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Crohn’s disease research goes to the dogs

Article Type
Changed
Thu, 05/26/2022 - 09:29

 

Why it might be better to be a dog person

Here’s that old debate again: Dogs or cats? You probably have your own opinion, but research presented at this year’s Digestive Disease Week may have tipped the scale by showing that children who lived with dogs may be less likely to have Crohn’s disease as adults.

The research was done by having approximately 4,300 people closely related to patients with Crohn’s disease fill out an environmental questionnaire. Using these data, the research team looked into environmental factors such as size of the families, where the home was, how many bathrooms the homes had, and quality of drinking water.

Piqsels

The researchers found that those who had or were exposed to dogs between the ages of 5 and 15 years were more likely to have healthy gut permeability and balanced microbes, which increased their protection against Crohn’s disease.

“Our study seems to add to others that have explored the ‘hygiene hypothesis’ which suggests that the lack of exposure to microbes early in life may lead to lack of immune regulation toward environmental microbes,” senior author Williams Turpin, PhD, said in the written statement.

The researchers aren’t sure why they didn’t get the same findings with cats, but Dr. Turpin theorized that dog owners tend to be outside more with their dogs or live in places with more green space, which are good protectors against Crohn’s disease.

It’s all good for dog owners, but do their pets’ parasites make you more attractive? Just more fuel for the ongoing debate.
 

Come for the history, stay for the fossilized parasites

Another week, another analysis of old British poop. LOTME really is your one-stop shop for all the important, hard-hitting news about historic parasites. You’re welcome, Internet.

Lisa-Marie Shillito
Human coprolite from Durrington Walls

The news this week is from Stonehenge, which is apparently kind of a big deal. Rocks in a circle, celestial calendar, cultural significance, whatever. We’re not here to talk about rocks. We’re here to talk about, uh, rocks. Smaller rocks. Specifically, coprolites, which are essentially poop turned into a rock. (Though now we’re imagining Stonehenge made out of fossilized poop rocks. Would it still be a big tourist destination? We can see both sides of the argument on that one.)

Archaeologists from the University of Cambridge have conducted an analysis of coprolites from Durrington Walls, a Neolithic settlement just a few kilometers from Stonehenge. The town dates to the same time that Stonehenge was constructed, and it’s believed that the residents were responsible for building the landmark. These coprolites, depending on what’s inside, can tell us a lot about how the builders of Stonehenge lived and, more specifically, how they ate.

In this case, the coprolites of one human and three dogs contained capillariid worm eggs. These worms come from cows, and when a human is typically infected, the eggs embed in the liver and do not pass through the body. Finding them in excrement indicates that the people were eating raw cow organs and feeding leftovers to their dogs. This is interesting, because a preponderance of pottery and cooking implements also found at the site indicates that the residents of Durrington Walls were spit-roasting or boiling their beef and pork. So the meat was cooked, but not the organs. That is an interesting dietary decision, ancient British people. Then again, modern British cuisine exists. At least now we know where they got it from.

This new research raises one other very important question: When are we going to get a full-on guided tour of all the important coprolite sites in Britain? They’ve clearly got plenty of them, and the tourist demand for ancient parasites must be sky-high. Come on, capitalism, follow through on this. We’d go.
 

 

 

Everyone lies: Food intake edition

Do you have any patients on special diets? Do you ask them if they are following those diets? Don’t bother, because they’re lying. Everyone lies about the food they eat. Everyone. Obese people lie, and nonobese people lie.

Peter Timmerhues/Pixabay

Investigators at the University of Essex in England asked 221 adults to keep food diaries, and then they checked on energy consumption by analyzing radioactive water levels in the participants’ urine over a 10-day period.

Underreporting of food consumption was rampant, even among those who were not obese. The obese subjects did underreport by a greater extent (1,200 calories per day) than did those who were not obese, who were off by only 800 calories, but the obese participants burned about 400 calories more each day than did the nonobese, so the difference was a wash.

Everyone ended up underreporting their calorie consumption by an average of about 900 calories, and the investigators were good enough to provide some food equivalents, tops on the list being three MacDonald’s cheeseburgers.

“Public health recommendations have historically relied heavily on self-reported energy intake values,” senior author Gavin Sandercock, PhD, said in a EurekAlert statement, and “recognising that the measures of energy intake are incorrect might result in the setting of more realistic targets.”

Maybe you can be more realistic with your patients, too. Go ahead and ask Mr. Smith about the burger sticking out of his coat pocket, because there are probably two more you can’t see. We’ve each got 900 calories hiding on us somewhere. Ours is usually pizza.
 

The art of the gallbladder

Ever thought you would see a portrait of a gallbladder hanging up in a gallery? Not just an artist’s rendition, but an actual photo from an actual patient? Well, you can at the Soloway Gallery in Brooklyn, N.Y., at least until June 12.

PxHere

The artist? K.C. Joseph, MD, a general surgeon from St. Marie, Pa., who died in 2015. His daughter Melissa is the curator of the show and told ARTnews about the interesting connection her father had with art and surgery.

In 2010, Dr. Joseph gave his daughter a box of photos and said “Make me a famous artist,” she recalled. At first, “I was like, ‘These are weird,’ and then I put them under my bed for 10 years.”

Apparently he had been making art with his patients’ organs for about 15 years and had a system in which he put each one together. Before a surgery Dr. Joseph would make a note card with the patient’s name handwritten in calligraphy with a couple of pages taken out of the magazine from the waiting room as the backdrop. Afterward, when the patient was in recovery, the removed organ would be placed among the pages and the name card. A photo was taken with the same endoscope that was used for the procedure.

After the show’s debut, people reached out expressing their love for their photos. “I wish, before he died, I had asked him more questions about it,” Ms. Joseph told ARTnews. “I’m regretting it so much now, kicking myself.”

Who gets to take home an artsy photo of their gallbladder after getting it removed? Not us, that’s who. Each collage is a one-of-a-kind piece. They definitely should be framed and shown in an art gallery. Oh, right. Never mind.

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Why it might be better to be a dog person

Here’s that old debate again: Dogs or cats? You probably have your own opinion, but research presented at this year’s Digestive Disease Week may have tipped the scale by showing that children who lived with dogs may be less likely to have Crohn’s disease as adults.

The research was done by having approximately 4,300 people closely related to patients with Crohn’s disease fill out an environmental questionnaire. Using these data, the research team looked into environmental factors such as size of the families, where the home was, how many bathrooms the homes had, and quality of drinking water.

Piqsels

The researchers found that those who had or were exposed to dogs between the ages of 5 and 15 years were more likely to have healthy gut permeability and balanced microbes, which increased their protection against Crohn’s disease.

“Our study seems to add to others that have explored the ‘hygiene hypothesis’ which suggests that the lack of exposure to microbes early in life may lead to lack of immune regulation toward environmental microbes,” senior author Williams Turpin, PhD, said in the written statement.

The researchers aren’t sure why they didn’t get the same findings with cats, but Dr. Turpin theorized that dog owners tend to be outside more with their dogs or live in places with more green space, which are good protectors against Crohn’s disease.

It’s all good for dog owners, but do their pets’ parasites make you more attractive? Just more fuel for the ongoing debate.
 

Come for the history, stay for the fossilized parasites

Another week, another analysis of old British poop. LOTME really is your one-stop shop for all the important, hard-hitting news about historic parasites. You’re welcome, Internet.

Lisa-Marie Shillito
Human coprolite from Durrington Walls

The news this week is from Stonehenge, which is apparently kind of a big deal. Rocks in a circle, celestial calendar, cultural significance, whatever. We’re not here to talk about rocks. We’re here to talk about, uh, rocks. Smaller rocks. Specifically, coprolites, which are essentially poop turned into a rock. (Though now we’re imagining Stonehenge made out of fossilized poop rocks. Would it still be a big tourist destination? We can see both sides of the argument on that one.)

Archaeologists from the University of Cambridge have conducted an analysis of coprolites from Durrington Walls, a Neolithic settlement just a few kilometers from Stonehenge. The town dates to the same time that Stonehenge was constructed, and it’s believed that the residents were responsible for building the landmark. These coprolites, depending on what’s inside, can tell us a lot about how the builders of Stonehenge lived and, more specifically, how they ate.

In this case, the coprolites of one human and three dogs contained capillariid worm eggs. These worms come from cows, and when a human is typically infected, the eggs embed in the liver and do not pass through the body. Finding them in excrement indicates that the people were eating raw cow organs and feeding leftovers to their dogs. This is interesting, because a preponderance of pottery and cooking implements also found at the site indicates that the residents of Durrington Walls were spit-roasting or boiling their beef and pork. So the meat was cooked, but not the organs. That is an interesting dietary decision, ancient British people. Then again, modern British cuisine exists. At least now we know where they got it from.

This new research raises one other very important question: When are we going to get a full-on guided tour of all the important coprolite sites in Britain? They’ve clearly got plenty of them, and the tourist demand for ancient parasites must be sky-high. Come on, capitalism, follow through on this. We’d go.
 

 

 

Everyone lies: Food intake edition

Do you have any patients on special diets? Do you ask them if they are following those diets? Don’t bother, because they’re lying. Everyone lies about the food they eat. Everyone. Obese people lie, and nonobese people lie.

Peter Timmerhues/Pixabay

Investigators at the University of Essex in England asked 221 adults to keep food diaries, and then they checked on energy consumption by analyzing radioactive water levels in the participants’ urine over a 10-day period.

Underreporting of food consumption was rampant, even among those who were not obese. The obese subjects did underreport by a greater extent (1,200 calories per day) than did those who were not obese, who were off by only 800 calories, but the obese participants burned about 400 calories more each day than did the nonobese, so the difference was a wash.

Everyone ended up underreporting their calorie consumption by an average of about 900 calories, and the investigators were good enough to provide some food equivalents, tops on the list being three MacDonald’s cheeseburgers.

“Public health recommendations have historically relied heavily on self-reported energy intake values,” senior author Gavin Sandercock, PhD, said in a EurekAlert statement, and “recognising that the measures of energy intake are incorrect might result in the setting of more realistic targets.”

Maybe you can be more realistic with your patients, too. Go ahead and ask Mr. Smith about the burger sticking out of his coat pocket, because there are probably two more you can’t see. We’ve each got 900 calories hiding on us somewhere. Ours is usually pizza.
 

The art of the gallbladder

Ever thought you would see a portrait of a gallbladder hanging up in a gallery? Not just an artist’s rendition, but an actual photo from an actual patient? Well, you can at the Soloway Gallery in Brooklyn, N.Y., at least until June 12.

PxHere

The artist? K.C. Joseph, MD, a general surgeon from St. Marie, Pa., who died in 2015. His daughter Melissa is the curator of the show and told ARTnews about the interesting connection her father had with art and surgery.

In 2010, Dr. Joseph gave his daughter a box of photos and said “Make me a famous artist,” she recalled. At first, “I was like, ‘These are weird,’ and then I put them under my bed for 10 years.”

Apparently he had been making art with his patients’ organs for about 15 years and had a system in which he put each one together. Before a surgery Dr. Joseph would make a note card with the patient’s name handwritten in calligraphy with a couple of pages taken out of the magazine from the waiting room as the backdrop. Afterward, when the patient was in recovery, the removed organ would be placed among the pages and the name card. A photo was taken with the same endoscope that was used for the procedure.

After the show’s debut, people reached out expressing their love for their photos. “I wish, before he died, I had asked him more questions about it,” Ms. Joseph told ARTnews. “I’m regretting it so much now, kicking myself.”

Who gets to take home an artsy photo of their gallbladder after getting it removed? Not us, that’s who. Each collage is a one-of-a-kind piece. They definitely should be framed and shown in an art gallery. Oh, right. Never mind.

 

Why it might be better to be a dog person

Here’s that old debate again: Dogs or cats? You probably have your own opinion, but research presented at this year’s Digestive Disease Week may have tipped the scale by showing that children who lived with dogs may be less likely to have Crohn’s disease as adults.

The research was done by having approximately 4,300 people closely related to patients with Crohn’s disease fill out an environmental questionnaire. Using these data, the research team looked into environmental factors such as size of the families, where the home was, how many bathrooms the homes had, and quality of drinking water.

Piqsels

The researchers found that those who had or were exposed to dogs between the ages of 5 and 15 years were more likely to have healthy gut permeability and balanced microbes, which increased their protection against Crohn’s disease.

“Our study seems to add to others that have explored the ‘hygiene hypothesis’ which suggests that the lack of exposure to microbes early in life may lead to lack of immune regulation toward environmental microbes,” senior author Williams Turpin, PhD, said in the written statement.

The researchers aren’t sure why they didn’t get the same findings with cats, but Dr. Turpin theorized that dog owners tend to be outside more with their dogs or live in places with more green space, which are good protectors against Crohn’s disease.

It’s all good for dog owners, but do their pets’ parasites make you more attractive? Just more fuel for the ongoing debate.
 

Come for the history, stay for the fossilized parasites

Another week, another analysis of old British poop. LOTME really is your one-stop shop for all the important, hard-hitting news about historic parasites. You’re welcome, Internet.

Lisa-Marie Shillito
Human coprolite from Durrington Walls

The news this week is from Stonehenge, which is apparently kind of a big deal. Rocks in a circle, celestial calendar, cultural significance, whatever. We’re not here to talk about rocks. We’re here to talk about, uh, rocks. Smaller rocks. Specifically, coprolites, which are essentially poop turned into a rock. (Though now we’re imagining Stonehenge made out of fossilized poop rocks. Would it still be a big tourist destination? We can see both sides of the argument on that one.)

Archaeologists from the University of Cambridge have conducted an analysis of coprolites from Durrington Walls, a Neolithic settlement just a few kilometers from Stonehenge. The town dates to the same time that Stonehenge was constructed, and it’s believed that the residents were responsible for building the landmark. These coprolites, depending on what’s inside, can tell us a lot about how the builders of Stonehenge lived and, more specifically, how they ate.

In this case, the coprolites of one human and three dogs contained capillariid worm eggs. These worms come from cows, and when a human is typically infected, the eggs embed in the liver and do not pass through the body. Finding them in excrement indicates that the people were eating raw cow organs and feeding leftovers to their dogs. This is interesting, because a preponderance of pottery and cooking implements also found at the site indicates that the residents of Durrington Walls were spit-roasting or boiling their beef and pork. So the meat was cooked, but not the organs. That is an interesting dietary decision, ancient British people. Then again, modern British cuisine exists. At least now we know where they got it from.

This new research raises one other very important question: When are we going to get a full-on guided tour of all the important coprolite sites in Britain? They’ve clearly got plenty of them, and the tourist demand for ancient parasites must be sky-high. Come on, capitalism, follow through on this. We’d go.
 

 

 

Everyone lies: Food intake edition

Do you have any patients on special diets? Do you ask them if they are following those diets? Don’t bother, because they’re lying. Everyone lies about the food they eat. Everyone. Obese people lie, and nonobese people lie.

Peter Timmerhues/Pixabay

Investigators at the University of Essex in England asked 221 adults to keep food diaries, and then they checked on energy consumption by analyzing radioactive water levels in the participants’ urine over a 10-day period.

Underreporting of food consumption was rampant, even among those who were not obese. The obese subjects did underreport by a greater extent (1,200 calories per day) than did those who were not obese, who were off by only 800 calories, but the obese participants burned about 400 calories more each day than did the nonobese, so the difference was a wash.

Everyone ended up underreporting their calorie consumption by an average of about 900 calories, and the investigators were good enough to provide some food equivalents, tops on the list being three MacDonald’s cheeseburgers.

“Public health recommendations have historically relied heavily on self-reported energy intake values,” senior author Gavin Sandercock, PhD, said in a EurekAlert statement, and “recognising that the measures of energy intake are incorrect might result in the setting of more realistic targets.”

Maybe you can be more realistic with your patients, too. Go ahead and ask Mr. Smith about the burger sticking out of his coat pocket, because there are probably two more you can’t see. We’ve each got 900 calories hiding on us somewhere. Ours is usually pizza.
 

The art of the gallbladder

Ever thought you would see a portrait of a gallbladder hanging up in a gallery? Not just an artist’s rendition, but an actual photo from an actual patient? Well, you can at the Soloway Gallery in Brooklyn, N.Y., at least until June 12.

PxHere

The artist? K.C. Joseph, MD, a general surgeon from St. Marie, Pa., who died in 2015. His daughter Melissa is the curator of the show and told ARTnews about the interesting connection her father had with art and surgery.

In 2010, Dr. Joseph gave his daughter a box of photos and said “Make me a famous artist,” she recalled. At first, “I was like, ‘These are weird,’ and then I put them under my bed for 10 years.”

Apparently he had been making art with his patients’ organs for about 15 years and had a system in which he put each one together. Before a surgery Dr. Joseph would make a note card with the patient’s name handwritten in calligraphy with a couple of pages taken out of the magazine from the waiting room as the backdrop. Afterward, when the patient was in recovery, the removed organ would be placed among the pages and the name card. A photo was taken with the same endoscope that was used for the procedure.

After the show’s debut, people reached out expressing their love for their photos. “I wish, before he died, I had asked him more questions about it,” Ms. Joseph told ARTnews. “I’m regretting it so much now, kicking myself.”

Who gets to take home an artsy photo of their gallbladder after getting it removed? Not us, that’s who. Each collage is a one-of-a-kind piece. They definitely should be framed and shown in an art gallery. Oh, right. Never mind.

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Metformin bombs in breast cancer in landmark trial

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Thu, 12/15/2022 - 17:21

 

In the largest investigation into the issue to date, metformin did not improve survival of patients with high-risk, operable breast cancer when added to standard adjuvant treatments.

Metformin, a common option for patients with type 2 diabetes, had previously been shown in observational studies to be associated with improved survival of cancer patients. Those studies mostly involved older patients with cancer who also had diabetes.

These findings have led to trials of the use of metformin for patients with cancer who do not have diabetes, but two lung cancer trials found no effect on survival.

Now this latest trial in breast cancer, which included 3,649 patients with hormone receptor–positive or –negative disease – who did not have diabetes – also found that metformin had no effect on survival.

These results “tell us that metformin is not effective against the most common types of breast cancer and any off-label use [of] this drug for the treatment of these common types of breast cancer should be stopped,” lead investigator and medical oncologist Pamela Goodwin, MD, a breast cancer researcher at the Lunenfeld-Tanenbaum Research Institute in Toronto, said in a press release.

The negative results “underscore the need for well-conducted randomized trials” before observational studies are put into practice, Dr. Goodwin and her team said.

However, the investigators cautioned against extrapolating their results to patients with diabetes, noting that “because metformin is effective in type 2 diabetes, the results ... should not affect the use of metformin” in breast cancer patients who have diabetes.

The study was published online in JAMA.

Patients were enrolled from 2010 to 2013 while undergoing adjuvant treatment – chemotherapy, radiotherapy, hormone therapy, and/or others – following complete resection of T1-3, N0-3 tumors. They were almost exclusively women (mean age, 52.4 years), and almost 90% were non-Hispanic White. They were primarily from the United States and Canada, with some patients from the United Kingdom and Switzerland.

Patients were randomly assigned equally to receive either metformin 850 mg twice daily or placebo for 5 years. Median follow-up was about 8 years.

Among 2,533 patients with estrogen receptor– and/or progesterone receptor–positive disease, the incidence of invasive disease–free survival events was 2.78 per 100 patient-years in the metformin group, vs. 2.74 per 100 patient-years in the placebo arm (hazard ratio [HR], 1.01, P = .93). There were 1.46 deaths per 100 patient-years with metformin, vs. 1.32 with placebo (HR, 1.10, P = .47).

Metformin was stopped early at about 3 years for the 1,116 hormone receptor–negative patients after futility was declared on interim analysis. The incidence of invasive disease–free survival events was 3.58 with metformin, vs. 3.60 with placebo per 100 patient-years (HR, 1.01, P = .92). There were 1.91 deaths per 100 patient-years in the metformin arm, vs. 2.15 in the group that received placebo (HR, 0.89, P = .46).

However, the findings were different and suggested a signal among the small subset of patients (17% of the total) who had HER2-positive disease. There were 1.93 disease-free survival events with metformin per 100 patient-years, vs. 3.05 events with placebo (HR, 0.64, P = .03), and 0.78 deaths in the metformin arm, vs. 1.43 deaths per 100 patient-years in the placebo arm (HR, 0.54, P = .04).

The benefit seen in this HER2-postive subgroup was limited to patients with any C allele of the rs11212617 single-nucleotide variant.

This was an exploratory analysis, so the results need to be confirmed in a randomized trial, but it’s possible that metformin “could provide an additional treatment option for HER2-positive breast cancer,” Dr. Goodwin said.

Grade 3 or higher adverse events were more common with metformin (21.5% vs. 17.5%). The most common such events were hypertension (2.4% vs. 1.9%), irregular menses (1.5% vs. 1.4%), and diarrhea (1.9% vs. 0.8%).

The study was conducted by the Canadian Cancer Trials Group and was funded by the Canadian Cancer Society, the National Cancer Institute, and others. Dr. Goodwin has disclosed no relevant financial relationships. Several coauthors reported ties to Pfizer, Eli Lilly, Roche, and a number of other companies. One coauthor is an AstraZeneca employee.

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

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In the largest investigation into the issue to date, metformin did not improve survival of patients with high-risk, operable breast cancer when added to standard adjuvant treatments.

Metformin, a common option for patients with type 2 diabetes, had previously been shown in observational studies to be associated with improved survival of cancer patients. Those studies mostly involved older patients with cancer who also had diabetes.

These findings have led to trials of the use of metformin for patients with cancer who do not have diabetes, but two lung cancer trials found no effect on survival.

Now this latest trial in breast cancer, which included 3,649 patients with hormone receptor–positive or –negative disease – who did not have diabetes – also found that metformin had no effect on survival.

These results “tell us that metformin is not effective against the most common types of breast cancer and any off-label use [of] this drug for the treatment of these common types of breast cancer should be stopped,” lead investigator and medical oncologist Pamela Goodwin, MD, a breast cancer researcher at the Lunenfeld-Tanenbaum Research Institute in Toronto, said in a press release.

The negative results “underscore the need for well-conducted randomized trials” before observational studies are put into practice, Dr. Goodwin and her team said.

However, the investigators cautioned against extrapolating their results to patients with diabetes, noting that “because metformin is effective in type 2 diabetes, the results ... should not affect the use of metformin” in breast cancer patients who have diabetes.

The study was published online in JAMA.

Patients were enrolled from 2010 to 2013 while undergoing adjuvant treatment – chemotherapy, radiotherapy, hormone therapy, and/or others – following complete resection of T1-3, N0-3 tumors. They were almost exclusively women (mean age, 52.4 years), and almost 90% were non-Hispanic White. They were primarily from the United States and Canada, with some patients from the United Kingdom and Switzerland.

Patients were randomly assigned equally to receive either metformin 850 mg twice daily or placebo for 5 years. Median follow-up was about 8 years.

Among 2,533 patients with estrogen receptor– and/or progesterone receptor–positive disease, the incidence of invasive disease–free survival events was 2.78 per 100 patient-years in the metformin group, vs. 2.74 per 100 patient-years in the placebo arm (hazard ratio [HR], 1.01, P = .93). There were 1.46 deaths per 100 patient-years with metformin, vs. 1.32 with placebo (HR, 1.10, P = .47).

Metformin was stopped early at about 3 years for the 1,116 hormone receptor–negative patients after futility was declared on interim analysis. The incidence of invasive disease–free survival events was 3.58 with metformin, vs. 3.60 with placebo per 100 patient-years (HR, 1.01, P = .92). There were 1.91 deaths per 100 patient-years in the metformin arm, vs. 2.15 in the group that received placebo (HR, 0.89, P = .46).

However, the findings were different and suggested a signal among the small subset of patients (17% of the total) who had HER2-positive disease. There were 1.93 disease-free survival events with metformin per 100 patient-years, vs. 3.05 events with placebo (HR, 0.64, P = .03), and 0.78 deaths in the metformin arm, vs. 1.43 deaths per 100 patient-years in the placebo arm (HR, 0.54, P = .04).

The benefit seen in this HER2-postive subgroup was limited to patients with any C allele of the rs11212617 single-nucleotide variant.

This was an exploratory analysis, so the results need to be confirmed in a randomized trial, but it’s possible that metformin “could provide an additional treatment option for HER2-positive breast cancer,” Dr. Goodwin said.

Grade 3 or higher adverse events were more common with metformin (21.5% vs. 17.5%). The most common such events were hypertension (2.4% vs. 1.9%), irregular menses (1.5% vs. 1.4%), and diarrhea (1.9% vs. 0.8%).

The study was conducted by the Canadian Cancer Trials Group and was funded by the Canadian Cancer Society, the National Cancer Institute, and others. Dr. Goodwin has disclosed no relevant financial relationships. Several coauthors reported ties to Pfizer, Eli Lilly, Roche, and a number of other companies. One coauthor is an AstraZeneca employee.

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

 

In the largest investigation into the issue to date, metformin did not improve survival of patients with high-risk, operable breast cancer when added to standard adjuvant treatments.

Metformin, a common option for patients with type 2 diabetes, had previously been shown in observational studies to be associated with improved survival of cancer patients. Those studies mostly involved older patients with cancer who also had diabetes.

These findings have led to trials of the use of metformin for patients with cancer who do not have diabetes, but two lung cancer trials found no effect on survival.

Now this latest trial in breast cancer, which included 3,649 patients with hormone receptor–positive or –negative disease – who did not have diabetes – also found that metformin had no effect on survival.

These results “tell us that metformin is not effective against the most common types of breast cancer and any off-label use [of] this drug for the treatment of these common types of breast cancer should be stopped,” lead investigator and medical oncologist Pamela Goodwin, MD, a breast cancer researcher at the Lunenfeld-Tanenbaum Research Institute in Toronto, said in a press release.

The negative results “underscore the need for well-conducted randomized trials” before observational studies are put into practice, Dr. Goodwin and her team said.

However, the investigators cautioned against extrapolating their results to patients with diabetes, noting that “because metformin is effective in type 2 diabetes, the results ... should not affect the use of metformin” in breast cancer patients who have diabetes.

The study was published online in JAMA.

Patients were enrolled from 2010 to 2013 while undergoing adjuvant treatment – chemotherapy, radiotherapy, hormone therapy, and/or others – following complete resection of T1-3, N0-3 tumors. They were almost exclusively women (mean age, 52.4 years), and almost 90% were non-Hispanic White. They were primarily from the United States and Canada, with some patients from the United Kingdom and Switzerland.

Patients were randomly assigned equally to receive either metformin 850 mg twice daily or placebo for 5 years. Median follow-up was about 8 years.

Among 2,533 patients with estrogen receptor– and/or progesterone receptor–positive disease, the incidence of invasive disease–free survival events was 2.78 per 100 patient-years in the metformin group, vs. 2.74 per 100 patient-years in the placebo arm (hazard ratio [HR], 1.01, P = .93). There were 1.46 deaths per 100 patient-years with metformin, vs. 1.32 with placebo (HR, 1.10, P = .47).

Metformin was stopped early at about 3 years for the 1,116 hormone receptor–negative patients after futility was declared on interim analysis. The incidence of invasive disease–free survival events was 3.58 with metformin, vs. 3.60 with placebo per 100 patient-years (HR, 1.01, P = .92). There were 1.91 deaths per 100 patient-years in the metformin arm, vs. 2.15 in the group that received placebo (HR, 0.89, P = .46).

However, the findings were different and suggested a signal among the small subset of patients (17% of the total) who had HER2-positive disease. There were 1.93 disease-free survival events with metformin per 100 patient-years, vs. 3.05 events with placebo (HR, 0.64, P = .03), and 0.78 deaths in the metformin arm, vs. 1.43 deaths per 100 patient-years in the placebo arm (HR, 0.54, P = .04).

The benefit seen in this HER2-postive subgroup was limited to patients with any C allele of the rs11212617 single-nucleotide variant.

This was an exploratory analysis, so the results need to be confirmed in a randomized trial, but it’s possible that metformin “could provide an additional treatment option for HER2-positive breast cancer,” Dr. Goodwin said.

Grade 3 or higher adverse events were more common with metformin (21.5% vs. 17.5%). The most common such events were hypertension (2.4% vs. 1.9%), irregular menses (1.5% vs. 1.4%), and diarrhea (1.9% vs. 0.8%).

The study was conducted by the Canadian Cancer Trials Group and was funded by the Canadian Cancer Society, the National Cancer Institute, and others. Dr. Goodwin has disclosed no relevant financial relationships. Several coauthors reported ties to Pfizer, Eli Lilly, Roche, and a number of other companies. One coauthor is an AstraZeneca employee.

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

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Births jump for first time since 2014

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Wed, 05/25/2022 - 10:41

More than 3 million live births occurred in the United States in 2021, the largest increase in the nation’s birth rate since 2014, according to the U.S. Centers for Disease Control and Prevention.

Provisional data showed a 1% uptick in births, to 3.66 million, after 6 years of dropping by approximately 2% per year. The gains were concentrated among birthing people ages 25 and older. Teenage births, on the other hand, are at their lowest level since the 1990s, according to the CDC. The agency reported a record 6% decrease in births for teenagers aged 15 to 19 years between 2020 and 2021. Women ages 20 to 25 years also had a record decrease in births of 4% during that period.

Brady E. Hamilton, PhD, of the CDC’s National Center for Health Statistics, and the lead author of the new report, said the rise in births points to childbearing that was postponed during the pandemic. Data from 2021 showed a 4% drop in the nation’s birth rate between 2019 and 2020.

“The option to forgo birth is not always viable for older women, but you saw a lot of that during the pandemic,” Dr. Hamilton said. “Events happened related to job security and the economy that caused people to wait to have a child.”

Dr. Hamilton said more data are needed to determine the full impact of increased overall birth rates on individuals. The final report, which will be released in July, will delve deeper into the influence increased birth rates had on demographics and preterm births, which Dr. Hamilton and his team found have increased by 4%.

“For those beginning to have children, we see these trends, but it will be interesting to see what happens to younger women in the future,” Dr. Hamilton said. “Once we have the final data for 2021, we will be able to see a more detailed pattern emerge and draw conclusions from that.”

Dr. Hamilton has disclosed no relevant financial relationships.

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

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More than 3 million live births occurred in the United States in 2021, the largest increase in the nation’s birth rate since 2014, according to the U.S. Centers for Disease Control and Prevention.

Provisional data showed a 1% uptick in births, to 3.66 million, after 6 years of dropping by approximately 2% per year. The gains were concentrated among birthing people ages 25 and older. Teenage births, on the other hand, are at their lowest level since the 1990s, according to the CDC. The agency reported a record 6% decrease in births for teenagers aged 15 to 19 years between 2020 and 2021. Women ages 20 to 25 years also had a record decrease in births of 4% during that period.

Brady E. Hamilton, PhD, of the CDC’s National Center for Health Statistics, and the lead author of the new report, said the rise in births points to childbearing that was postponed during the pandemic. Data from 2021 showed a 4% drop in the nation’s birth rate between 2019 and 2020.

“The option to forgo birth is not always viable for older women, but you saw a lot of that during the pandemic,” Dr. Hamilton said. “Events happened related to job security and the economy that caused people to wait to have a child.”

Dr. Hamilton said more data are needed to determine the full impact of increased overall birth rates on individuals. The final report, which will be released in July, will delve deeper into the influence increased birth rates had on demographics and preterm births, which Dr. Hamilton and his team found have increased by 4%.

“For those beginning to have children, we see these trends, but it will be interesting to see what happens to younger women in the future,” Dr. Hamilton said. “Once we have the final data for 2021, we will be able to see a more detailed pattern emerge and draw conclusions from that.”

Dr. Hamilton has disclosed no relevant financial relationships.

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

More than 3 million live births occurred in the United States in 2021, the largest increase in the nation’s birth rate since 2014, according to the U.S. Centers for Disease Control and Prevention.

Provisional data showed a 1% uptick in births, to 3.66 million, after 6 years of dropping by approximately 2% per year. The gains were concentrated among birthing people ages 25 and older. Teenage births, on the other hand, are at their lowest level since the 1990s, according to the CDC. The agency reported a record 6% decrease in births for teenagers aged 15 to 19 years between 2020 and 2021. Women ages 20 to 25 years also had a record decrease in births of 4% during that period.

Brady E. Hamilton, PhD, of the CDC’s National Center for Health Statistics, and the lead author of the new report, said the rise in births points to childbearing that was postponed during the pandemic. Data from 2021 showed a 4% drop in the nation’s birth rate between 2019 and 2020.

“The option to forgo birth is not always viable for older women, but you saw a lot of that during the pandemic,” Dr. Hamilton said. “Events happened related to job security and the economy that caused people to wait to have a child.”

Dr. Hamilton said more data are needed to determine the full impact of increased overall birth rates on individuals. The final report, which will be released in July, will delve deeper into the influence increased birth rates had on demographics and preterm births, which Dr. Hamilton and his team found have increased by 4%.

“For those beginning to have children, we see these trends, but it will be interesting to see what happens to younger women in the future,” Dr. Hamilton said. “Once we have the final data for 2021, we will be able to see a more detailed pattern emerge and draw conclusions from that.”

Dr. Hamilton has disclosed no relevant financial relationships.

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

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Müllerian anomalies – old problem, new approach and classification

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Wed, 05/25/2022 - 09:01

The American Society for Reproductive Medicine’s classification system for müllerian anomalies was the standard until the revision in 2021 by ASRM, which updated and expanded the classification presenting nine classes and imaging criteria: müllerian agenesis, cervical agenesis, unicornuate, uterus didelphys, bicornuate, septate, longitudinal vaginal septum, transverse vaginal septum, and complex anomalies. This month’s article addresses müllerian anomalies from embryology to treatment options.

The early embryo has the capability of developing a wolffian (internal male) or müllerian (internal female) system. Unless anti-müllerian hormone (formerly müllerian-inhibiting substance) is produced, the embryo develops a female reproductive system beginning with two lateral uterine anlagen that fuse in the midline and canalize. Müllerian anomalies occur because of accidents during fusion and canalization (see Table).

Dr. Mark P. Trolice

The incidence of müllerian anomalies is difficult to discern, given the potential for a normal reproductive outcome precluding an evaluation and based on the population studied. Müllerian anomalies are found in approximately 4.3% of fertile women, 3.5%-8% of infertile patients, 12.3%-13% of those with recurrent pregnancy losses, and 24.5% of patients with miscarriage and infertility. Of the müllerian anomalies, the most common is septate (35%), followed by bicornuate (26%), arcuate (18%), unicornuate (10%), didelphys (8%), and agenesis (3%) (Hum Reprod Update. 2001;7[2]:161; Hum Reprod Update. 2011;17[6]:761-71).

In 20%-30% of patients with müllerian anomalies, particularly in women with a unicornuate uterus, renal anomalies exist that are typically ipsilateral to the absent or rudimentary contralateral uterine horn (J Pediatr Adolesc Gynecol. 2021;34[2]:154-60). As there is no definitive evidence to suggest an association between a septate uterus and renal anomalies, the renal system evaluation can be deferred in this population (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Diagnosis

2-D ultrasound can be a screen for müllerian anomalies and genitourinary anatomic variants. The diagnostic accuracy of 3-D ultrasound with müllerian anomalies is reported to be 97.6% with sensitivity and specificity of 98.3% and 99.4%, respectively (Hum. Reprod. 2016;31[1]:2-7). As a result, office 3-D has essentially replaced MRI in the diagnosis of müllerian anomalies (Ultrasound Obstet Gynecol. 2015 Nov;46[5]:616-22), with one exception because of the avoidance of a transvaginal probe in the non–sexually active adult and younger adolescent/child. MRI is reserved for diagnosing complex müllerian anomalies or if there is a diagnostic challenge.

Criteria to diagnose müllerian anomalies by radiology begins with the “reference line,” i.e., a line joining both tubal ostia (interostial line). A septate uterus is diagnosed if the distance from the interostial line to the cephalad endometrium is more than 1 cm, otherwise it is considered normal or arcuate based on its appearance. An arcuate uterus has not been associated with impaired reproduction and can be viewed as a normal variant. Alternatively, a bicornuate uterus is diagnosed when the external fundal indentation is more than 1 cm (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Clinical course

Women with müllerian anomalies may experience pelvic pain and prolonged and/or abnormal bleeding at the time of menarche. While the ability to conceive may not be impaired from müllerian anomalies with the possible exception of the septate uterus, the pregnancy course can be affected, i.e., recurrent pregnancy loss, preterm birth, perinatal mortality, and malpresentation in labor (Reprod Biomed Online. 2014;29[6]:665). In women with septate, bicornuate, and uterine didelphys, fetal growth restriction appears to be increased. Spontaneous abortion rates of 32% and preterm birth rates of 28% have been reported in patients with uterus didelphys (Obstet Gynecol. 1990;75[6]:906).

Special consideration of the unicornuate is given because of the potential for a rudimentary horn that may communicate with the main uterine cavity and/or have functional endometrium which places the woman at risk of an ectopic pregnancy in the smaller horn. Patients with a unicornuate uterus are at higher risk for preterm labor and breech presentation. An obstructed (noncommunicating) functional rudimentary horn is a risk for endometriosis with cyclic pain because of outflow tract obstruction and an ectopic pregnancy prompting consideration for hemihysterectomy based on symptoms.
 

The septate uterus – old dogma revisited

The incidence of uterine septa is approximately 1-15 per 1,000. As the most common müllerian anomaly, the septate uterus has traditionally been associated with an increased risk for spontaneous abortion (21%-44%) and preterm birth (12%-33%). The live birth rate ranges from 50% to 72% (Hum Reprod Update. 2001;7[2]:161-74). A uterine septum is believed to develop as a result of failure of resorption of the tissue connecting the two paramesonephric (müllerian) ducts prior to the 20th embryonic week.

Incising the uterine septum (metroplasty) dates back to 1884 when Ruge described a blind transcervical metroplasty in a woman with two previous miscarriages who, postoperatively, delivered a healthy baby. In the early 1900s, Tompkins reported an abdominal metroplasty (Fertil Stertil. 2021;115:1140-2). The decision to proceed with metroplasty is based on only established observational studies (Fertil Steril. 2016;106:530-40). Until recently, the majority of studies suggested that metroplasty is associated with decreased spontaneous abortion rates and improved obstetrical outcomes. A retrospective case series of 361 patients with a septate uterus who had primary infertility of >2 years’ duration, a history of 1-2 spontaneous abortions, or recurrent pregnancy loss suggested a significant improvement in the live birth rate and reduction in miscarriage (Arch Gynecol Obstet. 2003;268:289-92). A meta-analysis found that the overall pregnancy rate after septum incision was 67.8% and the live-birth rate was 53.5% (J Minim Invas Gynecol. 2013;20:22-42).

Recently, two multinational studies question the prevailing dogma (Fertil Steril. 2021 Sep;116[3]:693-4). Both studies could not demonstrate any increase in live birth rate, reduction in preterm birth, or in pregnancy loss after metroplasty. A significant limitation was the lack of a uniform consensus on the definition of the septate uterus and allowing the discretion of the physician to diagnosis a septum (Hum Reprod. 2020;35:1578-88; Hum Reprod. 2021;36:1260-7).

Hysteroscopic metroplasty is not without complications. Uterine rupture during pregnancy or delivery, while rare, may be linked to significant entry into the myometrium and/or overzealous cauterization and perforation, which emphasizes the importance of appropriate techniques.
 

Conclusion

A diagnosis of müllerian anomalies justifies a comprehensive consultation with the patient given the risk of pregnancy complications. Management of the septate uterus has become controversial. In a patient with infertility, prior pregnancy loss, or poor obstetrical outcome, it is reasonable to consider metroplasty; otherwise, expectant management is an option.




 

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. Email him at [email protected].

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The American Society for Reproductive Medicine’s classification system for müllerian anomalies was the standard until the revision in 2021 by ASRM, which updated and expanded the classification presenting nine classes and imaging criteria: müllerian agenesis, cervical agenesis, unicornuate, uterus didelphys, bicornuate, septate, longitudinal vaginal septum, transverse vaginal septum, and complex anomalies. This month’s article addresses müllerian anomalies from embryology to treatment options.

The early embryo has the capability of developing a wolffian (internal male) or müllerian (internal female) system. Unless anti-müllerian hormone (formerly müllerian-inhibiting substance) is produced, the embryo develops a female reproductive system beginning with two lateral uterine anlagen that fuse in the midline and canalize. Müllerian anomalies occur because of accidents during fusion and canalization (see Table).

Dr. Mark P. Trolice

The incidence of müllerian anomalies is difficult to discern, given the potential for a normal reproductive outcome precluding an evaluation and based on the population studied. Müllerian anomalies are found in approximately 4.3% of fertile women, 3.5%-8% of infertile patients, 12.3%-13% of those with recurrent pregnancy losses, and 24.5% of patients with miscarriage and infertility. Of the müllerian anomalies, the most common is septate (35%), followed by bicornuate (26%), arcuate (18%), unicornuate (10%), didelphys (8%), and agenesis (3%) (Hum Reprod Update. 2001;7[2]:161; Hum Reprod Update. 2011;17[6]:761-71).

In 20%-30% of patients with müllerian anomalies, particularly in women with a unicornuate uterus, renal anomalies exist that are typically ipsilateral to the absent or rudimentary contralateral uterine horn (J Pediatr Adolesc Gynecol. 2021;34[2]:154-60). As there is no definitive evidence to suggest an association between a septate uterus and renal anomalies, the renal system evaluation can be deferred in this population (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Diagnosis

2-D ultrasound can be a screen for müllerian anomalies and genitourinary anatomic variants. The diagnostic accuracy of 3-D ultrasound with müllerian anomalies is reported to be 97.6% with sensitivity and specificity of 98.3% and 99.4%, respectively (Hum. Reprod. 2016;31[1]:2-7). As a result, office 3-D has essentially replaced MRI in the diagnosis of müllerian anomalies (Ultrasound Obstet Gynecol. 2015 Nov;46[5]:616-22), with one exception because of the avoidance of a transvaginal probe in the non–sexually active adult and younger adolescent/child. MRI is reserved for diagnosing complex müllerian anomalies or if there is a diagnostic challenge.

Criteria to diagnose müllerian anomalies by radiology begins with the “reference line,” i.e., a line joining both tubal ostia (interostial line). A septate uterus is diagnosed if the distance from the interostial line to the cephalad endometrium is more than 1 cm, otherwise it is considered normal or arcuate based on its appearance. An arcuate uterus has not been associated with impaired reproduction and can be viewed as a normal variant. Alternatively, a bicornuate uterus is diagnosed when the external fundal indentation is more than 1 cm (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Clinical course

Women with müllerian anomalies may experience pelvic pain and prolonged and/or abnormal bleeding at the time of menarche. While the ability to conceive may not be impaired from müllerian anomalies with the possible exception of the septate uterus, the pregnancy course can be affected, i.e., recurrent pregnancy loss, preterm birth, perinatal mortality, and malpresentation in labor (Reprod Biomed Online. 2014;29[6]:665). In women with septate, bicornuate, and uterine didelphys, fetal growth restriction appears to be increased. Spontaneous abortion rates of 32% and preterm birth rates of 28% have been reported in patients with uterus didelphys (Obstet Gynecol. 1990;75[6]:906).

Special consideration of the unicornuate is given because of the potential for a rudimentary horn that may communicate with the main uterine cavity and/or have functional endometrium which places the woman at risk of an ectopic pregnancy in the smaller horn. Patients with a unicornuate uterus are at higher risk for preterm labor and breech presentation. An obstructed (noncommunicating) functional rudimentary horn is a risk for endometriosis with cyclic pain because of outflow tract obstruction and an ectopic pregnancy prompting consideration for hemihysterectomy based on symptoms.
 

The septate uterus – old dogma revisited

The incidence of uterine septa is approximately 1-15 per 1,000. As the most common müllerian anomaly, the septate uterus has traditionally been associated with an increased risk for spontaneous abortion (21%-44%) and preterm birth (12%-33%). The live birth rate ranges from 50% to 72% (Hum Reprod Update. 2001;7[2]:161-74). A uterine septum is believed to develop as a result of failure of resorption of the tissue connecting the two paramesonephric (müllerian) ducts prior to the 20th embryonic week.

Incising the uterine septum (metroplasty) dates back to 1884 when Ruge described a blind transcervical metroplasty in a woman with two previous miscarriages who, postoperatively, delivered a healthy baby. In the early 1900s, Tompkins reported an abdominal metroplasty (Fertil Stertil. 2021;115:1140-2). The decision to proceed with metroplasty is based on only established observational studies (Fertil Steril. 2016;106:530-40). Until recently, the majority of studies suggested that metroplasty is associated with decreased spontaneous abortion rates and improved obstetrical outcomes. A retrospective case series of 361 patients with a septate uterus who had primary infertility of >2 years’ duration, a history of 1-2 spontaneous abortions, or recurrent pregnancy loss suggested a significant improvement in the live birth rate and reduction in miscarriage (Arch Gynecol Obstet. 2003;268:289-92). A meta-analysis found that the overall pregnancy rate after septum incision was 67.8% and the live-birth rate was 53.5% (J Minim Invas Gynecol. 2013;20:22-42).

Recently, two multinational studies question the prevailing dogma (Fertil Steril. 2021 Sep;116[3]:693-4). Both studies could not demonstrate any increase in live birth rate, reduction in preterm birth, or in pregnancy loss after metroplasty. A significant limitation was the lack of a uniform consensus on the definition of the septate uterus and allowing the discretion of the physician to diagnosis a septum (Hum Reprod. 2020;35:1578-88; Hum Reprod. 2021;36:1260-7).

Hysteroscopic metroplasty is not without complications. Uterine rupture during pregnancy or delivery, while rare, may be linked to significant entry into the myometrium and/or overzealous cauterization and perforation, which emphasizes the importance of appropriate techniques.
 

Conclusion

A diagnosis of müllerian anomalies justifies a comprehensive consultation with the patient given the risk of pregnancy complications. Management of the septate uterus has become controversial. In a patient with infertility, prior pregnancy loss, or poor obstetrical outcome, it is reasonable to consider metroplasty; otherwise, expectant management is an option.




 

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. Email him at [email protected].

The American Society for Reproductive Medicine’s classification system for müllerian anomalies was the standard until the revision in 2021 by ASRM, which updated and expanded the classification presenting nine classes and imaging criteria: müllerian agenesis, cervical agenesis, unicornuate, uterus didelphys, bicornuate, septate, longitudinal vaginal septum, transverse vaginal septum, and complex anomalies. This month’s article addresses müllerian anomalies from embryology to treatment options.

The early embryo has the capability of developing a wolffian (internal male) or müllerian (internal female) system. Unless anti-müllerian hormone (formerly müllerian-inhibiting substance) is produced, the embryo develops a female reproductive system beginning with two lateral uterine anlagen that fuse in the midline and canalize. Müllerian anomalies occur because of accidents during fusion and canalization (see Table).

Dr. Mark P. Trolice

The incidence of müllerian anomalies is difficult to discern, given the potential for a normal reproductive outcome precluding an evaluation and based on the population studied. Müllerian anomalies are found in approximately 4.3% of fertile women, 3.5%-8% of infertile patients, 12.3%-13% of those with recurrent pregnancy losses, and 24.5% of patients with miscarriage and infertility. Of the müllerian anomalies, the most common is septate (35%), followed by bicornuate (26%), arcuate (18%), unicornuate (10%), didelphys (8%), and agenesis (3%) (Hum Reprod Update. 2001;7[2]:161; Hum Reprod Update. 2011;17[6]:761-71).

In 20%-30% of patients with müllerian anomalies, particularly in women with a unicornuate uterus, renal anomalies exist that are typically ipsilateral to the absent or rudimentary contralateral uterine horn (J Pediatr Adolesc Gynecol. 2021;34[2]:154-60). As there is no definitive evidence to suggest an association between a septate uterus and renal anomalies, the renal system evaluation can be deferred in this population (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Diagnosis

2-D ultrasound can be a screen for müllerian anomalies and genitourinary anatomic variants. The diagnostic accuracy of 3-D ultrasound with müllerian anomalies is reported to be 97.6% with sensitivity and specificity of 98.3% and 99.4%, respectively (Hum. Reprod. 2016;31[1]:2-7). As a result, office 3-D has essentially replaced MRI in the diagnosis of müllerian anomalies (Ultrasound Obstet Gynecol. 2015 Nov;46[5]:616-22), with one exception because of the avoidance of a transvaginal probe in the non–sexually active adult and younger adolescent/child. MRI is reserved for diagnosing complex müllerian anomalies or if there is a diagnostic challenge.

Criteria to diagnose müllerian anomalies by radiology begins with the “reference line,” i.e., a line joining both tubal ostia (interostial line). A septate uterus is diagnosed if the distance from the interostial line to the cephalad endometrium is more than 1 cm, otherwise it is considered normal or arcuate based on its appearance. An arcuate uterus has not been associated with impaired reproduction and can be viewed as a normal variant. Alternatively, a bicornuate uterus is diagnosed when the external fundal indentation is more than 1 cm (Fertil Steril. 2021 Nov;116[5]:1238-52).
 

Clinical course

Women with müllerian anomalies may experience pelvic pain and prolonged and/or abnormal bleeding at the time of menarche. While the ability to conceive may not be impaired from müllerian anomalies with the possible exception of the septate uterus, the pregnancy course can be affected, i.e., recurrent pregnancy loss, preterm birth, perinatal mortality, and malpresentation in labor (Reprod Biomed Online. 2014;29[6]:665). In women with septate, bicornuate, and uterine didelphys, fetal growth restriction appears to be increased. Spontaneous abortion rates of 32% and preterm birth rates of 28% have been reported in patients with uterus didelphys (Obstet Gynecol. 1990;75[6]:906).

Special consideration of the unicornuate is given because of the potential for a rudimentary horn that may communicate with the main uterine cavity and/or have functional endometrium which places the woman at risk of an ectopic pregnancy in the smaller horn. Patients with a unicornuate uterus are at higher risk for preterm labor and breech presentation. An obstructed (noncommunicating) functional rudimentary horn is a risk for endometriosis with cyclic pain because of outflow tract obstruction and an ectopic pregnancy prompting consideration for hemihysterectomy based on symptoms.
 

The septate uterus – old dogma revisited

The incidence of uterine septa is approximately 1-15 per 1,000. As the most common müllerian anomaly, the septate uterus has traditionally been associated with an increased risk for spontaneous abortion (21%-44%) and preterm birth (12%-33%). The live birth rate ranges from 50% to 72% (Hum Reprod Update. 2001;7[2]:161-74). A uterine septum is believed to develop as a result of failure of resorption of the tissue connecting the two paramesonephric (müllerian) ducts prior to the 20th embryonic week.

Incising the uterine septum (metroplasty) dates back to 1884 when Ruge described a blind transcervical metroplasty in a woman with two previous miscarriages who, postoperatively, delivered a healthy baby. In the early 1900s, Tompkins reported an abdominal metroplasty (Fertil Stertil. 2021;115:1140-2). The decision to proceed with metroplasty is based on only established observational studies (Fertil Steril. 2016;106:530-40). Until recently, the majority of studies suggested that metroplasty is associated with decreased spontaneous abortion rates and improved obstetrical outcomes. A retrospective case series of 361 patients with a septate uterus who had primary infertility of >2 years’ duration, a history of 1-2 spontaneous abortions, or recurrent pregnancy loss suggested a significant improvement in the live birth rate and reduction in miscarriage (Arch Gynecol Obstet. 2003;268:289-92). A meta-analysis found that the overall pregnancy rate after septum incision was 67.8% and the live-birth rate was 53.5% (J Minim Invas Gynecol. 2013;20:22-42).

Recently, two multinational studies question the prevailing dogma (Fertil Steril. 2021 Sep;116[3]:693-4). Both studies could not demonstrate any increase in live birth rate, reduction in preterm birth, or in pregnancy loss after metroplasty. A significant limitation was the lack of a uniform consensus on the definition of the septate uterus and allowing the discretion of the physician to diagnosis a septum (Hum Reprod. 2020;35:1578-88; Hum Reprod. 2021;36:1260-7).

Hysteroscopic metroplasty is not without complications. Uterine rupture during pregnancy or delivery, while rare, may be linked to significant entry into the myometrium and/or overzealous cauterization and perforation, which emphasizes the importance of appropriate techniques.
 

Conclusion

A diagnosis of müllerian anomalies justifies a comprehensive consultation with the patient given the risk of pregnancy complications. Management of the septate uterus has become controversial. In a patient with infertility, prior pregnancy loss, or poor obstetrical outcome, it is reasonable to consider metroplasty; otherwise, expectant management is an option.




 

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. Email him at [email protected].

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New tool may identify pregnant women with eating disorders

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Tue, 05/24/2022 - 12:11

A newly developed screening tool may help clinicians identify pregnant women with eating disorders.

The 12-question instrument is intended to be a quick way to help clinicians identify women who may need to be referred to a mental health expert for further evaluation, according to the researchers, who reported on the instrument in a study published in Archives of Women’s Mental Health.

“It would be most appropriate for clinical encounters so that women can get screened and referred,” said Elizabeth Claydon, MD, assistant professor in the department of social and behavioral sciences at West Virginia University’s School of Public Health, Morgantown, who led the study. “If you miss it, they may carry on their eating disorder throughout their pregnancy.”

Pregnant women who have an eating disorder are at increased risk for gestational diabetes, premature birth, labor complications, difficulties nursing, and postpartum depression, according to the National Eating Disorders Association. Their babies are at increased risk for premature birth, low birth weight, and poor development. However, clinicians have not had an accurate way of screening pregnant women who may have an eating disorder.

The American College of Obstetricians and Gynecologists offered its first clinical guidelines for managing anorexia in pregnancy in April 2022. The group’s recommendations include regular monitoring of cardiac and liver function, blood pressure, and heart rate, as well as tests to monitor iron, sodium, potassium, bone density, and blood sugar levels. Anorexia, bulimia, binge eating, and subthreshold disorders – also known as other specified feeding or eating disorders – are among the most common eating disorders among pregnant women.

There are no recent data on the incidence or prevalence of eating disorders among pregnant women, according to Lauren Smolar, vice president of mission and education at the National Eating Disorders Association.

“It’s hard to capture the number of pregnant women affected, since it so often goes undetected,” Ms. Smolar said.

Existing screening tools for eating disorders ask patients whether they’re currently pregnant; a questionnaire specifically tailored to pregnant women may help to better gather data on the prevalence within this group, Ms. Smolar said.

For the new study, Dr. Claydon and her colleagues tested the questionnaire among more than 400 mostly White women aged 25-34 years. They found that it could reliably identify women who may have an eating disorder. The questionnaire was validated for women to take during any trimester, according to the findings.

A score of 39 or above would serve as an indicator for follow-up. Women who score at least 39 were up to 16 times more likely to receive a diagnosis of an eating disorder, compared with women who scored less, the researchers found.
 

Eating disorders often escape the eye

Researchers developed the tool to screen all women, rather than just patients who present with recognizable symptoms, according to Dr. Claydon.

“Some people may relapse during pregnancy, some may develop [a disorder] while pregnant,” she said. “This makes sure there are no assumptions, because sometimes you can’t tell someone has an eating disorder just by looking at them.”

The researchers also worked to eliminate stigmatizing language to reduce the possibility of women withholding information about their symptoms.

The tool was developed following a qualitative study by Dr. Claydon and her colleagues that was published in 2018. In that study, the researchers analyzed self-perceptions and self-reported experiences of women going through pregnancy with an eating disorder.

“I heard a lot about how difficult it was to disclose eating disorders during pregnancy,” Dr. Claydon said. “It’s wonderful to do something applied to these findings. It’s very meaningful and personal work to me.”

Dr. Claydon said she and her colleagues now plan to test the tool by introducing it into clinics in West Virginia.

The Ophelia Fund/Rhode Island Foundation supported the creation of the tool and dissemination of the tool to clinicians. Research reported in the study was supported by the National Institute of General Medical Sciences of the National Institutes of Health.

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

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A newly developed screening tool may help clinicians identify pregnant women with eating disorders.

The 12-question instrument is intended to be a quick way to help clinicians identify women who may need to be referred to a mental health expert for further evaluation, according to the researchers, who reported on the instrument in a study published in Archives of Women’s Mental Health.

“It would be most appropriate for clinical encounters so that women can get screened and referred,” said Elizabeth Claydon, MD, assistant professor in the department of social and behavioral sciences at West Virginia University’s School of Public Health, Morgantown, who led the study. “If you miss it, they may carry on their eating disorder throughout their pregnancy.”

Pregnant women who have an eating disorder are at increased risk for gestational diabetes, premature birth, labor complications, difficulties nursing, and postpartum depression, according to the National Eating Disorders Association. Their babies are at increased risk for premature birth, low birth weight, and poor development. However, clinicians have not had an accurate way of screening pregnant women who may have an eating disorder.

The American College of Obstetricians and Gynecologists offered its first clinical guidelines for managing anorexia in pregnancy in April 2022. The group’s recommendations include regular monitoring of cardiac and liver function, blood pressure, and heart rate, as well as tests to monitor iron, sodium, potassium, bone density, and blood sugar levels. Anorexia, bulimia, binge eating, and subthreshold disorders – also known as other specified feeding or eating disorders – are among the most common eating disorders among pregnant women.

There are no recent data on the incidence or prevalence of eating disorders among pregnant women, according to Lauren Smolar, vice president of mission and education at the National Eating Disorders Association.

“It’s hard to capture the number of pregnant women affected, since it so often goes undetected,” Ms. Smolar said.

Existing screening tools for eating disorders ask patients whether they’re currently pregnant; a questionnaire specifically tailored to pregnant women may help to better gather data on the prevalence within this group, Ms. Smolar said.

For the new study, Dr. Claydon and her colleagues tested the questionnaire among more than 400 mostly White women aged 25-34 years. They found that it could reliably identify women who may have an eating disorder. The questionnaire was validated for women to take during any trimester, according to the findings.

A score of 39 or above would serve as an indicator for follow-up. Women who score at least 39 were up to 16 times more likely to receive a diagnosis of an eating disorder, compared with women who scored less, the researchers found.
 

Eating disorders often escape the eye

Researchers developed the tool to screen all women, rather than just patients who present with recognizable symptoms, according to Dr. Claydon.

“Some people may relapse during pregnancy, some may develop [a disorder] while pregnant,” she said. “This makes sure there are no assumptions, because sometimes you can’t tell someone has an eating disorder just by looking at them.”

The researchers also worked to eliminate stigmatizing language to reduce the possibility of women withholding information about their symptoms.

The tool was developed following a qualitative study by Dr. Claydon and her colleagues that was published in 2018. In that study, the researchers analyzed self-perceptions and self-reported experiences of women going through pregnancy with an eating disorder.

“I heard a lot about how difficult it was to disclose eating disorders during pregnancy,” Dr. Claydon said. “It’s wonderful to do something applied to these findings. It’s very meaningful and personal work to me.”

Dr. Claydon said she and her colleagues now plan to test the tool by introducing it into clinics in West Virginia.

The Ophelia Fund/Rhode Island Foundation supported the creation of the tool and dissemination of the tool to clinicians. Research reported in the study was supported by the National Institute of General Medical Sciences of the National Institutes of Health.

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

A newly developed screening tool may help clinicians identify pregnant women with eating disorders.

The 12-question instrument is intended to be a quick way to help clinicians identify women who may need to be referred to a mental health expert for further evaluation, according to the researchers, who reported on the instrument in a study published in Archives of Women’s Mental Health.

“It would be most appropriate for clinical encounters so that women can get screened and referred,” said Elizabeth Claydon, MD, assistant professor in the department of social and behavioral sciences at West Virginia University’s School of Public Health, Morgantown, who led the study. “If you miss it, they may carry on their eating disorder throughout their pregnancy.”

Pregnant women who have an eating disorder are at increased risk for gestational diabetes, premature birth, labor complications, difficulties nursing, and postpartum depression, according to the National Eating Disorders Association. Their babies are at increased risk for premature birth, low birth weight, and poor development. However, clinicians have not had an accurate way of screening pregnant women who may have an eating disorder.

The American College of Obstetricians and Gynecologists offered its first clinical guidelines for managing anorexia in pregnancy in April 2022. The group’s recommendations include regular monitoring of cardiac and liver function, blood pressure, and heart rate, as well as tests to monitor iron, sodium, potassium, bone density, and blood sugar levels. Anorexia, bulimia, binge eating, and subthreshold disorders – also known as other specified feeding or eating disorders – are among the most common eating disorders among pregnant women.

There are no recent data on the incidence or prevalence of eating disorders among pregnant women, according to Lauren Smolar, vice president of mission and education at the National Eating Disorders Association.

“It’s hard to capture the number of pregnant women affected, since it so often goes undetected,” Ms. Smolar said.

Existing screening tools for eating disorders ask patients whether they’re currently pregnant; a questionnaire specifically tailored to pregnant women may help to better gather data on the prevalence within this group, Ms. Smolar said.

For the new study, Dr. Claydon and her colleagues tested the questionnaire among more than 400 mostly White women aged 25-34 years. They found that it could reliably identify women who may have an eating disorder. The questionnaire was validated for women to take during any trimester, according to the findings.

A score of 39 or above would serve as an indicator for follow-up. Women who score at least 39 were up to 16 times more likely to receive a diagnosis of an eating disorder, compared with women who scored less, the researchers found.
 

Eating disorders often escape the eye

Researchers developed the tool to screen all women, rather than just patients who present with recognizable symptoms, according to Dr. Claydon.

“Some people may relapse during pregnancy, some may develop [a disorder] while pregnant,” she said. “This makes sure there are no assumptions, because sometimes you can’t tell someone has an eating disorder just by looking at them.”

The researchers also worked to eliminate stigmatizing language to reduce the possibility of women withholding information about their symptoms.

The tool was developed following a qualitative study by Dr. Claydon and her colleagues that was published in 2018. In that study, the researchers analyzed self-perceptions and self-reported experiences of women going through pregnancy with an eating disorder.

“I heard a lot about how difficult it was to disclose eating disorders during pregnancy,” Dr. Claydon said. “It’s wonderful to do something applied to these findings. It’s very meaningful and personal work to me.”

Dr. Claydon said she and her colleagues now plan to test the tool by introducing it into clinics in West Virginia.

The Ophelia Fund/Rhode Island Foundation supported the creation of the tool and dissemination of the tool to clinicians. Research reported in the study was supported by the National Institute of General Medical Sciences of the National Institutes of Health.

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

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Urinary incontinence in transfeminine patients

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Changed
Tue, 05/24/2022 - 11:41

Whether your patient is a cisgender female or a transfeminine patient, urinary incontinence is unfortunately common and can have a significant negative effect on a person’s quality of life. While the incidence of incontinence is relatively well established in the cisgender population, these statistics remain elusive among transfeminine individuals. Many studies today currently examine cosmetic results, sexual function, and major complications rates, and are now starting to explore the long-term effects of these surgeries on the urinary tract.1

As gender-affirming surgery increases in prevalence, our knowledge regarding long-term outcomes impacting quality of life needs to subsequently improve. A few small studies have examined the rates of incontinence and urinary dysfunction among transfeminine patients. In one study, changes in voiding were reported in 32% of patients, with 19% reporting worse voiding and 19% reporting some degree of incontinence.2 A small series of 52 transgender female patients found rates of urinary urgency to be 24.6% and stress incontinence 23%.1,3 Another study of only 18 patients demonstrated a significant rate of incontinence at 33%, which was due to stress urinary incontinence and overactive bladder.1,4 Other studies noted postvoid dribbling to be as high as 79%.1,2

Dr. K. Ashley Brandt

Obtaining a thorough history is essential in evaluating patients with incontinence. Compared with cisgender females, risk factors for urinary incontinence in cisgender males are naturally different. For example, increasing age, parity, vaginal delivery, history of hysterectomy, and obesity are some risk factors for incontinence in cisgender women.1,6 However, in men, overall rates are lower and tend to be associated with factors such as a history of stroke, diabetes, and injury to the urethral sphincter – which can occur in radical prostatectomy.1

In addition to asking standard questions, such as caffeine use, beverage consumption, medication changes, physical activity, etc., the relationship of a patient’s symptoms to her vaginoplasty is crucial. Providers should elucidate whether patients experienced urinary symptoms prior to surgery, note the type of vaginoplasty performed, and determine if any temporal relationship exists with dilation or intercourse.

Communicating with the original surgeon and obtaining operative reports is often necessary to understand the flaps utilized and the current anatomic structures that were altered during surgery. Creation of the neovagina involves dissection through the levator ani, which can lead to neurologic injury and subsequently predispose patients to incontinence. The surgeon must be meticulous in their creation of the neovaginal space, particularly between the rectum and the prostatic urethra. As the dissection continues in a cephalad direction to the peritoneal reflection, the bladder can also suffer an iatrogenic injury.

In cases of the penile inversion vaginoplasty, a skin graft is typically used to line the neovaginal canal. If this graft fails to take appropriately it can prolapse and can contribute to urinary incontinence symptoms. Some surgeons will suspend the apical portion of the neovagina; however, the effect on rates of incontinence is mixed.

The physical exam of a transfeminine patient should consist of a general health assessment, neurological, abdominal, and genitourinary examinations. Palpation of the prostate is performed through the neovaginal canal if patent. During the urinary exam, the provider should make note of stenosis at the urethral meatus or urethral hypermobility. For patients reporting symptoms of stress incontinence, a cough stress test is useful. The neovagina should be carefully examined for fistula formation or any other structural abnormality.

Testing for urinary incontinence is similar to the evaluation in cisgender females in that every patient should undergo a urinalysis and a postvoid residual volume measurement, and should maintain a voiding diary. Indications for urodynamic testing are the same for transfeminine women and cisgender women – symptoms do not correlate with objective findings, failure to improve with treatment, prior incontinence from pelvic floor surgery, difficult diagnostic evaluation with unclear diagnosis.5,6 Cystoscopy is useful for patients experiencing hematuria, before anti-incontinence surgery, or prior to transurethral prostate intervention.1

Treatment is tailored to the type of incontinence diagnosed; however, there are no specific guidelines that are evidence-based for transfeminine patients after vaginoplasty. The therapies available are extrapolated from the general patient population. All patients can benefit from dietary modifications such as avoiding bladder irritants, monitoring fluid and caffeine intake, timed voiding, and pelvic floor exercises.1,6 If patients do not experience improvement from conservative measures, the mainstay treatment for overactive bladder is antimuscarinic agents. However, in cisgender male patients who have a prostate, these agents can lead to urinary retention related to bladder outlet obstruction, although the rates of urinary retention are low.1 Overall, these agents are relatively safe and effective in cisgender men with a prostate and by extension should be utilized in transfeminine patients when indicated.

In patients diagnosed with stress urinary incontinence, conservative options with weight loss, smoking cessation, and pelvic floor exercises should be attempted. If these measures fail in cisgender women, surgical treatment is often recommended. However, surgical treatment in transfeminine patients is significantly less straightforward and beyond the scope of this article.

Obstetrician/gynecologists are familiar with assessing and treating cisgender female patients reporting incontinence and should use this same knowledge for diagnosing and treating transfeminine patients. In addition, providers should be aware of complications of these procedures in evaluating patients presenting for symptoms of incontinence, as these complications directly contribute to incontinence in this patient population.1

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. Email her at [email protected] .

References

1. Ginzburg N. Care of transgender patients: Incontinence. In: Nikolavsky D, Blakley SA, eds. Urological Care for the Transgender Patient: A Comprehensive Guide. Syracuse, NY: Springer, 2021:203-17.

2. Hoebeke P et al. Eur Urol. 2005;47(3):398-402.

3. Kuhn A et al. Fertil Steril. 2011;95(7):2379-82.

4. Kuhn A et al. Eur J Obstet Gynecol Reprod Biol. 2007;131(2):226-30.

5. Winters JC et al. J Urol. 2012;188(6s):2464-72.

6. Practice Bulletin No. 155. American College of Obstetricians and Gynecologists. Obstet Gynecol 2015;126:e66-81.

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Whether your patient is a cisgender female or a transfeminine patient, urinary incontinence is unfortunately common and can have a significant negative effect on a person’s quality of life. While the incidence of incontinence is relatively well established in the cisgender population, these statistics remain elusive among transfeminine individuals. Many studies today currently examine cosmetic results, sexual function, and major complications rates, and are now starting to explore the long-term effects of these surgeries on the urinary tract.1

As gender-affirming surgery increases in prevalence, our knowledge regarding long-term outcomes impacting quality of life needs to subsequently improve. A few small studies have examined the rates of incontinence and urinary dysfunction among transfeminine patients. In one study, changes in voiding were reported in 32% of patients, with 19% reporting worse voiding and 19% reporting some degree of incontinence.2 A small series of 52 transgender female patients found rates of urinary urgency to be 24.6% and stress incontinence 23%.1,3 Another study of only 18 patients demonstrated a significant rate of incontinence at 33%, which was due to stress urinary incontinence and overactive bladder.1,4 Other studies noted postvoid dribbling to be as high as 79%.1,2

Dr. K. Ashley Brandt

Obtaining a thorough history is essential in evaluating patients with incontinence. Compared with cisgender females, risk factors for urinary incontinence in cisgender males are naturally different. For example, increasing age, parity, vaginal delivery, history of hysterectomy, and obesity are some risk factors for incontinence in cisgender women.1,6 However, in men, overall rates are lower and tend to be associated with factors such as a history of stroke, diabetes, and injury to the urethral sphincter – which can occur in radical prostatectomy.1

In addition to asking standard questions, such as caffeine use, beverage consumption, medication changes, physical activity, etc., the relationship of a patient’s symptoms to her vaginoplasty is crucial. Providers should elucidate whether patients experienced urinary symptoms prior to surgery, note the type of vaginoplasty performed, and determine if any temporal relationship exists with dilation or intercourse.

Communicating with the original surgeon and obtaining operative reports is often necessary to understand the flaps utilized and the current anatomic structures that were altered during surgery. Creation of the neovagina involves dissection through the levator ani, which can lead to neurologic injury and subsequently predispose patients to incontinence. The surgeon must be meticulous in their creation of the neovaginal space, particularly between the rectum and the prostatic urethra. As the dissection continues in a cephalad direction to the peritoneal reflection, the bladder can also suffer an iatrogenic injury.

In cases of the penile inversion vaginoplasty, a skin graft is typically used to line the neovaginal canal. If this graft fails to take appropriately it can prolapse and can contribute to urinary incontinence symptoms. Some surgeons will suspend the apical portion of the neovagina; however, the effect on rates of incontinence is mixed.

The physical exam of a transfeminine patient should consist of a general health assessment, neurological, abdominal, and genitourinary examinations. Palpation of the prostate is performed through the neovaginal canal if patent. During the urinary exam, the provider should make note of stenosis at the urethral meatus or urethral hypermobility. For patients reporting symptoms of stress incontinence, a cough stress test is useful. The neovagina should be carefully examined for fistula formation or any other structural abnormality.

Testing for urinary incontinence is similar to the evaluation in cisgender females in that every patient should undergo a urinalysis and a postvoid residual volume measurement, and should maintain a voiding diary. Indications for urodynamic testing are the same for transfeminine women and cisgender women – symptoms do not correlate with objective findings, failure to improve with treatment, prior incontinence from pelvic floor surgery, difficult diagnostic evaluation with unclear diagnosis.5,6 Cystoscopy is useful for patients experiencing hematuria, before anti-incontinence surgery, or prior to transurethral prostate intervention.1

Treatment is tailored to the type of incontinence diagnosed; however, there are no specific guidelines that are evidence-based for transfeminine patients after vaginoplasty. The therapies available are extrapolated from the general patient population. All patients can benefit from dietary modifications such as avoiding bladder irritants, monitoring fluid and caffeine intake, timed voiding, and pelvic floor exercises.1,6 If patients do not experience improvement from conservative measures, the mainstay treatment for overactive bladder is antimuscarinic agents. However, in cisgender male patients who have a prostate, these agents can lead to urinary retention related to bladder outlet obstruction, although the rates of urinary retention are low.1 Overall, these agents are relatively safe and effective in cisgender men with a prostate and by extension should be utilized in transfeminine patients when indicated.

In patients diagnosed with stress urinary incontinence, conservative options with weight loss, smoking cessation, and pelvic floor exercises should be attempted. If these measures fail in cisgender women, surgical treatment is often recommended. However, surgical treatment in transfeminine patients is significantly less straightforward and beyond the scope of this article.

Obstetrician/gynecologists are familiar with assessing and treating cisgender female patients reporting incontinence and should use this same knowledge for diagnosing and treating transfeminine patients. In addition, providers should be aware of complications of these procedures in evaluating patients presenting for symptoms of incontinence, as these complications directly contribute to incontinence in this patient population.1

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. Email her at [email protected] .

References

1. Ginzburg N. Care of transgender patients: Incontinence. In: Nikolavsky D, Blakley SA, eds. Urological Care for the Transgender Patient: A Comprehensive Guide. Syracuse, NY: Springer, 2021:203-17.

2. Hoebeke P et al. Eur Urol. 2005;47(3):398-402.

3. Kuhn A et al. Fertil Steril. 2011;95(7):2379-82.

4. Kuhn A et al. Eur J Obstet Gynecol Reprod Biol. 2007;131(2):226-30.

5. Winters JC et al. J Urol. 2012;188(6s):2464-72.

6. Practice Bulletin No. 155. American College of Obstetricians and Gynecologists. Obstet Gynecol 2015;126:e66-81.

Whether your patient is a cisgender female or a transfeminine patient, urinary incontinence is unfortunately common and can have a significant negative effect on a person’s quality of life. While the incidence of incontinence is relatively well established in the cisgender population, these statistics remain elusive among transfeminine individuals. Many studies today currently examine cosmetic results, sexual function, and major complications rates, and are now starting to explore the long-term effects of these surgeries on the urinary tract.1

As gender-affirming surgery increases in prevalence, our knowledge regarding long-term outcomes impacting quality of life needs to subsequently improve. A few small studies have examined the rates of incontinence and urinary dysfunction among transfeminine patients. In one study, changes in voiding were reported in 32% of patients, with 19% reporting worse voiding and 19% reporting some degree of incontinence.2 A small series of 52 transgender female patients found rates of urinary urgency to be 24.6% and stress incontinence 23%.1,3 Another study of only 18 patients demonstrated a significant rate of incontinence at 33%, which was due to stress urinary incontinence and overactive bladder.1,4 Other studies noted postvoid dribbling to be as high as 79%.1,2

Dr. K. Ashley Brandt

Obtaining a thorough history is essential in evaluating patients with incontinence. Compared with cisgender females, risk factors for urinary incontinence in cisgender males are naturally different. For example, increasing age, parity, vaginal delivery, history of hysterectomy, and obesity are some risk factors for incontinence in cisgender women.1,6 However, in men, overall rates are lower and tend to be associated with factors such as a history of stroke, diabetes, and injury to the urethral sphincter – which can occur in radical prostatectomy.1

In addition to asking standard questions, such as caffeine use, beverage consumption, medication changes, physical activity, etc., the relationship of a patient’s symptoms to her vaginoplasty is crucial. Providers should elucidate whether patients experienced urinary symptoms prior to surgery, note the type of vaginoplasty performed, and determine if any temporal relationship exists with dilation or intercourse.

Communicating with the original surgeon and obtaining operative reports is often necessary to understand the flaps utilized and the current anatomic structures that were altered during surgery. Creation of the neovagina involves dissection through the levator ani, which can lead to neurologic injury and subsequently predispose patients to incontinence. The surgeon must be meticulous in their creation of the neovaginal space, particularly between the rectum and the prostatic urethra. As the dissection continues in a cephalad direction to the peritoneal reflection, the bladder can also suffer an iatrogenic injury.

In cases of the penile inversion vaginoplasty, a skin graft is typically used to line the neovaginal canal. If this graft fails to take appropriately it can prolapse and can contribute to urinary incontinence symptoms. Some surgeons will suspend the apical portion of the neovagina; however, the effect on rates of incontinence is mixed.

The physical exam of a transfeminine patient should consist of a general health assessment, neurological, abdominal, and genitourinary examinations. Palpation of the prostate is performed through the neovaginal canal if patent. During the urinary exam, the provider should make note of stenosis at the urethral meatus or urethral hypermobility. For patients reporting symptoms of stress incontinence, a cough stress test is useful. The neovagina should be carefully examined for fistula formation or any other structural abnormality.

Testing for urinary incontinence is similar to the evaluation in cisgender females in that every patient should undergo a urinalysis and a postvoid residual volume measurement, and should maintain a voiding diary. Indications for urodynamic testing are the same for transfeminine women and cisgender women – symptoms do not correlate with objective findings, failure to improve with treatment, prior incontinence from pelvic floor surgery, difficult diagnostic evaluation with unclear diagnosis.5,6 Cystoscopy is useful for patients experiencing hematuria, before anti-incontinence surgery, or prior to transurethral prostate intervention.1

Treatment is tailored to the type of incontinence diagnosed; however, there are no specific guidelines that are evidence-based for transfeminine patients after vaginoplasty. The therapies available are extrapolated from the general patient population. All patients can benefit from dietary modifications such as avoiding bladder irritants, monitoring fluid and caffeine intake, timed voiding, and pelvic floor exercises.1,6 If patients do not experience improvement from conservative measures, the mainstay treatment for overactive bladder is antimuscarinic agents. However, in cisgender male patients who have a prostate, these agents can lead to urinary retention related to bladder outlet obstruction, although the rates of urinary retention are low.1 Overall, these agents are relatively safe and effective in cisgender men with a prostate and by extension should be utilized in transfeminine patients when indicated.

In patients diagnosed with stress urinary incontinence, conservative options with weight loss, smoking cessation, and pelvic floor exercises should be attempted. If these measures fail in cisgender women, surgical treatment is often recommended. However, surgical treatment in transfeminine patients is significantly less straightforward and beyond the scope of this article.

Obstetrician/gynecologists are familiar with assessing and treating cisgender female patients reporting incontinence and should use this same knowledge for diagnosing and treating transfeminine patients. In addition, providers should be aware of complications of these procedures in evaluating patients presenting for symptoms of incontinence, as these complications directly contribute to incontinence in this patient population.1

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. Email her at [email protected] .

References

1. Ginzburg N. Care of transgender patients: Incontinence. In: Nikolavsky D, Blakley SA, eds. Urological Care for the Transgender Patient: A Comprehensive Guide. Syracuse, NY: Springer, 2021:203-17.

2. Hoebeke P et al. Eur Urol. 2005;47(3):398-402.

3. Kuhn A et al. Fertil Steril. 2011;95(7):2379-82.

4. Kuhn A et al. Eur J Obstet Gynecol Reprod Biol. 2007;131(2):226-30.

5. Winters JC et al. J Urol. 2012;188(6s):2464-72.

6. Practice Bulletin No. 155. American College of Obstetricians and Gynecologists. Obstet Gynecol 2015;126:e66-81.

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Fewer teens giving birth, but cases are more complex

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Tue, 05/24/2022 - 10:25

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

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

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

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

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

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

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

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

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

Shifting health status

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

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

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

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

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

 

 

An often overlooked group

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

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

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

Behind the decline

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

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

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

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

Abortion shifts

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Shifting health status

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

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

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

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

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

 

 

An often overlooked group

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

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

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

Behind the decline

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

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

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

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

Abortion shifts

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Shifting health status

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

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

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

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

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

 

 

An often overlooked group

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

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

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

Behind the decline

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

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

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

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

Abortion shifts

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

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

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

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

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

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The perils of CA-125 as a diagnostic tool in patients with adnexal masses

Article Type
Changed
Tue, 05/24/2022 - 09:41

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

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

Dr. Katherine Tucker

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

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

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

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

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

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

References

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

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

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

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

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

Dr. Katherine Tucker

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

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

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

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

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

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

References

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

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

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

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

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

Dr. Katherine Tucker

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

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

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

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

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

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

References

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

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

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

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Food allergy risk not greater in C-section infants

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Changed
Tue, 05/24/2022 - 09:20

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

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

Dr. Rachel L. Peters

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

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

The HealthNuts study

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

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

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

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

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

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

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

Dr. Terri Brown-Whitehorn

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

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

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

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

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

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

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

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

Dr. Rachel L. Peters

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

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

The HealthNuts study

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

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

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

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

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

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

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

Dr. Terri Brown-Whitehorn

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

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

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

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

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

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

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

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

Dr. Rachel L. Peters

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

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

The HealthNuts study

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

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

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

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

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

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

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

Dr. Terri Brown-Whitehorn

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

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

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

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

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

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

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Contraceptive use boosted by enhanced counseling

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Tue, 10/18/2022 - 15:14

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

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

Dr. Heidi D. Nelson

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

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

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

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

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

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

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

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

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

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

 

 

Make easy, effective contraception accessible to all

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

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

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

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

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

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

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

Dr. Heidi D. Nelson

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

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

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

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

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

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

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

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

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

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

 

 

Make easy, effective contraception accessible to all

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

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

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

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

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

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

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

Dr. Heidi D. Nelson

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

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

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

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

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

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

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

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

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

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

 

 

Make easy, effective contraception accessible to all

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

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

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

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

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

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