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Medicare Rates in 2025 Would Cut Pay For Docs by 3%
Federal officials on July 11 proposed Medicare rates that effectively would cut physician pay by about 3% in 2025, touching off a fresh round of protests from medical associations.
, the Centers for Medicare & Medicaid Services said.
The American Medical Association (AMA), the American Academy of Family Physicians (AAFP) and other groups on July 10 reiterated calls on Congress to revise the law on Medicare payment for physicians and move away from short-term tweaks.
This proposed cut is mostly due to the 5-year freeze in the physician schedule base rate mandated by the 2015 Medicare Access and CHIP Reauthorization Act (MACRA). Congress designed MACRA with an aim of shifting clinicians toward programs that would peg pay increases to quality measures.
Lawmakers have since had to soften the blow of that freeze, acknowledging flaws in MACRA and inflation’s significant toll on medical practices. Yet lawmakers have made temporary fixes, such as a 2.93% increase in current payment that’s set to expire.
“Previous quick fixes have been insufficient — this situation requires a bold, substantial approach,” Bruce A. Scott, MD, the AMA president, said in a statement. “A Band-Aid goes only so far when the patient is in dire need.”
Dr. Scott noted that the Medicare Economic Index — a measure of practice cost inflation — is expected to rise by 3.6% in 2025.
“As a first step, Congress must enact an annual inflationary update to help physician payment rates keep pace with rising practice costs,” Steven P. Furr, MD, AAFP’s president, said in a statement released July 10. “Any payment reductions will threaten practices and exacerbate workforce shortages, preventing patients from accessing the primary care, behavioral health care, and other critical preventive services they need.”
Many medical groups, including the AMA, AAFP, and the Medical Group Management Association, are pressing Congress to pass a law that would tie the conversion factor of the physician fee schedule to inflation.
Influential advisory groups also have backed the idea of increasing the conversion factor. For example, the Medicare Payment Advisory Commission in March recommended to Congress that it increase the 2025 conversion factor, suggesting a bump of half of the projected increase in the Medicare Economic Index.
Congress seems unlikely to revamp the physician fee schedule this year, with members spending significant time away from Washington ahead of the November election.
That could make it likely that Congress’ next action on Medicare payment rates would be another short-term tweak — instead of long-lasting change.
A version of this article first appeared on Medscape.com.
Federal officials on July 11 proposed Medicare rates that effectively would cut physician pay by about 3% in 2025, touching off a fresh round of protests from medical associations.
, the Centers for Medicare & Medicaid Services said.
The American Medical Association (AMA), the American Academy of Family Physicians (AAFP) and other groups on July 10 reiterated calls on Congress to revise the law on Medicare payment for physicians and move away from short-term tweaks.
This proposed cut is mostly due to the 5-year freeze in the physician schedule base rate mandated by the 2015 Medicare Access and CHIP Reauthorization Act (MACRA). Congress designed MACRA with an aim of shifting clinicians toward programs that would peg pay increases to quality measures.
Lawmakers have since had to soften the blow of that freeze, acknowledging flaws in MACRA and inflation’s significant toll on medical practices. Yet lawmakers have made temporary fixes, such as a 2.93% increase in current payment that’s set to expire.
“Previous quick fixes have been insufficient — this situation requires a bold, substantial approach,” Bruce A. Scott, MD, the AMA president, said in a statement. “A Band-Aid goes only so far when the patient is in dire need.”
Dr. Scott noted that the Medicare Economic Index — a measure of practice cost inflation — is expected to rise by 3.6% in 2025.
“As a first step, Congress must enact an annual inflationary update to help physician payment rates keep pace with rising practice costs,” Steven P. Furr, MD, AAFP’s president, said in a statement released July 10. “Any payment reductions will threaten practices and exacerbate workforce shortages, preventing patients from accessing the primary care, behavioral health care, and other critical preventive services they need.”
Many medical groups, including the AMA, AAFP, and the Medical Group Management Association, are pressing Congress to pass a law that would tie the conversion factor of the physician fee schedule to inflation.
Influential advisory groups also have backed the idea of increasing the conversion factor. For example, the Medicare Payment Advisory Commission in March recommended to Congress that it increase the 2025 conversion factor, suggesting a bump of half of the projected increase in the Medicare Economic Index.
Congress seems unlikely to revamp the physician fee schedule this year, with members spending significant time away from Washington ahead of the November election.
That could make it likely that Congress’ next action on Medicare payment rates would be another short-term tweak — instead of long-lasting change.
A version of this article first appeared on Medscape.com.
Federal officials on July 11 proposed Medicare rates that effectively would cut physician pay by about 3% in 2025, touching off a fresh round of protests from medical associations.
, the Centers for Medicare & Medicaid Services said.
The American Medical Association (AMA), the American Academy of Family Physicians (AAFP) and other groups on July 10 reiterated calls on Congress to revise the law on Medicare payment for physicians and move away from short-term tweaks.
This proposed cut is mostly due to the 5-year freeze in the physician schedule base rate mandated by the 2015 Medicare Access and CHIP Reauthorization Act (MACRA). Congress designed MACRA with an aim of shifting clinicians toward programs that would peg pay increases to quality measures.
Lawmakers have since had to soften the blow of that freeze, acknowledging flaws in MACRA and inflation’s significant toll on medical practices. Yet lawmakers have made temporary fixes, such as a 2.93% increase in current payment that’s set to expire.
“Previous quick fixes have been insufficient — this situation requires a bold, substantial approach,” Bruce A. Scott, MD, the AMA president, said in a statement. “A Band-Aid goes only so far when the patient is in dire need.”
Dr. Scott noted that the Medicare Economic Index — a measure of practice cost inflation — is expected to rise by 3.6% in 2025.
“As a first step, Congress must enact an annual inflationary update to help physician payment rates keep pace with rising practice costs,” Steven P. Furr, MD, AAFP’s president, said in a statement released July 10. “Any payment reductions will threaten practices and exacerbate workforce shortages, preventing patients from accessing the primary care, behavioral health care, and other critical preventive services they need.”
Many medical groups, including the AMA, AAFP, and the Medical Group Management Association, are pressing Congress to pass a law that would tie the conversion factor of the physician fee schedule to inflation.
Influential advisory groups also have backed the idea of increasing the conversion factor. For example, the Medicare Payment Advisory Commission in March recommended to Congress that it increase the 2025 conversion factor, suggesting a bump of half of the projected increase in the Medicare Economic Index.
Congress seems unlikely to revamp the physician fee schedule this year, with members spending significant time away from Washington ahead of the November election.
That could make it likely that Congress’ next action on Medicare payment rates would be another short-term tweak — instead of long-lasting change.
A version of this article first appeared on Medscape.com.
Gut Biomarkers Accurately Flag Autism Spectrum Disorder
, new research shows.
The findings could form the basis for development of a noninvasive diagnostic test for ASD and also provide novel therapeutic targets, wrote investigators, led by Siew C. Ng, MBBS, PhD, with the Microbiota I-Center (MagIC), the Chinese University of Hong Kong.
Their study was published online in Nature Microbiology.
Beyond Bacteria
The gut microbiome has been shown to play a central role in modulating the gut-brain axis, potentially influencing the development of ASD.
However, most studies in ASD have focused on the bacterial component of the microbiome. Whether nonbacterial microorganisms (such as gut archaea, fungi, and viruses) or function of the gut microbiome are altered in ASD remains unclear.
To investigate, the researchers performed metagenomic sequencing on fecal samples from 1627 boys and girls aged 1-13 years with and without ASD from five cohorts in China.
After controlling for diet, medication, and comorbidity, they identified 14 archaea, 51 bacteria, 7 fungi, 18 viruses, 27 microbial genes, and 12 metabolic pathways that were altered in children with ASD.
Machine-learning models using single-kingdom panels (archaea, bacteria, fungi, viruses) achieved area under the curve (AUC) values ranging from 0.68 to 0.87 in differentiating children with ASD from neurotypical control children.
A model based on a panel of 31 multikingdom and functional markers achieved “high predictive value” for ASD, achieving an AUC of 0.91, with comparable performance among boys and girls.
“The reproducible performance of the models across ages, sexes, and cohorts highlights their potential as promising diagnostic tools for ASD,” the investigators wrote.
They also noted that the accuracy of the model was largely driven by the biosynthesis pathways of ubiquinol-7 and thiamine diphosphate, which were less abundant in children with ASD, and may serve as therapeutic targets.
‘Exciting’ Possibilities
“This study broadens our understanding by including fungi, archaea, and viruses, where previous studies have largely focused on the role of gut bacteria in autism,” Bhismadev Chakrabarti, PhD, research director of the Centre for Autism at the University of Reading, United Kingdom, said in a statement from the nonprofit UK Science Media Centre.
“The results are broadly in line with previous studies that show reduced microbial diversity in autistic individuals. It also examines one of the largest samples seen in a study like this, which further strengthens the results,” Dr. Chakrabarti added.
He said this research may provide “new ways of detecting autism, if microbial markers turn out to strengthen the ability of genetic and behavioral tests to detect autism. A future platform that can combine genetic, microbial, and simple behavioral assessments could help address the detection gap.
“One limitation of this data is that it cannot assess any causal role for the microbiota in the development of autism,” Dr. Chakrabarti noted.
This study was supported by InnoHK, the Government of Hong Kong, Special Administrative Region of the People’s Republic of China, The D. H. Chen Foundation, and the New Cornerstone Science Foundation through the New Cornerstone Investigator Program. Dr. Ng has served as an advisory board member for Pfizer, Ferring, Janssen, and AbbVie; has received honoraria as a speaker for Ferring, Tillotts, Menarini, Janssen, AbbVie, and Takeda; is a scientific cofounder and shareholder of GenieBiome; receives patent royalties through her affiliated institutions; and is named as a co-inventor of patent applications that cover the therapeutic and diagnostic use of microbiome. Dr. Chakrabarti has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
, new research shows.
The findings could form the basis for development of a noninvasive diagnostic test for ASD and also provide novel therapeutic targets, wrote investigators, led by Siew C. Ng, MBBS, PhD, with the Microbiota I-Center (MagIC), the Chinese University of Hong Kong.
Their study was published online in Nature Microbiology.
Beyond Bacteria
The gut microbiome has been shown to play a central role in modulating the gut-brain axis, potentially influencing the development of ASD.
However, most studies in ASD have focused on the bacterial component of the microbiome. Whether nonbacterial microorganisms (such as gut archaea, fungi, and viruses) or function of the gut microbiome are altered in ASD remains unclear.
To investigate, the researchers performed metagenomic sequencing on fecal samples from 1627 boys and girls aged 1-13 years with and without ASD from five cohorts in China.
After controlling for diet, medication, and comorbidity, they identified 14 archaea, 51 bacteria, 7 fungi, 18 viruses, 27 microbial genes, and 12 metabolic pathways that were altered in children with ASD.
Machine-learning models using single-kingdom panels (archaea, bacteria, fungi, viruses) achieved area under the curve (AUC) values ranging from 0.68 to 0.87 in differentiating children with ASD from neurotypical control children.
A model based on a panel of 31 multikingdom and functional markers achieved “high predictive value” for ASD, achieving an AUC of 0.91, with comparable performance among boys and girls.
“The reproducible performance of the models across ages, sexes, and cohorts highlights their potential as promising diagnostic tools for ASD,” the investigators wrote.
They also noted that the accuracy of the model was largely driven by the biosynthesis pathways of ubiquinol-7 and thiamine diphosphate, which were less abundant in children with ASD, and may serve as therapeutic targets.
‘Exciting’ Possibilities
“This study broadens our understanding by including fungi, archaea, and viruses, where previous studies have largely focused on the role of gut bacteria in autism,” Bhismadev Chakrabarti, PhD, research director of the Centre for Autism at the University of Reading, United Kingdom, said in a statement from the nonprofit UK Science Media Centre.
“The results are broadly in line with previous studies that show reduced microbial diversity in autistic individuals. It also examines one of the largest samples seen in a study like this, which further strengthens the results,” Dr. Chakrabarti added.
He said this research may provide “new ways of detecting autism, if microbial markers turn out to strengthen the ability of genetic and behavioral tests to detect autism. A future platform that can combine genetic, microbial, and simple behavioral assessments could help address the detection gap.
“One limitation of this data is that it cannot assess any causal role for the microbiota in the development of autism,” Dr. Chakrabarti noted.
This study was supported by InnoHK, the Government of Hong Kong, Special Administrative Region of the People’s Republic of China, The D. H. Chen Foundation, and the New Cornerstone Science Foundation through the New Cornerstone Investigator Program. Dr. Ng has served as an advisory board member for Pfizer, Ferring, Janssen, and AbbVie; has received honoraria as a speaker for Ferring, Tillotts, Menarini, Janssen, AbbVie, and Takeda; is a scientific cofounder and shareholder of GenieBiome; receives patent royalties through her affiliated institutions; and is named as a co-inventor of patent applications that cover the therapeutic and diagnostic use of microbiome. Dr. Chakrabarti has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
, new research shows.
The findings could form the basis for development of a noninvasive diagnostic test for ASD and also provide novel therapeutic targets, wrote investigators, led by Siew C. Ng, MBBS, PhD, with the Microbiota I-Center (MagIC), the Chinese University of Hong Kong.
Their study was published online in Nature Microbiology.
Beyond Bacteria
The gut microbiome has been shown to play a central role in modulating the gut-brain axis, potentially influencing the development of ASD.
However, most studies in ASD have focused on the bacterial component of the microbiome. Whether nonbacterial microorganisms (such as gut archaea, fungi, and viruses) or function of the gut microbiome are altered in ASD remains unclear.
To investigate, the researchers performed metagenomic sequencing on fecal samples from 1627 boys and girls aged 1-13 years with and without ASD from five cohorts in China.
After controlling for diet, medication, and comorbidity, they identified 14 archaea, 51 bacteria, 7 fungi, 18 viruses, 27 microbial genes, and 12 metabolic pathways that were altered in children with ASD.
Machine-learning models using single-kingdom panels (archaea, bacteria, fungi, viruses) achieved area under the curve (AUC) values ranging from 0.68 to 0.87 in differentiating children with ASD from neurotypical control children.
A model based on a panel of 31 multikingdom and functional markers achieved “high predictive value” for ASD, achieving an AUC of 0.91, with comparable performance among boys and girls.
“The reproducible performance of the models across ages, sexes, and cohorts highlights their potential as promising diagnostic tools for ASD,” the investigators wrote.
They also noted that the accuracy of the model was largely driven by the biosynthesis pathways of ubiquinol-7 and thiamine diphosphate, which were less abundant in children with ASD, and may serve as therapeutic targets.
‘Exciting’ Possibilities
“This study broadens our understanding by including fungi, archaea, and viruses, where previous studies have largely focused on the role of gut bacteria in autism,” Bhismadev Chakrabarti, PhD, research director of the Centre for Autism at the University of Reading, United Kingdom, said in a statement from the nonprofit UK Science Media Centre.
“The results are broadly in line with previous studies that show reduced microbial diversity in autistic individuals. It also examines one of the largest samples seen in a study like this, which further strengthens the results,” Dr. Chakrabarti added.
He said this research may provide “new ways of detecting autism, if microbial markers turn out to strengthen the ability of genetic and behavioral tests to detect autism. A future platform that can combine genetic, microbial, and simple behavioral assessments could help address the detection gap.
“One limitation of this data is that it cannot assess any causal role for the microbiota in the development of autism,” Dr. Chakrabarti noted.
This study was supported by InnoHK, the Government of Hong Kong, Special Administrative Region of the People’s Republic of China, The D. H. Chen Foundation, and the New Cornerstone Science Foundation through the New Cornerstone Investigator Program. Dr. Ng has served as an advisory board member for Pfizer, Ferring, Janssen, and AbbVie; has received honoraria as a speaker for Ferring, Tillotts, Menarini, Janssen, AbbVie, and Takeda; is a scientific cofounder and shareholder of GenieBiome; receives patent royalties through her affiliated institutions; and is named as a co-inventor of patent applications that cover the therapeutic and diagnostic use of microbiome. Dr. Chakrabarti has no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM NATURE MICROBIOLOGY
A Doctor’s Guide to Relocation
Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.
The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.
This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
1. Find Relocation Resources
First things first. Find out what your program or hospital has to offer.
Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.
Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.
Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.
When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.
If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
2. Reach Out and Buddy Up
Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.
Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.
On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.
Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.
To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
3. Play the ‘Doctor Card’
Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”
“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
4. Move Early
Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.
Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.
“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
5. Make Your New Home Your Sanctuary
During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.
Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”
Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.
“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
6. Consider a ‘Live’ Stress Reliever
When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.
Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”
Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.
Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”
A version of this article first appeared on Medscape.com.
Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.
The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.
This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
1. Find Relocation Resources
First things first. Find out what your program or hospital has to offer.
Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.
Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.
Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.
When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.
If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
2. Reach Out and Buddy Up
Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.
Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.
On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.
Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.
To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
3. Play the ‘Doctor Card’
Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”
“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
4. Move Early
Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.
Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.
“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
5. Make Your New Home Your Sanctuary
During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.
Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”
Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.
“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
6. Consider a ‘Live’ Stress Reliever
When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.
Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”
Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.
Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”
A version of this article first appeared on Medscape.com.
Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.
The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.
This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
1. Find Relocation Resources
First things first. Find out what your program or hospital has to offer.
Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.
Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.
Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.
When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.
If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
2. Reach Out and Buddy Up
Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.
Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.
On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.
Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.
To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
3. Play the ‘Doctor Card’
Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”
“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
4. Move Early
Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.
Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.
“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
5. Make Your New Home Your Sanctuary
During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.
Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”
Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.
“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
6. Consider a ‘Live’ Stress Reliever
When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.
Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”
Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.
Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”
A version of this article first appeared on Medscape.com.
How Has the RSV Season Changed Since the Pandemic Began?
A recent study published in JAMA Network Open described the epidemiological characteristics of respiratory syncytial virus (RSV) infection in Ontario, Canada, after the onset of the COVID-19 pandemic. It is the latest in a series of studies that suggest that virus circulation dynamics and hospitalizations have changed over time. These are crucial pieces of information for managing the seasonal epidemic.
News From Canada
The Canadian study compared hospitalization rates and characteristics of children aged < 5 years who were admitted to the hospital for RSV infection during three prepandemic seasons (2017-2020) and two “postpandemic” seasons (2021-2023).
Compared with the prepandemic period, the 2021-2022 RSV season peaked a little earlier (early December instead of mid-December) but had comparable hospitalization rates. The 2022-2023 season, on the other hand, peaked a month earlier with a more than doubled hospitalization rate. Hospitalizations increased from about 2000 to 4977. In 2022, hospitalizations also occurred in spring and summer. In 2022-2023, more hospitalizations than expected were observed, especially in the 24-59–month-old group.
The percentage of patients hospitalized in intensive care units (ICUs) increased (11.4% in 2021-2022 and 13.9% in 2022-2023 compared with 9.8% in 2017-2018), and the ICU hospitalization rate tripled compared with the prepandemic period. No differences were observed in ICU length of stay or severe outcomes (such as use of extracorporeal membrane oxygenation or hospital mortality). The use of mechanical ventilation increased, however.
News From the USA
Another recent study, published in Pediatrics, provides an overview of RSV epidemiology in the United States based on data collected from seven pediatric hospitals across the country. Data from 2021 and 2022 were compared with those from four prepandemic seasons (2016-2020).
Most observations agree with what was reported in the Canadian study. In the four prepandemic years, the peak of RSV-associated hospitalizations was recorded in December-January. In 2021, it was in July, and in 2022, it was in November. Hospitalization rates of RSV-positive patients in 2021 and 2022 were higher than those in the prepandemic period. In 2022, compared with 2021, the hospitalization rate of children aged < 2 years did not change, while that of children aged 24-59 months increased significantly.
In 2022, the percentage of children requiring oxygen therapy was higher. But unlike in the other study, the percentage of children undergoing mechanical ventilation or those hospitalized in ICUs was not significantly different from the past. It is worth noting that in 2022, multiple respiratory coinfections were more frequently found in RSV-positive hospitalized children.
News From Italy
“In our experience, as well, the epidemiology of RSV has shown changes following the pandemic,” Marta Luisa Ciofi degli Atti, MD, head of the Epidemiology, Clinical Pathways, and Clinical Risk Complex Operating Unit at the Bambino Gesù Pediatric Hospital in Rome, Italy, told Univadis Italy. “Before the pandemic, RSV infection peaks were regularly in late December-January. The pandemic, with its containment measures, interrupted the typical seasonality of RSV: A season was skipped, and in 2021, there was a season that was different from all previous ones because it was anticipated, with a peak in October-November and a much higher incidence. In 2022, we also had a higher autumn incidence compared with the past, with a peak in November. However, the number of confirmed infections approached prepandemic levels. The season was also anticipated in 2023, so prepandemic epidemiology does not seem to have stabilized yet.”
As did Canada and the USA, Italy had an increase in incidence among older children in 2022. “Cases of children aged 1-4 years increased from 24% in 2018 to 30%, and those of children aged 5-9 years from 5.4% to 8.7%,” said Dr. Ciofi degli Atti. “Children in the first year of life were similarly affected in the pre- and postpandemic periods, while cases increased among older children. It is as if there has been an accumulation of susceptible patients: Children who did not get sick in the first year of life during the pandemic and got sick later in the postpandemic period.”
Predicting (and Preventing) Chaos
As described in an article recently published in the Italian Journal of Pediatrics, Dr. Ciofi degli Atti worked on a model to predict the peak of RSV infections. “It is a mathematical predictive model that, based on observations in a certain number of seasons, allows the estimation of expectations,” she explained. It is challenging to develop a model when there are highly disruptive events such as a pandemic, she added, but these situations make predictive tools of the utmost interest. “The predictive capacity for the 2023 season was good: We had predicted that the peak would be reached in week 49, and indeed, the peak was observed in December.”
“RSV infection causes severe clinical conditions that affect young children who may need hospitalization and sometimes respiratory assistance. The epidemic peaks within a few weeks and has a disruptive effect on healthcare organization,” said Dr. Ciofi degli Atti. “Preventive vaccination is a huge opportunity in terms of health benefits for young children, who are directly involved, and also to reduce the impact that seasonal RSV epidemics have on hospital pathways. At the national and regional levels, work is therefore underway to start vaccination to prevent the circulation of this virus.”
This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
A recent study published in JAMA Network Open described the epidemiological characteristics of respiratory syncytial virus (RSV) infection in Ontario, Canada, after the onset of the COVID-19 pandemic. It is the latest in a series of studies that suggest that virus circulation dynamics and hospitalizations have changed over time. These are crucial pieces of information for managing the seasonal epidemic.
News From Canada
The Canadian study compared hospitalization rates and characteristics of children aged < 5 years who were admitted to the hospital for RSV infection during three prepandemic seasons (2017-2020) and two “postpandemic” seasons (2021-2023).
Compared with the prepandemic period, the 2021-2022 RSV season peaked a little earlier (early December instead of mid-December) but had comparable hospitalization rates. The 2022-2023 season, on the other hand, peaked a month earlier with a more than doubled hospitalization rate. Hospitalizations increased from about 2000 to 4977. In 2022, hospitalizations also occurred in spring and summer. In 2022-2023, more hospitalizations than expected were observed, especially in the 24-59–month-old group.
The percentage of patients hospitalized in intensive care units (ICUs) increased (11.4% in 2021-2022 and 13.9% in 2022-2023 compared with 9.8% in 2017-2018), and the ICU hospitalization rate tripled compared with the prepandemic period. No differences were observed in ICU length of stay or severe outcomes (such as use of extracorporeal membrane oxygenation or hospital mortality). The use of mechanical ventilation increased, however.
News From the USA
Another recent study, published in Pediatrics, provides an overview of RSV epidemiology in the United States based on data collected from seven pediatric hospitals across the country. Data from 2021 and 2022 were compared with those from four prepandemic seasons (2016-2020).
Most observations agree with what was reported in the Canadian study. In the four prepandemic years, the peak of RSV-associated hospitalizations was recorded in December-January. In 2021, it was in July, and in 2022, it was in November. Hospitalization rates of RSV-positive patients in 2021 and 2022 were higher than those in the prepandemic period. In 2022, compared with 2021, the hospitalization rate of children aged < 2 years did not change, while that of children aged 24-59 months increased significantly.
In 2022, the percentage of children requiring oxygen therapy was higher. But unlike in the other study, the percentage of children undergoing mechanical ventilation or those hospitalized in ICUs was not significantly different from the past. It is worth noting that in 2022, multiple respiratory coinfections were more frequently found in RSV-positive hospitalized children.
News From Italy
“In our experience, as well, the epidemiology of RSV has shown changes following the pandemic,” Marta Luisa Ciofi degli Atti, MD, head of the Epidemiology, Clinical Pathways, and Clinical Risk Complex Operating Unit at the Bambino Gesù Pediatric Hospital in Rome, Italy, told Univadis Italy. “Before the pandemic, RSV infection peaks were regularly in late December-January. The pandemic, with its containment measures, interrupted the typical seasonality of RSV: A season was skipped, and in 2021, there was a season that was different from all previous ones because it was anticipated, with a peak in October-November and a much higher incidence. In 2022, we also had a higher autumn incidence compared with the past, with a peak in November. However, the number of confirmed infections approached prepandemic levels. The season was also anticipated in 2023, so prepandemic epidemiology does not seem to have stabilized yet.”
As did Canada and the USA, Italy had an increase in incidence among older children in 2022. “Cases of children aged 1-4 years increased from 24% in 2018 to 30%, and those of children aged 5-9 years from 5.4% to 8.7%,” said Dr. Ciofi degli Atti. “Children in the first year of life were similarly affected in the pre- and postpandemic periods, while cases increased among older children. It is as if there has been an accumulation of susceptible patients: Children who did not get sick in the first year of life during the pandemic and got sick later in the postpandemic period.”
Predicting (and Preventing) Chaos
As described in an article recently published in the Italian Journal of Pediatrics, Dr. Ciofi degli Atti worked on a model to predict the peak of RSV infections. “It is a mathematical predictive model that, based on observations in a certain number of seasons, allows the estimation of expectations,” she explained. It is challenging to develop a model when there are highly disruptive events such as a pandemic, she added, but these situations make predictive tools of the utmost interest. “The predictive capacity for the 2023 season was good: We had predicted that the peak would be reached in week 49, and indeed, the peak was observed in December.”
“RSV infection causes severe clinical conditions that affect young children who may need hospitalization and sometimes respiratory assistance. The epidemic peaks within a few weeks and has a disruptive effect on healthcare organization,” said Dr. Ciofi degli Atti. “Preventive vaccination is a huge opportunity in terms of health benefits for young children, who are directly involved, and also to reduce the impact that seasonal RSV epidemics have on hospital pathways. At the national and regional levels, work is therefore underway to start vaccination to prevent the circulation of this virus.”
This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
A recent study published in JAMA Network Open described the epidemiological characteristics of respiratory syncytial virus (RSV) infection in Ontario, Canada, after the onset of the COVID-19 pandemic. It is the latest in a series of studies that suggest that virus circulation dynamics and hospitalizations have changed over time. These are crucial pieces of information for managing the seasonal epidemic.
News From Canada
The Canadian study compared hospitalization rates and characteristics of children aged < 5 years who were admitted to the hospital for RSV infection during three prepandemic seasons (2017-2020) and two “postpandemic” seasons (2021-2023).
Compared with the prepandemic period, the 2021-2022 RSV season peaked a little earlier (early December instead of mid-December) but had comparable hospitalization rates. The 2022-2023 season, on the other hand, peaked a month earlier with a more than doubled hospitalization rate. Hospitalizations increased from about 2000 to 4977. In 2022, hospitalizations also occurred in spring and summer. In 2022-2023, more hospitalizations than expected were observed, especially in the 24-59–month-old group.
The percentage of patients hospitalized in intensive care units (ICUs) increased (11.4% in 2021-2022 and 13.9% in 2022-2023 compared with 9.8% in 2017-2018), and the ICU hospitalization rate tripled compared with the prepandemic period. No differences were observed in ICU length of stay or severe outcomes (such as use of extracorporeal membrane oxygenation or hospital mortality). The use of mechanical ventilation increased, however.
News From the USA
Another recent study, published in Pediatrics, provides an overview of RSV epidemiology in the United States based on data collected from seven pediatric hospitals across the country. Data from 2021 and 2022 were compared with those from four prepandemic seasons (2016-2020).
Most observations agree with what was reported in the Canadian study. In the four prepandemic years, the peak of RSV-associated hospitalizations was recorded in December-January. In 2021, it was in July, and in 2022, it was in November. Hospitalization rates of RSV-positive patients in 2021 and 2022 were higher than those in the prepandemic period. In 2022, compared with 2021, the hospitalization rate of children aged < 2 years did not change, while that of children aged 24-59 months increased significantly.
In 2022, the percentage of children requiring oxygen therapy was higher. But unlike in the other study, the percentage of children undergoing mechanical ventilation or those hospitalized in ICUs was not significantly different from the past. It is worth noting that in 2022, multiple respiratory coinfections were more frequently found in RSV-positive hospitalized children.
News From Italy
“In our experience, as well, the epidemiology of RSV has shown changes following the pandemic,” Marta Luisa Ciofi degli Atti, MD, head of the Epidemiology, Clinical Pathways, and Clinical Risk Complex Operating Unit at the Bambino Gesù Pediatric Hospital in Rome, Italy, told Univadis Italy. “Before the pandemic, RSV infection peaks were regularly in late December-January. The pandemic, with its containment measures, interrupted the typical seasonality of RSV: A season was skipped, and in 2021, there was a season that was different from all previous ones because it was anticipated, with a peak in October-November and a much higher incidence. In 2022, we also had a higher autumn incidence compared with the past, with a peak in November. However, the number of confirmed infections approached prepandemic levels. The season was also anticipated in 2023, so prepandemic epidemiology does not seem to have stabilized yet.”
As did Canada and the USA, Italy had an increase in incidence among older children in 2022. “Cases of children aged 1-4 years increased from 24% in 2018 to 30%, and those of children aged 5-9 years from 5.4% to 8.7%,” said Dr. Ciofi degli Atti. “Children in the first year of life were similarly affected in the pre- and postpandemic periods, while cases increased among older children. It is as if there has been an accumulation of susceptible patients: Children who did not get sick in the first year of life during the pandemic and got sick later in the postpandemic period.”
Predicting (and Preventing) Chaos
As described in an article recently published in the Italian Journal of Pediatrics, Dr. Ciofi degli Atti worked on a model to predict the peak of RSV infections. “It is a mathematical predictive model that, based on observations in a certain number of seasons, allows the estimation of expectations,” she explained. It is challenging to develop a model when there are highly disruptive events such as a pandemic, she added, but these situations make predictive tools of the utmost interest. “The predictive capacity for the 2023 season was good: We had predicted that the peak would be reached in week 49, and indeed, the peak was observed in December.”
“RSV infection causes severe clinical conditions that affect young children who may need hospitalization and sometimes respiratory assistance. The epidemic peaks within a few weeks and has a disruptive effect on healthcare organization,” said Dr. Ciofi degli Atti. “Preventive vaccination is a huge opportunity in terms of health benefits for young children, who are directly involved, and also to reduce the impact that seasonal RSV epidemics have on hospital pathways. At the national and regional levels, work is therefore underway to start vaccination to prevent the circulation of this virus.”
This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Confronting Healthcare Disinformation on Social Media
More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.
These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.
This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.
Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
Tenuous Causal Link
While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.
Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.
“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
Institutions’ Role
Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”
The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
A Doctor’s Role
And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.
From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
Misinformation vs Disinformation
The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.
The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.
These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.
This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.
Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
Tenuous Causal Link
While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.
Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.
“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
Institutions’ Role
Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”
The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
A Doctor’s Role
And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.
From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
Misinformation vs Disinformation
The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.
The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.
These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.
This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.
Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
Tenuous Causal Link
While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.
Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.
“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
Institutions’ Role
Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”
The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
A Doctor’s Role
And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.
From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
Misinformation vs Disinformation
The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.
The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Should Cancer Trial Eligibility Become More Inclusive?
The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.
“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”
Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.
In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.
In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.
Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing.
The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers.
Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.
A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.
The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).
“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.
The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.
So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.
Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.
Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”
However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.
“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”
Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
A version of this article appeared on Medscape.com.
The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.
“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”
Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.
In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.
In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.
Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing.
The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers.
Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.
A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.
The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).
“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.
The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.
So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.
Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.
Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”
However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.
“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”
Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
A version of this article appeared on Medscape.com.
The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.
“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”
Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.
In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.
In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.
Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing.
The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers.
Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.
A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.
The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).
“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.
The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.
So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.
Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.
Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”
However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.
“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”
Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
A version of this article appeared on Medscape.com.
Opioids Post T&A
I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.
On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.
Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.
First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.
However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.
As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.
Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.
I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.
I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.
On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.
Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.
First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.
However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.
As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.
Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.
I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.
I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.
On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.
Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.
First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.
However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.
As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.
Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.
I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.
I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Philips Respironics Issues Update on Ventilator Alarm Failure
, according to a recall statement from the US Food and Drug Administration (FDA).
The OLA+ Ventilator is designed for use by individuals with obstructive sleep apnea, breathing problems, and mixed apnea and is approved for children aged 7 years and older, as well as adults.
The recall does not involve removal of the devices from where they are used or sold but does update the instructions for use, and its use without following the updated instructions could result in serious injury or death, according to the statement.
Following an alarm failure, the device may fail in one of two ways: By entering a ventilator inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present) or by entering a ventilator inoperative state without rebooting first.
According to the statement, the alarm issue may be corrected with a software patch, available from Philips, or the company will offer a replacement device for patients until the affected devices are repaired. The statement updates an April 1, 2024, urgent recall from Philips urging the immediate removal of a patient from an OLA+ Ventilator and connecting them to alternative ventilation if possible if the ventilator’s inoperative alarm occurs.
The device failures may cause interruption or loss of therapy with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and even death in especially vulnerable individuals. One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.
US customers can contact Philips Respironics Inc. at 1-800-345-6443 or [email protected] with questions, according to the FDA, and clinicians and patients may report adverse reactions or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
A version of this article appeared on Medscape.com.
, according to a recall statement from the US Food and Drug Administration (FDA).
The OLA+ Ventilator is designed for use by individuals with obstructive sleep apnea, breathing problems, and mixed apnea and is approved for children aged 7 years and older, as well as adults.
The recall does not involve removal of the devices from where they are used or sold but does update the instructions for use, and its use without following the updated instructions could result in serious injury or death, according to the statement.
Following an alarm failure, the device may fail in one of two ways: By entering a ventilator inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present) or by entering a ventilator inoperative state without rebooting first.
According to the statement, the alarm issue may be corrected with a software patch, available from Philips, or the company will offer a replacement device for patients until the affected devices are repaired. The statement updates an April 1, 2024, urgent recall from Philips urging the immediate removal of a patient from an OLA+ Ventilator and connecting them to alternative ventilation if possible if the ventilator’s inoperative alarm occurs.
The device failures may cause interruption or loss of therapy with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and even death in especially vulnerable individuals. One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.
US customers can contact Philips Respironics Inc. at 1-800-345-6443 or [email protected] with questions, according to the FDA, and clinicians and patients may report adverse reactions or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
A version of this article appeared on Medscape.com.
, according to a recall statement from the US Food and Drug Administration (FDA).
The OLA+ Ventilator is designed for use by individuals with obstructive sleep apnea, breathing problems, and mixed apnea and is approved for children aged 7 years and older, as well as adults.
The recall does not involve removal of the devices from where they are used or sold but does update the instructions for use, and its use without following the updated instructions could result in serious injury or death, according to the statement.
Following an alarm failure, the device may fail in one of two ways: By entering a ventilator inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present) or by entering a ventilator inoperative state without rebooting first.
According to the statement, the alarm issue may be corrected with a software patch, available from Philips, or the company will offer a replacement device for patients until the affected devices are repaired. The statement updates an April 1, 2024, urgent recall from Philips urging the immediate removal of a patient from an OLA+ Ventilator and connecting them to alternative ventilation if possible if the ventilator’s inoperative alarm occurs.
The device failures may cause interruption or loss of therapy with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnea, tachycardia, respiratory failure, and even death in especially vulnerable individuals. One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.
US customers can contact Philips Respironics Inc. at 1-800-345-6443 or [email protected] with questions, according to the FDA, and clinicians and patients may report adverse reactions or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
A version of this article appeared on Medscape.com.
Dupilumab Effective in PPI-Refractory Pediatric EoE
Good news for younger children suffering from the uncommon but debilitating gastrointestinal condition eosinophilic esophagitis (EoE): Data from this trial led to a January US Food and Drug Administration (FDA) approval of the anti-inflammatory biologic for patients aged 1-11 years weighing at least 15 kg.
In addition, the trial, published in The New England Journal of Medicine, found that a higher-exposure dupilumab regimen (approximating the trough concentration of a 300-mg dose administered once weekly versus every 2 weeks) improved key secondary end points, according to gastroenterologist Mirna Chehade, MD, MPH, AGAF, a professor of pediatrics at Icahn School of Medicine at Mount Sinai and Mount Sinai Kravis Children’s Hospital in New York City, and colleagues.
In 2022, the FDA approved the drug for those aged 12 or older weighing at least 40 kg.
“Left untreated or inadequately treated, EoE can progress to esophageal narrowing and strictures, leading to increased risk of food impactions and the need for esophageal dilations,” Dr. Chehade said in an interview. “Therefore, it’s important that children with EoE have the FDA-approved treatment option based on our study that can address their underlying disease starting at a young age.”
She added that dupilumab has the exciting potential to transform the standard of care for many young children living with EoE. “There are, however, factors to consider before switching a child to dupilumab — all related to the child’s specific medical history and therefore the perceived potential benefits from the drug.”
Commenting on the study but not involved in it, Toni Webster, DO, a pediatric gastroenterologist at Cohen Children’s Medical Center in Queens, New York, and an assistant professor at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, said, “Like many allergic diseases, EoE is on the rise and, unfortunately, is affecting our children at alarming rates and at earlier ages. Given its efficacy and side-effect profile, dupilumab will vastly change our ability to treat EoE, especially for families who find diet and daily medication to be a challenge.”
Dr. Webster noted that an elimination diet is a rigorous choice that is often difficult to navigate. And the oral administration of off-label choices, proton pump inhibitors, and swallowed topical steroids, as well as the newly FDA-approved oral budesonide therapy (Eohilia), may also be challenging because many children have precluding aversions to oral therapy. “Regardless of age, treatment choice for EoE should be a good fit that is a plausible addition to a family’s lifestyle,” she said.
Blocking interleukin 4 and interleukin 13 inflammatory pathways, dupilumab has shown efficacy in other atopic diseases such as eczema. It broadly inhibits most aspects of type 2 inflammation and that action is reflected in its histologic and transcriptomic effects in affected tissues, Dr. Chehade and associates explained.
The Trial
Conducted at one Canadian and 26 US sites, the two-part phase 3 study randomly assigned 102 EoE patients aged 1-11 years who were refractory to proton pump inhibition in a 2:2:1:1 ratio.
Part A enrolled 102 patients and evaluated dupilumab at a weight-tiered higher-dose or lower-dose regimen vs placebo (two groups) for 16 weeks.
Part B was a 36-week extended active treatment period in which eligible dupilumab recipients from part A maintained their weight-tiered higher- or lower-dose regimen, whereas those in the placebo groups switched to weight-tiered higher- or lower-dose dupilumab.
The primary end point was histologic remission (peak esophageal intraepithelial eosinophil count, ≤ 6 per high-power field) at week 16. Continued dupilumab treatment appeared to maintain its effect through week 52.
During part A, histologic remission occurred in 25 of the 37 higher-exposure patients (68%), 18 of the 31 lower-exposure patients (58%), and one of the 34 placebo patients (3%).
The difference between the higher-exposure regimen and placebo was 65 percentage points (95% confidence interval [CI], 48-81; P < .001), whereas that between the lower-exposure regimen and placebo was 55 percentage points (95% CI, 37-73; P < .001).
Higher exposure led to significant improvements in histologic, endoscopic, and transcriptomic measures over placebo. Improvements between baseline and week 52 in all patients were generally similar to those between baseline and week 16 in patients who received dupilumab in part A.
As for adverse events, in part A, the incidence of coronavirus disease, nausea, injection-site pain, and headache was at least 10 percentage points higher among dupilumab recipients at either dose than among placebo recipients. Serious adverse events were reported in three dupilumab patients during part A and in six patients overall during part B.
A Balanced Approach
On a cautionary note, Eric H. Chiou, MD, an assistant professor of pediatrics at Baylor College of Medicine and a pediatric gastroenterologist at Texas Children’s Hospital in Houston, said that while dupilumab shows great promise, further research is needed on its cost-effectiveness in EoE.
“The cost of treatment will need to be compared relative to potential long-term savings from reduced hospitalizations, fewer complications, and improved quality of life,” said Dr. Chiou, who was not involved in the study. “A balanced approach that considers clinical efficacy, patient well-being, cost-effectiveness, and equity is essential.”
He added that despite the study’s encouraging results, long-term safety and efficacy data are needed to fully understand the impact of dupilumab on pediatric patients with EoE. “Dupilumab will need to be compared with existing treatments for EoE such as dietary management and swallowed topical corticosteroids in terms of efficacy, safety, and quality of life improvements.”
Additionally, further research is required to identify which patients are most likely to benefit from this therapy and to explore any potential complications associated with its long-term use. “Understanding the optimal dosing and duration of treatment will also be crucial for maximizing benefits while minimizing risks,” Dr. Chiou said.
Dr. Chehade agreed. “While it’s that great that young children finally have an FDA-approved drug to treat their EoE, more research is needed to learn which patient subsets would derive maximum benefit from dupilumab and at which specific steps in their medical management journey should dupilumab be used.”
This study was supported by Sanofi and Regeneron Pharmaceuticals. Dr. Chehade disclosed research funding from and consulting for numerous private sector companies, among others, Sanofi and Regeneron Pharmaceuticals, AstraZeneca, Shire-Takeda, and Bristol-Myers Squibb. Multiple study coauthors disclosed various relationships with private-sector companies, including Sanofi and Regeneron Pharmaceuticals, for research funding, consulting, travel, employment, and stock or intellectual ownership. Dr. Webster and Dr. Chiou disclosed no competing interests relevant to their comments.
A version of this article first appeared on Medscape.com.
Good news for younger children suffering from the uncommon but debilitating gastrointestinal condition eosinophilic esophagitis (EoE): Data from this trial led to a January US Food and Drug Administration (FDA) approval of the anti-inflammatory biologic for patients aged 1-11 years weighing at least 15 kg.
In addition, the trial, published in The New England Journal of Medicine, found that a higher-exposure dupilumab regimen (approximating the trough concentration of a 300-mg dose administered once weekly versus every 2 weeks) improved key secondary end points, according to gastroenterologist Mirna Chehade, MD, MPH, AGAF, a professor of pediatrics at Icahn School of Medicine at Mount Sinai and Mount Sinai Kravis Children’s Hospital in New York City, and colleagues.
In 2022, the FDA approved the drug for those aged 12 or older weighing at least 40 kg.
“Left untreated or inadequately treated, EoE can progress to esophageal narrowing and strictures, leading to increased risk of food impactions and the need for esophageal dilations,” Dr. Chehade said in an interview. “Therefore, it’s important that children with EoE have the FDA-approved treatment option based on our study that can address their underlying disease starting at a young age.”
She added that dupilumab has the exciting potential to transform the standard of care for many young children living with EoE. “There are, however, factors to consider before switching a child to dupilumab — all related to the child’s specific medical history and therefore the perceived potential benefits from the drug.”
Commenting on the study but not involved in it, Toni Webster, DO, a pediatric gastroenterologist at Cohen Children’s Medical Center in Queens, New York, and an assistant professor at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, said, “Like many allergic diseases, EoE is on the rise and, unfortunately, is affecting our children at alarming rates and at earlier ages. Given its efficacy and side-effect profile, dupilumab will vastly change our ability to treat EoE, especially for families who find diet and daily medication to be a challenge.”
Dr. Webster noted that an elimination diet is a rigorous choice that is often difficult to navigate. And the oral administration of off-label choices, proton pump inhibitors, and swallowed topical steroids, as well as the newly FDA-approved oral budesonide therapy (Eohilia), may also be challenging because many children have precluding aversions to oral therapy. “Regardless of age, treatment choice for EoE should be a good fit that is a plausible addition to a family’s lifestyle,” she said.
Blocking interleukin 4 and interleukin 13 inflammatory pathways, dupilumab has shown efficacy in other atopic diseases such as eczema. It broadly inhibits most aspects of type 2 inflammation and that action is reflected in its histologic and transcriptomic effects in affected tissues, Dr. Chehade and associates explained.
The Trial
Conducted at one Canadian and 26 US sites, the two-part phase 3 study randomly assigned 102 EoE patients aged 1-11 years who were refractory to proton pump inhibition in a 2:2:1:1 ratio.
Part A enrolled 102 patients and evaluated dupilumab at a weight-tiered higher-dose or lower-dose regimen vs placebo (two groups) for 16 weeks.
Part B was a 36-week extended active treatment period in which eligible dupilumab recipients from part A maintained their weight-tiered higher- or lower-dose regimen, whereas those in the placebo groups switched to weight-tiered higher- or lower-dose dupilumab.
The primary end point was histologic remission (peak esophageal intraepithelial eosinophil count, ≤ 6 per high-power field) at week 16. Continued dupilumab treatment appeared to maintain its effect through week 52.
During part A, histologic remission occurred in 25 of the 37 higher-exposure patients (68%), 18 of the 31 lower-exposure patients (58%), and one of the 34 placebo patients (3%).
The difference between the higher-exposure regimen and placebo was 65 percentage points (95% confidence interval [CI], 48-81; P < .001), whereas that between the lower-exposure regimen and placebo was 55 percentage points (95% CI, 37-73; P < .001).
Higher exposure led to significant improvements in histologic, endoscopic, and transcriptomic measures over placebo. Improvements between baseline and week 52 in all patients were generally similar to those between baseline and week 16 in patients who received dupilumab in part A.
As for adverse events, in part A, the incidence of coronavirus disease, nausea, injection-site pain, and headache was at least 10 percentage points higher among dupilumab recipients at either dose than among placebo recipients. Serious adverse events were reported in three dupilumab patients during part A and in six patients overall during part B.
A Balanced Approach
On a cautionary note, Eric H. Chiou, MD, an assistant professor of pediatrics at Baylor College of Medicine and a pediatric gastroenterologist at Texas Children’s Hospital in Houston, said that while dupilumab shows great promise, further research is needed on its cost-effectiveness in EoE.
“The cost of treatment will need to be compared relative to potential long-term savings from reduced hospitalizations, fewer complications, and improved quality of life,” said Dr. Chiou, who was not involved in the study. “A balanced approach that considers clinical efficacy, patient well-being, cost-effectiveness, and equity is essential.”
He added that despite the study’s encouraging results, long-term safety and efficacy data are needed to fully understand the impact of dupilumab on pediatric patients with EoE. “Dupilumab will need to be compared with existing treatments for EoE such as dietary management and swallowed topical corticosteroids in terms of efficacy, safety, and quality of life improvements.”
Additionally, further research is required to identify which patients are most likely to benefit from this therapy and to explore any potential complications associated with its long-term use. “Understanding the optimal dosing and duration of treatment will also be crucial for maximizing benefits while minimizing risks,” Dr. Chiou said.
Dr. Chehade agreed. “While it’s that great that young children finally have an FDA-approved drug to treat their EoE, more research is needed to learn which patient subsets would derive maximum benefit from dupilumab and at which specific steps in their medical management journey should dupilumab be used.”
This study was supported by Sanofi and Regeneron Pharmaceuticals. Dr. Chehade disclosed research funding from and consulting for numerous private sector companies, among others, Sanofi and Regeneron Pharmaceuticals, AstraZeneca, Shire-Takeda, and Bristol-Myers Squibb. Multiple study coauthors disclosed various relationships with private-sector companies, including Sanofi and Regeneron Pharmaceuticals, for research funding, consulting, travel, employment, and stock or intellectual ownership. Dr. Webster and Dr. Chiou disclosed no competing interests relevant to their comments.
A version of this article first appeared on Medscape.com.
Good news for younger children suffering from the uncommon but debilitating gastrointestinal condition eosinophilic esophagitis (EoE): Data from this trial led to a January US Food and Drug Administration (FDA) approval of the anti-inflammatory biologic for patients aged 1-11 years weighing at least 15 kg.
In addition, the trial, published in The New England Journal of Medicine, found that a higher-exposure dupilumab regimen (approximating the trough concentration of a 300-mg dose administered once weekly versus every 2 weeks) improved key secondary end points, according to gastroenterologist Mirna Chehade, MD, MPH, AGAF, a professor of pediatrics at Icahn School of Medicine at Mount Sinai and Mount Sinai Kravis Children’s Hospital in New York City, and colleagues.
In 2022, the FDA approved the drug for those aged 12 or older weighing at least 40 kg.
“Left untreated or inadequately treated, EoE can progress to esophageal narrowing and strictures, leading to increased risk of food impactions and the need for esophageal dilations,” Dr. Chehade said in an interview. “Therefore, it’s important that children with EoE have the FDA-approved treatment option based on our study that can address their underlying disease starting at a young age.”
She added that dupilumab has the exciting potential to transform the standard of care for many young children living with EoE. “There are, however, factors to consider before switching a child to dupilumab — all related to the child’s specific medical history and therefore the perceived potential benefits from the drug.”
Commenting on the study but not involved in it, Toni Webster, DO, a pediatric gastroenterologist at Cohen Children’s Medical Center in Queens, New York, and an assistant professor at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, said, “Like many allergic diseases, EoE is on the rise and, unfortunately, is affecting our children at alarming rates and at earlier ages. Given its efficacy and side-effect profile, dupilumab will vastly change our ability to treat EoE, especially for families who find diet and daily medication to be a challenge.”
Dr. Webster noted that an elimination diet is a rigorous choice that is often difficult to navigate. And the oral administration of off-label choices, proton pump inhibitors, and swallowed topical steroids, as well as the newly FDA-approved oral budesonide therapy (Eohilia), may also be challenging because many children have precluding aversions to oral therapy. “Regardless of age, treatment choice for EoE should be a good fit that is a plausible addition to a family’s lifestyle,” she said.
Blocking interleukin 4 and interleukin 13 inflammatory pathways, dupilumab has shown efficacy in other atopic diseases such as eczema. It broadly inhibits most aspects of type 2 inflammation and that action is reflected in its histologic and transcriptomic effects in affected tissues, Dr. Chehade and associates explained.
The Trial
Conducted at one Canadian and 26 US sites, the two-part phase 3 study randomly assigned 102 EoE patients aged 1-11 years who were refractory to proton pump inhibition in a 2:2:1:1 ratio.
Part A enrolled 102 patients and evaluated dupilumab at a weight-tiered higher-dose or lower-dose regimen vs placebo (two groups) for 16 weeks.
Part B was a 36-week extended active treatment period in which eligible dupilumab recipients from part A maintained their weight-tiered higher- or lower-dose regimen, whereas those in the placebo groups switched to weight-tiered higher- or lower-dose dupilumab.
The primary end point was histologic remission (peak esophageal intraepithelial eosinophil count, ≤ 6 per high-power field) at week 16. Continued dupilumab treatment appeared to maintain its effect through week 52.
During part A, histologic remission occurred in 25 of the 37 higher-exposure patients (68%), 18 of the 31 lower-exposure patients (58%), and one of the 34 placebo patients (3%).
The difference between the higher-exposure regimen and placebo was 65 percentage points (95% confidence interval [CI], 48-81; P < .001), whereas that between the lower-exposure regimen and placebo was 55 percentage points (95% CI, 37-73; P < .001).
Higher exposure led to significant improvements in histologic, endoscopic, and transcriptomic measures over placebo. Improvements between baseline and week 52 in all patients were generally similar to those between baseline and week 16 in patients who received dupilumab in part A.
As for adverse events, in part A, the incidence of coronavirus disease, nausea, injection-site pain, and headache was at least 10 percentage points higher among dupilumab recipients at either dose than among placebo recipients. Serious adverse events were reported in three dupilumab patients during part A and in six patients overall during part B.
A Balanced Approach
On a cautionary note, Eric H. Chiou, MD, an assistant professor of pediatrics at Baylor College of Medicine and a pediatric gastroenterologist at Texas Children’s Hospital in Houston, said that while dupilumab shows great promise, further research is needed on its cost-effectiveness in EoE.
“The cost of treatment will need to be compared relative to potential long-term savings from reduced hospitalizations, fewer complications, and improved quality of life,” said Dr. Chiou, who was not involved in the study. “A balanced approach that considers clinical efficacy, patient well-being, cost-effectiveness, and equity is essential.”
He added that despite the study’s encouraging results, long-term safety and efficacy data are needed to fully understand the impact of dupilumab on pediatric patients with EoE. “Dupilumab will need to be compared with existing treatments for EoE such as dietary management and swallowed topical corticosteroids in terms of efficacy, safety, and quality of life improvements.”
Additionally, further research is required to identify which patients are most likely to benefit from this therapy and to explore any potential complications associated with its long-term use. “Understanding the optimal dosing and duration of treatment will also be crucial for maximizing benefits while minimizing risks,” Dr. Chiou said.
Dr. Chehade agreed. “While it’s that great that young children finally have an FDA-approved drug to treat their EoE, more research is needed to learn which patient subsets would derive maximum benefit from dupilumab and at which specific steps in their medical management journey should dupilumab be used.”
This study was supported by Sanofi and Regeneron Pharmaceuticals. Dr. Chehade disclosed research funding from and consulting for numerous private sector companies, among others, Sanofi and Regeneron Pharmaceuticals, AstraZeneca, Shire-Takeda, and Bristol-Myers Squibb. Multiple study coauthors disclosed various relationships with private-sector companies, including Sanofi and Regeneron Pharmaceuticals, for research funding, consulting, travel, employment, and stock or intellectual ownership. Dr. Webster and Dr. Chiou disclosed no competing interests relevant to their comments.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
An Overview of Gender-Affirming Care for Children and Adolescents
As Pride Month drew to a close, the Supreme Court made a shocking announcement. For the first time in the history of the court, it is willing to hear a legal challenge regarding gender-affirming care for minors. The justices will review whether a 2023 Tennessee law, SB1, which bans hormone therapy, puberty blockers, and surgery for transgender minors, is unconstitutional. This is the first time the Supreme Court will directly weigh in on gender-affirming care.
There are few topics as politically and medically divisive as gender-affirming care for minors. When the World Professional Association for Transgender Health (WPATH) released its updated Standards of Care, SOC8, one of the noticeable changes to the document was its approach to caring for transgender children and adolescents.
Before I highlight these recommendations and the ensuing controversy, it is imperative to establish proper terminology. Unfortunately, medical and legal terms often differ. Both activists and opponents use these terms interchangeably, which makes discourse about an already emotionally charged topic extremely difficult. From a legal perspective, the terms “minor” and “child” often refer to individuals under the age of majority. In the United States, the age of majority is 18. However, the term child also has a well-established medical definition. A child is an individual between the stages of infancy and puberty. Adolescence is a transitional period marked by the onset of puberty until adulthood (typically the age of majority). As medical providers, understanding these definitions is essential to identifying misinformation pertaining to this type of healthcare.
For the purposes of this article, I will be adhering to the medical terminology. Now, I want to be very clear. WPATH does not endorse surgical procedures on children. Furthermore, surgeons are not performing gender-affirming surgeries on children. On adolescents, rarely. But children, never.
According to the updated SOC8, the only acceptable gender-affirming intervention for children is psychosocial support.1 This does not include puberty blockers, hormones, or surgery, but rather allowing a child to explore their gender identity by experimenting with different clothing, toys, hairstyles, and even an alternative name that aligns more closely with their gender identity.1
It is only after children reach adolescence that medical, and in rare cases, surgical interventions, can be considered. Puberty blockers are appropriate for patients who have started puberty and experience gender dysphoria. These medications are reversible, and their purpose is to temporarily pause puberty to allow the adolescent to further explore their gender identity.
The most significant side effect of puberty blockers is decreased bone density.1 As a result, providers typically do not prescribe these medications for more than 2-3 years. After discontinuation of the medication, bone density returns to baseline.1 If the adolescent’s gender identity is marked and sustained over time, hormone therapy, such as testosterone or estrogen is then considered. Unlike puberty blockers, these medications can have permanent side effects. Testosterone use can lead to irreversible hair growth, alopecia, clitoromegaly, and voice deepening, while estrogen can cause permanent breast growth and halt sperm production.1 Future fertility and these side effects are discussed with the patient in detail prior to the initiation of these medications.
Contrary to the current political narrative, gender-affirming care for children and adolescents is not taken lightly. These individuals often receive years of multidisciplinary assessments, with a focus on gender identity development, social development and support, and diagnostic assessment of possible co-occurring mental health or developmental concerns and capacity for decision making.1 The clinical visits also occur with parental support and consent.
WPATH SOC8 also delineates the provider qualifications for health care professionals assessing these patients. Providers must be licensed by their statutory bodies and hold a postgraduate degree by a nationally accredited statutory institution; receive theoretical and evidence-based training and develop expertise in child, adolescent, and family mental health across the developmental spectrum; receive training and have expertise in gender identity development and gender diversity in children and adolescence; have the ability to assess capacity to assent/consent; receive training and develop expertise in autism spectrum disorders and other neurodevelopmental presentations; and to continue engaging in professional development in all areas relevant to gender-diverse children, adolescents, and families.1
The most controversial aspect of gender-affirming care for children and adolescents relates to surgical treatment. While the rates of gender-affirming surgeries have increased for this age group over the years, the overall rate of gender-affirming surgery for adolescents is markedly lower compared with other adolescents seeking cosmetic surgeries and compared with transgender adults undergoing gender-affirming surgery.
In a cohort study conducted between 2016 to 2020, 48,019 patients were identified who had undergone gender-affirming surgery.2 Only 3678 or 7.7% of patients were aged between 12 and 18, with the most common procedure being chest/breast surgery.2 So, under about 1000 cases per year were gender-affirming surgeries on patients under 18.
During 2020 alone, the number of cisgender adolescents between the ages of 13 and 19 who underwent breast augmentation and breast reduction was 3233 and 4666, respectively.3 The outrage about gender-affirming surgeries on transgender youth, yet the silence on cosmetic procedures in this same age group, speaks volumes.
All surgeries on adolescents should be taken seriously and with caution, regardless of gender identity. However, current legislation disproportionately targets only transgender youth. For whatever reason, surgeries on transgender individuals are labeled as “body mutilation,” whereas surgeries on cisgender youth are not even discussed. Such inflammatory rhetoric and complete lack of empathy impedes the common goal of all parties: what is in the best interest of the minor? Unfortunately, in a few short months, the answer to this question will be determined by a group of nine justices who have no experience in medicine or transgender health care, instead of by medical experts and the parents who care for these individuals.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pennsylvania. She has no conflicts of interest.
References
1. Coleman E et al. Standards of care for the health of transgender and gender diverse people, version 8. Int J Transgender Health. 2022;23(sup):S1-S259.
2. Wright JD et al. National estimates of gender affirming surgery in the US. JAMA Netw Open. 2023 Aug 1;6(8):e2330348.
3. American Society of Plastic Surgeons. Plastic Surgery Statistics Report. ASPS National Clearinghouse of Plastic Surgery Procedural Statistics. 2020.
As Pride Month drew to a close, the Supreme Court made a shocking announcement. For the first time in the history of the court, it is willing to hear a legal challenge regarding gender-affirming care for minors. The justices will review whether a 2023 Tennessee law, SB1, which bans hormone therapy, puberty blockers, and surgery for transgender minors, is unconstitutional. This is the first time the Supreme Court will directly weigh in on gender-affirming care.
There are few topics as politically and medically divisive as gender-affirming care for minors. When the World Professional Association for Transgender Health (WPATH) released its updated Standards of Care, SOC8, one of the noticeable changes to the document was its approach to caring for transgender children and adolescents.
Before I highlight these recommendations and the ensuing controversy, it is imperative to establish proper terminology. Unfortunately, medical and legal terms often differ. Both activists and opponents use these terms interchangeably, which makes discourse about an already emotionally charged topic extremely difficult. From a legal perspective, the terms “minor” and “child” often refer to individuals under the age of majority. In the United States, the age of majority is 18. However, the term child also has a well-established medical definition. A child is an individual between the stages of infancy and puberty. Adolescence is a transitional period marked by the onset of puberty until adulthood (typically the age of majority). As medical providers, understanding these definitions is essential to identifying misinformation pertaining to this type of healthcare.
For the purposes of this article, I will be adhering to the medical terminology. Now, I want to be very clear. WPATH does not endorse surgical procedures on children. Furthermore, surgeons are not performing gender-affirming surgeries on children. On adolescents, rarely. But children, never.
According to the updated SOC8, the only acceptable gender-affirming intervention for children is psychosocial support.1 This does not include puberty blockers, hormones, or surgery, but rather allowing a child to explore their gender identity by experimenting with different clothing, toys, hairstyles, and even an alternative name that aligns more closely with their gender identity.1
It is only after children reach adolescence that medical, and in rare cases, surgical interventions, can be considered. Puberty blockers are appropriate for patients who have started puberty and experience gender dysphoria. These medications are reversible, and their purpose is to temporarily pause puberty to allow the adolescent to further explore their gender identity.
The most significant side effect of puberty blockers is decreased bone density.1 As a result, providers typically do not prescribe these medications for more than 2-3 years. After discontinuation of the medication, bone density returns to baseline.1 If the adolescent’s gender identity is marked and sustained over time, hormone therapy, such as testosterone or estrogen is then considered. Unlike puberty blockers, these medications can have permanent side effects. Testosterone use can lead to irreversible hair growth, alopecia, clitoromegaly, and voice deepening, while estrogen can cause permanent breast growth and halt sperm production.1 Future fertility and these side effects are discussed with the patient in detail prior to the initiation of these medications.
Contrary to the current political narrative, gender-affirming care for children and adolescents is not taken lightly. These individuals often receive years of multidisciplinary assessments, with a focus on gender identity development, social development and support, and diagnostic assessment of possible co-occurring mental health or developmental concerns and capacity for decision making.1 The clinical visits also occur with parental support and consent.
WPATH SOC8 also delineates the provider qualifications for health care professionals assessing these patients. Providers must be licensed by their statutory bodies and hold a postgraduate degree by a nationally accredited statutory institution; receive theoretical and evidence-based training and develop expertise in child, adolescent, and family mental health across the developmental spectrum; receive training and have expertise in gender identity development and gender diversity in children and adolescence; have the ability to assess capacity to assent/consent; receive training and develop expertise in autism spectrum disorders and other neurodevelopmental presentations; and to continue engaging in professional development in all areas relevant to gender-diverse children, adolescents, and families.1
The most controversial aspect of gender-affirming care for children and adolescents relates to surgical treatment. While the rates of gender-affirming surgeries have increased for this age group over the years, the overall rate of gender-affirming surgery for adolescents is markedly lower compared with other adolescents seeking cosmetic surgeries and compared with transgender adults undergoing gender-affirming surgery.
In a cohort study conducted between 2016 to 2020, 48,019 patients were identified who had undergone gender-affirming surgery.2 Only 3678 or 7.7% of patients were aged between 12 and 18, with the most common procedure being chest/breast surgery.2 So, under about 1000 cases per year were gender-affirming surgeries on patients under 18.
During 2020 alone, the number of cisgender adolescents between the ages of 13 and 19 who underwent breast augmentation and breast reduction was 3233 and 4666, respectively.3 The outrage about gender-affirming surgeries on transgender youth, yet the silence on cosmetic procedures in this same age group, speaks volumes.
All surgeries on adolescents should be taken seriously and with caution, regardless of gender identity. However, current legislation disproportionately targets only transgender youth. For whatever reason, surgeries on transgender individuals are labeled as “body mutilation,” whereas surgeries on cisgender youth are not even discussed. Such inflammatory rhetoric and complete lack of empathy impedes the common goal of all parties: what is in the best interest of the minor? Unfortunately, in a few short months, the answer to this question will be determined by a group of nine justices who have no experience in medicine or transgender health care, instead of by medical experts and the parents who care for these individuals.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pennsylvania. She has no conflicts of interest.
References
1. Coleman E et al. Standards of care for the health of transgender and gender diverse people, version 8. Int J Transgender Health. 2022;23(sup):S1-S259.
2. Wright JD et al. National estimates of gender affirming surgery in the US. JAMA Netw Open. 2023 Aug 1;6(8):e2330348.
3. American Society of Plastic Surgeons. Plastic Surgery Statistics Report. ASPS National Clearinghouse of Plastic Surgery Procedural Statistics. 2020.
As Pride Month drew to a close, the Supreme Court made a shocking announcement. For the first time in the history of the court, it is willing to hear a legal challenge regarding gender-affirming care for minors. The justices will review whether a 2023 Tennessee law, SB1, which bans hormone therapy, puberty blockers, and surgery for transgender minors, is unconstitutional. This is the first time the Supreme Court will directly weigh in on gender-affirming care.
There are few topics as politically and medically divisive as gender-affirming care for minors. When the World Professional Association for Transgender Health (WPATH) released its updated Standards of Care, SOC8, one of the noticeable changes to the document was its approach to caring for transgender children and adolescents.
Before I highlight these recommendations and the ensuing controversy, it is imperative to establish proper terminology. Unfortunately, medical and legal terms often differ. Both activists and opponents use these terms interchangeably, which makes discourse about an already emotionally charged topic extremely difficult. From a legal perspective, the terms “minor” and “child” often refer to individuals under the age of majority. In the United States, the age of majority is 18. However, the term child also has a well-established medical definition. A child is an individual between the stages of infancy and puberty. Adolescence is a transitional period marked by the onset of puberty until adulthood (typically the age of majority). As medical providers, understanding these definitions is essential to identifying misinformation pertaining to this type of healthcare.
For the purposes of this article, I will be adhering to the medical terminology. Now, I want to be very clear. WPATH does not endorse surgical procedures on children. Furthermore, surgeons are not performing gender-affirming surgeries on children. On adolescents, rarely. But children, never.
According to the updated SOC8, the only acceptable gender-affirming intervention for children is psychosocial support.1 This does not include puberty blockers, hormones, or surgery, but rather allowing a child to explore their gender identity by experimenting with different clothing, toys, hairstyles, and even an alternative name that aligns more closely with their gender identity.1
It is only after children reach adolescence that medical, and in rare cases, surgical interventions, can be considered. Puberty blockers are appropriate for patients who have started puberty and experience gender dysphoria. These medications are reversible, and their purpose is to temporarily pause puberty to allow the adolescent to further explore their gender identity.
The most significant side effect of puberty blockers is decreased bone density.1 As a result, providers typically do not prescribe these medications for more than 2-3 years. After discontinuation of the medication, bone density returns to baseline.1 If the adolescent’s gender identity is marked and sustained over time, hormone therapy, such as testosterone or estrogen is then considered. Unlike puberty blockers, these medications can have permanent side effects. Testosterone use can lead to irreversible hair growth, alopecia, clitoromegaly, and voice deepening, while estrogen can cause permanent breast growth and halt sperm production.1 Future fertility and these side effects are discussed with the patient in detail prior to the initiation of these medications.
Contrary to the current political narrative, gender-affirming care for children and adolescents is not taken lightly. These individuals often receive years of multidisciplinary assessments, with a focus on gender identity development, social development and support, and diagnostic assessment of possible co-occurring mental health or developmental concerns and capacity for decision making.1 The clinical visits also occur with parental support and consent.
WPATH SOC8 also delineates the provider qualifications for health care professionals assessing these patients. Providers must be licensed by their statutory bodies and hold a postgraduate degree by a nationally accredited statutory institution; receive theoretical and evidence-based training and develop expertise in child, adolescent, and family mental health across the developmental spectrum; receive training and have expertise in gender identity development and gender diversity in children and adolescence; have the ability to assess capacity to assent/consent; receive training and develop expertise in autism spectrum disorders and other neurodevelopmental presentations; and to continue engaging in professional development in all areas relevant to gender-diverse children, adolescents, and families.1
The most controversial aspect of gender-affirming care for children and adolescents relates to surgical treatment. While the rates of gender-affirming surgeries have increased for this age group over the years, the overall rate of gender-affirming surgery for adolescents is markedly lower compared with other adolescents seeking cosmetic surgeries and compared with transgender adults undergoing gender-affirming surgery.
In a cohort study conducted between 2016 to 2020, 48,019 patients were identified who had undergone gender-affirming surgery.2 Only 3678 or 7.7% of patients were aged between 12 and 18, with the most common procedure being chest/breast surgery.2 So, under about 1000 cases per year were gender-affirming surgeries on patients under 18.
During 2020 alone, the number of cisgender adolescents between the ages of 13 and 19 who underwent breast augmentation and breast reduction was 3233 and 4666, respectively.3 The outrage about gender-affirming surgeries on transgender youth, yet the silence on cosmetic procedures in this same age group, speaks volumes.
All surgeries on adolescents should be taken seriously and with caution, regardless of gender identity. However, current legislation disproportionately targets only transgender youth. For whatever reason, surgeries on transgender individuals are labeled as “body mutilation,” whereas surgeries on cisgender youth are not even discussed. Such inflammatory rhetoric and complete lack of empathy impedes the common goal of all parties: what is in the best interest of the minor? Unfortunately, in a few short months, the answer to this question will be determined by a group of nine justices who have no experience in medicine or transgender health care, instead of by medical experts and the parents who care for these individuals.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pennsylvania. She has no conflicts of interest.
References
1. Coleman E et al. Standards of care for the health of transgender and gender diverse people, version 8. Int J Transgender Health. 2022;23(sup):S1-S259.
2. Wright JD et al. National estimates of gender affirming surgery in the US. JAMA Netw Open. 2023 Aug 1;6(8):e2330348.
3. American Society of Plastic Surgeons. Plastic Surgery Statistics Report. ASPS National Clearinghouse of Plastic Surgery Procedural Statistics. 2020.