Visionary Surgery Saved Pitcher’s Arm. Now Even Children Get It

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Tue, 04/02/2024 - 15:26

In 1974, Tommy John of the Los Angeles Dodgers was 31 and a 12-year veteran of Major League Baseball when he became the unwitting vanguard of a revolution in baseball and orthopedics. Fifty years later, Mr. John might not be a candidate for the latest advances to a procedure that bears his name.

The southpaw pitcher had faced the abrupt end of his career when, after one fateful delivery, he found himself unable to throw to home. So he took a gamble on the surgical equivalent of a Hail Mary: the reconstruction of a torn ligament in his pitching elbow.

The experiment was a wild success. Mr. John pitched— and better than he had before — for another 14 seasons, retiring in 1989 at the age of 46. How much better? After the surgery, he tallied three 20-win seasons compared with none before the operation, and he finished among the top five vote-getters for the annual Cy Young Award three times. He was named an All-Star once before the surgery and three times after.

The triumph notwithstanding, Tommy John now cautions against Tommy John surgery. What’s given him and clinicians pause is a trend in recent years of ever-younger athletes who undergo the procedure.

Along with the surgical improvements in repairing a torn ulnar collateral ligament (UCL) is a demographic shift toward school-aged athletes who get it. By 2014, one study concluded that 67.4% of UCL reconstruction surgeries were performed on athletes between 16 and 20 years of age. Some patients are still in Little League when they undergo the procedure.

Experts say these athletes have weakened their UCLs through overuse. They disagree on whether to call it an “epidemic,” but if it is, “the vaccine is awareness” against throwing too hard and too often, said Eric Makhni, MD, an orthopedic surgeon at Henry Ford Health in Detroit.
 

From Career-Ending to Routine

Mr. John’s entry into baseball and orthopedic lore was initially slow, but the trickle turned into a tide. After Frank Jobe, MD, swapped a healthy tendon from John’s right wrist for his worn and torn left UCL on September 25, 1974, he didn’t perform his second surgery for another 1194 days. By the time “Tommy John surgery” became a recognized phrase, Mr. John was still active but only 14 professional baseball players had undergone the operation.

Prior to the start of spring training this year, an oft-cited database listed 366 pro players who’d undergone the operation. 

“Before Tommy John, that was a career-ending injury,” said Grant E. Garrigues, MD, an orthopedic surgeon at Midwest Orthopaedics at RUSH in Chicago, who called Mr. John “a pure revolutionary.”

Tommy John surgery is “the only one that I can think of that is named after the patient rather than the doctor who first did it,” said Patrick McCulloch, MD, an orthopedic surgeon in Houston and a team physician for the Astros.

Dr. McCulloch, who performs about 25 UCL repairs a year, said that by recent estimates, one-third of pro pitchers had had some sort of surgical repair. He hesitated to call the increasing number of operations an epidemic but acknowledged that the ingredients exist for more elbow trauma among baseball players.

“More people are playing more often, and people are bigger and stronger and throwing harder,” he said.

Either way, Dr. McCulloch said, “the procedure is a victim of its own success” because it is “just done phenomenally well.”

The surgery is now commonplace — perhaps too commonplace, said David W. Altchek, MD, attending surgeon and co-chief emeritus at Hospital for Special Surgery in New York City.

Dr. Altchek played a key role in the popularity of the operation. Twenty-two years after Mr. John’s surgery, he helped develop a variation of the procedure called the docking technique. 

Whereas Dr. Jobe sutured Mr. John’s replacement graft to itself, “we developed a different way of tying it over a bone bridge, which was more secure and more easy to tension,” Dr. Altchek explained.

The advance meant less drilling into bone and enabled surgeons to avoid moving a problem-free ulnar nerve or removing the flexor-pronator muscle that protects the elbow from stress. “The trauma of the surgery is significantly less,” he said. “We just made it a lot easier very quickly,” cutting the surgery time from 2 hours to 30-40 minutes.

Maybe the surgery became too easy, said Dr. Altchek, who estimates he has done 2000 of them over the past 30 years. “I don’t want to condemn my colleagues, but there are a lot of people doing the surgery,” he said. “And not a lot of people are doing a lot of them, and they don’t know the nuances of doing the surgery.”

The older procedures are known as the “full Tommy John”; each has a 12- to 18-month healing process, with a success rate of 80%-85%. Pitchers typically sit out a season while recovering.

Brandon Erickson, MD, an orthopedic surgeon at Rothman Orthopaedic Institute in New York City, said that in younger patients he has recently turned more often to the suture of the future: an internal brace that provides a repair rather than reconstruction.

The procedure, pioneered by Felix H. Savoie III, MD, the Ray J. Haddad Professor of Orthopaedics at Tulane University School of Medicine in New Orleans, and Jeffrey R. Dugas, MD, of Andrews Sports Medicine & Orthopaedic Center in Birmingham, Alabama, uses collagen-coated tape that looks like a shoelace and provides a scaffold that Dr. McCulloch said “is inductive to healing and growth of ligament tissue.”

The brace is intended for an “overhead” athlete (mostly baseball players but also javelin throwers and gymnasts) whose UCL is torn on only one side but is otherwise in good shape. In a pitcher the same age as Mr. John was when Dr. Jobe performed the first procedure, “that ligament may not be of very good quality,” Dr. McCulloch said. “It may have thickened. It may have calcifications.” But for a high-school junior with aspirations to pitch in college or beyond without “way too many miles on the elbow,” the approach is a good fit. The healing process is as little as 6 months.

“The ones who have a good ligament are very likely to do well,” said Dr. Erickson, an assistant team doctor for the Philadelphia Phillies.

“If the patient’s ligament is generally ‘good’ with only a tear, the InternalBrace procedure may be used to repair the native ligament. On the other end of the spectrum, if the patient’s ligament is torn and degenerative the surgeon may opt to do a UCL reconstruction using an auto or allograft — ie, Tommy John surgery,” Allen Holowecky, senior product manager of Arthrex of Naples, Florida, the maker of the InternalBrace, told this news organization. “Before UCL repair, Tommy John surgery was the only real treatment option. We tend to see repairs done on younger patients since their ligament hasn’t seen years of use-damage.”
 

 

 

Calls for Caution

Tommy John III wanted to play baseball like his dad until near-fatal complications from shoulder surgery altered his path. He was drawn to chiropractic and consults on injury prevention. “All surgeries and all medical interventions are cut first, ask questions later,” he said. “I was born with that.”

He saw his dad’s slow, heroic comeback from the surgery and described him as the perfect candidate for Dr. Jobe’s experiment. Tommy John spent his recovery time squeezing Silly Putty and throwing tennis balls. “He was willing to do anything necessary. He wanted to throw. That was his brush.” When the son was recovering from his own injury, “he said, ‘Learn the knuckleball.’ I said, ‘I don’t want to. I’ve reached my point.’ ”

He said he tells young patients with UCL injuries to rest. But instead “we have year-round sports with the promise that the more you play, the better,” he said. “They’re over-activitied.”

According to the American Academy of Orthopaedic Surgeons, 6.4 million children and adolescents in the United States played organized baseball in 2022, down from 11.5 million in 2014. Nearly half of pitchers played in a league with no maximum pitch counts, and 43.5% pitched on consecutive days, the group said.

How many UCL repair or reconstruction surgeries are performed on youth athletes each year is unclear. A 2019 study, however, found that although baseball injuries decreased between 2006 and 2016, the elbow was “the only location of injury that saw an increase.”

Dr. Garrigues said some parents of throwing athletes have asked about prophylactic Tommy John surgery for their children. He said it shouldn’t apply to pitchers.

“People have taken it a little too far,” he said. Dr. Garrigues and others argue against children throwing weighted balls when coming back from surgery. Instead, “we’re shutting them down,” he said.

Throwing any pitch is an act of violence on the body, Dr. Garrigues said, with the elbow taking the final brunt of the force. “These pitchers are functioning at the absolute limits of what the human body can take,” he said. “There’s only so many bullets in a gun,” which is why pitchers often feel the twinge of a torn UCL on a routine pitch.

Dr. Makhni suggested cross-training for pitchers in the off-season instead of playing baseball year-round. “If you play soccer, your footwork is going to be better,” he said.

“Kids shouldn’t be doing this all year round,” said Rebecca Carl, MD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “We are recommending that kids take 2 or 3 months off.” In the off-season, she urges them to strengthen their backs and cores. 

Such advice can “feel like a bombshell,” said Dr. Carl, who chairs the Council on Sports Medicine and Fitness for the American Academy of Pediatrics. ‘Some started at a very young age. They go to camps. If I say to a teenager, ‘If you do this, I can keep you from getting injured,’ they think, ‘I won’t be injured.’” Most parents, however, understand the risk of “doing too much, too soon.”

Justin Orenduff, a former pitching prospect until his arm blew out, has made a career teaching head-to-toe pitching mechanics. He founded DVS Baseball, which uses software to teach pitchers how to properly use every muscle, starting with the orientation of the back foot. He, too, argues against pitching year-round. “Everyone on that travel team expects to get their fair share of playing time,” he said. “It just never stops.”

Organized baseball is paying attention. It has come up with the Pitch Smart program that gives maximum pitch counts for young players, but experts said children often get around that by belonging to several leagues.

Dr. Altchek said some surgeons have added platelet-rich plasma, stem cells, and bone marrow during surgery to quicken the slow healing time from UCL replacement. But he said, “it has to heal. Can you speed up biology?”

Dr. McCulloch said that, all the advances in Tommy John surgery aside, “the next frontier is really trying to crack the code on prevention.”

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

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In 1974, Tommy John of the Los Angeles Dodgers was 31 and a 12-year veteran of Major League Baseball when he became the unwitting vanguard of a revolution in baseball and orthopedics. Fifty years later, Mr. John might not be a candidate for the latest advances to a procedure that bears his name.

The southpaw pitcher had faced the abrupt end of his career when, after one fateful delivery, he found himself unable to throw to home. So he took a gamble on the surgical equivalent of a Hail Mary: the reconstruction of a torn ligament in his pitching elbow.

The experiment was a wild success. Mr. John pitched— and better than he had before — for another 14 seasons, retiring in 1989 at the age of 46. How much better? After the surgery, he tallied three 20-win seasons compared with none before the operation, and he finished among the top five vote-getters for the annual Cy Young Award three times. He was named an All-Star once before the surgery and three times after.

The triumph notwithstanding, Tommy John now cautions against Tommy John surgery. What’s given him and clinicians pause is a trend in recent years of ever-younger athletes who undergo the procedure.

Along with the surgical improvements in repairing a torn ulnar collateral ligament (UCL) is a demographic shift toward school-aged athletes who get it. By 2014, one study concluded that 67.4% of UCL reconstruction surgeries were performed on athletes between 16 and 20 years of age. Some patients are still in Little League when they undergo the procedure.

Experts say these athletes have weakened their UCLs through overuse. They disagree on whether to call it an “epidemic,” but if it is, “the vaccine is awareness” against throwing too hard and too often, said Eric Makhni, MD, an orthopedic surgeon at Henry Ford Health in Detroit.
 

From Career-Ending to Routine

Mr. John’s entry into baseball and orthopedic lore was initially slow, but the trickle turned into a tide. After Frank Jobe, MD, swapped a healthy tendon from John’s right wrist for his worn and torn left UCL on September 25, 1974, he didn’t perform his second surgery for another 1194 days. By the time “Tommy John surgery” became a recognized phrase, Mr. John was still active but only 14 professional baseball players had undergone the operation.

Prior to the start of spring training this year, an oft-cited database listed 366 pro players who’d undergone the operation. 

“Before Tommy John, that was a career-ending injury,” said Grant E. Garrigues, MD, an orthopedic surgeon at Midwest Orthopaedics at RUSH in Chicago, who called Mr. John “a pure revolutionary.”

Tommy John surgery is “the only one that I can think of that is named after the patient rather than the doctor who first did it,” said Patrick McCulloch, MD, an orthopedic surgeon in Houston and a team physician for the Astros.

Dr. McCulloch, who performs about 25 UCL repairs a year, said that by recent estimates, one-third of pro pitchers had had some sort of surgical repair. He hesitated to call the increasing number of operations an epidemic but acknowledged that the ingredients exist for more elbow trauma among baseball players.

“More people are playing more often, and people are bigger and stronger and throwing harder,” he said.

Either way, Dr. McCulloch said, “the procedure is a victim of its own success” because it is “just done phenomenally well.”

The surgery is now commonplace — perhaps too commonplace, said David W. Altchek, MD, attending surgeon and co-chief emeritus at Hospital for Special Surgery in New York City.

Dr. Altchek played a key role in the popularity of the operation. Twenty-two years after Mr. John’s surgery, he helped develop a variation of the procedure called the docking technique. 

Whereas Dr. Jobe sutured Mr. John’s replacement graft to itself, “we developed a different way of tying it over a bone bridge, which was more secure and more easy to tension,” Dr. Altchek explained.

The advance meant less drilling into bone and enabled surgeons to avoid moving a problem-free ulnar nerve or removing the flexor-pronator muscle that protects the elbow from stress. “The trauma of the surgery is significantly less,” he said. “We just made it a lot easier very quickly,” cutting the surgery time from 2 hours to 30-40 minutes.

Maybe the surgery became too easy, said Dr. Altchek, who estimates he has done 2000 of them over the past 30 years. “I don’t want to condemn my colleagues, but there are a lot of people doing the surgery,” he said. “And not a lot of people are doing a lot of them, and they don’t know the nuances of doing the surgery.”

The older procedures are known as the “full Tommy John”; each has a 12- to 18-month healing process, with a success rate of 80%-85%. Pitchers typically sit out a season while recovering.

Brandon Erickson, MD, an orthopedic surgeon at Rothman Orthopaedic Institute in New York City, said that in younger patients he has recently turned more often to the suture of the future: an internal brace that provides a repair rather than reconstruction.

The procedure, pioneered by Felix H. Savoie III, MD, the Ray J. Haddad Professor of Orthopaedics at Tulane University School of Medicine in New Orleans, and Jeffrey R. Dugas, MD, of Andrews Sports Medicine & Orthopaedic Center in Birmingham, Alabama, uses collagen-coated tape that looks like a shoelace and provides a scaffold that Dr. McCulloch said “is inductive to healing and growth of ligament tissue.”

The brace is intended for an “overhead” athlete (mostly baseball players but also javelin throwers and gymnasts) whose UCL is torn on only one side but is otherwise in good shape. In a pitcher the same age as Mr. John was when Dr. Jobe performed the first procedure, “that ligament may not be of very good quality,” Dr. McCulloch said. “It may have thickened. It may have calcifications.” But for a high-school junior with aspirations to pitch in college or beyond without “way too many miles on the elbow,” the approach is a good fit. The healing process is as little as 6 months.

“The ones who have a good ligament are very likely to do well,” said Dr. Erickson, an assistant team doctor for the Philadelphia Phillies.

“If the patient’s ligament is generally ‘good’ with only a tear, the InternalBrace procedure may be used to repair the native ligament. On the other end of the spectrum, if the patient’s ligament is torn and degenerative the surgeon may opt to do a UCL reconstruction using an auto or allograft — ie, Tommy John surgery,” Allen Holowecky, senior product manager of Arthrex of Naples, Florida, the maker of the InternalBrace, told this news organization. “Before UCL repair, Tommy John surgery was the only real treatment option. We tend to see repairs done on younger patients since their ligament hasn’t seen years of use-damage.”
 

 

 

Calls for Caution

Tommy John III wanted to play baseball like his dad until near-fatal complications from shoulder surgery altered his path. He was drawn to chiropractic and consults on injury prevention. “All surgeries and all medical interventions are cut first, ask questions later,” he said. “I was born with that.”

He saw his dad’s slow, heroic comeback from the surgery and described him as the perfect candidate for Dr. Jobe’s experiment. Tommy John spent his recovery time squeezing Silly Putty and throwing tennis balls. “He was willing to do anything necessary. He wanted to throw. That was his brush.” When the son was recovering from his own injury, “he said, ‘Learn the knuckleball.’ I said, ‘I don’t want to. I’ve reached my point.’ ”

He said he tells young patients with UCL injuries to rest. But instead “we have year-round sports with the promise that the more you play, the better,” he said. “They’re over-activitied.”

According to the American Academy of Orthopaedic Surgeons, 6.4 million children and adolescents in the United States played organized baseball in 2022, down from 11.5 million in 2014. Nearly half of pitchers played in a league with no maximum pitch counts, and 43.5% pitched on consecutive days, the group said.

How many UCL repair or reconstruction surgeries are performed on youth athletes each year is unclear. A 2019 study, however, found that although baseball injuries decreased between 2006 and 2016, the elbow was “the only location of injury that saw an increase.”

Dr. Garrigues said some parents of throwing athletes have asked about prophylactic Tommy John surgery for their children. He said it shouldn’t apply to pitchers.

“People have taken it a little too far,” he said. Dr. Garrigues and others argue against children throwing weighted balls when coming back from surgery. Instead, “we’re shutting them down,” he said.

Throwing any pitch is an act of violence on the body, Dr. Garrigues said, with the elbow taking the final brunt of the force. “These pitchers are functioning at the absolute limits of what the human body can take,” he said. “There’s only so many bullets in a gun,” which is why pitchers often feel the twinge of a torn UCL on a routine pitch.

Dr. Makhni suggested cross-training for pitchers in the off-season instead of playing baseball year-round. “If you play soccer, your footwork is going to be better,” he said.

“Kids shouldn’t be doing this all year round,” said Rebecca Carl, MD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “We are recommending that kids take 2 or 3 months off.” In the off-season, she urges them to strengthen their backs and cores. 

Such advice can “feel like a bombshell,” said Dr. Carl, who chairs the Council on Sports Medicine and Fitness for the American Academy of Pediatrics. ‘Some started at a very young age. They go to camps. If I say to a teenager, ‘If you do this, I can keep you from getting injured,’ they think, ‘I won’t be injured.’” Most parents, however, understand the risk of “doing too much, too soon.”

Justin Orenduff, a former pitching prospect until his arm blew out, has made a career teaching head-to-toe pitching mechanics. He founded DVS Baseball, which uses software to teach pitchers how to properly use every muscle, starting with the orientation of the back foot. He, too, argues against pitching year-round. “Everyone on that travel team expects to get their fair share of playing time,” he said. “It just never stops.”

Organized baseball is paying attention. It has come up with the Pitch Smart program that gives maximum pitch counts for young players, but experts said children often get around that by belonging to several leagues.

Dr. Altchek said some surgeons have added platelet-rich plasma, stem cells, and bone marrow during surgery to quicken the slow healing time from UCL replacement. But he said, “it has to heal. Can you speed up biology?”

Dr. McCulloch said that, all the advances in Tommy John surgery aside, “the next frontier is really trying to crack the code on prevention.”

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

In 1974, Tommy John of the Los Angeles Dodgers was 31 and a 12-year veteran of Major League Baseball when he became the unwitting vanguard of a revolution in baseball and orthopedics. Fifty years later, Mr. John might not be a candidate for the latest advances to a procedure that bears his name.

The southpaw pitcher had faced the abrupt end of his career when, after one fateful delivery, he found himself unable to throw to home. So he took a gamble on the surgical equivalent of a Hail Mary: the reconstruction of a torn ligament in his pitching elbow.

The experiment was a wild success. Mr. John pitched— and better than he had before — for another 14 seasons, retiring in 1989 at the age of 46. How much better? After the surgery, he tallied three 20-win seasons compared with none before the operation, and he finished among the top five vote-getters for the annual Cy Young Award three times. He was named an All-Star once before the surgery and three times after.

The triumph notwithstanding, Tommy John now cautions against Tommy John surgery. What’s given him and clinicians pause is a trend in recent years of ever-younger athletes who undergo the procedure.

Along with the surgical improvements in repairing a torn ulnar collateral ligament (UCL) is a demographic shift toward school-aged athletes who get it. By 2014, one study concluded that 67.4% of UCL reconstruction surgeries were performed on athletes between 16 and 20 years of age. Some patients are still in Little League when they undergo the procedure.

Experts say these athletes have weakened their UCLs through overuse. They disagree on whether to call it an “epidemic,” but if it is, “the vaccine is awareness” against throwing too hard and too often, said Eric Makhni, MD, an orthopedic surgeon at Henry Ford Health in Detroit.
 

From Career-Ending to Routine

Mr. John’s entry into baseball and orthopedic lore was initially slow, but the trickle turned into a tide. After Frank Jobe, MD, swapped a healthy tendon from John’s right wrist for his worn and torn left UCL on September 25, 1974, he didn’t perform his second surgery for another 1194 days. By the time “Tommy John surgery” became a recognized phrase, Mr. John was still active but only 14 professional baseball players had undergone the operation.

Prior to the start of spring training this year, an oft-cited database listed 366 pro players who’d undergone the operation. 

“Before Tommy John, that was a career-ending injury,” said Grant E. Garrigues, MD, an orthopedic surgeon at Midwest Orthopaedics at RUSH in Chicago, who called Mr. John “a pure revolutionary.”

Tommy John surgery is “the only one that I can think of that is named after the patient rather than the doctor who first did it,” said Patrick McCulloch, MD, an orthopedic surgeon in Houston and a team physician for the Astros.

Dr. McCulloch, who performs about 25 UCL repairs a year, said that by recent estimates, one-third of pro pitchers had had some sort of surgical repair. He hesitated to call the increasing number of operations an epidemic but acknowledged that the ingredients exist for more elbow trauma among baseball players.

“More people are playing more often, and people are bigger and stronger and throwing harder,” he said.

Either way, Dr. McCulloch said, “the procedure is a victim of its own success” because it is “just done phenomenally well.”

The surgery is now commonplace — perhaps too commonplace, said David W. Altchek, MD, attending surgeon and co-chief emeritus at Hospital for Special Surgery in New York City.

Dr. Altchek played a key role in the popularity of the operation. Twenty-two years after Mr. John’s surgery, he helped develop a variation of the procedure called the docking technique. 

Whereas Dr. Jobe sutured Mr. John’s replacement graft to itself, “we developed a different way of tying it over a bone bridge, which was more secure and more easy to tension,” Dr. Altchek explained.

The advance meant less drilling into bone and enabled surgeons to avoid moving a problem-free ulnar nerve or removing the flexor-pronator muscle that protects the elbow from stress. “The trauma of the surgery is significantly less,” he said. “We just made it a lot easier very quickly,” cutting the surgery time from 2 hours to 30-40 minutes.

Maybe the surgery became too easy, said Dr. Altchek, who estimates he has done 2000 of them over the past 30 years. “I don’t want to condemn my colleagues, but there are a lot of people doing the surgery,” he said. “And not a lot of people are doing a lot of them, and they don’t know the nuances of doing the surgery.”

The older procedures are known as the “full Tommy John”; each has a 12- to 18-month healing process, with a success rate of 80%-85%. Pitchers typically sit out a season while recovering.

Brandon Erickson, MD, an orthopedic surgeon at Rothman Orthopaedic Institute in New York City, said that in younger patients he has recently turned more often to the suture of the future: an internal brace that provides a repair rather than reconstruction.

The procedure, pioneered by Felix H. Savoie III, MD, the Ray J. Haddad Professor of Orthopaedics at Tulane University School of Medicine in New Orleans, and Jeffrey R. Dugas, MD, of Andrews Sports Medicine & Orthopaedic Center in Birmingham, Alabama, uses collagen-coated tape that looks like a shoelace and provides a scaffold that Dr. McCulloch said “is inductive to healing and growth of ligament tissue.”

The brace is intended for an “overhead” athlete (mostly baseball players but also javelin throwers and gymnasts) whose UCL is torn on only one side but is otherwise in good shape. In a pitcher the same age as Mr. John was when Dr. Jobe performed the first procedure, “that ligament may not be of very good quality,” Dr. McCulloch said. “It may have thickened. It may have calcifications.” But for a high-school junior with aspirations to pitch in college or beyond without “way too many miles on the elbow,” the approach is a good fit. The healing process is as little as 6 months.

“The ones who have a good ligament are very likely to do well,” said Dr. Erickson, an assistant team doctor for the Philadelphia Phillies.

“If the patient’s ligament is generally ‘good’ with only a tear, the InternalBrace procedure may be used to repair the native ligament. On the other end of the spectrum, if the patient’s ligament is torn and degenerative the surgeon may opt to do a UCL reconstruction using an auto or allograft — ie, Tommy John surgery,” Allen Holowecky, senior product manager of Arthrex of Naples, Florida, the maker of the InternalBrace, told this news organization. “Before UCL repair, Tommy John surgery was the only real treatment option. We tend to see repairs done on younger patients since their ligament hasn’t seen years of use-damage.”
 

 

 

Calls for Caution

Tommy John III wanted to play baseball like his dad until near-fatal complications from shoulder surgery altered his path. He was drawn to chiropractic and consults on injury prevention. “All surgeries and all medical interventions are cut first, ask questions later,” he said. “I was born with that.”

He saw his dad’s slow, heroic comeback from the surgery and described him as the perfect candidate for Dr. Jobe’s experiment. Tommy John spent his recovery time squeezing Silly Putty and throwing tennis balls. “He was willing to do anything necessary. He wanted to throw. That was his brush.” When the son was recovering from his own injury, “he said, ‘Learn the knuckleball.’ I said, ‘I don’t want to. I’ve reached my point.’ ”

He said he tells young patients with UCL injuries to rest. But instead “we have year-round sports with the promise that the more you play, the better,” he said. “They’re over-activitied.”

According to the American Academy of Orthopaedic Surgeons, 6.4 million children and adolescents in the United States played organized baseball in 2022, down from 11.5 million in 2014. Nearly half of pitchers played in a league with no maximum pitch counts, and 43.5% pitched on consecutive days, the group said.

How many UCL repair or reconstruction surgeries are performed on youth athletes each year is unclear. A 2019 study, however, found that although baseball injuries decreased between 2006 and 2016, the elbow was “the only location of injury that saw an increase.”

Dr. Garrigues said some parents of throwing athletes have asked about prophylactic Tommy John surgery for their children. He said it shouldn’t apply to pitchers.

“People have taken it a little too far,” he said. Dr. Garrigues and others argue against children throwing weighted balls when coming back from surgery. Instead, “we’re shutting them down,” he said.

Throwing any pitch is an act of violence on the body, Dr. Garrigues said, with the elbow taking the final brunt of the force. “These pitchers are functioning at the absolute limits of what the human body can take,” he said. “There’s only so many bullets in a gun,” which is why pitchers often feel the twinge of a torn UCL on a routine pitch.

Dr. Makhni suggested cross-training for pitchers in the off-season instead of playing baseball year-round. “If you play soccer, your footwork is going to be better,” he said.

“Kids shouldn’t be doing this all year round,” said Rebecca Carl, MD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “We are recommending that kids take 2 or 3 months off.” In the off-season, she urges them to strengthen their backs and cores. 

Such advice can “feel like a bombshell,” said Dr. Carl, who chairs the Council on Sports Medicine and Fitness for the American Academy of Pediatrics. ‘Some started at a very young age. They go to camps. If I say to a teenager, ‘If you do this, I can keep you from getting injured,’ they think, ‘I won’t be injured.’” Most parents, however, understand the risk of “doing too much, too soon.”

Justin Orenduff, a former pitching prospect until his arm blew out, has made a career teaching head-to-toe pitching mechanics. He founded DVS Baseball, which uses software to teach pitchers how to properly use every muscle, starting with the orientation of the back foot. He, too, argues against pitching year-round. “Everyone on that travel team expects to get their fair share of playing time,” he said. “It just never stops.”

Organized baseball is paying attention. It has come up with the Pitch Smart program that gives maximum pitch counts for young players, but experts said children often get around that by belonging to several leagues.

Dr. Altchek said some surgeons have added platelet-rich plasma, stem cells, and bone marrow during surgery to quicken the slow healing time from UCL replacement. But he said, “it has to heal. Can you speed up biology?”

Dr. McCulloch said that, all the advances in Tommy John surgery aside, “the next frontier is really trying to crack the code on prevention.”

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

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Money, Ethnicity, and Access Linked to Cervical Cancer Disparities

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Tue, 04/02/2024 - 14:49

 

Disparities and geographical variations in cervical cancer outcomes appear to be related to social determinants of health, including socioeconomic status, race or ethnicity, and proximity to facilities skilled at early-stage diagnosis and treatment.

These findings come from analyses of insurance data gathered via the Cervical Cancer Geo-Analyzer tool, a publicly available online instrument designed to provide visual representation of recurrent or metastatic cervical cancer burden across metropolitan statistical areas in the United States over multiple years.

[Reporting the findings of] “this study is the first step to optimize healthcare resources allocations, advocate for policy changes that will minimize access barriers, and tailor education for modern treatment options to help reduce and improve outcomes for cervical cancer in US patients,” said Tara Castellano, MD, an author and presenter of this new research, at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego.

Seeing Cancer Cases

Dr. Castellano and colleagues previously reported that the Geo-Analyzer tool effectively provides quantified evidence of cervical cancer disease burden and graphic representation of geographical variations across the United States for both incident and recurrent/metastatic cervical cancer.

In the current analysis, Dr. Castellano, of Louisiana State University School of Medicine in New Orleans, discussed potential factors related to cervical cancer incidence and geographic variations.

The study builds on previous studies that have shown that Black and Hispanic women have longer time to treatment and worse cervical cancer outcomes than White women.

For example, in a study published in the International Journal of Gynecologic Cancer, Marilyn Huang, MD, and colleagues from the University of Miami Miller School of Medicine, Miami, Florida, and other centers in Miami looked at time to treatment in a diverse population of 274 women starting therapy for cervical cancer.

They found that insurance type (private, public, or none) contributed to delay in treatment initiation regardless of the treatment modality, and that the patient’s language and institution of diagnosis also influenced time to treatment.

In a separate scientific poster presented at SGO 2024, Dr. Castellano and colleagues reported that, among women with newly diagnosed endometrial cancer, the median time to treatment was 7 days longer for both Hispanic and Black women, compared with non-Hispanic White women. In addition, Black women had a 7-day longer time to receiving their first therapy for advanced disease. All of these differences were statistically significant.

Dr. Castellano told this news organization that the time-to-treatment disparities in the endometrial cancer study were determined by diagnostic codes and the timing of insurance claims.

Reasons for the disparities may include more limited access to care and structural and systemic biases in the healthcare systems where the majority of Black and Hispanic patients live, she said.

Insurance Database

In the new study on cervical cancer, Dr. Castellano and her team defined cervical cancer burden as prevalent cervical cancer diagnosis per 100,000 eligible women enrolled in a commercial insurance plan, Medicaid, or Medicare Advantage. Recurrent or metastatic cancer was determined to be the proportion of patients with cervical cancer who initiated systemic therapy.

 

 

The goals of the study were to provide a visualization of geographical distribution of cervical cancer in the US, and to quantify associations between early or advanced cancers with screening rates, poverty level, race/ethnicity, and access to brachytherapy.

The administrative claims database queried for the study included information on 75,521 women (median age 53) with a first diagnosis of cervical cancer from 2015 through 2022, and 14,033 women with recurrent or metastatic malignancies (median age 59 years).

Distribution of cases was higher in the South compared with in other US regions (37% vs approximately 20% for other regions).

Looking at the association between screening rates and disease burden from 2017 through 2022, the Geo-Analyzer showed that higher screening rates were significantly associated with decreased burden of new cases only in the South, whereas higher screening rates were associated with lower recurrent/metastatic disease burden in the Midwest and South, but a higher disease burden in the West.

In all regions, there was a significant association between decreased early cancer burden in areas with high percentages of women of Asian heritage, and significantly increased burden in areas with large populations of women of Hispanic origin.

The only significant association of race/ethnicity with recurrent/metastatic burden was a decrease in the Midwest in populations with large Asian populations.

An analysis of the how poverty levels affected screening and disease burden showed that in areas with a high percentage of low-income households there were significant associations with decreased cervical cancer screening and higher burden of newly diagnosed cases.

Poverty levels were significantly associated with recurrent/metastatic cancers only in the South.

The investigators also found that the presence of one or more brachytherapy centers within a ZIP-3 region (that is, a large geographic area designated by the first 3 digits of ZIP codes rather than 5-digit city codes) was associated with a 2.7% reduction in recurrent or metastatic cervical cancer burden (P less than .001).

Demographic Marker?

Reasons for disparities are complex and may involve a combination of inadequate health literacy and social and economic circumstances, said Cesar Castro, MD, commenting on the new cervical cancer study.

He noted in an interview that “the concept that a single Pap smear is often insufficient to capture precancerous changes, and hence the need for serial testing every 3 years, can be lost on individuals who also have competing challenges securing paychecks and/or dependent care. Historical barriers such as perceptions of the underlying cause of cervical cancer, the HPV virus, being a sexually transmitted disease and hence a taboo subject, also underpin decision-making. These sentiments have also fueled resistance towards HPV vaccination in young girls and boys.”

Dr. Castro, who is Program Director for Gynecologic Oncology at the Mass General Cancer Center in Boston, pointed out that treatments for cervical cancer often involve surgery or a combination of chemotherapy and radiation, and that side effects from these interventions may be especially disruptive to the lives of women who are breadwinners or caregivers for their families.

“These are the shackles that poverty places on many Black and Hispanic women notably in under-resourced regions domestically and globally,” he said.

The study was supported by Seagen and Genmab. Dr. Castellano disclosed consulting fees from GSK and Nykode and grant support from BMS. Dr. Castro reported no relevant conflicts of interest and was not involved in either of the studies presented at the meeting.

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Disparities and geographical variations in cervical cancer outcomes appear to be related to social determinants of health, including socioeconomic status, race or ethnicity, and proximity to facilities skilled at early-stage diagnosis and treatment.

These findings come from analyses of insurance data gathered via the Cervical Cancer Geo-Analyzer tool, a publicly available online instrument designed to provide visual representation of recurrent or metastatic cervical cancer burden across metropolitan statistical areas in the United States over multiple years.

[Reporting the findings of] “this study is the first step to optimize healthcare resources allocations, advocate for policy changes that will minimize access barriers, and tailor education for modern treatment options to help reduce and improve outcomes for cervical cancer in US patients,” said Tara Castellano, MD, an author and presenter of this new research, at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego.

Seeing Cancer Cases

Dr. Castellano and colleagues previously reported that the Geo-Analyzer tool effectively provides quantified evidence of cervical cancer disease burden and graphic representation of geographical variations across the United States for both incident and recurrent/metastatic cervical cancer.

In the current analysis, Dr. Castellano, of Louisiana State University School of Medicine in New Orleans, discussed potential factors related to cervical cancer incidence and geographic variations.

The study builds on previous studies that have shown that Black and Hispanic women have longer time to treatment and worse cervical cancer outcomes than White women.

For example, in a study published in the International Journal of Gynecologic Cancer, Marilyn Huang, MD, and colleagues from the University of Miami Miller School of Medicine, Miami, Florida, and other centers in Miami looked at time to treatment in a diverse population of 274 women starting therapy for cervical cancer.

They found that insurance type (private, public, or none) contributed to delay in treatment initiation regardless of the treatment modality, and that the patient’s language and institution of diagnosis also influenced time to treatment.

In a separate scientific poster presented at SGO 2024, Dr. Castellano and colleagues reported that, among women with newly diagnosed endometrial cancer, the median time to treatment was 7 days longer for both Hispanic and Black women, compared with non-Hispanic White women. In addition, Black women had a 7-day longer time to receiving their first therapy for advanced disease. All of these differences were statistically significant.

Dr. Castellano told this news organization that the time-to-treatment disparities in the endometrial cancer study were determined by diagnostic codes and the timing of insurance claims.

Reasons for the disparities may include more limited access to care and structural and systemic biases in the healthcare systems where the majority of Black and Hispanic patients live, she said.

Insurance Database

In the new study on cervical cancer, Dr. Castellano and her team defined cervical cancer burden as prevalent cervical cancer diagnosis per 100,000 eligible women enrolled in a commercial insurance plan, Medicaid, or Medicare Advantage. Recurrent or metastatic cancer was determined to be the proportion of patients with cervical cancer who initiated systemic therapy.

 

 

The goals of the study were to provide a visualization of geographical distribution of cervical cancer in the US, and to quantify associations between early or advanced cancers with screening rates, poverty level, race/ethnicity, and access to brachytherapy.

The administrative claims database queried for the study included information on 75,521 women (median age 53) with a first diagnosis of cervical cancer from 2015 through 2022, and 14,033 women with recurrent or metastatic malignancies (median age 59 years).

Distribution of cases was higher in the South compared with in other US regions (37% vs approximately 20% for other regions).

Looking at the association between screening rates and disease burden from 2017 through 2022, the Geo-Analyzer showed that higher screening rates were significantly associated with decreased burden of new cases only in the South, whereas higher screening rates were associated with lower recurrent/metastatic disease burden in the Midwest and South, but a higher disease burden in the West.

In all regions, there was a significant association between decreased early cancer burden in areas with high percentages of women of Asian heritage, and significantly increased burden in areas with large populations of women of Hispanic origin.

The only significant association of race/ethnicity with recurrent/metastatic burden was a decrease in the Midwest in populations with large Asian populations.

An analysis of the how poverty levels affected screening and disease burden showed that in areas with a high percentage of low-income households there were significant associations with decreased cervical cancer screening and higher burden of newly diagnosed cases.

Poverty levels were significantly associated with recurrent/metastatic cancers only in the South.

The investigators also found that the presence of one or more brachytherapy centers within a ZIP-3 region (that is, a large geographic area designated by the first 3 digits of ZIP codes rather than 5-digit city codes) was associated with a 2.7% reduction in recurrent or metastatic cervical cancer burden (P less than .001).

Demographic Marker?

Reasons for disparities are complex and may involve a combination of inadequate health literacy and social and economic circumstances, said Cesar Castro, MD, commenting on the new cervical cancer study.

He noted in an interview that “the concept that a single Pap smear is often insufficient to capture precancerous changes, and hence the need for serial testing every 3 years, can be lost on individuals who also have competing challenges securing paychecks and/or dependent care. Historical barriers such as perceptions of the underlying cause of cervical cancer, the HPV virus, being a sexually transmitted disease and hence a taboo subject, also underpin decision-making. These sentiments have also fueled resistance towards HPV vaccination in young girls and boys.”

Dr. Castro, who is Program Director for Gynecologic Oncology at the Mass General Cancer Center in Boston, pointed out that treatments for cervical cancer often involve surgery or a combination of chemotherapy and radiation, and that side effects from these interventions may be especially disruptive to the lives of women who are breadwinners or caregivers for their families.

“These are the shackles that poverty places on many Black and Hispanic women notably in under-resourced regions domestically and globally,” he said.

The study was supported by Seagen and Genmab. Dr. Castellano disclosed consulting fees from GSK and Nykode and grant support from BMS. Dr. Castro reported no relevant conflicts of interest and was not involved in either of the studies presented at the meeting.

 

Disparities and geographical variations in cervical cancer outcomes appear to be related to social determinants of health, including socioeconomic status, race or ethnicity, and proximity to facilities skilled at early-stage diagnosis and treatment.

These findings come from analyses of insurance data gathered via the Cervical Cancer Geo-Analyzer tool, a publicly available online instrument designed to provide visual representation of recurrent or metastatic cervical cancer burden across metropolitan statistical areas in the United States over multiple years.

[Reporting the findings of] “this study is the first step to optimize healthcare resources allocations, advocate for policy changes that will minimize access barriers, and tailor education for modern treatment options to help reduce and improve outcomes for cervical cancer in US patients,” said Tara Castellano, MD, an author and presenter of this new research, at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego.

Seeing Cancer Cases

Dr. Castellano and colleagues previously reported that the Geo-Analyzer tool effectively provides quantified evidence of cervical cancer disease burden and graphic representation of geographical variations across the United States for both incident and recurrent/metastatic cervical cancer.

In the current analysis, Dr. Castellano, of Louisiana State University School of Medicine in New Orleans, discussed potential factors related to cervical cancer incidence and geographic variations.

The study builds on previous studies that have shown that Black and Hispanic women have longer time to treatment and worse cervical cancer outcomes than White women.

For example, in a study published in the International Journal of Gynecologic Cancer, Marilyn Huang, MD, and colleagues from the University of Miami Miller School of Medicine, Miami, Florida, and other centers in Miami looked at time to treatment in a diverse population of 274 women starting therapy for cervical cancer.

They found that insurance type (private, public, or none) contributed to delay in treatment initiation regardless of the treatment modality, and that the patient’s language and institution of diagnosis also influenced time to treatment.

In a separate scientific poster presented at SGO 2024, Dr. Castellano and colleagues reported that, among women with newly diagnosed endometrial cancer, the median time to treatment was 7 days longer for both Hispanic and Black women, compared with non-Hispanic White women. In addition, Black women had a 7-day longer time to receiving their first therapy for advanced disease. All of these differences were statistically significant.

Dr. Castellano told this news organization that the time-to-treatment disparities in the endometrial cancer study were determined by diagnostic codes and the timing of insurance claims.

Reasons for the disparities may include more limited access to care and structural and systemic biases in the healthcare systems where the majority of Black and Hispanic patients live, she said.

Insurance Database

In the new study on cervical cancer, Dr. Castellano and her team defined cervical cancer burden as prevalent cervical cancer diagnosis per 100,000 eligible women enrolled in a commercial insurance plan, Medicaid, or Medicare Advantage. Recurrent or metastatic cancer was determined to be the proportion of patients with cervical cancer who initiated systemic therapy.

 

 

The goals of the study were to provide a visualization of geographical distribution of cervical cancer in the US, and to quantify associations between early or advanced cancers with screening rates, poverty level, race/ethnicity, and access to brachytherapy.

The administrative claims database queried for the study included information on 75,521 women (median age 53) with a first diagnosis of cervical cancer from 2015 through 2022, and 14,033 women with recurrent or metastatic malignancies (median age 59 years).

Distribution of cases was higher in the South compared with in other US regions (37% vs approximately 20% for other regions).

Looking at the association between screening rates and disease burden from 2017 through 2022, the Geo-Analyzer showed that higher screening rates were significantly associated with decreased burden of new cases only in the South, whereas higher screening rates were associated with lower recurrent/metastatic disease burden in the Midwest and South, but a higher disease burden in the West.

In all regions, there was a significant association between decreased early cancer burden in areas with high percentages of women of Asian heritage, and significantly increased burden in areas with large populations of women of Hispanic origin.

The only significant association of race/ethnicity with recurrent/metastatic burden was a decrease in the Midwest in populations with large Asian populations.

An analysis of the how poverty levels affected screening and disease burden showed that in areas with a high percentage of low-income households there were significant associations with decreased cervical cancer screening and higher burden of newly diagnosed cases.

Poverty levels were significantly associated with recurrent/metastatic cancers only in the South.

The investigators also found that the presence of one or more brachytherapy centers within a ZIP-3 region (that is, a large geographic area designated by the first 3 digits of ZIP codes rather than 5-digit city codes) was associated with a 2.7% reduction in recurrent or metastatic cervical cancer burden (P less than .001).

Demographic Marker?

Reasons for disparities are complex and may involve a combination of inadequate health literacy and social and economic circumstances, said Cesar Castro, MD, commenting on the new cervical cancer study.

He noted in an interview that “the concept that a single Pap smear is often insufficient to capture precancerous changes, and hence the need for serial testing every 3 years, can be lost on individuals who also have competing challenges securing paychecks and/or dependent care. Historical barriers such as perceptions of the underlying cause of cervical cancer, the HPV virus, being a sexually transmitted disease and hence a taboo subject, also underpin decision-making. These sentiments have also fueled resistance towards HPV vaccination in young girls and boys.”

Dr. Castro, who is Program Director for Gynecologic Oncology at the Mass General Cancer Center in Boston, pointed out that treatments for cervical cancer often involve surgery or a combination of chemotherapy and radiation, and that side effects from these interventions may be especially disruptive to the lives of women who are breadwinners or caregivers for their families.

“These are the shackles that poverty places on many Black and Hispanic women notably in under-resourced regions domestically and globally,” he said.

The study was supported by Seagen and Genmab. Dr. Castellano disclosed consulting fees from GSK and Nykode and grant support from BMS. Dr. Castro reported no relevant conflicts of interest and was not involved in either of the studies presented at the meeting.

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FROM SGO 2024

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FDA OKs Danicopan Add-On for Extravascular Hemolysis in Adults With PNH

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Tue, 04/02/2024 - 13:45

The US Food and Drug Administration has approved danicopan (Voydeya, AstraZeneca) as an add-on therapy to treat extravascular hemolysis in adults receiving ravulizumab or eculizumab for paroxysmal nocturnal hemoglobinuria (PNH), according to a press release from AstraZeneca.

PNH is a rare blood disorder affecting 1-10 individuals per million. The condition, which eliminates red blood cells and leads to blood clots and impaired bone marrow function, can cause life-threatening anemia, thrombosis, and bone marrow dysfunction. About half of people with the condition die from thrombotic complications.

Ravulizumab and eculizumab, also both made by AstraZeneca, inhibit the destruction of red blood cells. However, 10%-20% of patients treated with the antibody infusions experience significant extravascular hemolysis, in which these surviving red blood cells are eliminated by the spleen and liver. Extravascular hemolysis can lead to ongoing anemia, which can lead patients to require blood transfusions.

Danicopan, an investigational, first-in-class, oral complement factor D inhibitor, is designed to control intravascular hemolysis and prevent extravascular hemolysis.

Approval of the oral medication was based on the phase 3 ALPHA trial in 63 patients with PNH who received ravulizumab or eculizumab and experienced significant extravascular hemolysis. These patients were randomized 2:1 to either danicopan or placebo.

Danicopan add-on significantly improved hemoglobin concentrations at 12 weeks (least squares mean improvement from baseline: 2.94 g/dL with danicopan vs 0.50 g/dL with placebo) and made transfusions less likely.

Headache, nausea, arthralgia, and diarrhea were the most common treatment-emergent side effects. Serious adverse events in the danicopan group included cholecystitis and COVID-19 in one patient each.

Danicopan carries a boxed warning of serious infections and is available only through a Risk Evaluation and Mitigation Strategy program.

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration has approved danicopan (Voydeya, AstraZeneca) as an add-on therapy to treat extravascular hemolysis in adults receiving ravulizumab or eculizumab for paroxysmal nocturnal hemoglobinuria (PNH), according to a press release from AstraZeneca.

PNH is a rare blood disorder affecting 1-10 individuals per million. The condition, which eliminates red blood cells and leads to blood clots and impaired bone marrow function, can cause life-threatening anemia, thrombosis, and bone marrow dysfunction. About half of people with the condition die from thrombotic complications.

Ravulizumab and eculizumab, also both made by AstraZeneca, inhibit the destruction of red blood cells. However, 10%-20% of patients treated with the antibody infusions experience significant extravascular hemolysis, in which these surviving red blood cells are eliminated by the spleen and liver. Extravascular hemolysis can lead to ongoing anemia, which can lead patients to require blood transfusions.

Danicopan, an investigational, first-in-class, oral complement factor D inhibitor, is designed to control intravascular hemolysis and prevent extravascular hemolysis.

Approval of the oral medication was based on the phase 3 ALPHA trial in 63 patients with PNH who received ravulizumab or eculizumab and experienced significant extravascular hemolysis. These patients were randomized 2:1 to either danicopan or placebo.

Danicopan add-on significantly improved hemoglobin concentrations at 12 weeks (least squares mean improvement from baseline: 2.94 g/dL with danicopan vs 0.50 g/dL with placebo) and made transfusions less likely.

Headache, nausea, arthralgia, and diarrhea were the most common treatment-emergent side effects. Serious adverse events in the danicopan group included cholecystitis and COVID-19 in one patient each.

Danicopan carries a boxed warning of serious infections and is available only through a Risk Evaluation and Mitigation Strategy program.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has approved danicopan (Voydeya, AstraZeneca) as an add-on therapy to treat extravascular hemolysis in adults receiving ravulizumab or eculizumab for paroxysmal nocturnal hemoglobinuria (PNH), according to a press release from AstraZeneca.

PNH is a rare blood disorder affecting 1-10 individuals per million. The condition, which eliminates red blood cells and leads to blood clots and impaired bone marrow function, can cause life-threatening anemia, thrombosis, and bone marrow dysfunction. About half of people with the condition die from thrombotic complications.

Ravulizumab and eculizumab, also both made by AstraZeneca, inhibit the destruction of red blood cells. However, 10%-20% of patients treated with the antibody infusions experience significant extravascular hemolysis, in which these surviving red blood cells are eliminated by the spleen and liver. Extravascular hemolysis can lead to ongoing anemia, which can lead patients to require blood transfusions.

Danicopan, an investigational, first-in-class, oral complement factor D inhibitor, is designed to control intravascular hemolysis and prevent extravascular hemolysis.

Approval of the oral medication was based on the phase 3 ALPHA trial in 63 patients with PNH who received ravulizumab or eculizumab and experienced significant extravascular hemolysis. These patients were randomized 2:1 to either danicopan or placebo.

Danicopan add-on significantly improved hemoglobin concentrations at 12 weeks (least squares mean improvement from baseline: 2.94 g/dL with danicopan vs 0.50 g/dL with placebo) and made transfusions less likely.

Headache, nausea, arthralgia, and diarrhea were the most common treatment-emergent side effects. Serious adverse events in the danicopan group included cholecystitis and COVID-19 in one patient each.

Danicopan carries a boxed warning of serious infections and is available only through a Risk Evaluation and Mitigation Strategy program.

A version of this article appeared on Medscape.com.

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Single Session Mindfulness Intervention Linked to Reduced Depression

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TOPLINE:

One session of a telehealth intervention combining mindfulness and compassion significantly lowered self-perceived stress and symptoms of depression and anxiety compared with a waitlist control group, results of a new trial showed. 

METHODOLOGY:

  • The randomized clinical trial (RCT) included 91 participants aged 18-70 years recruited from the community and the University of Texas at Austin and followed from 2020 to 2021.
  • To be included in the trial, participants had to be sheltering at home during the pandemic and endorse loneliness as one of the top issues affecting them.
  • Participants were randomized to one of three groups that received single-session online interventions. These included mindfulness-only (MO), mindfulness and compassion (MC), and a waitlist control (WL) group.
  • During the compassion component, participants were instructed to focus on a person, place, object, or spiritual figure that evoked feelings of warmth, love, and kindness in them. The primary outcome was self-reported loneliness and secondary outcomes were self-reported stress, depression, and anxiety.

TAKEAWAY:

  • At 1-week follow-up, the MC group led to reductions in perceived stress (b = −3.75), anxiety (b = −3.79), and depression (b = −3.01) but not loneliness compared with control individuals.
  • Compared with the MO group alone, the MC group had no meaningful differences in perceived depression (b = −1.08) or anxiety (b = −1.50), and the same was true at the 2-week follow-up.
  • Researchers speculated that the lack of difference between outcomes in the two mindfulness groups probably meant that the MC group may have only been effective in reducing self-perceived symptoms of stress, anxiety, and depression compared with the control group.

IN PRACTICE:

“This brief single session mindfulness intervention offers an approach that can be easily adopted in a range of contexts. It is important for future research to evaluate this approach with larger samples and to examine whether changes in symptoms are maintained over longer periods of time,” the researchers wrote. 

SOURCE:

Mikael Rubin, PhD, of Palo Alto University in Palo Alto, California, led the study, which was published online in PLOS ONE.

LIMITATIONS:

The study was limited by its small sample size and short follow-up period.

DISCLOSURES:

There was no funding listed for the study nor were there any reported disclosures. 

A version of this article appeared on Medscape.com.

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TOPLINE:

One session of a telehealth intervention combining mindfulness and compassion significantly lowered self-perceived stress and symptoms of depression and anxiety compared with a waitlist control group, results of a new trial showed. 

METHODOLOGY:

  • The randomized clinical trial (RCT) included 91 participants aged 18-70 years recruited from the community and the University of Texas at Austin and followed from 2020 to 2021.
  • To be included in the trial, participants had to be sheltering at home during the pandemic and endorse loneliness as one of the top issues affecting them.
  • Participants were randomized to one of three groups that received single-session online interventions. These included mindfulness-only (MO), mindfulness and compassion (MC), and a waitlist control (WL) group.
  • During the compassion component, participants were instructed to focus on a person, place, object, or spiritual figure that evoked feelings of warmth, love, and kindness in them. The primary outcome was self-reported loneliness and secondary outcomes were self-reported stress, depression, and anxiety.

TAKEAWAY:

  • At 1-week follow-up, the MC group led to reductions in perceived stress (b = −3.75), anxiety (b = −3.79), and depression (b = −3.01) but not loneliness compared with control individuals.
  • Compared with the MO group alone, the MC group had no meaningful differences in perceived depression (b = −1.08) or anxiety (b = −1.50), and the same was true at the 2-week follow-up.
  • Researchers speculated that the lack of difference between outcomes in the two mindfulness groups probably meant that the MC group may have only been effective in reducing self-perceived symptoms of stress, anxiety, and depression compared with the control group.

IN PRACTICE:

“This brief single session mindfulness intervention offers an approach that can be easily adopted in a range of contexts. It is important for future research to evaluate this approach with larger samples and to examine whether changes in symptoms are maintained over longer periods of time,” the researchers wrote. 

SOURCE:

Mikael Rubin, PhD, of Palo Alto University in Palo Alto, California, led the study, which was published online in PLOS ONE.

LIMITATIONS:

The study was limited by its small sample size and short follow-up period.

DISCLOSURES:

There was no funding listed for the study nor were there any reported disclosures. 

A version of this article appeared on Medscape.com.

 

TOPLINE:

One session of a telehealth intervention combining mindfulness and compassion significantly lowered self-perceived stress and symptoms of depression and anxiety compared with a waitlist control group, results of a new trial showed. 

METHODOLOGY:

  • The randomized clinical trial (RCT) included 91 participants aged 18-70 years recruited from the community and the University of Texas at Austin and followed from 2020 to 2021.
  • To be included in the trial, participants had to be sheltering at home during the pandemic and endorse loneliness as one of the top issues affecting them.
  • Participants were randomized to one of three groups that received single-session online interventions. These included mindfulness-only (MO), mindfulness and compassion (MC), and a waitlist control (WL) group.
  • During the compassion component, participants were instructed to focus on a person, place, object, or spiritual figure that evoked feelings of warmth, love, and kindness in them. The primary outcome was self-reported loneliness and secondary outcomes were self-reported stress, depression, and anxiety.

TAKEAWAY:

  • At 1-week follow-up, the MC group led to reductions in perceived stress (b = −3.75), anxiety (b = −3.79), and depression (b = −3.01) but not loneliness compared with control individuals.
  • Compared with the MO group alone, the MC group had no meaningful differences in perceived depression (b = −1.08) or anxiety (b = −1.50), and the same was true at the 2-week follow-up.
  • Researchers speculated that the lack of difference between outcomes in the two mindfulness groups probably meant that the MC group may have only been effective in reducing self-perceived symptoms of stress, anxiety, and depression compared with the control group.

IN PRACTICE:

“This brief single session mindfulness intervention offers an approach that can be easily adopted in a range of contexts. It is important for future research to evaluate this approach with larger samples and to examine whether changes in symptoms are maintained over longer periods of time,” the researchers wrote. 

SOURCE:

Mikael Rubin, PhD, of Palo Alto University in Palo Alto, California, led the study, which was published online in PLOS ONE.

LIMITATIONS:

The study was limited by its small sample size and short follow-up period.

DISCLOSURES:

There was no funding listed for the study nor were there any reported disclosures. 

A version of this article appeared on Medscape.com.

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Maternal Lifestyle Interventions Boost Babies’ Heart Health

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Tue, 04/02/2024 - 13:03

Infants born to women with obesity showed improved measures of cardiovascular health when their mothers adopted healthier lifestyles before and during pregnancy, based on data from a systematic review presented at the annual meeting of the Society for Reproductive Investigation.

Previous research has shown that children born to mothers with a high body mass index (BMI) are more likely to die from cardiovascular disease in later life, said presenting author Samuel J. Burden, PhD, in an interview.

“Surprisingly, early signs of these heart issues can start before birth and continue into childhood,” said Dr. Burden, a research associate in the Department of Women & Children’s Health, School of Life Course & Population Sciences, King’s College London, London, United Kingdom.

To examine the effect of interventions such as a healthy diet and exercise in pregnant women with obesity on the heart health of their infants, Dr. Burden and colleagues reviewed data from eight randomized, controlled trials involving diet and exercise for pregnant women with obesity. Of these, two used antenatal exercise, two used diet and physical activity, and one used preconception diet and physical activity. The studies ranged in size from 18 to 404 participants. Two studies included infants younger than 2 months of age, and four studies included children aged 3-7 years.

Overall, lifestyle interventions before conception and before birth were associated with significant changes in cardiac remodeling, specifically reduced interventricular septal wall thickness.

In addition, one of three studies of cardiac diastolic function and four of five studies of systolic function showed significant improvements. The five studies of cardiac systolic function and three studies of diastolic function also showed improvement in systolic and diastolic blood pressure in infants of mothers who took part in the interventions. The studies were limited mainly by large attrition rates, the researchers wrote in their presentation. However, more studies in larger populations that also include older children could confirm the findings and inform public health strategies to promote healthy lifestyles for pregnant women, they noted.

Encourage Healthy Lifestyle Before and During Pregnancy

The evidence supports the findings from animal studies showing that an offspring’s health is influenced by maternal lifestyle before and during pregnancy, Dr. Burden said in an interview. The data suggest that healthcare providers should encourage women with a high BMI who want to become pregnant to eat healthfully and become more active as a way to enhance the future cardiovascular health of their children, he said.

The full results of the current study are soon to be published, but more work is needed, said Dr. Burden. “While we observed a protective effect from these lifestyle programs, there is a need for more extensive studies involving a larger number of women (and their children) who were part of the initial research,” he said. “Additionally, it will be crucial to track these children into adulthood to determine whether these antenatal lifestyle interventions persist in lowering the risk of future cardiovascular disease.”

Beginning healthy lifestyle programs prior to pregnancy might yield the best results for promoting infant cardiovascular health, and more prepregnancy interventions for women with obesity are needed, Dr. Burden added.

The current study adds to the growing body of evidence that the in utero environment can have lifelong effects on offspring, Joseph R. Biggio Jr, MD, system chair of maternal fetal medicine at Ochsner Health, New Orleans, Louisiana, said in an interview.

“Several studies have previously shown that the children of mothers with diabetes, hypertension, or obesity are at increased risk for developing signs of metabolic syndrome and cardiovascular changes during childhood or adolescence,” said Dr. Biggio.

The data from this systematic review support the potential value of interventions aimed at improving maternal weight gain and cardiovascular performance before and during pregnancy that may result in reduced cardiovascular remodeling and myocardial thickening in infants, he said.   

The study was supported by a British Heart Foundation Special Project Grant. The researchers had no financial conflicts to disclose. Dr. Biggio had no financial conflicts to disclose.

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Infants born to women with obesity showed improved measures of cardiovascular health when their mothers adopted healthier lifestyles before and during pregnancy, based on data from a systematic review presented at the annual meeting of the Society for Reproductive Investigation.

Previous research has shown that children born to mothers with a high body mass index (BMI) are more likely to die from cardiovascular disease in later life, said presenting author Samuel J. Burden, PhD, in an interview.

“Surprisingly, early signs of these heart issues can start before birth and continue into childhood,” said Dr. Burden, a research associate in the Department of Women & Children’s Health, School of Life Course & Population Sciences, King’s College London, London, United Kingdom.

To examine the effect of interventions such as a healthy diet and exercise in pregnant women with obesity on the heart health of their infants, Dr. Burden and colleagues reviewed data from eight randomized, controlled trials involving diet and exercise for pregnant women with obesity. Of these, two used antenatal exercise, two used diet and physical activity, and one used preconception diet and physical activity. The studies ranged in size from 18 to 404 participants. Two studies included infants younger than 2 months of age, and four studies included children aged 3-7 years.

Overall, lifestyle interventions before conception and before birth were associated with significant changes in cardiac remodeling, specifically reduced interventricular septal wall thickness.

In addition, one of three studies of cardiac diastolic function and four of five studies of systolic function showed significant improvements. The five studies of cardiac systolic function and three studies of diastolic function also showed improvement in systolic and diastolic blood pressure in infants of mothers who took part in the interventions. The studies were limited mainly by large attrition rates, the researchers wrote in their presentation. However, more studies in larger populations that also include older children could confirm the findings and inform public health strategies to promote healthy lifestyles for pregnant women, they noted.

Encourage Healthy Lifestyle Before and During Pregnancy

The evidence supports the findings from animal studies showing that an offspring’s health is influenced by maternal lifestyle before and during pregnancy, Dr. Burden said in an interview. The data suggest that healthcare providers should encourage women with a high BMI who want to become pregnant to eat healthfully and become more active as a way to enhance the future cardiovascular health of their children, he said.

The full results of the current study are soon to be published, but more work is needed, said Dr. Burden. “While we observed a protective effect from these lifestyle programs, there is a need for more extensive studies involving a larger number of women (and their children) who were part of the initial research,” he said. “Additionally, it will be crucial to track these children into adulthood to determine whether these antenatal lifestyle interventions persist in lowering the risk of future cardiovascular disease.”

Beginning healthy lifestyle programs prior to pregnancy might yield the best results for promoting infant cardiovascular health, and more prepregnancy interventions for women with obesity are needed, Dr. Burden added.

The current study adds to the growing body of evidence that the in utero environment can have lifelong effects on offspring, Joseph R. Biggio Jr, MD, system chair of maternal fetal medicine at Ochsner Health, New Orleans, Louisiana, said in an interview.

“Several studies have previously shown that the children of mothers with diabetes, hypertension, or obesity are at increased risk for developing signs of metabolic syndrome and cardiovascular changes during childhood or adolescence,” said Dr. Biggio.

The data from this systematic review support the potential value of interventions aimed at improving maternal weight gain and cardiovascular performance before and during pregnancy that may result in reduced cardiovascular remodeling and myocardial thickening in infants, he said.   

The study was supported by a British Heart Foundation Special Project Grant. The researchers had no financial conflicts to disclose. Dr. Biggio had no financial conflicts to disclose.

Infants born to women with obesity showed improved measures of cardiovascular health when their mothers adopted healthier lifestyles before and during pregnancy, based on data from a systematic review presented at the annual meeting of the Society for Reproductive Investigation.

Previous research has shown that children born to mothers with a high body mass index (BMI) are more likely to die from cardiovascular disease in later life, said presenting author Samuel J. Burden, PhD, in an interview.

“Surprisingly, early signs of these heart issues can start before birth and continue into childhood,” said Dr. Burden, a research associate in the Department of Women & Children’s Health, School of Life Course & Population Sciences, King’s College London, London, United Kingdom.

To examine the effect of interventions such as a healthy diet and exercise in pregnant women with obesity on the heart health of their infants, Dr. Burden and colleagues reviewed data from eight randomized, controlled trials involving diet and exercise for pregnant women with obesity. Of these, two used antenatal exercise, two used diet and physical activity, and one used preconception diet and physical activity. The studies ranged in size from 18 to 404 participants. Two studies included infants younger than 2 months of age, and four studies included children aged 3-7 years.

Overall, lifestyle interventions before conception and before birth were associated with significant changes in cardiac remodeling, specifically reduced interventricular septal wall thickness.

In addition, one of three studies of cardiac diastolic function and four of five studies of systolic function showed significant improvements. The five studies of cardiac systolic function and three studies of diastolic function also showed improvement in systolic and diastolic blood pressure in infants of mothers who took part in the interventions. The studies were limited mainly by large attrition rates, the researchers wrote in their presentation. However, more studies in larger populations that also include older children could confirm the findings and inform public health strategies to promote healthy lifestyles for pregnant women, they noted.

Encourage Healthy Lifestyle Before and During Pregnancy

The evidence supports the findings from animal studies showing that an offspring’s health is influenced by maternal lifestyle before and during pregnancy, Dr. Burden said in an interview. The data suggest that healthcare providers should encourage women with a high BMI who want to become pregnant to eat healthfully and become more active as a way to enhance the future cardiovascular health of their children, he said.

The full results of the current study are soon to be published, but more work is needed, said Dr. Burden. “While we observed a protective effect from these lifestyle programs, there is a need for more extensive studies involving a larger number of women (and their children) who were part of the initial research,” he said. “Additionally, it will be crucial to track these children into adulthood to determine whether these antenatal lifestyle interventions persist in lowering the risk of future cardiovascular disease.”

Beginning healthy lifestyle programs prior to pregnancy might yield the best results for promoting infant cardiovascular health, and more prepregnancy interventions for women with obesity are needed, Dr. Burden added.

The current study adds to the growing body of evidence that the in utero environment can have lifelong effects on offspring, Joseph R. Biggio Jr, MD, system chair of maternal fetal medicine at Ochsner Health, New Orleans, Louisiana, said in an interview.

“Several studies have previously shown that the children of mothers with diabetes, hypertension, or obesity are at increased risk for developing signs of metabolic syndrome and cardiovascular changes during childhood or adolescence,” said Dr. Biggio.

The data from this systematic review support the potential value of interventions aimed at improving maternal weight gain and cardiovascular performance before and during pregnancy that may result in reduced cardiovascular remodeling and myocardial thickening in infants, he said.   

The study was supported by a British Heart Foundation Special Project Grant. The researchers had no financial conflicts to disclose. Dr. Biggio had no financial conflicts to disclose.

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Improved Communication Center Stage in Multiple Sclerosis

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Fri, 10/25/2024 - 14:19

This transcript has been edited for clarity.

 

Joseph R. Berger, MD: Hi. I'm Dr Joseph Berger, and I'm joined for this Care Cues conversation with my patient, Michelle Biloon, who has had multiple sclerosis (MS) for the past 6 years. Hello, Michelle. Welcome.

Michelle Biloon: Thank you, Dr Berger.

Berger: Can you tell us a little bit about yourself, how you came to understand you had MS, and how you've done since the diagnosis was rendered?

Biloon: Yeah. It was a very short diagnosis period for me. In the winter of 2017, I started experiencing dizzy spells, and I didn't really know why. I eventually went to my primary care clinic where my doctor is, and they did blood work. Then, they did a CT and didn't see anything, and I just kind of kept feeling worse.

Then, finally, I went to an ENT just to see if it was maybe related to my ears. The ENT actually said, "You need to go to the ER and get an MRI." And while I was in the MRI, I could feel the dizzy spells. And I thought, Well, something is happening. I don't know what it is. And then a resident came in and said that they saw lesions on my brain, and they knew that it was going to be MS or something like it.

Berger: How did you feel about that?

Biloon: At the time, I was kind of glad to hear it was something. And I just asked her if, like, you die from it. That was the first thing I asked. It was like falling off a cliff.

It was making it hard for me to function in what I was doing, which was stand-up comedy, because of the cognitive issues I was having, the cognitive fog. That was how I ended up with you. Right away, you talked to me and were actually able to introduce to me some new medications that are out and are phenomenally better for MS plus were not pills or shots every day. It's made my MS over the years a lot more manageable.

Berger: I'd like to pick up on a couple of things you said.

Biloon: Sure.

Berger: One is, because most people envision MS as this terrible, crippling illness that's going to leave them wheelchair-bound, deprived of their profession, finding it difficult to stay in a marriage it's vested with what has been termed "lamentable results." And one of the first things that we as physicians have to do is to calm people down and say, "You know what. You have MS. You're going to be just fine. Trust me. We have wonderful medications for what you have, and we'll take care of it." In fact, I've made a habit of telling people quit worrying. You hired me to worry for you.

Biloon: Yep.

Berger: And I think that's helpful.

Biloon: I've been just so appreciative of that. There's a balance of being condescended to — do you know what I mean — and also being given information. I'm very sensitive to that balance because I consider myself an intelligent person. And you're being put in a position where someone knows more than you, and you have to listen.

Berger: One of the other challenges we face is getting somebody on a treatment. And we elected to put you on an intravenous therapy every 6 months.

Biloon: Especially because as a stand-up comedian, I was traveling a lot, doing these every-6-months infusion, especially with the high efficacy rate that it had been reported from what we had read and the low amount of side effects. I mean, just those things together was just something that seemed the easiest for me.

Berger: So did you encounter any challenges when we first got you started on the infusion therapy?

Biloon: The first infusion I got was at the hospital. But then after that, I had to go to the suburbs, to a center out there for the infusion. That was difficult because to get a ride out there and a ride back — it was a long trip for someone to wait with me. Taking an Uber is expensive, so was it for me to drive. You don't feel good for a couple of days after. So that was how it was, and I complained about it. Probably at every appointment we had, I complained about it.

Berger: Yeah. So some of the challenges you talked about are very, very common. As a physician on medications myself, I can tell you that I am not particularly compliant. And what I love about infusion therapies is that I know that the patient is getting their medicine. Because when they don't show up for a scheduled appointment, I'm called, and I know.

Biloon: I do have a bit of an allergic reaction to the drug. But that's been easily managed over time. Now, the drug infusions are actually being done at my home, which makes the whole process twice-a-year–world's better.

Berger: But there are other barriers that people confront other than the initiation of drugs. Had you encountered any?

Biloon: I think the problem that I had more so was finding the drugs that would manage some of my symptoms. It took a couple of years to sort of figure out what that would be, both with figuring them out and both dealing with insurance on certain medications.

Berger: That's one sort of problem that we confront. The other, of course, are those individuals who, for a variety of reasons, have difficulty with the diagnosis because of their backgrounds. And they may be sociocultural in nature. Every time you go to the physical therapist, it's some degree of money.

Now for some people, it's trivial. But for others, it's a considerable amount of money, relative to what it is that they earn. And you simply have to work within those confines as best you can.

We do have various programs that help people. So we try to employ them. There are, in addition to the sociocultural barriers, language barriers that we often confront. We, in our situation here in a large city, have a very large migrant population.

Fortunately, most of the people speak languages that either you speak as well, or there's somebody in the next room that speaks pretty well. But that's not always the case. So we do have an interpreter service that has to be employed.

Biloon: I cannot imagine the nuance in speaking to people from different ages and different backgrounds, who have different types of lifestyles, for them to understand.

Berger: I don't write at a computer. I think that really degrades the patient-physician relationship. What I do is I obtain a history. I do it on a piece of paper with a pen or a pencil.

I recapitulate them to the patient in paraphrasing it, to make sure that I have gotten it right and that they understand what I think I heard. That, I think, has been enormously helpful in helping people understand what may happen in the absence of treatment and why the treatment is important. That you can do, regardless of what the person's background is. So that's how I approach it.

Biloon: How do you deal with patients when they're not on the same page with you?

Berger: One important thing is that you have to be patient. That is something that it took me 50 years in medicine to learn. And then accepting the patient's opinion and saying, "All right, go home and think about it," because you often don't convince them when they're in the office with you.

Biloon: I did have a little bit of a cushion between my diagnosis and when we actually saw each other, where I was able to really sit in my thoughts on the different treatments and stuff. By the time that we were able to talk, it reassured me on that was the right plan.

Berger: I'm curious what your experience has been with our MS center.

Biloon: Through the portal, every time I need something, I'm usually reaching out, keeping you up-to-date on my primary care or whether it's trying to get a refill on one of my medications that I have to reach out. I really do feel that having that team there, being able to reach out, that's been extremely helpful to have and keeps me very secure because that's all I really need, especially during the pandemic, right? Because then I was very isolated and dealing with going through MS. So it was great to at least ­— and I did — shoot off emails or texts in the portal, and that's usually primarily how I communicated.

Berger: I will tell you, in my opinion, maybe nine out of 10 messages in the portal or calls that we get simply require reassurance.

Biloon: Yes.

Berger: You just either pick up the phone or shoot back a note, say, "This is not your MS. Don't worry about it." I mean, the most important thing for me is to keep people from worrying because that doesn't solve any problem.

Biloon: No, and it causes stress, which causes fatigue. I mean, it's a bad cycle.

Berger: In the past year, you've actually felt better, and you've gone back to performing. It sounds like the volume of performances has gotten back to what it was pre-illness. What do you see for the future?

Biloon: What I see is traveling more for stand-up and doing the sort of clubs and cities that I had kind of stopped doing from before I was diagnosed, so 2017 and prior to that. And then also even working on other things, writing and maybe even doing sort of books or one-person shows that even talk about sort of my struggles with MS and kind of coming back to where I am. I'm looking forward to the future, and I hope that that's the track I can keep going on.

Berger: I see no reason why you shouldn't.

Biloon: Thank you.

Berger: Michelle, thank you very much for joining me today in this conversation.

Biloon: Thank you so much for having me. It's been really wonderful to be able to sit down here with you.

 


 

Joseph R. Berger, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Celgene/Bristol-Myers Squibb; Cellevolve; EMD Serono/Merck/Genentech; Genzyme; Janssen/Johnson & Johnson; Morphic; Novartis; Roche; Sanofi; Takeda; TG Therapeutics; MAPI; Excision Bio
Received research grant from: Genentech/Roche

Michelle Biloon has disclosed no relevant financial relationships

 

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This transcript has been edited for clarity.

 

Joseph R. Berger, MD: Hi. I'm Dr Joseph Berger, and I'm joined for this Care Cues conversation with my patient, Michelle Biloon, who has had multiple sclerosis (MS) for the past 6 years. Hello, Michelle. Welcome.

Michelle Biloon: Thank you, Dr Berger.

Berger: Can you tell us a little bit about yourself, how you came to understand you had MS, and how you've done since the diagnosis was rendered?

Biloon: Yeah. It was a very short diagnosis period for me. In the winter of 2017, I started experiencing dizzy spells, and I didn't really know why. I eventually went to my primary care clinic where my doctor is, and they did blood work. Then, they did a CT and didn't see anything, and I just kind of kept feeling worse.

Then, finally, I went to an ENT just to see if it was maybe related to my ears. The ENT actually said, "You need to go to the ER and get an MRI." And while I was in the MRI, I could feel the dizzy spells. And I thought, Well, something is happening. I don't know what it is. And then a resident came in and said that they saw lesions on my brain, and they knew that it was going to be MS or something like it.

Berger: How did you feel about that?

Biloon: At the time, I was kind of glad to hear it was something. And I just asked her if, like, you die from it. That was the first thing I asked. It was like falling off a cliff.

It was making it hard for me to function in what I was doing, which was stand-up comedy, because of the cognitive issues I was having, the cognitive fog. That was how I ended up with you. Right away, you talked to me and were actually able to introduce to me some new medications that are out and are phenomenally better for MS plus were not pills or shots every day. It's made my MS over the years a lot more manageable.

Berger: I'd like to pick up on a couple of things you said.

Biloon: Sure.

Berger: One is, because most people envision MS as this terrible, crippling illness that's going to leave them wheelchair-bound, deprived of their profession, finding it difficult to stay in a marriage it's vested with what has been termed "lamentable results." And one of the first things that we as physicians have to do is to calm people down and say, "You know what. You have MS. You're going to be just fine. Trust me. We have wonderful medications for what you have, and we'll take care of it." In fact, I've made a habit of telling people quit worrying. You hired me to worry for you.

Biloon: Yep.

Berger: And I think that's helpful.

Biloon: I've been just so appreciative of that. There's a balance of being condescended to — do you know what I mean — and also being given information. I'm very sensitive to that balance because I consider myself an intelligent person. And you're being put in a position where someone knows more than you, and you have to listen.

Berger: One of the other challenges we face is getting somebody on a treatment. And we elected to put you on an intravenous therapy every 6 months.

Biloon: Especially because as a stand-up comedian, I was traveling a lot, doing these every-6-months infusion, especially with the high efficacy rate that it had been reported from what we had read and the low amount of side effects. I mean, just those things together was just something that seemed the easiest for me.

Berger: So did you encounter any challenges when we first got you started on the infusion therapy?

Biloon: The first infusion I got was at the hospital. But then after that, I had to go to the suburbs, to a center out there for the infusion. That was difficult because to get a ride out there and a ride back — it was a long trip for someone to wait with me. Taking an Uber is expensive, so was it for me to drive. You don't feel good for a couple of days after. So that was how it was, and I complained about it. Probably at every appointment we had, I complained about it.

Berger: Yeah. So some of the challenges you talked about are very, very common. As a physician on medications myself, I can tell you that I am not particularly compliant. And what I love about infusion therapies is that I know that the patient is getting their medicine. Because when they don't show up for a scheduled appointment, I'm called, and I know.

Biloon: I do have a bit of an allergic reaction to the drug. But that's been easily managed over time. Now, the drug infusions are actually being done at my home, which makes the whole process twice-a-year–world's better.

Berger: But there are other barriers that people confront other than the initiation of drugs. Had you encountered any?

Biloon: I think the problem that I had more so was finding the drugs that would manage some of my symptoms. It took a couple of years to sort of figure out what that would be, both with figuring them out and both dealing with insurance on certain medications.

Berger: That's one sort of problem that we confront. The other, of course, are those individuals who, for a variety of reasons, have difficulty with the diagnosis because of their backgrounds. And they may be sociocultural in nature. Every time you go to the physical therapist, it's some degree of money.

Now for some people, it's trivial. But for others, it's a considerable amount of money, relative to what it is that they earn. And you simply have to work within those confines as best you can.

We do have various programs that help people. So we try to employ them. There are, in addition to the sociocultural barriers, language barriers that we often confront. We, in our situation here in a large city, have a very large migrant population.

Fortunately, most of the people speak languages that either you speak as well, or there's somebody in the next room that speaks pretty well. But that's not always the case. So we do have an interpreter service that has to be employed.

Biloon: I cannot imagine the nuance in speaking to people from different ages and different backgrounds, who have different types of lifestyles, for them to understand.

Berger: I don't write at a computer. I think that really degrades the patient-physician relationship. What I do is I obtain a history. I do it on a piece of paper with a pen or a pencil.

I recapitulate them to the patient in paraphrasing it, to make sure that I have gotten it right and that they understand what I think I heard. That, I think, has been enormously helpful in helping people understand what may happen in the absence of treatment and why the treatment is important. That you can do, regardless of what the person's background is. So that's how I approach it.

Biloon: How do you deal with patients when they're not on the same page with you?

Berger: One important thing is that you have to be patient. That is something that it took me 50 years in medicine to learn. And then accepting the patient's opinion and saying, "All right, go home and think about it," because you often don't convince them when they're in the office with you.

Biloon: I did have a little bit of a cushion between my diagnosis and when we actually saw each other, where I was able to really sit in my thoughts on the different treatments and stuff. By the time that we were able to talk, it reassured me on that was the right plan.

Berger: I'm curious what your experience has been with our MS center.

Biloon: Through the portal, every time I need something, I'm usually reaching out, keeping you up-to-date on my primary care or whether it's trying to get a refill on one of my medications that I have to reach out. I really do feel that having that team there, being able to reach out, that's been extremely helpful to have and keeps me very secure because that's all I really need, especially during the pandemic, right? Because then I was very isolated and dealing with going through MS. So it was great to at least ­— and I did — shoot off emails or texts in the portal, and that's usually primarily how I communicated.

Berger: I will tell you, in my opinion, maybe nine out of 10 messages in the portal or calls that we get simply require reassurance.

Biloon: Yes.

Berger: You just either pick up the phone or shoot back a note, say, "This is not your MS. Don't worry about it." I mean, the most important thing for me is to keep people from worrying because that doesn't solve any problem.

Biloon: No, and it causes stress, which causes fatigue. I mean, it's a bad cycle.

Berger: In the past year, you've actually felt better, and you've gone back to performing. It sounds like the volume of performances has gotten back to what it was pre-illness. What do you see for the future?

Biloon: What I see is traveling more for stand-up and doing the sort of clubs and cities that I had kind of stopped doing from before I was diagnosed, so 2017 and prior to that. And then also even working on other things, writing and maybe even doing sort of books or one-person shows that even talk about sort of my struggles with MS and kind of coming back to where I am. I'm looking forward to the future, and I hope that that's the track I can keep going on.

Berger: I see no reason why you shouldn't.

Biloon: Thank you.

Berger: Michelle, thank you very much for joining me today in this conversation.

Biloon: Thank you so much for having me. It's been really wonderful to be able to sit down here with you.

 


 

Joseph R. Berger, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Celgene/Bristol-Myers Squibb; Cellevolve; EMD Serono/Merck/Genentech; Genzyme; Janssen/Johnson & Johnson; Morphic; Novartis; Roche; Sanofi; Takeda; TG Therapeutics; MAPI; Excision Bio
Received research grant from: Genentech/Roche

Michelle Biloon has disclosed no relevant financial relationships

 

This transcript has been edited for clarity.

 

Joseph R. Berger, MD: Hi. I'm Dr Joseph Berger, and I'm joined for this Care Cues conversation with my patient, Michelle Biloon, who has had multiple sclerosis (MS) for the past 6 years. Hello, Michelle. Welcome.

Michelle Biloon: Thank you, Dr Berger.

Berger: Can you tell us a little bit about yourself, how you came to understand you had MS, and how you've done since the diagnosis was rendered?

Biloon: Yeah. It was a very short diagnosis period for me. In the winter of 2017, I started experiencing dizzy spells, and I didn't really know why. I eventually went to my primary care clinic where my doctor is, and they did blood work. Then, they did a CT and didn't see anything, and I just kind of kept feeling worse.

Then, finally, I went to an ENT just to see if it was maybe related to my ears. The ENT actually said, "You need to go to the ER and get an MRI." And while I was in the MRI, I could feel the dizzy spells. And I thought, Well, something is happening. I don't know what it is. And then a resident came in and said that they saw lesions on my brain, and they knew that it was going to be MS or something like it.

Berger: How did you feel about that?

Biloon: At the time, I was kind of glad to hear it was something. And I just asked her if, like, you die from it. That was the first thing I asked. It was like falling off a cliff.

It was making it hard for me to function in what I was doing, which was stand-up comedy, because of the cognitive issues I was having, the cognitive fog. That was how I ended up with you. Right away, you talked to me and were actually able to introduce to me some new medications that are out and are phenomenally better for MS plus were not pills or shots every day. It's made my MS over the years a lot more manageable.

Berger: I'd like to pick up on a couple of things you said.

Biloon: Sure.

Berger: One is, because most people envision MS as this terrible, crippling illness that's going to leave them wheelchair-bound, deprived of their profession, finding it difficult to stay in a marriage it's vested with what has been termed "lamentable results." And one of the first things that we as physicians have to do is to calm people down and say, "You know what. You have MS. You're going to be just fine. Trust me. We have wonderful medications for what you have, and we'll take care of it." In fact, I've made a habit of telling people quit worrying. You hired me to worry for you.

Biloon: Yep.

Berger: And I think that's helpful.

Biloon: I've been just so appreciative of that. There's a balance of being condescended to — do you know what I mean — and also being given information. I'm very sensitive to that balance because I consider myself an intelligent person. And you're being put in a position where someone knows more than you, and you have to listen.

Berger: One of the other challenges we face is getting somebody on a treatment. And we elected to put you on an intravenous therapy every 6 months.

Biloon: Especially because as a stand-up comedian, I was traveling a lot, doing these every-6-months infusion, especially with the high efficacy rate that it had been reported from what we had read and the low amount of side effects. I mean, just those things together was just something that seemed the easiest for me.

Berger: So did you encounter any challenges when we first got you started on the infusion therapy?

Biloon: The first infusion I got was at the hospital. But then after that, I had to go to the suburbs, to a center out there for the infusion. That was difficult because to get a ride out there and a ride back — it was a long trip for someone to wait with me. Taking an Uber is expensive, so was it for me to drive. You don't feel good for a couple of days after. So that was how it was, and I complained about it. Probably at every appointment we had, I complained about it.

Berger: Yeah. So some of the challenges you talked about are very, very common. As a physician on medications myself, I can tell you that I am not particularly compliant. And what I love about infusion therapies is that I know that the patient is getting their medicine. Because when they don't show up for a scheduled appointment, I'm called, and I know.

Biloon: I do have a bit of an allergic reaction to the drug. But that's been easily managed over time. Now, the drug infusions are actually being done at my home, which makes the whole process twice-a-year–world's better.

Berger: But there are other barriers that people confront other than the initiation of drugs. Had you encountered any?

Biloon: I think the problem that I had more so was finding the drugs that would manage some of my symptoms. It took a couple of years to sort of figure out what that would be, both with figuring them out and both dealing with insurance on certain medications.

Berger: That's one sort of problem that we confront. The other, of course, are those individuals who, for a variety of reasons, have difficulty with the diagnosis because of their backgrounds. And they may be sociocultural in nature. Every time you go to the physical therapist, it's some degree of money.

Now for some people, it's trivial. But for others, it's a considerable amount of money, relative to what it is that they earn. And you simply have to work within those confines as best you can.

We do have various programs that help people. So we try to employ them. There are, in addition to the sociocultural barriers, language barriers that we often confront. We, in our situation here in a large city, have a very large migrant population.

Fortunately, most of the people speak languages that either you speak as well, or there's somebody in the next room that speaks pretty well. But that's not always the case. So we do have an interpreter service that has to be employed.

Biloon: I cannot imagine the nuance in speaking to people from different ages and different backgrounds, who have different types of lifestyles, for them to understand.

Berger: I don't write at a computer. I think that really degrades the patient-physician relationship. What I do is I obtain a history. I do it on a piece of paper with a pen or a pencil.

I recapitulate them to the patient in paraphrasing it, to make sure that I have gotten it right and that they understand what I think I heard. That, I think, has been enormously helpful in helping people understand what may happen in the absence of treatment and why the treatment is important. That you can do, regardless of what the person's background is. So that's how I approach it.

Biloon: How do you deal with patients when they're not on the same page with you?

Berger: One important thing is that you have to be patient. That is something that it took me 50 years in medicine to learn. And then accepting the patient's opinion and saying, "All right, go home and think about it," because you often don't convince them when they're in the office with you.

Biloon: I did have a little bit of a cushion between my diagnosis and when we actually saw each other, where I was able to really sit in my thoughts on the different treatments and stuff. By the time that we were able to talk, it reassured me on that was the right plan.

Berger: I'm curious what your experience has been with our MS center.

Biloon: Through the portal, every time I need something, I'm usually reaching out, keeping you up-to-date on my primary care or whether it's trying to get a refill on one of my medications that I have to reach out. I really do feel that having that team there, being able to reach out, that's been extremely helpful to have and keeps me very secure because that's all I really need, especially during the pandemic, right? Because then I was very isolated and dealing with going through MS. So it was great to at least ­— and I did — shoot off emails or texts in the portal, and that's usually primarily how I communicated.

Berger: I will tell you, in my opinion, maybe nine out of 10 messages in the portal or calls that we get simply require reassurance.

Biloon: Yes.

Berger: You just either pick up the phone or shoot back a note, say, "This is not your MS. Don't worry about it." I mean, the most important thing for me is to keep people from worrying because that doesn't solve any problem.

Biloon: No, and it causes stress, which causes fatigue. I mean, it's a bad cycle.

Berger: In the past year, you've actually felt better, and you've gone back to performing. It sounds like the volume of performances has gotten back to what it was pre-illness. What do you see for the future?

Biloon: What I see is traveling more for stand-up and doing the sort of clubs and cities that I had kind of stopped doing from before I was diagnosed, so 2017 and prior to that. And then also even working on other things, writing and maybe even doing sort of books or one-person shows that even talk about sort of my struggles with MS and kind of coming back to where I am. I'm looking forward to the future, and I hope that that's the track I can keep going on.

Berger: I see no reason why you shouldn't.

Biloon: Thank you.

Berger: Michelle, thank you very much for joining me today in this conversation.

Biloon: Thank you so much for having me. It's been really wonderful to be able to sit down here with you.

 


 

Joseph R. Berger, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Celgene/Bristol-Myers Squibb; Cellevolve; EMD Serono/Merck/Genentech; Genzyme; Janssen/Johnson & Johnson; Morphic; Novartis; Roche; Sanofi; Takeda; TG Therapeutics; MAPI; Excision Bio
Received research grant from: Genentech/Roche

Michelle Biloon has disclosed no relevant financial relationships

 

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Delaying Embryo Transfers May Benefit Patients With Endometrial Polyps

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Changed
Tue, 04/02/2024 - 11:58

A longer time between hysteroscopic polypectomy and frozen embryo transfer may improve the odds of successful pregnancy, based on data from a new analysis presented at the annual meeting of the Society for Reproductive Investigation.

Although uterine polyps have a negative effect on pregnancy rates, data supporting a specific time interval between hysteroscopic polypectomy (HP) and frozen embryo transfer (FET) are limited, according to Audrey Messelt, MD, of Baylor College of Medicine, Houston, Texas, and colleagues.

“Hysteroscopic polypectomy is a common procedure performed before embryo transfer to optimize the receptivity of the endometrium. Currently, there is no ideal recovery time lapse between surgery and an embryo transfer,” said senior author Laura Detti, MD, professor of obstetrics and gynecology at Baylor, in an interview. “This is often the last step prior to embryo transfer, and identifying a recovery time that allows the best outcome is important.”

In a retrospective analysis, the researchers examined the effect of the time between HP and FET on pregnancy outcomes. They identified 65 patients with uterine pathology based on saline-infusion sonogram who underwent hysteroscopy and FET between June 1, 2022, and September 30, 2023.

The endometrial preparation for FET included sequential administration of oral or transdermal estradiol and intramuscular progesterone.

Overall, 46 patients were diagnosed with endometrial polyps at the time of surgery; three had endometritis, one had a uterine septum that was resected, 15 had no abnormal pathology or had normal endometrium at the time of examination. No cases of hyperplasia or malignancy were identified.

A total of 58 patients underwent FET with a single euploid embryo, four with a single untested embryo, one with a low-mosaic embryo, and two with a double-embryo transfer (one euploid and one low mosaic).

After FET, 50 patients conceived and 15 did not. Patients with ongoing pregnancies who had a history of endometrial polyps had significantly more days from surgery to FET, compared to patients with a history of polyps who failed to conceive (median 70 days vs 45 days, P = .01).

By contrast, the time between hysteroscopy and FET was similar among patients with no endometrial pathology who did and did not have ongoing pregnancies (median 45 vs 52.5 days, P = .95).

The findings were limited by the relatively small sample size and exclusion of patients with pathologies other than polyps, as well as a lack of data on age group breakdowns. However, the results suggest that patients with uterine polyps may benefit from more time between HP and FET, while patients with normal surgical findings could undergo FET sooner, the researchers concluded.
 

Postpolypectomy Timing May Affect Pregnancy Outcomes

“We used to think that having had the first menses from surgery would be enough recovery time for the uterine cavity, even if it was just 2 weeks,” Dr. Detti said in an interview. “This still holds true when no endometrial polyps are diagnosed in the pathological specimen; however, we learned that if endometrial polyps are removed at the time of hysteroscopy, the ideal recovery time prior to an embryo transfer should be longer,” she said.

The current study is important because approximately 15% of women are diagnosed with endometrial polyps during their reproductive years, said Mark P. Trolice, MD, professor at the University of Central Florida, Orlando, and founder/medical director of the IVF Center of Central Florida in Winter Park, in an interview.

“Abnormalities of the uterine cavity have been shown to reduce embryo implantation and increase the risk of miscarriage,” said Dr. Trolice. Although the impact of small endometrial polyps on fertility and pregnancy are uncertain, most infertility specialists recommend removal of endometrial polyps via hysteroscopic polypectomy in general and prior to IVF embryo transfer in particular, he said.

Although infertility patients are anxious to undergo embryo transfer, the current study suggests a benefit in delaying the procedure following the removal of any polyps identified during the pretransfer evaluation, Dr. Trolice said in an interview. As for additional research, “it would be helpful to know the age group breakdown of patients and if the results were consistent among all categories,” he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

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A longer time between hysteroscopic polypectomy and frozen embryo transfer may improve the odds of successful pregnancy, based on data from a new analysis presented at the annual meeting of the Society for Reproductive Investigation.

Although uterine polyps have a negative effect on pregnancy rates, data supporting a specific time interval between hysteroscopic polypectomy (HP) and frozen embryo transfer (FET) are limited, according to Audrey Messelt, MD, of Baylor College of Medicine, Houston, Texas, and colleagues.

“Hysteroscopic polypectomy is a common procedure performed before embryo transfer to optimize the receptivity of the endometrium. Currently, there is no ideal recovery time lapse between surgery and an embryo transfer,” said senior author Laura Detti, MD, professor of obstetrics and gynecology at Baylor, in an interview. “This is often the last step prior to embryo transfer, and identifying a recovery time that allows the best outcome is important.”

In a retrospective analysis, the researchers examined the effect of the time between HP and FET on pregnancy outcomes. They identified 65 patients with uterine pathology based on saline-infusion sonogram who underwent hysteroscopy and FET between June 1, 2022, and September 30, 2023.

The endometrial preparation for FET included sequential administration of oral or transdermal estradiol and intramuscular progesterone.

Overall, 46 patients were diagnosed with endometrial polyps at the time of surgery; three had endometritis, one had a uterine septum that was resected, 15 had no abnormal pathology or had normal endometrium at the time of examination. No cases of hyperplasia or malignancy were identified.

A total of 58 patients underwent FET with a single euploid embryo, four with a single untested embryo, one with a low-mosaic embryo, and two with a double-embryo transfer (one euploid and one low mosaic).

After FET, 50 patients conceived and 15 did not. Patients with ongoing pregnancies who had a history of endometrial polyps had significantly more days from surgery to FET, compared to patients with a history of polyps who failed to conceive (median 70 days vs 45 days, P = .01).

By contrast, the time between hysteroscopy and FET was similar among patients with no endometrial pathology who did and did not have ongoing pregnancies (median 45 vs 52.5 days, P = .95).

The findings were limited by the relatively small sample size and exclusion of patients with pathologies other than polyps, as well as a lack of data on age group breakdowns. However, the results suggest that patients with uterine polyps may benefit from more time between HP and FET, while patients with normal surgical findings could undergo FET sooner, the researchers concluded.
 

Postpolypectomy Timing May Affect Pregnancy Outcomes

“We used to think that having had the first menses from surgery would be enough recovery time for the uterine cavity, even if it was just 2 weeks,” Dr. Detti said in an interview. “This still holds true when no endometrial polyps are diagnosed in the pathological specimen; however, we learned that if endometrial polyps are removed at the time of hysteroscopy, the ideal recovery time prior to an embryo transfer should be longer,” she said.

The current study is important because approximately 15% of women are diagnosed with endometrial polyps during their reproductive years, said Mark P. Trolice, MD, professor at the University of Central Florida, Orlando, and founder/medical director of the IVF Center of Central Florida in Winter Park, in an interview.

“Abnormalities of the uterine cavity have been shown to reduce embryo implantation and increase the risk of miscarriage,” said Dr. Trolice. Although the impact of small endometrial polyps on fertility and pregnancy are uncertain, most infertility specialists recommend removal of endometrial polyps via hysteroscopic polypectomy in general and prior to IVF embryo transfer in particular, he said.

Although infertility patients are anxious to undergo embryo transfer, the current study suggests a benefit in delaying the procedure following the removal of any polyps identified during the pretransfer evaluation, Dr. Trolice said in an interview. As for additional research, “it would be helpful to know the age group breakdown of patients and if the results were consistent among all categories,” he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

A longer time between hysteroscopic polypectomy and frozen embryo transfer may improve the odds of successful pregnancy, based on data from a new analysis presented at the annual meeting of the Society for Reproductive Investigation.

Although uterine polyps have a negative effect on pregnancy rates, data supporting a specific time interval between hysteroscopic polypectomy (HP) and frozen embryo transfer (FET) are limited, according to Audrey Messelt, MD, of Baylor College of Medicine, Houston, Texas, and colleagues.

“Hysteroscopic polypectomy is a common procedure performed before embryo transfer to optimize the receptivity of the endometrium. Currently, there is no ideal recovery time lapse between surgery and an embryo transfer,” said senior author Laura Detti, MD, professor of obstetrics and gynecology at Baylor, in an interview. “This is often the last step prior to embryo transfer, and identifying a recovery time that allows the best outcome is important.”

In a retrospective analysis, the researchers examined the effect of the time between HP and FET on pregnancy outcomes. They identified 65 patients with uterine pathology based on saline-infusion sonogram who underwent hysteroscopy and FET between June 1, 2022, and September 30, 2023.

The endometrial preparation for FET included sequential administration of oral or transdermal estradiol and intramuscular progesterone.

Overall, 46 patients were diagnosed with endometrial polyps at the time of surgery; three had endometritis, one had a uterine septum that was resected, 15 had no abnormal pathology or had normal endometrium at the time of examination. No cases of hyperplasia or malignancy were identified.

A total of 58 patients underwent FET with a single euploid embryo, four with a single untested embryo, one with a low-mosaic embryo, and two with a double-embryo transfer (one euploid and one low mosaic).

After FET, 50 patients conceived and 15 did not. Patients with ongoing pregnancies who had a history of endometrial polyps had significantly more days from surgery to FET, compared to patients with a history of polyps who failed to conceive (median 70 days vs 45 days, P = .01).

By contrast, the time between hysteroscopy and FET was similar among patients with no endometrial pathology who did and did not have ongoing pregnancies (median 45 vs 52.5 days, P = .95).

The findings were limited by the relatively small sample size and exclusion of patients with pathologies other than polyps, as well as a lack of data on age group breakdowns. However, the results suggest that patients with uterine polyps may benefit from more time between HP and FET, while patients with normal surgical findings could undergo FET sooner, the researchers concluded.
 

Postpolypectomy Timing May Affect Pregnancy Outcomes

“We used to think that having had the first menses from surgery would be enough recovery time for the uterine cavity, even if it was just 2 weeks,” Dr. Detti said in an interview. “This still holds true when no endometrial polyps are diagnosed in the pathological specimen; however, we learned that if endometrial polyps are removed at the time of hysteroscopy, the ideal recovery time prior to an embryo transfer should be longer,” she said.

The current study is important because approximately 15% of women are diagnosed with endometrial polyps during their reproductive years, said Mark P. Trolice, MD, professor at the University of Central Florida, Orlando, and founder/medical director of the IVF Center of Central Florida in Winter Park, in an interview.

“Abnormalities of the uterine cavity have been shown to reduce embryo implantation and increase the risk of miscarriage,” said Dr. Trolice. Although the impact of small endometrial polyps on fertility and pregnancy are uncertain, most infertility specialists recommend removal of endometrial polyps via hysteroscopic polypectomy in general and prior to IVF embryo transfer in particular, he said.

Although infertility patients are anxious to undergo embryo transfer, the current study suggests a benefit in delaying the procedure following the removal of any polyps identified during the pretransfer evaluation, Dr. Trolice said in an interview. As for additional research, “it would be helpful to know the age group breakdown of patients and if the results were consistent among all categories,” he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

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‘From Interpretation to Action’: Using CGM to Manage T2D

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Tue, 04/02/2024 - 11:23

Data derived from continuous glucose monitoring (CGM) devices can help guide nutrition management and insulin dosing in people with type 2 diabetes (T2D) in primary care settings.

At the Advanced Technologies & Treatments for Diabetes meeting, two experts from the International Diabetes Center – HealthPartners Institute, Minneapolis, offered advice for clinicians. Tara Ettestad, RN, LD, CDCES, program manager for care transformation and training at the center, shared tips for helping patients change their diet based on CGM readings. The center’s medical director Thomas Martens, MD, provided a systematic approach to using CGM to guide adjustment of insulin doses and other medications for insulin-treated patients with T2D.
 

CGM-Guided Nutrition: Focus on Sustainable Changes

With CGM, people with diabetes get real-time feedback about the impact of foods on their glucose levels. This can help them learn not just what they can’t eat but what they can eat, Ms. Ettestad pointed out.

“People want to know what to eat. This is the number-one question that people who are newly diagnosed with diabetes ask, and unfortunately, they typically hear what not to eat. No carbohydrates, no sugar, no white foods, no sweets. This can be really disheartening and confusing for many. We should be focusing on sustainable changes to help improve diets,” she said.

She added, “Not everyone can see a dietitian, but all clinicians can help provide evidence-based nutrition guidance.”

When guiding patients, it’s important to focus on the four “core concepts” outlined in the American Diabetes Association’s nutrition consensus report:

  • Emphasize nonstarchy vegetables
  • Minimize added sugars and refined grains
  • Eat more whole foods, less highly processed foods
  • Replace sugar-sweetened beverages with water as often as possible

With CGM, patients can see the differences in response to refined carbs (wheat, rice, and potato), sugars (sucrose, fructose, and glucose), and resistant starches (whole grains, fruits, and legumes). Typically, glucose responses are steeper and higher for the first two compared to resistant starches.

CGM can also show the effects of eating fat and protein, in that they can delay glucose responses to meals even with the same carbohydrate content, Ms. Ettestad said.

It’s important to remind patients that although one goal of using CGM is to reduce post-meal glucose spikes, eating a lot of high-saturated fat, high-calorie foods isn’t the healthful way to do it. “What’s really important when we’re using CGM to help guide nutrition is remembering nutrition quality and what can be good for glucose is not always good for our overall health,” Ms. Ettestad stressed.

She provided these further tips:

  • Pick one meal at a time to focus on. Collaborate with patients to see what changes they are able and willing to make. For example, rather than entirely giving up rice or noodles at dinner, try eating less of those and adding more vegetables.
  • Suggest that patients keep a food log or use a tracking app so that the source of specific glucose patterns can be identified and addressed.
  • Show patients how to check their time in range (TIR) on their mobile device or reader each week so they can see big-picture results of their changes. “This can be really motivating for people to see,” she said.
  • Remind people that glucose rises with meals. This seems obvious but may not be to those newly diagnosed, she pointed out.
  • Educate patients on glucose targets and explain that other factors such as stress and activity can influence glucose levels.
  • Focus on the positive. “What have you been learning about how your meals and beverages affect your glucose?”
  • Help guide patients toward better diet quality, even when TIR is a goal, using the four core concepts.
  • Encourage curiosity, such as by experimenting with portions, timing, or food order. “What if you try eating nonstarchy foods first?”
  • Before adjusting a medication dose, consider asking if the patient is willing to make a nutrition change. “Every visit is an opportunity!”
 

 

Adjusting Insulin With the Help of CGM: Focus on Four Patient Subgroups

Dr. Martens noted that about a quarter of people with T2D will require insulin treatment, despite increasing use of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists. And even when insulin is used as a “salvage therapy” in T2D, about two thirds of those individuals still struggle to achieve an A1c below 7% with or without other glucose-lowering medications, he noted.

“So, we have this huge population with type 2 diabetes who have limited access to endocrinology, and advanced insulin delivery devices are not yet available for them. Can better use of CGM drive improvements in care?”

He pointed to MOBILE, a randomized clinical trial, which showed that CGM use resulted in significantly improved A1c at 8 months compared with fingerstick monitoring among adults with T2D taking long-acting insulin alone without premeal insulin. However, TIR was still just 59% (vs 43% with fingerstick testing), suggesting room for improvement.

“This could have been much, much better…Rapid interpretation isn’t really enough. We need to move from interpretation into action,” Dr. Martens said.

His team recently developed a program called “CGM Clinician Guided Management (CCGM)” aimed at primary care that encourages the following principles:

  • Appropriate movement toward the safer “high value” noninsulin therapies, that is, GLP-1 agonists and SGLT2 inhibitors.
  • Appropriate insulin titration.
  • Appropriate cycle time in titration, that is, accelerating more rapidly when one dose isn’t working. “That’s the Achilles heel of primary care,” he noted.
  • Quick identification of when the limits of basal insulin therapy have been reached.
  • Team-based management for difficult situations and for individuals on multiple daily injections and mealtime insulin regimens. “This is a group that really struggles…in primary care settings,” he noted.

The following three steps are based on published T2D management guidelines:

  • Step 1: If the patient has atherosclerotic cardiovascular disease, start with either an SGLT2 inhibitor or GLP-1 agonist. For those with congestive heart failure and/or chronic kidney disease, SGLT2 inhibitors are indicated.
  • Step 2: Is the patient on sulfonylurea? Consider eliminating it before moving to CGM-based insulin titration.
  • Step 3: Was there a change in therapy based on steps 1 or 2? If not, move to CGM-guided insulin titration. If yes, wait 2-4 weeks to see the impact of therapy change before moving on.

The program categorizes patients into one of four groups based on CGM data, with respective management approaches:

  • Category 1: TIR > 70%, time below range (TBR) < 3%: Doing well, keep on going!
  • Category 2: TIR > 70%, TBR ≥ 3%: Too much hypoglycemia, need to decrease therapy. Stop sulfonylureas, and if TBR > 10%, also decrease basal insulin dose.
  • Category 3: TIR < 70%, TBR < 3%: Too much hyperglycemia — increase therapy.
  • Category 4: TIR < 70%, TBR ≥ 3%: This is the toughest category. Fix or advance therapy. These patients should be either referred to a diabetes care and education specialist (formerly known as “diabetes educators”) to troubleshoot their regimens or have their therapy advanced to multiple daily injections. The hypoglycemia should be addressed first for safety, then the hyperglycemia.

“We hope that CCGM is going to be the translation of CGM data into action in primary care, where we struggle with action and inaction,” Dr. Martens said. It’s expected to be posted on the IDC website soon.

Ms. Ettestad’s employer received educational grant funds from Abbott Diabetes Care and Sanofi-Aventis Groupe. She also worked as a product trainer with Tandem Diabetes Care. She is employed by nonprofit International Diabetes Center – HealthPartners Institute and received no personal income or honoraria from these activities. Dr. Martens’ employer received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Lilly, and Novo Nordisk and for consulting from Sanofi and Lilly. He is employed by nonprofit HealthPartners Institute – International Diabetes Center and received no personal income or honoraria from these activities.

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

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Data derived from continuous glucose monitoring (CGM) devices can help guide nutrition management and insulin dosing in people with type 2 diabetes (T2D) in primary care settings.

At the Advanced Technologies & Treatments for Diabetes meeting, two experts from the International Diabetes Center – HealthPartners Institute, Minneapolis, offered advice for clinicians. Tara Ettestad, RN, LD, CDCES, program manager for care transformation and training at the center, shared tips for helping patients change their diet based on CGM readings. The center’s medical director Thomas Martens, MD, provided a systematic approach to using CGM to guide adjustment of insulin doses and other medications for insulin-treated patients with T2D.
 

CGM-Guided Nutrition: Focus on Sustainable Changes

With CGM, people with diabetes get real-time feedback about the impact of foods on their glucose levels. This can help them learn not just what they can’t eat but what they can eat, Ms. Ettestad pointed out.

“People want to know what to eat. This is the number-one question that people who are newly diagnosed with diabetes ask, and unfortunately, they typically hear what not to eat. No carbohydrates, no sugar, no white foods, no sweets. This can be really disheartening and confusing for many. We should be focusing on sustainable changes to help improve diets,” she said.

She added, “Not everyone can see a dietitian, but all clinicians can help provide evidence-based nutrition guidance.”

When guiding patients, it’s important to focus on the four “core concepts” outlined in the American Diabetes Association’s nutrition consensus report:

  • Emphasize nonstarchy vegetables
  • Minimize added sugars and refined grains
  • Eat more whole foods, less highly processed foods
  • Replace sugar-sweetened beverages with water as often as possible

With CGM, patients can see the differences in response to refined carbs (wheat, rice, and potato), sugars (sucrose, fructose, and glucose), and resistant starches (whole grains, fruits, and legumes). Typically, glucose responses are steeper and higher for the first two compared to resistant starches.

CGM can also show the effects of eating fat and protein, in that they can delay glucose responses to meals even with the same carbohydrate content, Ms. Ettestad said.

It’s important to remind patients that although one goal of using CGM is to reduce post-meal glucose spikes, eating a lot of high-saturated fat, high-calorie foods isn’t the healthful way to do it. “What’s really important when we’re using CGM to help guide nutrition is remembering nutrition quality and what can be good for glucose is not always good for our overall health,” Ms. Ettestad stressed.

She provided these further tips:

  • Pick one meal at a time to focus on. Collaborate with patients to see what changes they are able and willing to make. For example, rather than entirely giving up rice or noodles at dinner, try eating less of those and adding more vegetables.
  • Suggest that patients keep a food log or use a tracking app so that the source of specific glucose patterns can be identified and addressed.
  • Show patients how to check their time in range (TIR) on their mobile device or reader each week so they can see big-picture results of their changes. “This can be really motivating for people to see,” she said.
  • Remind people that glucose rises with meals. This seems obvious but may not be to those newly diagnosed, she pointed out.
  • Educate patients on glucose targets and explain that other factors such as stress and activity can influence glucose levels.
  • Focus on the positive. “What have you been learning about how your meals and beverages affect your glucose?”
  • Help guide patients toward better diet quality, even when TIR is a goal, using the four core concepts.
  • Encourage curiosity, such as by experimenting with portions, timing, or food order. “What if you try eating nonstarchy foods first?”
  • Before adjusting a medication dose, consider asking if the patient is willing to make a nutrition change. “Every visit is an opportunity!”
 

 

Adjusting Insulin With the Help of CGM: Focus on Four Patient Subgroups

Dr. Martens noted that about a quarter of people with T2D will require insulin treatment, despite increasing use of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists. And even when insulin is used as a “salvage therapy” in T2D, about two thirds of those individuals still struggle to achieve an A1c below 7% with or without other glucose-lowering medications, he noted.

“So, we have this huge population with type 2 diabetes who have limited access to endocrinology, and advanced insulin delivery devices are not yet available for them. Can better use of CGM drive improvements in care?”

He pointed to MOBILE, a randomized clinical trial, which showed that CGM use resulted in significantly improved A1c at 8 months compared with fingerstick monitoring among adults with T2D taking long-acting insulin alone without premeal insulin. However, TIR was still just 59% (vs 43% with fingerstick testing), suggesting room for improvement.

“This could have been much, much better…Rapid interpretation isn’t really enough. We need to move from interpretation into action,” Dr. Martens said.

His team recently developed a program called “CGM Clinician Guided Management (CCGM)” aimed at primary care that encourages the following principles:

  • Appropriate movement toward the safer “high value” noninsulin therapies, that is, GLP-1 agonists and SGLT2 inhibitors.
  • Appropriate insulin titration.
  • Appropriate cycle time in titration, that is, accelerating more rapidly when one dose isn’t working. “That’s the Achilles heel of primary care,” he noted.
  • Quick identification of when the limits of basal insulin therapy have been reached.
  • Team-based management for difficult situations and for individuals on multiple daily injections and mealtime insulin regimens. “This is a group that really struggles…in primary care settings,” he noted.

The following three steps are based on published T2D management guidelines:

  • Step 1: If the patient has atherosclerotic cardiovascular disease, start with either an SGLT2 inhibitor or GLP-1 agonist. For those with congestive heart failure and/or chronic kidney disease, SGLT2 inhibitors are indicated.
  • Step 2: Is the patient on sulfonylurea? Consider eliminating it before moving to CGM-based insulin titration.
  • Step 3: Was there a change in therapy based on steps 1 or 2? If not, move to CGM-guided insulin titration. If yes, wait 2-4 weeks to see the impact of therapy change before moving on.

The program categorizes patients into one of four groups based on CGM data, with respective management approaches:

  • Category 1: TIR > 70%, time below range (TBR) < 3%: Doing well, keep on going!
  • Category 2: TIR > 70%, TBR ≥ 3%: Too much hypoglycemia, need to decrease therapy. Stop sulfonylureas, and if TBR > 10%, also decrease basal insulin dose.
  • Category 3: TIR < 70%, TBR < 3%: Too much hyperglycemia — increase therapy.
  • Category 4: TIR < 70%, TBR ≥ 3%: This is the toughest category. Fix or advance therapy. These patients should be either referred to a diabetes care and education specialist (formerly known as “diabetes educators”) to troubleshoot their regimens or have their therapy advanced to multiple daily injections. The hypoglycemia should be addressed first for safety, then the hyperglycemia.

“We hope that CCGM is going to be the translation of CGM data into action in primary care, where we struggle with action and inaction,” Dr. Martens said. It’s expected to be posted on the IDC website soon.

Ms. Ettestad’s employer received educational grant funds from Abbott Diabetes Care and Sanofi-Aventis Groupe. She also worked as a product trainer with Tandem Diabetes Care. She is employed by nonprofit International Diabetes Center – HealthPartners Institute and received no personal income or honoraria from these activities. Dr. Martens’ employer received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Lilly, and Novo Nordisk and for consulting from Sanofi and Lilly. He is employed by nonprofit HealthPartners Institute – International Diabetes Center and received no personal income or honoraria from these activities.

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

Data derived from continuous glucose monitoring (CGM) devices can help guide nutrition management and insulin dosing in people with type 2 diabetes (T2D) in primary care settings.

At the Advanced Technologies & Treatments for Diabetes meeting, two experts from the International Diabetes Center – HealthPartners Institute, Minneapolis, offered advice for clinicians. Tara Ettestad, RN, LD, CDCES, program manager for care transformation and training at the center, shared tips for helping patients change their diet based on CGM readings. The center’s medical director Thomas Martens, MD, provided a systematic approach to using CGM to guide adjustment of insulin doses and other medications for insulin-treated patients with T2D.
 

CGM-Guided Nutrition: Focus on Sustainable Changes

With CGM, people with diabetes get real-time feedback about the impact of foods on their glucose levels. This can help them learn not just what they can’t eat but what they can eat, Ms. Ettestad pointed out.

“People want to know what to eat. This is the number-one question that people who are newly diagnosed with diabetes ask, and unfortunately, they typically hear what not to eat. No carbohydrates, no sugar, no white foods, no sweets. This can be really disheartening and confusing for many. We should be focusing on sustainable changes to help improve diets,” she said.

She added, “Not everyone can see a dietitian, but all clinicians can help provide evidence-based nutrition guidance.”

When guiding patients, it’s important to focus on the four “core concepts” outlined in the American Diabetes Association’s nutrition consensus report:

  • Emphasize nonstarchy vegetables
  • Minimize added sugars and refined grains
  • Eat more whole foods, less highly processed foods
  • Replace sugar-sweetened beverages with water as often as possible

With CGM, patients can see the differences in response to refined carbs (wheat, rice, and potato), sugars (sucrose, fructose, and glucose), and resistant starches (whole grains, fruits, and legumes). Typically, glucose responses are steeper and higher for the first two compared to resistant starches.

CGM can also show the effects of eating fat and protein, in that they can delay glucose responses to meals even with the same carbohydrate content, Ms. Ettestad said.

It’s important to remind patients that although one goal of using CGM is to reduce post-meal glucose spikes, eating a lot of high-saturated fat, high-calorie foods isn’t the healthful way to do it. “What’s really important when we’re using CGM to help guide nutrition is remembering nutrition quality and what can be good for glucose is not always good for our overall health,” Ms. Ettestad stressed.

She provided these further tips:

  • Pick one meal at a time to focus on. Collaborate with patients to see what changes they are able and willing to make. For example, rather than entirely giving up rice or noodles at dinner, try eating less of those and adding more vegetables.
  • Suggest that patients keep a food log or use a tracking app so that the source of specific glucose patterns can be identified and addressed.
  • Show patients how to check their time in range (TIR) on their mobile device or reader each week so they can see big-picture results of their changes. “This can be really motivating for people to see,” she said.
  • Remind people that glucose rises with meals. This seems obvious but may not be to those newly diagnosed, she pointed out.
  • Educate patients on glucose targets and explain that other factors such as stress and activity can influence glucose levels.
  • Focus on the positive. “What have you been learning about how your meals and beverages affect your glucose?”
  • Help guide patients toward better diet quality, even when TIR is a goal, using the four core concepts.
  • Encourage curiosity, such as by experimenting with portions, timing, or food order. “What if you try eating nonstarchy foods first?”
  • Before adjusting a medication dose, consider asking if the patient is willing to make a nutrition change. “Every visit is an opportunity!”
 

 

Adjusting Insulin With the Help of CGM: Focus on Four Patient Subgroups

Dr. Martens noted that about a quarter of people with T2D will require insulin treatment, despite increasing use of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists. And even when insulin is used as a “salvage therapy” in T2D, about two thirds of those individuals still struggle to achieve an A1c below 7% with or without other glucose-lowering medications, he noted.

“So, we have this huge population with type 2 diabetes who have limited access to endocrinology, and advanced insulin delivery devices are not yet available for them. Can better use of CGM drive improvements in care?”

He pointed to MOBILE, a randomized clinical trial, which showed that CGM use resulted in significantly improved A1c at 8 months compared with fingerstick monitoring among adults with T2D taking long-acting insulin alone without premeal insulin. However, TIR was still just 59% (vs 43% with fingerstick testing), suggesting room for improvement.

“This could have been much, much better…Rapid interpretation isn’t really enough. We need to move from interpretation into action,” Dr. Martens said.

His team recently developed a program called “CGM Clinician Guided Management (CCGM)” aimed at primary care that encourages the following principles:

  • Appropriate movement toward the safer “high value” noninsulin therapies, that is, GLP-1 agonists and SGLT2 inhibitors.
  • Appropriate insulin titration.
  • Appropriate cycle time in titration, that is, accelerating more rapidly when one dose isn’t working. “That’s the Achilles heel of primary care,” he noted.
  • Quick identification of when the limits of basal insulin therapy have been reached.
  • Team-based management for difficult situations and for individuals on multiple daily injections and mealtime insulin regimens. “This is a group that really struggles…in primary care settings,” he noted.

The following three steps are based on published T2D management guidelines:

  • Step 1: If the patient has atherosclerotic cardiovascular disease, start with either an SGLT2 inhibitor or GLP-1 agonist. For those with congestive heart failure and/or chronic kidney disease, SGLT2 inhibitors are indicated.
  • Step 2: Is the patient on sulfonylurea? Consider eliminating it before moving to CGM-based insulin titration.
  • Step 3: Was there a change in therapy based on steps 1 or 2? If not, move to CGM-guided insulin titration. If yes, wait 2-4 weeks to see the impact of therapy change before moving on.

The program categorizes patients into one of four groups based on CGM data, with respective management approaches:

  • Category 1: TIR > 70%, time below range (TBR) < 3%: Doing well, keep on going!
  • Category 2: TIR > 70%, TBR ≥ 3%: Too much hypoglycemia, need to decrease therapy. Stop sulfonylureas, and if TBR > 10%, also decrease basal insulin dose.
  • Category 3: TIR < 70%, TBR < 3%: Too much hyperglycemia — increase therapy.
  • Category 4: TIR < 70%, TBR ≥ 3%: This is the toughest category. Fix or advance therapy. These patients should be either referred to a diabetes care and education specialist (formerly known as “diabetes educators”) to troubleshoot their regimens or have their therapy advanced to multiple daily injections. The hypoglycemia should be addressed first for safety, then the hyperglycemia.

“We hope that CCGM is going to be the translation of CGM data into action in primary care, where we struggle with action and inaction,” Dr. Martens said. It’s expected to be posted on the IDC website soon.

Ms. Ettestad’s employer received educational grant funds from Abbott Diabetes Care and Sanofi-Aventis Groupe. She also worked as a product trainer with Tandem Diabetes Care. She is employed by nonprofit International Diabetes Center – HealthPartners Institute and received no personal income or honoraria from these activities. Dr. Martens’ employer received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Lilly, and Novo Nordisk and for consulting from Sanofi and Lilly. He is employed by nonprofit HealthPartners Institute – International Diabetes Center and received no personal income or honoraria from these activities.

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

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Lung Cancer Vaccine Gets Injection of Funding for Research and Development

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Changed
Wed, 04/03/2024 - 12:01

Development of a DNA-based lung cancer vaccine in the United Kingdom received funding for 2 years of laboratory research and initial manufacture of 3000 doses, according to a press release from the University of Oxford, England.

A team of scientists from the University of Oxford, the Francis Crick Institute, and University College London (UCL) will receive funding from the Cancer Research UK and the CRIS Cancer Foundation.

The LungVax vaccine is based on technology similar to that used in the creation of the successful Oxford/AstraZeneca COVID-19 vaccine and will carry a DNA strand that trains the immune system to recognize the neoantigens that indicate abnormal lung cancer cells and then activate the immune system to kill these cells and stop the cancer, according to the statement.

Initially, scientists are working to develop a vaccine that triggers an immune response in the lab setting. If successful, the vaccine will move directly into a clinical trial. “If the subsequent early trial delivers promising results, the vaccine could then be scaled up to bigger trials for people at high risk of lung cancer,” according to the release.
 

Help for High-Risk Patients

Lung cancer is diagnosed in approximately 48,000 individuals in the United Kingdom each year, and the average 10-year survival is only 10%, Tim Elliott, MD, professor of immuno-oncology at the University of Oxford and lead researcher on the LungVax project, said in an interview. Nearly three-quarters of the 35,000 annual deaths are preventable by quitting smoking, which remains the best risk reduction strategy to date, he said. However, “an intervention such as a vaccine, given when people are healthy and are more likely to have a strong immune system, could benefit many thousands per year in the UK and 1.8 million patients worldwide,” he said.
 

Preliminary Trial Plans

The initial trial of the vaccine is a collaboration between Oxford University, UCL, and the Francis Crick Institute, Dr. Elliott said. The trial is a culmination of research into the biology and genetics of lung cancer at UCL and vaccine design research at the University of Oxford.

“We are at a very early stage of the program, which will develop over the next 6 years if all goes to plan,” said Dr. Elliott. The vaccine is designed on the basis of shared lung cancer antigens and packaged into the ChAdOx delivery system that proved successful as the Oxford-AstraZeneca COVID-19 vaccine, he said.

“We intend to vaccinate individuals who have had curative surgery for their lung cancer after being diagnosed with a very early stage of the disease,” Dr. Elliott said.

Challenges to vaccine development include knowing whether there is a clinical benefit, Dr. Elliott noted. “Our clinical trial is calculated to show up to 15% reduction in risk over 3-5 years, but only long-term follow-up will really tell us whether the immune responses we see to the vaccine within the first few weeks will have a long-term effect,” he emphasized.

In clinical practice, “these people are cancer-free and healthy after surgery,” said Dr. Elliott. However, “they are at a high risk of recurrence; 30%-70% of ex-patients will develop new cancer in their lifetime and in the majority of cases that will happen within 2 years after surgery,” he said. “We think that vaccinating them against common lung cancer antigens could reduce this risk significantly and remove some of the uncertainty that they live with after their operation.”
 

 

 

Vaccine Has Potential for Immense Impact

Lung cancer remains one of the most frequently diagnosed cancers. “In the past few decades, public health measures including tobacco cessation and lung cancer screening have contributed to the reduction of lung cancer incidence and improved survival in high-income countries, but lung cancer continues to be the leading cause of cancer-related deaths worldwide,” Saadia A. Faiz, MD, a member of the CHEST Physician editorial board, said in an interview.

“Further, new cancer diagnoses continue to increase in low-income countries where there may not be widespread public health initiatives and/or access to healthcare. Thus, development of a vaccine to prevent lung cancer could be very impactful,” she said.

Challenges to vaccine development include the heterogeneous nature of the disease, which may occur in smokers and nonsmokers, said Dr. Faiz. “Targeting the various molecular markers may be challenging,” she said. However, building on the success of other vaccine initiatives, such as the human papillomavirus vaccine for cervical cancer, and COVID-19 vaccines with collaboration and clinical research will ideally overcome these challenges, she added.

“The potential implications for a lung cancer vaccine are immense,” said Dr. Faiz.

A lung cancer vaccine could prevent a deadly disease, but continued efforts in risk factor reduction and lung cancer screening will also be important, she said.

“Depending on the results of this clinical research, longitudinal data regarding efficacy, side effects, and prevention will be vital prior to application in high-risk patients in clinical practice,” she emphasized.

The development of the lung cancer vaccine is supported in part by Cancer Research UK and the CRIS Cancer Foundation. Dr. Elliott has received support from Cancer Research UK but had no financial conflicts to disclose. Dr. Faiz had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Development of a DNA-based lung cancer vaccine in the United Kingdom received funding for 2 years of laboratory research and initial manufacture of 3000 doses, according to a press release from the University of Oxford, England.

A team of scientists from the University of Oxford, the Francis Crick Institute, and University College London (UCL) will receive funding from the Cancer Research UK and the CRIS Cancer Foundation.

The LungVax vaccine is based on technology similar to that used in the creation of the successful Oxford/AstraZeneca COVID-19 vaccine and will carry a DNA strand that trains the immune system to recognize the neoantigens that indicate abnormal lung cancer cells and then activate the immune system to kill these cells and stop the cancer, according to the statement.

Initially, scientists are working to develop a vaccine that triggers an immune response in the lab setting. If successful, the vaccine will move directly into a clinical trial. “If the subsequent early trial delivers promising results, the vaccine could then be scaled up to bigger trials for people at high risk of lung cancer,” according to the release.
 

Help for High-Risk Patients

Lung cancer is diagnosed in approximately 48,000 individuals in the United Kingdom each year, and the average 10-year survival is only 10%, Tim Elliott, MD, professor of immuno-oncology at the University of Oxford and lead researcher on the LungVax project, said in an interview. Nearly three-quarters of the 35,000 annual deaths are preventable by quitting smoking, which remains the best risk reduction strategy to date, he said. However, “an intervention such as a vaccine, given when people are healthy and are more likely to have a strong immune system, could benefit many thousands per year in the UK and 1.8 million patients worldwide,” he said.
 

Preliminary Trial Plans

The initial trial of the vaccine is a collaboration between Oxford University, UCL, and the Francis Crick Institute, Dr. Elliott said. The trial is a culmination of research into the biology and genetics of lung cancer at UCL and vaccine design research at the University of Oxford.

“We are at a very early stage of the program, which will develop over the next 6 years if all goes to plan,” said Dr. Elliott. The vaccine is designed on the basis of shared lung cancer antigens and packaged into the ChAdOx delivery system that proved successful as the Oxford-AstraZeneca COVID-19 vaccine, he said.

“We intend to vaccinate individuals who have had curative surgery for their lung cancer after being diagnosed with a very early stage of the disease,” Dr. Elliott said.

Challenges to vaccine development include knowing whether there is a clinical benefit, Dr. Elliott noted. “Our clinical trial is calculated to show up to 15% reduction in risk over 3-5 years, but only long-term follow-up will really tell us whether the immune responses we see to the vaccine within the first few weeks will have a long-term effect,” he emphasized.

In clinical practice, “these people are cancer-free and healthy after surgery,” said Dr. Elliott. However, “they are at a high risk of recurrence; 30%-70% of ex-patients will develop new cancer in their lifetime and in the majority of cases that will happen within 2 years after surgery,” he said. “We think that vaccinating them against common lung cancer antigens could reduce this risk significantly and remove some of the uncertainty that they live with after their operation.”
 

 

 

Vaccine Has Potential for Immense Impact

Lung cancer remains one of the most frequently diagnosed cancers. “In the past few decades, public health measures including tobacco cessation and lung cancer screening have contributed to the reduction of lung cancer incidence and improved survival in high-income countries, but lung cancer continues to be the leading cause of cancer-related deaths worldwide,” Saadia A. Faiz, MD, a member of the CHEST Physician editorial board, said in an interview.

“Further, new cancer diagnoses continue to increase in low-income countries where there may not be widespread public health initiatives and/or access to healthcare. Thus, development of a vaccine to prevent lung cancer could be very impactful,” she said.

Challenges to vaccine development include the heterogeneous nature of the disease, which may occur in smokers and nonsmokers, said Dr. Faiz. “Targeting the various molecular markers may be challenging,” she said. However, building on the success of other vaccine initiatives, such as the human papillomavirus vaccine for cervical cancer, and COVID-19 vaccines with collaboration and clinical research will ideally overcome these challenges, she added.

“The potential implications for a lung cancer vaccine are immense,” said Dr. Faiz.

A lung cancer vaccine could prevent a deadly disease, but continued efforts in risk factor reduction and lung cancer screening will also be important, she said.

“Depending on the results of this clinical research, longitudinal data regarding efficacy, side effects, and prevention will be vital prior to application in high-risk patients in clinical practice,” she emphasized.

The development of the lung cancer vaccine is supported in part by Cancer Research UK and the CRIS Cancer Foundation. Dr. Elliott has received support from Cancer Research UK but had no financial conflicts to disclose. Dr. Faiz had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Development of a DNA-based lung cancer vaccine in the United Kingdom received funding for 2 years of laboratory research and initial manufacture of 3000 doses, according to a press release from the University of Oxford, England.

A team of scientists from the University of Oxford, the Francis Crick Institute, and University College London (UCL) will receive funding from the Cancer Research UK and the CRIS Cancer Foundation.

The LungVax vaccine is based on technology similar to that used in the creation of the successful Oxford/AstraZeneca COVID-19 vaccine and will carry a DNA strand that trains the immune system to recognize the neoantigens that indicate abnormal lung cancer cells and then activate the immune system to kill these cells and stop the cancer, according to the statement.

Initially, scientists are working to develop a vaccine that triggers an immune response in the lab setting. If successful, the vaccine will move directly into a clinical trial. “If the subsequent early trial delivers promising results, the vaccine could then be scaled up to bigger trials for people at high risk of lung cancer,” according to the release.
 

Help for High-Risk Patients

Lung cancer is diagnosed in approximately 48,000 individuals in the United Kingdom each year, and the average 10-year survival is only 10%, Tim Elliott, MD, professor of immuno-oncology at the University of Oxford and lead researcher on the LungVax project, said in an interview. Nearly three-quarters of the 35,000 annual deaths are preventable by quitting smoking, which remains the best risk reduction strategy to date, he said. However, “an intervention such as a vaccine, given when people are healthy and are more likely to have a strong immune system, could benefit many thousands per year in the UK and 1.8 million patients worldwide,” he said.
 

Preliminary Trial Plans

The initial trial of the vaccine is a collaboration between Oxford University, UCL, and the Francis Crick Institute, Dr. Elliott said. The trial is a culmination of research into the biology and genetics of lung cancer at UCL and vaccine design research at the University of Oxford.

“We are at a very early stage of the program, which will develop over the next 6 years if all goes to plan,” said Dr. Elliott. The vaccine is designed on the basis of shared lung cancer antigens and packaged into the ChAdOx delivery system that proved successful as the Oxford-AstraZeneca COVID-19 vaccine, he said.

“We intend to vaccinate individuals who have had curative surgery for their lung cancer after being diagnosed with a very early stage of the disease,” Dr. Elliott said.

Challenges to vaccine development include knowing whether there is a clinical benefit, Dr. Elliott noted. “Our clinical trial is calculated to show up to 15% reduction in risk over 3-5 years, but only long-term follow-up will really tell us whether the immune responses we see to the vaccine within the first few weeks will have a long-term effect,” he emphasized.

In clinical practice, “these people are cancer-free and healthy after surgery,” said Dr. Elliott. However, “they are at a high risk of recurrence; 30%-70% of ex-patients will develop new cancer in their lifetime and in the majority of cases that will happen within 2 years after surgery,” he said. “We think that vaccinating them against common lung cancer antigens could reduce this risk significantly and remove some of the uncertainty that they live with after their operation.”
 

 

 

Vaccine Has Potential for Immense Impact

Lung cancer remains one of the most frequently diagnosed cancers. “In the past few decades, public health measures including tobacco cessation and lung cancer screening have contributed to the reduction of lung cancer incidence and improved survival in high-income countries, but lung cancer continues to be the leading cause of cancer-related deaths worldwide,” Saadia A. Faiz, MD, a member of the CHEST Physician editorial board, said in an interview.

“Further, new cancer diagnoses continue to increase in low-income countries where there may not be widespread public health initiatives and/or access to healthcare. Thus, development of a vaccine to prevent lung cancer could be very impactful,” she said.

Challenges to vaccine development include the heterogeneous nature of the disease, which may occur in smokers and nonsmokers, said Dr. Faiz. “Targeting the various molecular markers may be challenging,” she said. However, building on the success of other vaccine initiatives, such as the human papillomavirus vaccine for cervical cancer, and COVID-19 vaccines with collaboration and clinical research will ideally overcome these challenges, she added.

“The potential implications for a lung cancer vaccine are immense,” said Dr. Faiz.

A lung cancer vaccine could prevent a deadly disease, but continued efforts in risk factor reduction and lung cancer screening will also be important, she said.

“Depending on the results of this clinical research, longitudinal data regarding efficacy, side effects, and prevention will be vital prior to application in high-risk patients in clinical practice,” she emphasized.

The development of the lung cancer vaccine is supported in part by Cancer Research UK and the CRIS Cancer Foundation. Dr. Elliott has received support from Cancer Research UK but had no financial conflicts to disclose. Dr. Faiz had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Teen Pregnancy Linked With Risk for Premature Death

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Changed
Tue, 04/02/2024 - 11:07

Teen pregnancy is associated with a higher risk for premature mortality, both among those who carry the pregnancies to term and those who miscarry, according to a new study.

Among 2.2 million female teenagers in Ontario, Canada, the risk for premature death by age 31 years was 1.5 times higher among those who had one teen pregnancy and 2.1 times higher among those with two or more teen pregnancies.

“No person should die during childhood or early adulthood. Such deaths, unexpected and tragic, are often from preventable causes, including intentional injury,” lead author Joel Ray, MD, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto, told this news organization. 

“Women who experience teen pregnancy appear more vulnerable, often having experienced a history of adverse experiences in childhood, including abuse and economic challenges,” he said.

The study was published online in JAMA Network Open.
 

Analyzing Pregnancy Associations

The investigators conducted a population-based cohort study of all girls who were alive at age 12 years from April 1991 to March 2021 in Ontario. They evaluated the risk for all-cause mortality from age 12 years onward in association with the number of teen pregnancies between ages 12 and 19 years and the age at first pregnancy. The investigators adjusted the hazard ratios for year of birth, comorbidities at ages 9-11 years, area-level education, income level, and rural status.

Among more than 2.2 million teens, 163,124 (7.3%) had a pregnancy at a median age of 18 years, including 121,276 (74.3%) who had one pregnancy and 41,848 (25.6%) who had two or more. These teens were more likely to live in the lowest neighborhood income quintile and in an area with a lower rate of high school completion. They also had a higher prevalence of self-harm history between ages 12 and 19 years but not a higher prevalence of physical or mental comorbidities.

Among all teens who had a pregnancy, 60,037 (36.8%) ended in a birth, including 59,485 (99.1%) live births. A further 106,135 (65.1%) ended in induced abortion, and 17,945 (11%) ended in miscarriage or ectopic pregnancy.

Overall, there were 6030 premature deaths among those without a teen pregnancy, or 1.9 per 10,000 person-years. There were 701 deaths among those with one teen pregnancy (4.1 per 10,000 person-years) and 345 deaths among those with two or more teen pregnancies (6.1 per 10,000 person-years).

The adjusted hazard ratios (AHRs) for mortality were 1.51 for those with one pregnancy and 2.14 for those with two or more pregnancies. Compared with no teen pregnancy, the AHRs for premature death were 1.41 if the first teen pregnancy ended in an induced abortion and 2.10 if it ended in a miscarriage or birth.

Comparing those with a teen pregnancy and those without, the AHRs for premature death were 1.25 from noninjury, 2.06 from unintentional injury, and 2.02 from intentional injury. Among patients with teen pregnancy, noninjury-related premature mortality was more common, at 2.0 per 10,000 person-years, than unintentional and intentional injuries, at 1.0 per 10,000 person-years and 0.4 per 10,000 person-years, respectively.

A teen pregnancy before age 16 years entailed the highest associated risk for premature death, with an AHR of 2.00.
 

 

 

Next Research Steps

“We were not surprised by our findings, but it was new to us to see that the risk for premature death was higher for women who had an induced abortion in their teen years,” said Dr. Ray. “It was even higher in those whose pregnancy ended in a birth or miscarriage.”

The investigators plan to evaluate whether the future risk for premature death after teen pregnancy differs by the type of induced abortion, such as procedural or pharmaceutical, or by whether the pregnancy ended in a live birth, stillbirth, or miscarriage. Among those with a live birth, the researchers will also analyze the risk for premature death in relation to whether the newborn was taken into custody by child protection services in Canada.

Other factors associated with teen pregnancy and overall mortality, particularly adverse childhood experiences, may point to the reasons for premature mortality and should be studied further, the authors wrote. Structural and systems-related factors should be considered as well.
 

Stigmatization and Isolation 

“Some teens choose to become pregnant, but most teen pregnancies are unintended, which exposes shortcomings in the systems that exist to educate, guide, and support young people,” said Elizabeth Cook, a research scientist at Child Trends in Rockville, Maryland.

Dr. Cook, who wasn’t involved with this study, wrote an accompanying editorial in JAMA Network Open. She conducts studies of sexual and reproductive health for Child Trends.

“Teens who become pregnant often experience stigmatization and isolation that can make it more difficult to thrive in adulthood, especially if they lack the necessary support to navigate such a significant decision,” she said. “Fortunately, the systems that youths encounter, such as healthcare, education, and child welfare, are taking on a larger role in prevention efforts than they have in the past.”

These systems are shifting the burden of unintended teen pregnancy from the teens themselves and their behaviors to the health and education systems, Dr. Cook noted, though more work is needed around local policies and lack of access to healthcare facilities. 

“Teen pregnancy may offer an opportunity to intervene in the lives of people at higher risk for premature death, but knowing how best to offer support requires an understanding of the context of their lives,” she said. “As a starting point, we must celebrate and listen to all pregnant young people so they can tell us what they need to live long, fulfilled lives.”

The study was funded by grants from the PSI Foundation and the Canadian Institutes of Health Research, as well as ICES, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Ray and Dr. Cook reported no relevant disclosures. 

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

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Teen pregnancy is associated with a higher risk for premature mortality, both among those who carry the pregnancies to term and those who miscarry, according to a new study.

Among 2.2 million female teenagers in Ontario, Canada, the risk for premature death by age 31 years was 1.5 times higher among those who had one teen pregnancy and 2.1 times higher among those with two or more teen pregnancies.

“No person should die during childhood or early adulthood. Such deaths, unexpected and tragic, are often from preventable causes, including intentional injury,” lead author Joel Ray, MD, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto, told this news organization. 

“Women who experience teen pregnancy appear more vulnerable, often having experienced a history of adverse experiences in childhood, including abuse and economic challenges,” he said.

The study was published online in JAMA Network Open.
 

Analyzing Pregnancy Associations

The investigators conducted a population-based cohort study of all girls who were alive at age 12 years from April 1991 to March 2021 in Ontario. They evaluated the risk for all-cause mortality from age 12 years onward in association with the number of teen pregnancies between ages 12 and 19 years and the age at first pregnancy. The investigators adjusted the hazard ratios for year of birth, comorbidities at ages 9-11 years, area-level education, income level, and rural status.

Among more than 2.2 million teens, 163,124 (7.3%) had a pregnancy at a median age of 18 years, including 121,276 (74.3%) who had one pregnancy and 41,848 (25.6%) who had two or more. These teens were more likely to live in the lowest neighborhood income quintile and in an area with a lower rate of high school completion. They also had a higher prevalence of self-harm history between ages 12 and 19 years but not a higher prevalence of physical or mental comorbidities.

Among all teens who had a pregnancy, 60,037 (36.8%) ended in a birth, including 59,485 (99.1%) live births. A further 106,135 (65.1%) ended in induced abortion, and 17,945 (11%) ended in miscarriage or ectopic pregnancy.

Overall, there were 6030 premature deaths among those without a teen pregnancy, or 1.9 per 10,000 person-years. There were 701 deaths among those with one teen pregnancy (4.1 per 10,000 person-years) and 345 deaths among those with two or more teen pregnancies (6.1 per 10,000 person-years).

The adjusted hazard ratios (AHRs) for mortality were 1.51 for those with one pregnancy and 2.14 for those with two or more pregnancies. Compared with no teen pregnancy, the AHRs for premature death were 1.41 if the first teen pregnancy ended in an induced abortion and 2.10 if it ended in a miscarriage or birth.

Comparing those with a teen pregnancy and those without, the AHRs for premature death were 1.25 from noninjury, 2.06 from unintentional injury, and 2.02 from intentional injury. Among patients with teen pregnancy, noninjury-related premature mortality was more common, at 2.0 per 10,000 person-years, than unintentional and intentional injuries, at 1.0 per 10,000 person-years and 0.4 per 10,000 person-years, respectively.

A teen pregnancy before age 16 years entailed the highest associated risk for premature death, with an AHR of 2.00.
 

 

 

Next Research Steps

“We were not surprised by our findings, but it was new to us to see that the risk for premature death was higher for women who had an induced abortion in their teen years,” said Dr. Ray. “It was even higher in those whose pregnancy ended in a birth or miscarriage.”

The investigators plan to evaluate whether the future risk for premature death after teen pregnancy differs by the type of induced abortion, such as procedural or pharmaceutical, or by whether the pregnancy ended in a live birth, stillbirth, or miscarriage. Among those with a live birth, the researchers will also analyze the risk for premature death in relation to whether the newborn was taken into custody by child protection services in Canada.

Other factors associated with teen pregnancy and overall mortality, particularly adverse childhood experiences, may point to the reasons for premature mortality and should be studied further, the authors wrote. Structural and systems-related factors should be considered as well.
 

Stigmatization and Isolation 

“Some teens choose to become pregnant, but most teen pregnancies are unintended, which exposes shortcomings in the systems that exist to educate, guide, and support young people,” said Elizabeth Cook, a research scientist at Child Trends in Rockville, Maryland.

Dr. Cook, who wasn’t involved with this study, wrote an accompanying editorial in JAMA Network Open. She conducts studies of sexual and reproductive health for Child Trends.

“Teens who become pregnant often experience stigmatization and isolation that can make it more difficult to thrive in adulthood, especially if they lack the necessary support to navigate such a significant decision,” she said. “Fortunately, the systems that youths encounter, such as healthcare, education, and child welfare, are taking on a larger role in prevention efforts than they have in the past.”

These systems are shifting the burden of unintended teen pregnancy from the teens themselves and their behaviors to the health and education systems, Dr. Cook noted, though more work is needed around local policies and lack of access to healthcare facilities. 

“Teen pregnancy may offer an opportunity to intervene in the lives of people at higher risk for premature death, but knowing how best to offer support requires an understanding of the context of their lives,” she said. “As a starting point, we must celebrate and listen to all pregnant young people so they can tell us what they need to live long, fulfilled lives.”

The study was funded by grants from the PSI Foundation and the Canadian Institutes of Health Research, as well as ICES, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Ray and Dr. Cook reported no relevant disclosures. 

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

Teen pregnancy is associated with a higher risk for premature mortality, both among those who carry the pregnancies to term and those who miscarry, according to a new study.

Among 2.2 million female teenagers in Ontario, Canada, the risk for premature death by age 31 years was 1.5 times higher among those who had one teen pregnancy and 2.1 times higher among those with two or more teen pregnancies.

“No person should die during childhood or early adulthood. Such deaths, unexpected and tragic, are often from preventable causes, including intentional injury,” lead author Joel Ray, MD, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto, told this news organization. 

“Women who experience teen pregnancy appear more vulnerable, often having experienced a history of adverse experiences in childhood, including abuse and economic challenges,” he said.

The study was published online in JAMA Network Open.
 

Analyzing Pregnancy Associations

The investigators conducted a population-based cohort study of all girls who were alive at age 12 years from April 1991 to March 2021 in Ontario. They evaluated the risk for all-cause mortality from age 12 years onward in association with the number of teen pregnancies between ages 12 and 19 years and the age at first pregnancy. The investigators adjusted the hazard ratios for year of birth, comorbidities at ages 9-11 years, area-level education, income level, and rural status.

Among more than 2.2 million teens, 163,124 (7.3%) had a pregnancy at a median age of 18 years, including 121,276 (74.3%) who had one pregnancy and 41,848 (25.6%) who had two or more. These teens were more likely to live in the lowest neighborhood income quintile and in an area with a lower rate of high school completion. They also had a higher prevalence of self-harm history between ages 12 and 19 years but not a higher prevalence of physical or mental comorbidities.

Among all teens who had a pregnancy, 60,037 (36.8%) ended in a birth, including 59,485 (99.1%) live births. A further 106,135 (65.1%) ended in induced abortion, and 17,945 (11%) ended in miscarriage or ectopic pregnancy.

Overall, there were 6030 premature deaths among those without a teen pregnancy, or 1.9 per 10,000 person-years. There were 701 deaths among those with one teen pregnancy (4.1 per 10,000 person-years) and 345 deaths among those with two or more teen pregnancies (6.1 per 10,000 person-years).

The adjusted hazard ratios (AHRs) for mortality were 1.51 for those with one pregnancy and 2.14 for those with two or more pregnancies. Compared with no teen pregnancy, the AHRs for premature death were 1.41 if the first teen pregnancy ended in an induced abortion and 2.10 if it ended in a miscarriage or birth.

Comparing those with a teen pregnancy and those without, the AHRs for premature death were 1.25 from noninjury, 2.06 from unintentional injury, and 2.02 from intentional injury. Among patients with teen pregnancy, noninjury-related premature mortality was more common, at 2.0 per 10,000 person-years, than unintentional and intentional injuries, at 1.0 per 10,000 person-years and 0.4 per 10,000 person-years, respectively.

A teen pregnancy before age 16 years entailed the highest associated risk for premature death, with an AHR of 2.00.
 

 

 

Next Research Steps

“We were not surprised by our findings, but it was new to us to see that the risk for premature death was higher for women who had an induced abortion in their teen years,” said Dr. Ray. “It was even higher in those whose pregnancy ended in a birth or miscarriage.”

The investigators plan to evaluate whether the future risk for premature death after teen pregnancy differs by the type of induced abortion, such as procedural or pharmaceutical, or by whether the pregnancy ended in a live birth, stillbirth, or miscarriage. Among those with a live birth, the researchers will also analyze the risk for premature death in relation to whether the newborn was taken into custody by child protection services in Canada.

Other factors associated with teen pregnancy and overall mortality, particularly adverse childhood experiences, may point to the reasons for premature mortality and should be studied further, the authors wrote. Structural and systems-related factors should be considered as well.
 

Stigmatization and Isolation 

“Some teens choose to become pregnant, but most teen pregnancies are unintended, which exposes shortcomings in the systems that exist to educate, guide, and support young people,” said Elizabeth Cook, a research scientist at Child Trends in Rockville, Maryland.

Dr. Cook, who wasn’t involved with this study, wrote an accompanying editorial in JAMA Network Open. She conducts studies of sexual and reproductive health for Child Trends.

“Teens who become pregnant often experience stigmatization and isolation that can make it more difficult to thrive in adulthood, especially if they lack the necessary support to navigate such a significant decision,” she said. “Fortunately, the systems that youths encounter, such as healthcare, education, and child welfare, are taking on a larger role in prevention efforts than they have in the past.”

These systems are shifting the burden of unintended teen pregnancy from the teens themselves and their behaviors to the health and education systems, Dr. Cook noted, though more work is needed around local policies and lack of access to healthcare facilities. 

“Teen pregnancy may offer an opportunity to intervene in the lives of people at higher risk for premature death, but knowing how best to offer support requires an understanding of the context of their lives,” she said. “As a starting point, we must celebrate and listen to all pregnant young people so they can tell us what they need to live long, fulfilled lives.”

The study was funded by grants from the PSI Foundation and the Canadian Institutes of Health Research, as well as ICES, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Ray and Dr. Cook reported no relevant disclosures. 

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

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