that 70% of the genetic signal associated with schizophrenia was also associated with bipolar disorder. 

Results also showed that anorexia nervosa and OCD have a strong, shared genetic architecture and that individuals with a genetic predisposition to low body mass index also tend to have a genetic predisposition to these two disorders.

Not surprisingly, the researchers note, there was a large genetic overlap between anxiety disorder and major depressive disorder.

They also observed that psychiatric disorders that tend to cluster together also tend to share genes that influence how and when individuals are physically active during the day.

For example, patients with internalizing disorders such as anxiety and depression tend to have a genetic architecture associated with low movement throughout the day. On the other hand, those with OCD and anorexia tend to have genes associated with higher movement throughout the day. 

“When you think about it, it makes sense,” said Dr. Grotzinger. Depressed individuals often experience fatigue or low energy while those with compulsive disorders may have a tough time sitting still, he noted.
 

One treatment for multiple disorders?

“Collectively, these results offer key insights into the shared and disorder-specific mechanisms of genetic risk for psychiatric disease,” the investigators write.

Their research is also a first step toward developing therapies that can address multiple disorders with one treatment, they add.

“People are more likely today to be prescribed multiple medications intended to treat multiple diagnoses, and in some instances those medicines can have side effects,” Dr. Grotzinger said.

“By identifying what is shared across these issues, we can hopefully come up with ways to target them in a different way that doesn’t require four separate pills or four separate psychotherapy interventions,” he added.

Dr. Grotzinger noted that, for now, the knowledge that genetics are underlying their disorders may provide comfort to some patients.

“It’s important for people to know that they didn’t just get a terrible roll of the dice in life – that they are not facing multiple different issues but rather one set of risk factors bleeding into them all,” he said.

This research had no commercial funding. Dr. Grotzinger reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Different psychiatric disorders often share the same genetic architecture, which may help explain why many individuals diagnosed with one psychiatric disorder will be diagnosed with another in their lifetime, new research suggests.

Investigators conducted a genetic analysis of 11 major psychiatric disorders, including schizophrenia and bipolar disorder.

“Our findings confirm that high comorbidity across some disorders in part reflects overlapping pathways of genetic risk,” lead author Andrew Grotzinger, PhD, department of psychology and neuroscience, University of Colorado at Boulder, said in a press release.

The results could lead to the development of treatments that address multiple psychiatric disorders at once and help reshape the way diagnoses are established, the researchers note.

The findings were published online in Nature Genetics.
 

Common genetic patterns

Using the massive UK Biobank and the Psychiatric Genomics Consortium, the researchers applied novel statistical genetic methods to identify common patterns across 11 major psychiatric disorders: schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, anorexia nervosa, obsessive-compulsive disorder (OCD), Tourette syndrome, post traumatic stress disorder, problematic alcohol use, attention deficit hyperactive disorder, and autism. 

The average total sample size per disorder was 156,771 participants, with a range of 9,725 to 802,939 participants.

In all, the investigators identified 152 genetic variants shared across multiple disorders, including those already known to influence certain types of brain cells.

For example, they found that 70% of the genetic signal associated with schizophrenia was also associated with bipolar disorder. 

Results also showed that anorexia nervosa and OCD have a strong, shared genetic architecture and that individuals with a genetic predisposition to low body mass index also tend to have a genetic predisposition to these two disorders.

Not surprisingly, the researchers note, there was a large genetic overlap between anxiety disorder and major depressive disorder.

They also observed that psychiatric disorders that tend to cluster together also tend to share genes that influence how and when individuals are physically active during the day.

For example, patients with internalizing disorders such as anxiety and depression tend to have a genetic architecture associated with low movement throughout the day. On the other hand, those with OCD and anorexia tend to have genes associated with higher movement throughout the day. 

“When you think about it, it makes sense,” said Dr. Grotzinger. Depressed individuals often experience fatigue or low energy while those with compulsive disorders may have a tough time sitting still, he noted.
 

One treatment for multiple disorders?

“Collectively, these results offer key insights into the shared and disorder-specific mechanisms of genetic risk for psychiatric disease,” the investigators write.

Their research is also a first step toward developing therapies that can address multiple disorders with one treatment, they add.

“People are more likely today to be prescribed multiple medications intended to treat multiple diagnoses, and in some instances those medicines can have side effects,” Dr. Grotzinger said.

“By identifying what is shared across these issues, we can hopefully come up with ways to target them in a different way that doesn’t require four separate pills or four separate psychotherapy interventions,” he added.

Dr. Grotzinger noted that, for now, the knowledge that genetics are underlying their disorders may provide comfort to some patients.

“It’s important for people to know that they didn’t just get a terrible roll of the dice in life – that they are not facing multiple different issues but rather one set of risk factors bleeding into them all,” he said.

This research had no commercial funding. Dr. Grotzinger reported no relevant disclosures.

A version of this article first appeared on Medscape.com.