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The four questions you should ask about sexual health
This transcript has been edited for clarity.
When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.
What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.
As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.
Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.
Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.
We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.
Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.
Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.
Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.
Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.
Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.
What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.
As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.
Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.
Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.
We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.
Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.
Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.
Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.
Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.
Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.
What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.
As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.
Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.
Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.
We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.
Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.
Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.
Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.
Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.
Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
Psilocybin shows early promise for anorexia nervosa
The psychedelic psilocybin may have a role in the treatment of anorexia nervosa (AN), an eating disorder that is notoriously difficult and costly to treat.
Stephanie Knatz Peck, PhD, and colleagues with the eating disorders treatment & research center, University of California San Diego, write that the “robust response” in a subset of women after a single dose of psilocybin is “notable,” given that currently available treatments for adult anorexia result in only modest improvements in symptoms and often focus on weight and nutritional rehabilitation without adequately addressing underlying psychopathology.
However, given this was a small, phase 1, open-label feasibility study, these effects are “preliminary and inconclusive,” they caution.
The study was published online in Nature Medicine.
Meaningful experience
The 10 women in the study met DSM-5 criteria for AN or partial remission of AN. They were between age 18 and 40 years with a mean body mass index (BMI) of 19.7 kg/m2.
Following the single 25-mg dose of psilocybin, no clinically significant changes were observed in ECG, vital signs, laboratory values, or suicidality.
All adverse events were mild and mirrored typical psilocybin-associated symptoms such as transient headache, nausea, and fatigue.
Psilocybin was associated with reduced levels of anxiety and preoccupations surrounding food, eating, and body shape at the 1-month follow-up.
Weight concerns decreased significantly at the 1-month (P = .036, Cohen’s d = .78) and 3-month (P = .04, d = .78) follow-up, with a medium to large effect.
Shape concerns significantly decreased at 1-month follow-up (P = .036, d = .78) but were no longer significant at 3-month follow-up (P = .081, d = .62).
Four of the 10 women (40%) had clinically significant reductions in eating disorder scores at 3 months, which qualified for remission from eating-disorder psychopathology.
However, the researchers caution that the effects on eating disorder psychopathology were “highly variable.”
On average, changes in BMI were not significant during the 3 months following psilocybin treatment. However, five women had an increase in BMI at 3 months, ranging from 0.4 to 1.2 kg/m2.
Overall, the psilocybin experience was regarded as meaningful by participants; 80% endorsed the experience as one of the top five most meaningful of life; 90% endorsed feeling more positive about life endeavors; and 70% reported experiencing a shift in personal identity and overall quality of life.
The vast majority of women (90%) felt that one dosing session was not enough.
The fact that the treatment was regarded as beneficial by most women and that there were no dropouts are “promising signs of engagement,” given that dropout rates for currently available AN treatments tend to be high, the researchers note.
They urge caution in interpreting the results considering they were based on a small sample size and did not include a placebo group. They note that larger, adequately powered, randomized controlled trials are needed to draw any conclusions about the role of psilocybin for anorexia nervosa.
Encouraging data
The coauthors of a Nature Medicine News & Views commentary say this “encouraging” phase 1 trial “underscores the necessity for more research into classic psychedelics to address the urgent need for effective treatments” for AN.
Outside experts also weighed in on the study in a statement from the U.K.-based nonprofit Science Media Centre.
Alexandra Pike, DPhil, MSc, with University of York, England, noted that this study is “a first step in showing that psilocybin may be a safe treatment for those with anorexia nervosa, but we cannot conclude from this work that it will be effective in this chronic, complex illness.”
Trevor Steward, MD, with University of Melbourne, noted that psilocybin therapy has provided “glimmers of hope in other mental health disorders, notably by providing evidence that it can improve anxiety, cognitive flexibility, and self-acceptance for some people. These are all features of anorexia nervosa and the rationale for exploring psilocybin therapy as an option in the case of anorexia is strong.”
Dr. Steward also noted that the field is only beginning to “scratch the surface in terms of understanding how psilocybin impacts the brain. Dedicated funding to exploring how it specifically acts to target anorexia nervosa symptoms is crucial to advancing this important avenue of research.
“As there are no approved medications available specifically for anorexia nervosa treatment, psilocybin therapy may prove to be a promising option, though additional research is needed to test this,” Dr. Steward said.
The study used an investigational synthetic formulation of psilocybin (COMP360 psilocybin) developed by COMPASS Pathways, which funded the study. Two coauthors have financial and scientific relationships with COMPASS Pathways. The commentary authors and Dr. Steward report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The psychedelic psilocybin may have a role in the treatment of anorexia nervosa (AN), an eating disorder that is notoriously difficult and costly to treat.
Stephanie Knatz Peck, PhD, and colleagues with the eating disorders treatment & research center, University of California San Diego, write that the “robust response” in a subset of women after a single dose of psilocybin is “notable,” given that currently available treatments for adult anorexia result in only modest improvements in symptoms and often focus on weight and nutritional rehabilitation without adequately addressing underlying psychopathology.
However, given this was a small, phase 1, open-label feasibility study, these effects are “preliminary and inconclusive,” they caution.
The study was published online in Nature Medicine.
Meaningful experience
The 10 women in the study met DSM-5 criteria for AN or partial remission of AN. They were between age 18 and 40 years with a mean body mass index (BMI) of 19.7 kg/m2.
Following the single 25-mg dose of psilocybin, no clinically significant changes were observed in ECG, vital signs, laboratory values, or suicidality.
All adverse events were mild and mirrored typical psilocybin-associated symptoms such as transient headache, nausea, and fatigue.
Psilocybin was associated with reduced levels of anxiety and preoccupations surrounding food, eating, and body shape at the 1-month follow-up.
Weight concerns decreased significantly at the 1-month (P = .036, Cohen’s d = .78) and 3-month (P = .04, d = .78) follow-up, with a medium to large effect.
Shape concerns significantly decreased at 1-month follow-up (P = .036, d = .78) but were no longer significant at 3-month follow-up (P = .081, d = .62).
Four of the 10 women (40%) had clinically significant reductions in eating disorder scores at 3 months, which qualified for remission from eating-disorder psychopathology.
However, the researchers caution that the effects on eating disorder psychopathology were “highly variable.”
On average, changes in BMI were not significant during the 3 months following psilocybin treatment. However, five women had an increase in BMI at 3 months, ranging from 0.4 to 1.2 kg/m2.
Overall, the psilocybin experience was regarded as meaningful by participants; 80% endorsed the experience as one of the top five most meaningful of life; 90% endorsed feeling more positive about life endeavors; and 70% reported experiencing a shift in personal identity and overall quality of life.
The vast majority of women (90%) felt that one dosing session was not enough.
The fact that the treatment was regarded as beneficial by most women and that there were no dropouts are “promising signs of engagement,” given that dropout rates for currently available AN treatments tend to be high, the researchers note.
They urge caution in interpreting the results considering they were based on a small sample size and did not include a placebo group. They note that larger, adequately powered, randomized controlled trials are needed to draw any conclusions about the role of psilocybin for anorexia nervosa.
Encouraging data
The coauthors of a Nature Medicine News & Views commentary say this “encouraging” phase 1 trial “underscores the necessity for more research into classic psychedelics to address the urgent need for effective treatments” for AN.
Outside experts also weighed in on the study in a statement from the U.K.-based nonprofit Science Media Centre.
Alexandra Pike, DPhil, MSc, with University of York, England, noted that this study is “a first step in showing that psilocybin may be a safe treatment for those with anorexia nervosa, but we cannot conclude from this work that it will be effective in this chronic, complex illness.”
Trevor Steward, MD, with University of Melbourne, noted that psilocybin therapy has provided “glimmers of hope in other mental health disorders, notably by providing evidence that it can improve anxiety, cognitive flexibility, and self-acceptance for some people. These are all features of anorexia nervosa and the rationale for exploring psilocybin therapy as an option in the case of anorexia is strong.”
Dr. Steward also noted that the field is only beginning to “scratch the surface in terms of understanding how psilocybin impacts the brain. Dedicated funding to exploring how it specifically acts to target anorexia nervosa symptoms is crucial to advancing this important avenue of research.
“As there are no approved medications available specifically for anorexia nervosa treatment, psilocybin therapy may prove to be a promising option, though additional research is needed to test this,” Dr. Steward said.
The study used an investigational synthetic formulation of psilocybin (COMP360 psilocybin) developed by COMPASS Pathways, which funded the study. Two coauthors have financial and scientific relationships with COMPASS Pathways. The commentary authors and Dr. Steward report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The psychedelic psilocybin may have a role in the treatment of anorexia nervosa (AN), an eating disorder that is notoriously difficult and costly to treat.
Stephanie Knatz Peck, PhD, and colleagues with the eating disorders treatment & research center, University of California San Diego, write that the “robust response” in a subset of women after a single dose of psilocybin is “notable,” given that currently available treatments for adult anorexia result in only modest improvements in symptoms and often focus on weight and nutritional rehabilitation without adequately addressing underlying psychopathology.
However, given this was a small, phase 1, open-label feasibility study, these effects are “preliminary and inconclusive,” they caution.
The study was published online in Nature Medicine.
Meaningful experience
The 10 women in the study met DSM-5 criteria for AN or partial remission of AN. They were between age 18 and 40 years with a mean body mass index (BMI) of 19.7 kg/m2.
Following the single 25-mg dose of psilocybin, no clinically significant changes were observed in ECG, vital signs, laboratory values, or suicidality.
All adverse events were mild and mirrored typical psilocybin-associated symptoms such as transient headache, nausea, and fatigue.
Psilocybin was associated with reduced levels of anxiety and preoccupations surrounding food, eating, and body shape at the 1-month follow-up.
Weight concerns decreased significantly at the 1-month (P = .036, Cohen’s d = .78) and 3-month (P = .04, d = .78) follow-up, with a medium to large effect.
Shape concerns significantly decreased at 1-month follow-up (P = .036, d = .78) but were no longer significant at 3-month follow-up (P = .081, d = .62).
Four of the 10 women (40%) had clinically significant reductions in eating disorder scores at 3 months, which qualified for remission from eating-disorder psychopathology.
However, the researchers caution that the effects on eating disorder psychopathology were “highly variable.”
On average, changes in BMI were not significant during the 3 months following psilocybin treatment. However, five women had an increase in BMI at 3 months, ranging from 0.4 to 1.2 kg/m2.
Overall, the psilocybin experience was regarded as meaningful by participants; 80% endorsed the experience as one of the top five most meaningful of life; 90% endorsed feeling more positive about life endeavors; and 70% reported experiencing a shift in personal identity and overall quality of life.
The vast majority of women (90%) felt that one dosing session was not enough.
The fact that the treatment was regarded as beneficial by most women and that there were no dropouts are “promising signs of engagement,” given that dropout rates for currently available AN treatments tend to be high, the researchers note.
They urge caution in interpreting the results considering they were based on a small sample size and did not include a placebo group. They note that larger, adequately powered, randomized controlled trials are needed to draw any conclusions about the role of psilocybin for anorexia nervosa.
Encouraging data
The coauthors of a Nature Medicine News & Views commentary say this “encouraging” phase 1 trial “underscores the necessity for more research into classic psychedelics to address the urgent need for effective treatments” for AN.
Outside experts also weighed in on the study in a statement from the U.K.-based nonprofit Science Media Centre.
Alexandra Pike, DPhil, MSc, with University of York, England, noted that this study is “a first step in showing that psilocybin may be a safe treatment for those with anorexia nervosa, but we cannot conclude from this work that it will be effective in this chronic, complex illness.”
Trevor Steward, MD, with University of Melbourne, noted that psilocybin therapy has provided “glimmers of hope in other mental health disorders, notably by providing evidence that it can improve anxiety, cognitive flexibility, and self-acceptance for some people. These are all features of anorexia nervosa and the rationale for exploring psilocybin therapy as an option in the case of anorexia is strong.”
Dr. Steward also noted that the field is only beginning to “scratch the surface in terms of understanding how psilocybin impacts the brain. Dedicated funding to exploring how it specifically acts to target anorexia nervosa symptoms is crucial to advancing this important avenue of research.
“As there are no approved medications available specifically for anorexia nervosa treatment, psilocybin therapy may prove to be a promising option, though additional research is needed to test this,” Dr. Steward said.
The study used an investigational synthetic formulation of psilocybin (COMP360 psilocybin) developed by COMPASS Pathways, which funded the study. Two coauthors have financial and scientific relationships with COMPASS Pathways. The commentary authors and Dr. Steward report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NATURE MEDICINE
Fast-acting postpartum depression drug is effective
The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.
Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.
The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.
The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.
Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work.
Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.
A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.
Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.
The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.
The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.
Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work.
Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.
A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.
Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.
The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.
The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.
Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work.
Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.
A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.
A version of this article first appeared on WebMD.com.
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Women increasingly dying of alcohol-related causes
The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.
“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.
Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”
Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men.
“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:
- 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
- 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said.
- 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.
The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year.
Explaining the increase
“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.
Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.
The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
Other findings on women, alcohol
Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men.
A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.
Expert perspectives
Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.
“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.”
In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually.
While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.
However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.”
Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies.
Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”
Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.
A version of this article first appeared on WebMD.com.
The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.
“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.
Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”
Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men.
“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:
- 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
- 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said.
- 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.
The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year.
Explaining the increase
“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.
Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.
The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
Other findings on women, alcohol
Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men.
A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.
Expert perspectives
Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.
“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.”
In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually.
While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.
However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.”
Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies.
Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”
Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.
A version of this article first appeared on WebMD.com.
The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.
“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.
Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”
Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men.
“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:
- 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
- 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said.
- 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.
The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year.
Explaining the increase
“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.
Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.
The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
Other findings on women, alcohol
Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men.
A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.
Expert perspectives
Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.
“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.”
In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually.
While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.
However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.”
Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies.
Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”
Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.
A version of this article first appeared on WebMD.com.
FROM JAMA NETWORK OPEN
The fertile future of fertility technology
Fifth pregnancy, first baby.
After four pregnancies resulted in losses – and doing things as natural as possible and leaving it up to the birds, bees, and fate – my husband and I decided to explore in vitro fertilization (IVF).
Drugs to direct my follicles to produce more eggs, an egg retrieval procedure, genetic testing of our embryos, a quick procedure to remove a residual uterine septum from my uterus, drugs to thicken my endometrial lining to prepare my body to receive an embryo, an embryo transfer, steroids to suppress my immune system so my body would accept the pregnancy, blood thinner shots to promote blood flow to the baby, and 10 weeks of progesterone in oil shots later and we’re days away from welcoming our first baby into our lives.
In short, there’s more than one way to define “miracle baby.”
Global estimates say 48 million couples and 186 million individuals struggle with infertility. On average, 2 million infants born in the United States each year are conceived through assisted reproductive technology and the demand for treatments like IVF have doubled in the last decade.
Now the need for treatments outweighs clinician availability. “We have about 1,250 practicing fertility physicians in the U.S. to serve the whole country, which is highly inadequate,” said Eduardo Hariton, MD, a reproductive endocrinology physician in San Francisco and managing director of the U.S. Fertility Innovation Fund. “We have people that want to get care waiting 1 to 3 months to be seen.”
Dr. Hariton explains that U.S. IVF clinics are performing around 250,000 to 300,000 IVF cycles per year and need to be doing a million-plus to meet demand. This, plus the cost of fertility treatments – an average IVF cycle runs $23,500 and the majority of patients need multiple cycles to conceive – keeps the barrier to entry high.
Enter technology: New advances are on the way to help the assisted fertility process to run smoother and be less costly. “The field is really coming into an age of great progress and innovation,” added S. Zev Williams, MD, PhD, chief of the division of reproductive endocrinology and Infertility at Columbia University Irving Medical Center, New York City.
I’m personally grateful that such technology exists.
AI will help, of course
Fertility treatments involve endless analysis, diagnosis, and recommendations – dozens if not hundreds of decisions from each physician for each patient. Human action and reaction can affect this process, Dr. Hariton explained.
For example, if he hyperstimulated a woman during the follicle growing stage of her egg retrieval and ended up with eggs too large to retrieve, Dr. Hariton said he may subconsciously be more inclined to be extra cautious with his patients the week after, and vice versa.
This is where AI can help. “Rather than me making decisions from a couple of thousands of cycles of experience, I get to leverage hundreds of thousands of cycles from different providers over different people,” said Dr. Hariton. “I get to use all the data from that patient today – her age, her weight, what happened last cycle, how she’s doing – and make a very objective decision about the optimal time to give that woman or that couple the best outcome possible.”
AI can also assist with tasks like embryo grading. “Once our embryos are made in the lab, we usually have an embryologist looking at those embryos, grading them on a three-variable scale, and then picking the nicest one for transfer,” said Dr. Hariton. Machine learning computer vision software can help doctors select the best embryo.
Many of these AI products are in trials in the United States and some AI-based technology is already being used in fertility labs, especially in other countries. “ALife recently launched a suite of products to help with their decisions during stimulation that can help with the quality KPIs [key performance indicators] in the lab,” said Dr. Hariton. “There’s also a company that does AI-based predictions of success to give patients a better estimate called Univfy.” More AI products are still in development or awaiting Food and Drug Administration clearance.
Robots lend a hand
Like artificial intelligence, robots can be a big help in the IVF lab. Columbia University Fertility Center recently became the first to use an articulated (ART) robot to handle precise and highly repetitive work.
“IVF, from the initial point, involves creating these special plates where embryos can grow, and you do that by making little droplets,” said Dr. Williams. “It’s very time-consuming to create tons of these little droplets for the embryos to grow.” Thus, the lab created a robot to help squirt drops of the media substance required to sustain embryos in a way that is 10 times more precise than that of a trained embryologist.
“It’s a win-win because you allow the robots to do things better than a human can and this allows the humans to do things that a robot just can’t do,” explained Dr. Williams. He and his team began using this technology in the beginning of November 2022.
Dr. Williams sees ART robots being used in many more parts of the fertility treatment journey along the way, like preparing eggs after they are retrieved and performing intracytoplasmic sperm injection (ICSI), with the robot injecting the sperm into the egg.
Launching with the plate making, said Dr. Williams, is a low stakes entry point for robotic technology in the lab. “It allows us to introduce robotics to automate and optimize each step along the way, but to do so in the safest possible way.”
Dr. Williams estimates that robots will have their hands on actual eggs and sperm in 5 years.
Updates in genetic testing
Currently, if a couple wants to have their embryos genetically tested, also known as preimplantation genetic testing, each embryo must be frozen, then a biopsy of that embryo is performed and sent to the lab.
“It takes time to get the results,” said Dr. Williams. “The whole time you’re waiting, you don’t know if you’re going to have any embryos that are transferable or if next month you’re going to have to do another IVF cycle.”
Columbia researchers recently developed a new in-house test that can determine if a fetus or embryo has the right number of chromosomes. This STORK (Short-read Transpore Rapid Karyotyping) can be performed without freezing embryos and sending them out, which Dr. Williams said can save couples money and time, as they won’t necessarily need to do a separate embryo transfer cycle and can transfer an embryo in the same cycle. “You can test in the morning and transfer in the afternoon,” said Dr. Williams.
The test is currently awaiting approval and will first be used to test miscarriage samples to see if embryos were genetically normal or not, which he said should cost around $200 vs. the $2,000 to $4,000 it can cost to have fetal tissue sent to the lab – and insurance doesn’t cover the procedure until after a second or third miscarriage.
This, said Dr. Williams, should be in the field in less than a year, and he estimates that the test will be used for fresh embryos in about a year and a half.
Sperm collection made simpler
Typically, a man delivers a sperm sample in a room at an IVF clinic or by collecting a sample at home and rushing it to the clinic before it degrades, which Dr. Williams said can happen in as little as 15 minutes.
In 2020, Dr. Williams and his team began using a custom at-home sperm collection box that houses sperm in a recyclable foam container that holds a sample cup, which is filled with special sperm-supporting media, at an angle that prevents evaporation and maintains temperature and pH. This allows patients to collect samples in the comfort of their homes and increases the clock to 3 hours.
“It’s great for the patients because it’s much more comfortable,” said Dr. Williams, who notes that having to “perform” on site can be stressful for men. Studies the team has conducted have shown sperm collected in this manner have a better success rate than those collected in the lab, and 90% of Columbia’s Fertility Center patients are now providing sperm samples this way.
Similar innovations to deliver sperm, like Protex, are now on the market, while companies like myLabBox and Legacy are offering at-home sperm testing kits to mail in for a full semen analysis.
At-home monitoring: More and better
Wearable reproductive health devices are also helping more women get pregnant. “I am very excited about biometric data harnessed in wearables to predict periods, ovulation, and fertility,” said Amander Clark, PhD, director of the UCLA Center for Reproductive Science, Health, and Education, Los Angeles.
The Tempdrop Fertility and Ovulation Tracker, for instance, is a wearable sensor with an accompanying charting app that helps a woman identify her most fertile days to conceive. The Bellabeat Ivy is a women’s health smart bracelet with a strong focus on tracking a woman’s cycle and fertility, pregnancy, and postnatal symptoms. And Mirvie, which is currently in development, is a blood test that will be able to predict pregnancy complications earlier.
Physicians are also looking to move as much of the lab experience as they can into a patient’s home, which streamlines processes while offering privacy and comfort. For example, Dr. Hariton, who runs a strategic venture capital fund for physicians, said his team is currently working with a company that does remote ultrasounds.
And Mira, an at-home hormone monitor, uses patented AI algorithms to accurately measure the levels of major reproductive health hormones (E3G, LH, PdG, FSH) in urine, said Meir Olcha, MD, chief medical officer at Sama Fertility. The product recently completed a clinical trial, which showed it was a viable alternative to blood serum for patients undergoing IVF.
Stem cells could make eggs ageless
Research shows that a woman’s egg quality decreases gradually but significantly starting at age 32 and more rapidly after 37. Sperm quality may also decrease with age. A possible workaround: Scientists are actively researching how to create eggs and sperm from stem cells.
“I think getting eggs from stem cells will happen in the future,” said Dr. Hariton, who notes that this type of technology would be a game changer in his clinic. “It will make some of the hardest diagnoses that I have – which is on a daily basis, ‘I’m so sorry, you’re in premature menopause’ or ‘I don’t think we’re going to be successful getting you pregnant with your own eggs; here are some other options like donor eggs’ – much better,” he added. And stem cells are currently being used to research causes of infertility.
Clinics like UCLA have already been making strides. “We are using stem cells to identify new genes required for reproduction and to define the role of these genes in human fertility and infertility,” said Dr. Clark, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who recently led a study in this arena. “In vitro gametogenesis (IVG), another stem cell technology, is currently used in the research lab to understand causes of infertility.”
These stem cell-based embryo models, she said, can help researchers understand the first few days of embryo development after an embryo implants and be used to provide critical information on causes of early pregnancy loss or birth defects.
A version of this article appeared on Medscape.com.
Fifth pregnancy, first baby.
After four pregnancies resulted in losses – and doing things as natural as possible and leaving it up to the birds, bees, and fate – my husband and I decided to explore in vitro fertilization (IVF).
Drugs to direct my follicles to produce more eggs, an egg retrieval procedure, genetic testing of our embryos, a quick procedure to remove a residual uterine septum from my uterus, drugs to thicken my endometrial lining to prepare my body to receive an embryo, an embryo transfer, steroids to suppress my immune system so my body would accept the pregnancy, blood thinner shots to promote blood flow to the baby, and 10 weeks of progesterone in oil shots later and we’re days away from welcoming our first baby into our lives.
In short, there’s more than one way to define “miracle baby.”
Global estimates say 48 million couples and 186 million individuals struggle with infertility. On average, 2 million infants born in the United States each year are conceived through assisted reproductive technology and the demand for treatments like IVF have doubled in the last decade.
Now the need for treatments outweighs clinician availability. “We have about 1,250 practicing fertility physicians in the U.S. to serve the whole country, which is highly inadequate,” said Eduardo Hariton, MD, a reproductive endocrinology physician in San Francisco and managing director of the U.S. Fertility Innovation Fund. “We have people that want to get care waiting 1 to 3 months to be seen.”
Dr. Hariton explains that U.S. IVF clinics are performing around 250,000 to 300,000 IVF cycles per year and need to be doing a million-plus to meet demand. This, plus the cost of fertility treatments – an average IVF cycle runs $23,500 and the majority of patients need multiple cycles to conceive – keeps the barrier to entry high.
Enter technology: New advances are on the way to help the assisted fertility process to run smoother and be less costly. “The field is really coming into an age of great progress and innovation,” added S. Zev Williams, MD, PhD, chief of the division of reproductive endocrinology and Infertility at Columbia University Irving Medical Center, New York City.
I’m personally grateful that such technology exists.
AI will help, of course
Fertility treatments involve endless analysis, diagnosis, and recommendations – dozens if not hundreds of decisions from each physician for each patient. Human action and reaction can affect this process, Dr. Hariton explained.
For example, if he hyperstimulated a woman during the follicle growing stage of her egg retrieval and ended up with eggs too large to retrieve, Dr. Hariton said he may subconsciously be more inclined to be extra cautious with his patients the week after, and vice versa.
This is where AI can help. “Rather than me making decisions from a couple of thousands of cycles of experience, I get to leverage hundreds of thousands of cycles from different providers over different people,” said Dr. Hariton. “I get to use all the data from that patient today – her age, her weight, what happened last cycle, how she’s doing – and make a very objective decision about the optimal time to give that woman or that couple the best outcome possible.”
AI can also assist with tasks like embryo grading. “Once our embryos are made in the lab, we usually have an embryologist looking at those embryos, grading them on a three-variable scale, and then picking the nicest one for transfer,” said Dr. Hariton. Machine learning computer vision software can help doctors select the best embryo.
Many of these AI products are in trials in the United States and some AI-based technology is already being used in fertility labs, especially in other countries. “ALife recently launched a suite of products to help with their decisions during stimulation that can help with the quality KPIs [key performance indicators] in the lab,” said Dr. Hariton. “There’s also a company that does AI-based predictions of success to give patients a better estimate called Univfy.” More AI products are still in development or awaiting Food and Drug Administration clearance.
Robots lend a hand
Like artificial intelligence, robots can be a big help in the IVF lab. Columbia University Fertility Center recently became the first to use an articulated (ART) robot to handle precise and highly repetitive work.
“IVF, from the initial point, involves creating these special plates where embryos can grow, and you do that by making little droplets,” said Dr. Williams. “It’s very time-consuming to create tons of these little droplets for the embryos to grow.” Thus, the lab created a robot to help squirt drops of the media substance required to sustain embryos in a way that is 10 times more precise than that of a trained embryologist.
“It’s a win-win because you allow the robots to do things better than a human can and this allows the humans to do things that a robot just can’t do,” explained Dr. Williams. He and his team began using this technology in the beginning of November 2022.
Dr. Williams sees ART robots being used in many more parts of the fertility treatment journey along the way, like preparing eggs after they are retrieved and performing intracytoplasmic sperm injection (ICSI), with the robot injecting the sperm into the egg.
Launching with the plate making, said Dr. Williams, is a low stakes entry point for robotic technology in the lab. “It allows us to introduce robotics to automate and optimize each step along the way, but to do so in the safest possible way.”
Dr. Williams estimates that robots will have their hands on actual eggs and sperm in 5 years.
Updates in genetic testing
Currently, if a couple wants to have their embryos genetically tested, also known as preimplantation genetic testing, each embryo must be frozen, then a biopsy of that embryo is performed and sent to the lab.
“It takes time to get the results,” said Dr. Williams. “The whole time you’re waiting, you don’t know if you’re going to have any embryos that are transferable or if next month you’re going to have to do another IVF cycle.”
Columbia researchers recently developed a new in-house test that can determine if a fetus or embryo has the right number of chromosomes. This STORK (Short-read Transpore Rapid Karyotyping) can be performed without freezing embryos and sending them out, which Dr. Williams said can save couples money and time, as they won’t necessarily need to do a separate embryo transfer cycle and can transfer an embryo in the same cycle. “You can test in the morning and transfer in the afternoon,” said Dr. Williams.
The test is currently awaiting approval and will first be used to test miscarriage samples to see if embryos were genetically normal or not, which he said should cost around $200 vs. the $2,000 to $4,000 it can cost to have fetal tissue sent to the lab – and insurance doesn’t cover the procedure until after a second or third miscarriage.
This, said Dr. Williams, should be in the field in less than a year, and he estimates that the test will be used for fresh embryos in about a year and a half.
Sperm collection made simpler
Typically, a man delivers a sperm sample in a room at an IVF clinic or by collecting a sample at home and rushing it to the clinic before it degrades, which Dr. Williams said can happen in as little as 15 minutes.
In 2020, Dr. Williams and his team began using a custom at-home sperm collection box that houses sperm in a recyclable foam container that holds a sample cup, which is filled with special sperm-supporting media, at an angle that prevents evaporation and maintains temperature and pH. This allows patients to collect samples in the comfort of their homes and increases the clock to 3 hours.
“It’s great for the patients because it’s much more comfortable,” said Dr. Williams, who notes that having to “perform” on site can be stressful for men. Studies the team has conducted have shown sperm collected in this manner have a better success rate than those collected in the lab, and 90% of Columbia’s Fertility Center patients are now providing sperm samples this way.
Similar innovations to deliver sperm, like Protex, are now on the market, while companies like myLabBox and Legacy are offering at-home sperm testing kits to mail in for a full semen analysis.
At-home monitoring: More and better
Wearable reproductive health devices are also helping more women get pregnant. “I am very excited about biometric data harnessed in wearables to predict periods, ovulation, and fertility,” said Amander Clark, PhD, director of the UCLA Center for Reproductive Science, Health, and Education, Los Angeles.
The Tempdrop Fertility and Ovulation Tracker, for instance, is a wearable sensor with an accompanying charting app that helps a woman identify her most fertile days to conceive. The Bellabeat Ivy is a women’s health smart bracelet with a strong focus on tracking a woman’s cycle and fertility, pregnancy, and postnatal symptoms. And Mirvie, which is currently in development, is a blood test that will be able to predict pregnancy complications earlier.
Physicians are also looking to move as much of the lab experience as they can into a patient’s home, which streamlines processes while offering privacy and comfort. For example, Dr. Hariton, who runs a strategic venture capital fund for physicians, said his team is currently working with a company that does remote ultrasounds.
And Mira, an at-home hormone monitor, uses patented AI algorithms to accurately measure the levels of major reproductive health hormones (E3G, LH, PdG, FSH) in urine, said Meir Olcha, MD, chief medical officer at Sama Fertility. The product recently completed a clinical trial, which showed it was a viable alternative to blood serum for patients undergoing IVF.
Stem cells could make eggs ageless
Research shows that a woman’s egg quality decreases gradually but significantly starting at age 32 and more rapidly after 37. Sperm quality may also decrease with age. A possible workaround: Scientists are actively researching how to create eggs and sperm from stem cells.
“I think getting eggs from stem cells will happen in the future,” said Dr. Hariton, who notes that this type of technology would be a game changer in his clinic. “It will make some of the hardest diagnoses that I have – which is on a daily basis, ‘I’m so sorry, you’re in premature menopause’ or ‘I don’t think we’re going to be successful getting you pregnant with your own eggs; here are some other options like donor eggs’ – much better,” he added. And stem cells are currently being used to research causes of infertility.
Clinics like UCLA have already been making strides. “We are using stem cells to identify new genes required for reproduction and to define the role of these genes in human fertility and infertility,” said Dr. Clark, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who recently led a study in this arena. “In vitro gametogenesis (IVG), another stem cell technology, is currently used in the research lab to understand causes of infertility.”
These stem cell-based embryo models, she said, can help researchers understand the first few days of embryo development after an embryo implants and be used to provide critical information on causes of early pregnancy loss or birth defects.
A version of this article appeared on Medscape.com.
Fifth pregnancy, first baby.
After four pregnancies resulted in losses – and doing things as natural as possible and leaving it up to the birds, bees, and fate – my husband and I decided to explore in vitro fertilization (IVF).
Drugs to direct my follicles to produce more eggs, an egg retrieval procedure, genetic testing of our embryos, a quick procedure to remove a residual uterine septum from my uterus, drugs to thicken my endometrial lining to prepare my body to receive an embryo, an embryo transfer, steroids to suppress my immune system so my body would accept the pregnancy, blood thinner shots to promote blood flow to the baby, and 10 weeks of progesterone in oil shots later and we’re days away from welcoming our first baby into our lives.
In short, there’s more than one way to define “miracle baby.”
Global estimates say 48 million couples and 186 million individuals struggle with infertility. On average, 2 million infants born in the United States each year are conceived through assisted reproductive technology and the demand for treatments like IVF have doubled in the last decade.
Now the need for treatments outweighs clinician availability. “We have about 1,250 practicing fertility physicians in the U.S. to serve the whole country, which is highly inadequate,” said Eduardo Hariton, MD, a reproductive endocrinology physician in San Francisco and managing director of the U.S. Fertility Innovation Fund. “We have people that want to get care waiting 1 to 3 months to be seen.”
Dr. Hariton explains that U.S. IVF clinics are performing around 250,000 to 300,000 IVF cycles per year and need to be doing a million-plus to meet demand. This, plus the cost of fertility treatments – an average IVF cycle runs $23,500 and the majority of patients need multiple cycles to conceive – keeps the barrier to entry high.
Enter technology: New advances are on the way to help the assisted fertility process to run smoother and be less costly. “The field is really coming into an age of great progress and innovation,” added S. Zev Williams, MD, PhD, chief of the division of reproductive endocrinology and Infertility at Columbia University Irving Medical Center, New York City.
I’m personally grateful that such technology exists.
AI will help, of course
Fertility treatments involve endless analysis, diagnosis, and recommendations – dozens if not hundreds of decisions from each physician for each patient. Human action and reaction can affect this process, Dr. Hariton explained.
For example, if he hyperstimulated a woman during the follicle growing stage of her egg retrieval and ended up with eggs too large to retrieve, Dr. Hariton said he may subconsciously be more inclined to be extra cautious with his patients the week after, and vice versa.
This is where AI can help. “Rather than me making decisions from a couple of thousands of cycles of experience, I get to leverage hundreds of thousands of cycles from different providers over different people,” said Dr. Hariton. “I get to use all the data from that patient today – her age, her weight, what happened last cycle, how she’s doing – and make a very objective decision about the optimal time to give that woman or that couple the best outcome possible.”
AI can also assist with tasks like embryo grading. “Once our embryos are made in the lab, we usually have an embryologist looking at those embryos, grading them on a three-variable scale, and then picking the nicest one for transfer,” said Dr. Hariton. Machine learning computer vision software can help doctors select the best embryo.
Many of these AI products are in trials in the United States and some AI-based technology is already being used in fertility labs, especially in other countries. “ALife recently launched a suite of products to help with their decisions during stimulation that can help with the quality KPIs [key performance indicators] in the lab,” said Dr. Hariton. “There’s also a company that does AI-based predictions of success to give patients a better estimate called Univfy.” More AI products are still in development or awaiting Food and Drug Administration clearance.
Robots lend a hand
Like artificial intelligence, robots can be a big help in the IVF lab. Columbia University Fertility Center recently became the first to use an articulated (ART) robot to handle precise and highly repetitive work.
“IVF, from the initial point, involves creating these special plates where embryos can grow, and you do that by making little droplets,” said Dr. Williams. “It’s very time-consuming to create tons of these little droplets for the embryos to grow.” Thus, the lab created a robot to help squirt drops of the media substance required to sustain embryos in a way that is 10 times more precise than that of a trained embryologist.
“It’s a win-win because you allow the robots to do things better than a human can and this allows the humans to do things that a robot just can’t do,” explained Dr. Williams. He and his team began using this technology in the beginning of November 2022.
Dr. Williams sees ART robots being used in many more parts of the fertility treatment journey along the way, like preparing eggs after they are retrieved and performing intracytoplasmic sperm injection (ICSI), with the robot injecting the sperm into the egg.
Launching with the plate making, said Dr. Williams, is a low stakes entry point for robotic technology in the lab. “It allows us to introduce robotics to automate and optimize each step along the way, but to do so in the safest possible way.”
Dr. Williams estimates that robots will have their hands on actual eggs and sperm in 5 years.
Updates in genetic testing
Currently, if a couple wants to have their embryos genetically tested, also known as preimplantation genetic testing, each embryo must be frozen, then a biopsy of that embryo is performed and sent to the lab.
“It takes time to get the results,” said Dr. Williams. “The whole time you’re waiting, you don’t know if you’re going to have any embryos that are transferable or if next month you’re going to have to do another IVF cycle.”
Columbia researchers recently developed a new in-house test that can determine if a fetus or embryo has the right number of chromosomes. This STORK (Short-read Transpore Rapid Karyotyping) can be performed without freezing embryos and sending them out, which Dr. Williams said can save couples money and time, as they won’t necessarily need to do a separate embryo transfer cycle and can transfer an embryo in the same cycle. “You can test in the morning and transfer in the afternoon,” said Dr. Williams.
The test is currently awaiting approval and will first be used to test miscarriage samples to see if embryos were genetically normal or not, which he said should cost around $200 vs. the $2,000 to $4,000 it can cost to have fetal tissue sent to the lab – and insurance doesn’t cover the procedure until after a second or third miscarriage.
This, said Dr. Williams, should be in the field in less than a year, and he estimates that the test will be used for fresh embryos in about a year and a half.
Sperm collection made simpler
Typically, a man delivers a sperm sample in a room at an IVF clinic or by collecting a sample at home and rushing it to the clinic before it degrades, which Dr. Williams said can happen in as little as 15 minutes.
In 2020, Dr. Williams and his team began using a custom at-home sperm collection box that houses sperm in a recyclable foam container that holds a sample cup, which is filled with special sperm-supporting media, at an angle that prevents evaporation and maintains temperature and pH. This allows patients to collect samples in the comfort of their homes and increases the clock to 3 hours.
“It’s great for the patients because it’s much more comfortable,” said Dr. Williams, who notes that having to “perform” on site can be stressful for men. Studies the team has conducted have shown sperm collected in this manner have a better success rate than those collected in the lab, and 90% of Columbia’s Fertility Center patients are now providing sperm samples this way.
Similar innovations to deliver sperm, like Protex, are now on the market, while companies like myLabBox and Legacy are offering at-home sperm testing kits to mail in for a full semen analysis.
At-home monitoring: More and better
Wearable reproductive health devices are also helping more women get pregnant. “I am very excited about biometric data harnessed in wearables to predict periods, ovulation, and fertility,” said Amander Clark, PhD, director of the UCLA Center for Reproductive Science, Health, and Education, Los Angeles.
The Tempdrop Fertility and Ovulation Tracker, for instance, is a wearable sensor with an accompanying charting app that helps a woman identify her most fertile days to conceive. The Bellabeat Ivy is a women’s health smart bracelet with a strong focus on tracking a woman’s cycle and fertility, pregnancy, and postnatal symptoms. And Mirvie, which is currently in development, is a blood test that will be able to predict pregnancy complications earlier.
Physicians are also looking to move as much of the lab experience as they can into a patient’s home, which streamlines processes while offering privacy and comfort. For example, Dr. Hariton, who runs a strategic venture capital fund for physicians, said his team is currently working with a company that does remote ultrasounds.
And Mira, an at-home hormone monitor, uses patented AI algorithms to accurately measure the levels of major reproductive health hormones (E3G, LH, PdG, FSH) in urine, said Meir Olcha, MD, chief medical officer at Sama Fertility. The product recently completed a clinical trial, which showed it was a viable alternative to blood serum for patients undergoing IVF.
Stem cells could make eggs ageless
Research shows that a woman’s egg quality decreases gradually but significantly starting at age 32 and more rapidly after 37. Sperm quality may also decrease with age. A possible workaround: Scientists are actively researching how to create eggs and sperm from stem cells.
“I think getting eggs from stem cells will happen in the future,” said Dr. Hariton, who notes that this type of technology would be a game changer in his clinic. “It will make some of the hardest diagnoses that I have – which is on a daily basis, ‘I’m so sorry, you’re in premature menopause’ or ‘I don’t think we’re going to be successful getting you pregnant with your own eggs; here are some other options like donor eggs’ – much better,” he added. And stem cells are currently being used to research causes of infertility.
Clinics like UCLA have already been making strides. “We are using stem cells to identify new genes required for reproduction and to define the role of these genes in human fertility and infertility,” said Dr. Clark, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who recently led a study in this arena. “In vitro gametogenesis (IVG), another stem cell technology, is currently used in the research lab to understand causes of infertility.”
These stem cell-based embryo models, she said, can help researchers understand the first few days of embryo development after an embryo implants and be used to provide critical information on causes of early pregnancy loss or birth defects.
A version of this article appeared on Medscape.com.
Woman with transplanted uterus gives birth to boy
It’s the first time that a baby has been born to a woman with a transplanted uterus outside of a clinical trial. Officials from University of Alabama–Birmingham Hospital, where the 2-year process took place, said in a statement on July 24 that the birth sets its uterus transplant program on track to perhaps become covered under insurance plans.
The process of uterus transplant, in vitro fertilization, and pregnancy involves 50 medical providers and is open to women who have uterine factor infertility (UFI). The condition may affect up to 5% of reproductive-age women worldwide. Women with UFI cannot carry a pregnancy to term because they were either born without a uterus, had it removed via hysterectomy, or have a uterus that does not function properly.
The woman, whom the hospital identified as Mallory, moved with her family to the Birmingham area to enter the transplant program, which is one of four programs operating in the United States. Mallory learned when she was 17 years old that she was born without a uterus because of Mayer-Rokitansky-Küster-Hauser syndrome. Her first child, a daughter, was born after her sister carried the pregnancy as a surrogate.
Mallory received her uterus from a deceased donor. Her son was born in May.
“As with other types of organ transplants, the woman must take immunosuppressive medications to prevent the body from rejecting the transplanted uterus,” the transplant program’s website states. “After the baby is born and if the woman does not want more children, the transplanted uterus is removed with a hysterectomy procedure, and the woman no longer needs to take antirejection medications.”
“There are all different ways to grow your family if you have uterine factor infertility, but this [uterus transplantation] is what I feel like I knew that I was supposed to do,” Mallory said in a statement. “I mean, just hearing the cry at first was just, you know, mind blowing.”
A version of this article first appeared on WebMD.com.
It’s the first time that a baby has been born to a woman with a transplanted uterus outside of a clinical trial. Officials from University of Alabama–Birmingham Hospital, where the 2-year process took place, said in a statement on July 24 that the birth sets its uterus transplant program on track to perhaps become covered under insurance plans.
The process of uterus transplant, in vitro fertilization, and pregnancy involves 50 medical providers and is open to women who have uterine factor infertility (UFI). The condition may affect up to 5% of reproductive-age women worldwide. Women with UFI cannot carry a pregnancy to term because they were either born without a uterus, had it removed via hysterectomy, or have a uterus that does not function properly.
The woman, whom the hospital identified as Mallory, moved with her family to the Birmingham area to enter the transplant program, which is one of four programs operating in the United States. Mallory learned when she was 17 years old that she was born without a uterus because of Mayer-Rokitansky-Küster-Hauser syndrome. Her first child, a daughter, was born after her sister carried the pregnancy as a surrogate.
Mallory received her uterus from a deceased donor. Her son was born in May.
“As with other types of organ transplants, the woman must take immunosuppressive medications to prevent the body from rejecting the transplanted uterus,” the transplant program’s website states. “After the baby is born and if the woman does not want more children, the transplanted uterus is removed with a hysterectomy procedure, and the woman no longer needs to take antirejection medications.”
“There are all different ways to grow your family if you have uterine factor infertility, but this [uterus transplantation] is what I feel like I knew that I was supposed to do,” Mallory said in a statement. “I mean, just hearing the cry at first was just, you know, mind blowing.”
A version of this article first appeared on WebMD.com.
It’s the first time that a baby has been born to a woman with a transplanted uterus outside of a clinical trial. Officials from University of Alabama–Birmingham Hospital, where the 2-year process took place, said in a statement on July 24 that the birth sets its uterus transplant program on track to perhaps become covered under insurance plans.
The process of uterus transplant, in vitro fertilization, and pregnancy involves 50 medical providers and is open to women who have uterine factor infertility (UFI). The condition may affect up to 5% of reproductive-age women worldwide. Women with UFI cannot carry a pregnancy to term because they were either born without a uterus, had it removed via hysterectomy, or have a uterus that does not function properly.
The woman, whom the hospital identified as Mallory, moved with her family to the Birmingham area to enter the transplant program, which is one of four programs operating in the United States. Mallory learned when she was 17 years old that she was born without a uterus because of Mayer-Rokitansky-Küster-Hauser syndrome. Her first child, a daughter, was born after her sister carried the pregnancy as a surrogate.
Mallory received her uterus from a deceased donor. Her son was born in May.
“As with other types of organ transplants, the woman must take immunosuppressive medications to prevent the body from rejecting the transplanted uterus,” the transplant program’s website states. “After the baby is born and if the woman does not want more children, the transplanted uterus is removed with a hysterectomy procedure, and the woman no longer needs to take antirejection medications.”
“There are all different ways to grow your family if you have uterine factor infertility, but this [uterus transplantation] is what I feel like I knew that I was supposed to do,” Mallory said in a statement. “I mean, just hearing the cry at first was just, you know, mind blowing.”
A version of this article first appeared on WebMD.com.
Pregnancy risks elevated in women with chronic pancreatitis
TOPLINE:
METHODOLOGY:
- A retrospective analysis of hospital discharge records from the National Inpatient Sample database between 2009 and 2019 was conducted.
- The sample included 3,094 pregnancies with chronic pancreatitis and roughly 40.8 million pregnancies without this condition.
- The study focused on primary maternal outcomes and primary perinatal outcomes in pregnancies affected by chronic pancreatitis after accounting for relevant covariates.
TAKEAWAY:
- Chronic pancreatitis pregnancies had elevated rates of gestational diabetes (adjusted odds ratio, 1.63), gestational hypertensive complications (aOR, 2.48), preterm labor (aOR, 3.10), and small size for gestational age (aOR, 2.40).
- Women with chronic pancreatitis and a history of renal failure were more prone to gestational hypertensive complications (aOR, 20.09).
- Women with alcohol-induced chronic pancreatitis had a 17-fold higher risk for fetal death (aOR, 17.15).
- Pregnancies with chronic pancreatitis were associated with longer hospital stays and higher hospital costs.
IN PRACTICE:
“Our study provides novel insights into the impact of chronic pancreatitis on maternal and fetal health. The implications of our findings are critical for health care professionals, particularly those involved in preconception counseling. Pregnant women with chronic pancreatitis should be under the care of a multidisciplinary team of health care providers,” the authors advise.
SOURCE:
The study was led by Chengu Niu, MD, with Rochester General Hospital, Rochester, N.Y. It was published online July 18 in Digestive and Liver Disease. The study had no specific funding.
LIMITATIONS:
The authors note potential inaccuracies because of coding in the National Inpatient Sample database, a lack of detailed information regarding medication use, and a lack of follow-up clinical information. The findings are specific to the United States and may not be applicable to other countries.
DISCLOSURES:
The authors have no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- A retrospective analysis of hospital discharge records from the National Inpatient Sample database between 2009 and 2019 was conducted.
- The sample included 3,094 pregnancies with chronic pancreatitis and roughly 40.8 million pregnancies without this condition.
- The study focused on primary maternal outcomes and primary perinatal outcomes in pregnancies affected by chronic pancreatitis after accounting for relevant covariates.
TAKEAWAY:
- Chronic pancreatitis pregnancies had elevated rates of gestational diabetes (adjusted odds ratio, 1.63), gestational hypertensive complications (aOR, 2.48), preterm labor (aOR, 3.10), and small size for gestational age (aOR, 2.40).
- Women with chronic pancreatitis and a history of renal failure were more prone to gestational hypertensive complications (aOR, 20.09).
- Women with alcohol-induced chronic pancreatitis had a 17-fold higher risk for fetal death (aOR, 17.15).
- Pregnancies with chronic pancreatitis were associated with longer hospital stays and higher hospital costs.
IN PRACTICE:
“Our study provides novel insights into the impact of chronic pancreatitis on maternal and fetal health. The implications of our findings are critical for health care professionals, particularly those involved in preconception counseling. Pregnant women with chronic pancreatitis should be under the care of a multidisciplinary team of health care providers,” the authors advise.
SOURCE:
The study was led by Chengu Niu, MD, with Rochester General Hospital, Rochester, N.Y. It was published online July 18 in Digestive and Liver Disease. The study had no specific funding.
LIMITATIONS:
The authors note potential inaccuracies because of coding in the National Inpatient Sample database, a lack of detailed information regarding medication use, and a lack of follow-up clinical information. The findings are specific to the United States and may not be applicable to other countries.
DISCLOSURES:
The authors have no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- A retrospective analysis of hospital discharge records from the National Inpatient Sample database between 2009 and 2019 was conducted.
- The sample included 3,094 pregnancies with chronic pancreatitis and roughly 40.8 million pregnancies without this condition.
- The study focused on primary maternal outcomes and primary perinatal outcomes in pregnancies affected by chronic pancreatitis after accounting for relevant covariates.
TAKEAWAY:
- Chronic pancreatitis pregnancies had elevated rates of gestational diabetes (adjusted odds ratio, 1.63), gestational hypertensive complications (aOR, 2.48), preterm labor (aOR, 3.10), and small size for gestational age (aOR, 2.40).
- Women with chronic pancreatitis and a history of renal failure were more prone to gestational hypertensive complications (aOR, 20.09).
- Women with alcohol-induced chronic pancreatitis had a 17-fold higher risk for fetal death (aOR, 17.15).
- Pregnancies with chronic pancreatitis were associated with longer hospital stays and higher hospital costs.
IN PRACTICE:
“Our study provides novel insights into the impact of chronic pancreatitis on maternal and fetal health. The implications of our findings are critical for health care professionals, particularly those involved in preconception counseling. Pregnant women with chronic pancreatitis should be under the care of a multidisciplinary team of health care providers,” the authors advise.
SOURCE:
The study was led by Chengu Niu, MD, with Rochester General Hospital, Rochester, N.Y. It was published online July 18 in Digestive and Liver Disease. The study had no specific funding.
LIMITATIONS:
The authors note potential inaccuracies because of coding in the National Inpatient Sample database, a lack of detailed information regarding medication use, and a lack of follow-up clinical information. The findings are specific to the United States and may not be applicable to other countries.
DISCLOSURES:
The authors have no relevant disclosures.
A version of this article appeared on Medscape.com.
Cancer Patients: Who’s at Risk for Venous Thromboembolism?
Patients with cancer are at a high risk of venous thromboembolism (VTE)—in fact, it’s one of the leading causes of death in patients who receive systemic therapy for cancer. But as cancer treatment has evolved, have the incidence and risk of VTE changed too?
Researchers from Veterans Affairs Boston Healthcare System in Massachusetts conducted a study with 434,203 veterans to evaluate the pattern of VTE incidence over 16 years, focusing on the types of cancer, treatment, race and ethnicity, and other factors related to cancer-associated thrombosis (CAT).
In contrast with other large population studies, this study found the overall incidence of CAT remained largely stable over time. At 12 months, the incidence was 4.5%, with yearly trends ranging between 4.2% and 4.7%. “As expected,” the researchers say, the subset of patients receiving systemic therapy had a higher incidence of VTE at 12 months (7.7%) than did the overall cohort. The pattern was “particularly pronounced” in gynecologic, testicular, and kidney cancers, where the incidence of VTE was 2 to 3 times higher in the treated cohort compared with the overall cohort.
Cancer type and diagnosis were the most statistically and clinically significant associations with CAT, with up to a 6-fold difference between cancer subtypes. The patients at the highest risk of VTE were those with pancreatic cancer and acute lymphoblastic leukemia.
Most studies have focused only on patients with solid tumors, but these researchers observed novel patterns among patients with hematologic neoplasms. Specifically, a higher incidence of VTE among patients with aggressive vs indolent leukemias and lymphomas. This trend, the researchers say, may be associated in part with catheter-related events.
Furthermore, the type of system treatment was associated with the risk of VTE, the researchers say, although to a lesser extent. Chemotherapy- and immunotherapy-based regimens had the highest risk of VTE, relative to no treatment. Targeted and endocrine therapy also carried a higher risk compared with no treatment but to a lesser degree.
The researchers found significant heterogeneity by race and ethnicity across cancer types. Non-Hispanic Black patients had about 20% higher risk of VTE compared with non-Hispanic White patients. Asian and Pacific Islander patients had about 20% lower risk compared with non-Hispanic White patients.
Male sex was also associated with VTE. However, “interestingly,” the researchers note, neighborhood-level socioeconomic factors and patients’ comorbidities were not associated with CAT but were associated with mortality.
Their results suggest that patient- and treatment-specific factors play a critical role in assessing the risk of CAT, and “ongoing efforts to identify these patterns are of utmost importance for risk stratification and prognostic assessment.”
Patients with cancer are at a high risk of venous thromboembolism (VTE)—in fact, it’s one of the leading causes of death in patients who receive systemic therapy for cancer. But as cancer treatment has evolved, have the incidence and risk of VTE changed too?
Researchers from Veterans Affairs Boston Healthcare System in Massachusetts conducted a study with 434,203 veterans to evaluate the pattern of VTE incidence over 16 years, focusing on the types of cancer, treatment, race and ethnicity, and other factors related to cancer-associated thrombosis (CAT).
In contrast with other large population studies, this study found the overall incidence of CAT remained largely stable over time. At 12 months, the incidence was 4.5%, with yearly trends ranging between 4.2% and 4.7%. “As expected,” the researchers say, the subset of patients receiving systemic therapy had a higher incidence of VTE at 12 months (7.7%) than did the overall cohort. The pattern was “particularly pronounced” in gynecologic, testicular, and kidney cancers, where the incidence of VTE was 2 to 3 times higher in the treated cohort compared with the overall cohort.
Cancer type and diagnosis were the most statistically and clinically significant associations with CAT, with up to a 6-fold difference between cancer subtypes. The patients at the highest risk of VTE were those with pancreatic cancer and acute lymphoblastic leukemia.
Most studies have focused only on patients with solid tumors, but these researchers observed novel patterns among patients with hematologic neoplasms. Specifically, a higher incidence of VTE among patients with aggressive vs indolent leukemias and lymphomas. This trend, the researchers say, may be associated in part with catheter-related events.
Furthermore, the type of system treatment was associated with the risk of VTE, the researchers say, although to a lesser extent. Chemotherapy- and immunotherapy-based regimens had the highest risk of VTE, relative to no treatment. Targeted and endocrine therapy also carried a higher risk compared with no treatment but to a lesser degree.
The researchers found significant heterogeneity by race and ethnicity across cancer types. Non-Hispanic Black patients had about 20% higher risk of VTE compared with non-Hispanic White patients. Asian and Pacific Islander patients had about 20% lower risk compared with non-Hispanic White patients.
Male sex was also associated with VTE. However, “interestingly,” the researchers note, neighborhood-level socioeconomic factors and patients’ comorbidities were not associated with CAT but were associated with mortality.
Their results suggest that patient- and treatment-specific factors play a critical role in assessing the risk of CAT, and “ongoing efforts to identify these patterns are of utmost importance for risk stratification and prognostic assessment.”
Patients with cancer are at a high risk of venous thromboembolism (VTE)—in fact, it’s one of the leading causes of death in patients who receive systemic therapy for cancer. But as cancer treatment has evolved, have the incidence and risk of VTE changed too?
Researchers from Veterans Affairs Boston Healthcare System in Massachusetts conducted a study with 434,203 veterans to evaluate the pattern of VTE incidence over 16 years, focusing on the types of cancer, treatment, race and ethnicity, and other factors related to cancer-associated thrombosis (CAT).
In contrast with other large population studies, this study found the overall incidence of CAT remained largely stable over time. At 12 months, the incidence was 4.5%, with yearly trends ranging between 4.2% and 4.7%. “As expected,” the researchers say, the subset of patients receiving systemic therapy had a higher incidence of VTE at 12 months (7.7%) than did the overall cohort. The pattern was “particularly pronounced” in gynecologic, testicular, and kidney cancers, where the incidence of VTE was 2 to 3 times higher in the treated cohort compared with the overall cohort.
Cancer type and diagnosis were the most statistically and clinically significant associations with CAT, with up to a 6-fold difference between cancer subtypes. The patients at the highest risk of VTE were those with pancreatic cancer and acute lymphoblastic leukemia.
Most studies have focused only on patients with solid tumors, but these researchers observed novel patterns among patients with hematologic neoplasms. Specifically, a higher incidence of VTE among patients with aggressive vs indolent leukemias and lymphomas. This trend, the researchers say, may be associated in part with catheter-related events.
Furthermore, the type of system treatment was associated with the risk of VTE, the researchers say, although to a lesser extent. Chemotherapy- and immunotherapy-based regimens had the highest risk of VTE, relative to no treatment. Targeted and endocrine therapy also carried a higher risk compared with no treatment but to a lesser degree.
The researchers found significant heterogeneity by race and ethnicity across cancer types. Non-Hispanic Black patients had about 20% higher risk of VTE compared with non-Hispanic White patients. Asian and Pacific Islander patients had about 20% lower risk compared with non-Hispanic White patients.
Male sex was also associated with VTE. However, “interestingly,” the researchers note, neighborhood-level socioeconomic factors and patients’ comorbidities were not associated with CAT but were associated with mortality.
Their results suggest that patient- and treatment-specific factors play a critical role in assessing the risk of CAT, and “ongoing efforts to identify these patterns are of utmost importance for risk stratification and prognostic assessment.”
Regional Meeting Focuses on Women’s Cancer Survivorship
As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.
The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”
In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.
Adherence Challenges
Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”
Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.
In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”
Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”
It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”
Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”
As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.
Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”
Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.
The Role of Nurse Navigators
In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.
“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.
As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.”
According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”
At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.
Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.
“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”
Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.
As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.
The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”
In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.
Adherence Challenges
Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”
Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.
In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”
Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”
It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”
Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”
As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.
Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”
Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.
The Role of Nurse Navigators
In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.
“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.
As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.”
According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”
At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.
Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.
“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”
Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.
As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.
The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”
In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.
Adherence Challenges
Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”
Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.
In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”
Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”
It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”
Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”
As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.
Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”
Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.
The Role of Nurse Navigators
In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.
“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.
As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.”
According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”
At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.
Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.
“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”
Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.
Number of cervical cancer screenings linked to higher preterm birth risk
For each additional recommended screening before childbirth, there was a direct increase in absolute PTD risk of 0.073 (95% confidence interval, 0.026-0.120), according to a study led by Rebecca A. Bromley-Dulfano, MS, an MD candidate at Stanford (Calif.) University and a PhD candidate in health policy at Harvard University, Cambridge, Mass.
There was no significant change in very preterm delivery (VPTD) risk, but mothers with hypertension or diabetes were at higher PTD risk.
Women in this younger age group are more prone to PTD. According to the study’s estimate, an additional 73 PTDs per 100,000 women could be expected for every 1 additional recommended screening before childbirth. For the year 2018, that translated to an estimated 1,348 PTDs that could have been averted, with reduced screening requirements (3% relative reduction).
“If you screen someone for cervical cancer and find a cervical lesion, the possible next steps can include a biopsy and an excisional procedure to remove the lesion,” Ms. Bromley-Dulfano explained, “and these procedures which remove a small (mostly diseased) part of the cervix have been shown to slightly increase the risk of PTD. Particularly in young individuals with a cervix who are known to have high rates of lesion regression and who have more potential childbearing years ahead of them, it is important to weigh the oncological benefits with the adverse birth outcome risks.”
Young women are more likely to have false-positive results on Papanicolaou tests and lesion regression within 2 years but may undergo unnecessary treatment, the authors noted.
Cervical excision procedures have previously been associated in clinical trials with an increase in PTB risk.
In their 2017 decision model in a fictive cohort, for example, Kamphuis and colleagues found the most intensive screening program was associated with an increase in maternal life years of 9%, a decrease in cervical cancer incidence of 67%, and a decrease in cervical cancer deaths of 75%. But those gains came at the cost of 250% more preterm births, compared with the least intensive program.
“These results can be used in future simulation models integrating oncological trade-offs to help ascertain optimal screening strategies,” the researchers wrote.
While the optimal screening strategy must trade off the oncologic benefits of cancer detection against the neonatal harms of overtreatment, the ideal age of cervical cancer screening onset and frequency remain uncertain, the authors noted. Recent American Cancer Society guidelines recommending less frequent screening for some diverge from those of other societies.
“The first and foremost priority is for gynecologists to continue to have individualized conversations with patients about all of the benefits and risks of procedures that patients undergo and to understand the benefits and risks influencing screening guidelines,” Ms. Bromley-Dulfano said.
Cross-sectional study
The study used data from the Centers for Disease Control and Prevention’s National Center for Health Statistics to analyze associations between cervical cancer screening guidelines and birth outcomes women who had a singleton nulliparous birth from 19916 to 2018. Gestational age and maternal characteristics were drawn from birth certificates.
The mean age of the 11,333,151 multiracial cohort of women was 20.9 years, and 6.8% had hypertension or diabetes. The mean number of guideline-recommended screenings by time of childbirth was 2.4. Overall, PTD and very PTD occurred in 1,140,490 individuals (10.1%) and 333,040 (2.9%) of births, respectively.
Those with hypertension or diabetes had a somewhat higher PTD risk: 0.26% (95% CI, 0.11-0.4) versus 0.06% (95% CI, 0.01-0.10; Wald test, P < .001).
Offering an outsider’s perspective on the analysis, ob.gyn. Fidel A. Valea, MD, director of gynecologic oncology at the Northwell Health Cancer Institute in New Hyde Park, N.Y., urged caution in drawing conclusions from large population analyses such as this.
“This study had over 11 million data points. Often these large numbers will show statistical differences that are not clinically significant,” he said in an interview. He noted that while small studies have shown a possible impact of frequent Pap tests on cervical function, “this is not 100% proven. Research from Texas showed that screening made a difference only in cases of dysplasia.”
Dr. Valea also noted that screening guidelines have already changed over the lengthy time span of the study and do reflect the concerns of the study authors.
“We know that the HPV virus is cleared more readily by young women than older women and so we have made adjustments and test them less frequently and we test them less early.” He added that conservative options are recommended even in the case of dysplasia.
In defense of the Pap smear test, he added: “It has virtually wiped out cervical cancer in the U.S., bringing it from No. 1 to No. 13.” While broadening HPV vaccination programs may impact guidelines in the future, “vaccination is still in its infancy. We have to wait until women have lived long to enough to see an impact.”
As to why this age group is more vulnerable to PTD, Dr. Valea said, “It’s likely multifactorial, with lifestyle and other factors involved.” Although based on U.S. data, the authors said their results may be useful for other public health entities, particularly in countries where cervical cancer is considerably more prevalent.
This work received no specific funding. The authors and Dr. Valea disclosed no competing interests.
For each additional recommended screening before childbirth, there was a direct increase in absolute PTD risk of 0.073 (95% confidence interval, 0.026-0.120), according to a study led by Rebecca A. Bromley-Dulfano, MS, an MD candidate at Stanford (Calif.) University and a PhD candidate in health policy at Harvard University, Cambridge, Mass.
There was no significant change in very preterm delivery (VPTD) risk, but mothers with hypertension or diabetes were at higher PTD risk.
Women in this younger age group are more prone to PTD. According to the study’s estimate, an additional 73 PTDs per 100,000 women could be expected for every 1 additional recommended screening before childbirth. For the year 2018, that translated to an estimated 1,348 PTDs that could have been averted, with reduced screening requirements (3% relative reduction).
“If you screen someone for cervical cancer and find a cervical lesion, the possible next steps can include a biopsy and an excisional procedure to remove the lesion,” Ms. Bromley-Dulfano explained, “and these procedures which remove a small (mostly diseased) part of the cervix have been shown to slightly increase the risk of PTD. Particularly in young individuals with a cervix who are known to have high rates of lesion regression and who have more potential childbearing years ahead of them, it is important to weigh the oncological benefits with the adverse birth outcome risks.”
Young women are more likely to have false-positive results on Papanicolaou tests and lesion regression within 2 years but may undergo unnecessary treatment, the authors noted.
Cervical excision procedures have previously been associated in clinical trials with an increase in PTB risk.
In their 2017 decision model in a fictive cohort, for example, Kamphuis and colleagues found the most intensive screening program was associated with an increase in maternal life years of 9%, a decrease in cervical cancer incidence of 67%, and a decrease in cervical cancer deaths of 75%. But those gains came at the cost of 250% more preterm births, compared with the least intensive program.
“These results can be used in future simulation models integrating oncological trade-offs to help ascertain optimal screening strategies,” the researchers wrote.
While the optimal screening strategy must trade off the oncologic benefits of cancer detection against the neonatal harms of overtreatment, the ideal age of cervical cancer screening onset and frequency remain uncertain, the authors noted. Recent American Cancer Society guidelines recommending less frequent screening for some diverge from those of other societies.
“The first and foremost priority is for gynecologists to continue to have individualized conversations with patients about all of the benefits and risks of procedures that patients undergo and to understand the benefits and risks influencing screening guidelines,” Ms. Bromley-Dulfano said.
Cross-sectional study
The study used data from the Centers for Disease Control and Prevention’s National Center for Health Statistics to analyze associations between cervical cancer screening guidelines and birth outcomes women who had a singleton nulliparous birth from 19916 to 2018. Gestational age and maternal characteristics were drawn from birth certificates.
The mean age of the 11,333,151 multiracial cohort of women was 20.9 years, and 6.8% had hypertension or diabetes. The mean number of guideline-recommended screenings by time of childbirth was 2.4. Overall, PTD and very PTD occurred in 1,140,490 individuals (10.1%) and 333,040 (2.9%) of births, respectively.
Those with hypertension or diabetes had a somewhat higher PTD risk: 0.26% (95% CI, 0.11-0.4) versus 0.06% (95% CI, 0.01-0.10; Wald test, P < .001).
Offering an outsider’s perspective on the analysis, ob.gyn. Fidel A. Valea, MD, director of gynecologic oncology at the Northwell Health Cancer Institute in New Hyde Park, N.Y., urged caution in drawing conclusions from large population analyses such as this.
“This study had over 11 million data points. Often these large numbers will show statistical differences that are not clinically significant,” he said in an interview. He noted that while small studies have shown a possible impact of frequent Pap tests on cervical function, “this is not 100% proven. Research from Texas showed that screening made a difference only in cases of dysplasia.”
Dr. Valea also noted that screening guidelines have already changed over the lengthy time span of the study and do reflect the concerns of the study authors.
“We know that the HPV virus is cleared more readily by young women than older women and so we have made adjustments and test them less frequently and we test them less early.” He added that conservative options are recommended even in the case of dysplasia.
In defense of the Pap smear test, he added: “It has virtually wiped out cervical cancer in the U.S., bringing it from No. 1 to No. 13.” While broadening HPV vaccination programs may impact guidelines in the future, “vaccination is still in its infancy. We have to wait until women have lived long to enough to see an impact.”
As to why this age group is more vulnerable to PTD, Dr. Valea said, “It’s likely multifactorial, with lifestyle and other factors involved.” Although based on U.S. data, the authors said their results may be useful for other public health entities, particularly in countries where cervical cancer is considerably more prevalent.
This work received no specific funding. The authors and Dr. Valea disclosed no competing interests.
For each additional recommended screening before childbirth, there was a direct increase in absolute PTD risk of 0.073 (95% confidence interval, 0.026-0.120), according to a study led by Rebecca A. Bromley-Dulfano, MS, an MD candidate at Stanford (Calif.) University and a PhD candidate in health policy at Harvard University, Cambridge, Mass.
There was no significant change in very preterm delivery (VPTD) risk, but mothers with hypertension or diabetes were at higher PTD risk.
Women in this younger age group are more prone to PTD. According to the study’s estimate, an additional 73 PTDs per 100,000 women could be expected for every 1 additional recommended screening before childbirth. For the year 2018, that translated to an estimated 1,348 PTDs that could have been averted, with reduced screening requirements (3% relative reduction).
“If you screen someone for cervical cancer and find a cervical lesion, the possible next steps can include a biopsy and an excisional procedure to remove the lesion,” Ms. Bromley-Dulfano explained, “and these procedures which remove a small (mostly diseased) part of the cervix have been shown to slightly increase the risk of PTD. Particularly in young individuals with a cervix who are known to have high rates of lesion regression and who have more potential childbearing years ahead of them, it is important to weigh the oncological benefits with the adverse birth outcome risks.”
Young women are more likely to have false-positive results on Papanicolaou tests and lesion regression within 2 years but may undergo unnecessary treatment, the authors noted.
Cervical excision procedures have previously been associated in clinical trials with an increase in PTB risk.
In their 2017 decision model in a fictive cohort, for example, Kamphuis and colleagues found the most intensive screening program was associated with an increase in maternal life years of 9%, a decrease in cervical cancer incidence of 67%, and a decrease in cervical cancer deaths of 75%. But those gains came at the cost of 250% more preterm births, compared with the least intensive program.
“These results can be used in future simulation models integrating oncological trade-offs to help ascertain optimal screening strategies,” the researchers wrote.
While the optimal screening strategy must trade off the oncologic benefits of cancer detection against the neonatal harms of overtreatment, the ideal age of cervical cancer screening onset and frequency remain uncertain, the authors noted. Recent American Cancer Society guidelines recommending less frequent screening for some diverge from those of other societies.
“The first and foremost priority is for gynecologists to continue to have individualized conversations with patients about all of the benefits and risks of procedures that patients undergo and to understand the benefits and risks influencing screening guidelines,” Ms. Bromley-Dulfano said.
Cross-sectional study
The study used data from the Centers for Disease Control and Prevention’s National Center for Health Statistics to analyze associations between cervical cancer screening guidelines and birth outcomes women who had a singleton nulliparous birth from 19916 to 2018. Gestational age and maternal characteristics were drawn from birth certificates.
The mean age of the 11,333,151 multiracial cohort of women was 20.9 years, and 6.8% had hypertension or diabetes. The mean number of guideline-recommended screenings by time of childbirth was 2.4. Overall, PTD and very PTD occurred in 1,140,490 individuals (10.1%) and 333,040 (2.9%) of births, respectively.
Those with hypertension or diabetes had a somewhat higher PTD risk: 0.26% (95% CI, 0.11-0.4) versus 0.06% (95% CI, 0.01-0.10; Wald test, P < .001).
Offering an outsider’s perspective on the analysis, ob.gyn. Fidel A. Valea, MD, director of gynecologic oncology at the Northwell Health Cancer Institute in New Hyde Park, N.Y., urged caution in drawing conclusions from large population analyses such as this.
“This study had over 11 million data points. Often these large numbers will show statistical differences that are not clinically significant,” he said in an interview. He noted that while small studies have shown a possible impact of frequent Pap tests on cervical function, “this is not 100% proven. Research from Texas showed that screening made a difference only in cases of dysplasia.”
Dr. Valea also noted that screening guidelines have already changed over the lengthy time span of the study and do reflect the concerns of the study authors.
“We know that the HPV virus is cleared more readily by young women than older women and so we have made adjustments and test them less frequently and we test them less early.” He added that conservative options are recommended even in the case of dysplasia.
In defense of the Pap smear test, he added: “It has virtually wiped out cervical cancer in the U.S., bringing it from No. 1 to No. 13.” While broadening HPV vaccination programs may impact guidelines in the future, “vaccination is still in its infancy. We have to wait until women have lived long to enough to see an impact.”
As to why this age group is more vulnerable to PTD, Dr. Valea said, “It’s likely multifactorial, with lifestyle and other factors involved.” Although based on U.S. data, the authors said their results may be useful for other public health entities, particularly in countries where cervical cancer is considerably more prevalent.
This work received no specific funding. The authors and Dr. Valea disclosed no competing interests.
FROM JAMA HEALTH FORUM