User login
Abbott baby formula plant in Michigan reopens
The Abbott baby formula factory in Sturgis, Mich., has reopened, a move that could ease the nationwide baby formula shortage.
“Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16,” according to a company statement issued June 4.
“Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We’re also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.”
The FDA began investigating when at least four infants became ill with Cronobacter sakazakii bacteria after consuming infant formula produced in the Sturgis plant. Two infants died. Several Abbott baby formula products were recalled and the Sturgis plant was shut down for months.
Abbott said an investigation found no evidence to link the formulas to the infant illnesses, though bacteria was found in parts of the factory that didn’t have contact with formula.
The FDA entered into a consent decree with Abbott in mid-May that allowed the plant to reopen if the company took corrective actions, including the implementation of a sanitation plan and an environmental monitoring plan and employee training programs. Abbott must also retain an independent expert to monitor operations.
The Abbott shutdown, along with supply chain problems, contributed to a nationwide shortage of formula. Reuters, citing the data firm Datasembly, reported that about 73% of baby products were out of stock nationwide as of May 22.
The shortage is so severe that the federal government authorized the importing of formula from overseas.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements,” the Abbott statement said.
A version of this article first appeared on Webmd.com.
The Abbott baby formula factory in Sturgis, Mich., has reopened, a move that could ease the nationwide baby formula shortage.
“Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16,” according to a company statement issued June 4.
“Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We’re also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.”
The FDA began investigating when at least four infants became ill with Cronobacter sakazakii bacteria after consuming infant formula produced in the Sturgis plant. Two infants died. Several Abbott baby formula products were recalled and the Sturgis plant was shut down for months.
Abbott said an investigation found no evidence to link the formulas to the infant illnesses, though bacteria was found in parts of the factory that didn’t have contact with formula.
The FDA entered into a consent decree with Abbott in mid-May that allowed the plant to reopen if the company took corrective actions, including the implementation of a sanitation plan and an environmental monitoring plan and employee training programs. Abbott must also retain an independent expert to monitor operations.
The Abbott shutdown, along with supply chain problems, contributed to a nationwide shortage of formula. Reuters, citing the data firm Datasembly, reported that about 73% of baby products were out of stock nationwide as of May 22.
The shortage is so severe that the federal government authorized the importing of formula from overseas.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements,” the Abbott statement said.
A version of this article first appeared on Webmd.com.
The Abbott baby formula factory in Sturgis, Mich., has reopened, a move that could ease the nationwide baby formula shortage.
“Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16,” according to a company statement issued June 4.
“Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We’re also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.”
The FDA began investigating when at least four infants became ill with Cronobacter sakazakii bacteria after consuming infant formula produced in the Sturgis plant. Two infants died. Several Abbott baby formula products were recalled and the Sturgis plant was shut down for months.
Abbott said an investigation found no evidence to link the formulas to the infant illnesses, though bacteria was found in parts of the factory that didn’t have contact with formula.
The FDA entered into a consent decree with Abbott in mid-May that allowed the plant to reopen if the company took corrective actions, including the implementation of a sanitation plan and an environmental monitoring plan and employee training programs. Abbott must also retain an independent expert to monitor operations.
The Abbott shutdown, along with supply chain problems, contributed to a nationwide shortage of formula. Reuters, citing the data firm Datasembly, reported that about 73% of baby products were out of stock nationwide as of May 22.
The shortage is so severe that the federal government authorized the importing of formula from overseas.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements,” the Abbott statement said.
A version of this article first appeared on Webmd.com.
International trial finds best regimen for Ewing sarcoma
CHICAGO -- (RR-ES) in the practice-changing rEECur trial.
This international trial is the first randomized head-to-head comparison of commonly used chemotherapy regimens in patients with the rare and deadly disease.
The study results are expected to change the standard of care and be practice-changing on a global scale, commented Julie Gralow, MD, chief medical officer at the annual meeting of the American Society of Clinical Oncology, where the results were presented June 5 during a plenary session.
Ewing sarcoma is a very rare cancer of the bone and soft tissue that mainly affects children and young adults, particularly in the second decade of life, explained lead author Martin McCabe, MD, clinical senior lecturer in pediatric, teenage, and young adult cancer at the University of Manchester (England). The incidence rate is 3.2 per million people under age 25 years, he said.
Dr. Gralow explained in an interview that treatment of Ewing sarcoma differs from one cancer center to another. Several different chemotherapy regimens are being used, all based on single-arm trials, with no consensus on which is best.
This international trial set out to answer that question and compared four different regimens. Participating centers were “able to solve a question by partnering, coming together, and even in a very rare population get enough patients to define the winner,” she said.
Earlier findings from this trial had shown that ifosfamide had improved survival, compared with gemcitabine and docetaxel and compared with irinotecan and temozolomide.
At the meeting, results of the comparison of ifosfamide versus a combination of topotecan and cyclophosphamide (TC) were presented.
Median overall survival was 15.4 versus 10.5 months with ifosfamide versus TC, and 1-year overall survival was 55% versus 45%, respectively, for a 94% probability that ifosfamide is better than TC for overall survival, Dr. McCabe reported.
Median event-free survival was 16.8 months in 73 patients in the ifosfamide group versus 10.4 months for 73 patients in the TC group. Six-month event-free survival was 47% versus 37%, respectively. “Given the observed data, there is a 96% probability that ifosfamide is better than TC for event-free survival,” he said.
High-dose ifosfamide prolonged median event-free survival by 5.7 months, compared with 3.7 months for TC.
Notably, greater event-free survival and overall survival differences were observed for patients under age 14 years, compared with those aged 14 and older, Dr. McCabe noted.
As for toxicity, similar rates of neutropenic infections were seen in the two groups, but more severe renal and brain toxicity were observed with ifosfamide, with both occurring in less than 10% of patients, he said.
Despite the practice-changing results, Dr. McCabe stressed that the “differences [between treatments] are quite small, and what we actually need is better drugs to cure more patients.”
The rEEcur trial is continuing to recruit patients to the ifosfamide group, and a fifth chemotherapy group of carboplatin and etoposide has been added.
Later this year, investigators also plan to add a new group with a molecular targeted therapeutic.
Important global collaboration
Dr. Gralow emphasized the global collaboration that was behind this trial, which set out to answer important questions about how best to treat a rare disease. “In this really terrific collaboration ... there was an agreement to test all these regimens that are commonly used, and so we now have data on efficacy and toxicity.”
“It’s a really important concept in rare diseases: If we all work together, we actually can study them and get answers,” she said.
“I think pediatricians and oncologists are [now] better able to talk about the risks and benefits [of the regimens],” she added.
Vicki L. Keedy, MD, an ASCO Expert in sarcoma, concurred. The findings from the rEECur trial “could help physicians talk with patients and their families about the likelihood of response, survival, and toxicity for each regimen available for relapsed Ewing sarcoma based on objective, randomized data,” she commented in an ASCO press release.
A version of this article first appeared on Medscape.com.
CHICAGO -- (RR-ES) in the practice-changing rEECur trial.
This international trial is the first randomized head-to-head comparison of commonly used chemotherapy regimens in patients with the rare and deadly disease.
The study results are expected to change the standard of care and be practice-changing on a global scale, commented Julie Gralow, MD, chief medical officer at the annual meeting of the American Society of Clinical Oncology, where the results were presented June 5 during a plenary session.
Ewing sarcoma is a very rare cancer of the bone and soft tissue that mainly affects children and young adults, particularly in the second decade of life, explained lead author Martin McCabe, MD, clinical senior lecturer in pediatric, teenage, and young adult cancer at the University of Manchester (England). The incidence rate is 3.2 per million people under age 25 years, he said.
Dr. Gralow explained in an interview that treatment of Ewing sarcoma differs from one cancer center to another. Several different chemotherapy regimens are being used, all based on single-arm trials, with no consensus on which is best.
This international trial set out to answer that question and compared four different regimens. Participating centers were “able to solve a question by partnering, coming together, and even in a very rare population get enough patients to define the winner,” she said.
Earlier findings from this trial had shown that ifosfamide had improved survival, compared with gemcitabine and docetaxel and compared with irinotecan and temozolomide.
At the meeting, results of the comparison of ifosfamide versus a combination of topotecan and cyclophosphamide (TC) were presented.
Median overall survival was 15.4 versus 10.5 months with ifosfamide versus TC, and 1-year overall survival was 55% versus 45%, respectively, for a 94% probability that ifosfamide is better than TC for overall survival, Dr. McCabe reported.
Median event-free survival was 16.8 months in 73 patients in the ifosfamide group versus 10.4 months for 73 patients in the TC group. Six-month event-free survival was 47% versus 37%, respectively. “Given the observed data, there is a 96% probability that ifosfamide is better than TC for event-free survival,” he said.
High-dose ifosfamide prolonged median event-free survival by 5.7 months, compared with 3.7 months for TC.
Notably, greater event-free survival and overall survival differences were observed for patients under age 14 years, compared with those aged 14 and older, Dr. McCabe noted.
As for toxicity, similar rates of neutropenic infections were seen in the two groups, but more severe renal and brain toxicity were observed with ifosfamide, with both occurring in less than 10% of patients, he said.
Despite the practice-changing results, Dr. McCabe stressed that the “differences [between treatments] are quite small, and what we actually need is better drugs to cure more patients.”
The rEEcur trial is continuing to recruit patients to the ifosfamide group, and a fifth chemotherapy group of carboplatin and etoposide has been added.
Later this year, investigators also plan to add a new group with a molecular targeted therapeutic.
Important global collaboration
Dr. Gralow emphasized the global collaboration that was behind this trial, which set out to answer important questions about how best to treat a rare disease. “In this really terrific collaboration ... there was an agreement to test all these regimens that are commonly used, and so we now have data on efficacy and toxicity.”
“It’s a really important concept in rare diseases: If we all work together, we actually can study them and get answers,” she said.
“I think pediatricians and oncologists are [now] better able to talk about the risks and benefits [of the regimens],” she added.
Vicki L. Keedy, MD, an ASCO Expert in sarcoma, concurred. The findings from the rEECur trial “could help physicians talk with patients and their families about the likelihood of response, survival, and toxicity for each regimen available for relapsed Ewing sarcoma based on objective, randomized data,” she commented in an ASCO press release.
A version of this article first appeared on Medscape.com.
CHICAGO -- (RR-ES) in the practice-changing rEECur trial.
This international trial is the first randomized head-to-head comparison of commonly used chemotherapy regimens in patients with the rare and deadly disease.
The study results are expected to change the standard of care and be practice-changing on a global scale, commented Julie Gralow, MD, chief medical officer at the annual meeting of the American Society of Clinical Oncology, where the results were presented June 5 during a plenary session.
Ewing sarcoma is a very rare cancer of the bone and soft tissue that mainly affects children and young adults, particularly in the second decade of life, explained lead author Martin McCabe, MD, clinical senior lecturer in pediatric, teenage, and young adult cancer at the University of Manchester (England). The incidence rate is 3.2 per million people under age 25 years, he said.
Dr. Gralow explained in an interview that treatment of Ewing sarcoma differs from one cancer center to another. Several different chemotherapy regimens are being used, all based on single-arm trials, with no consensus on which is best.
This international trial set out to answer that question and compared four different regimens. Participating centers were “able to solve a question by partnering, coming together, and even in a very rare population get enough patients to define the winner,” she said.
Earlier findings from this trial had shown that ifosfamide had improved survival, compared with gemcitabine and docetaxel and compared with irinotecan and temozolomide.
At the meeting, results of the comparison of ifosfamide versus a combination of topotecan and cyclophosphamide (TC) were presented.
Median overall survival was 15.4 versus 10.5 months with ifosfamide versus TC, and 1-year overall survival was 55% versus 45%, respectively, for a 94% probability that ifosfamide is better than TC for overall survival, Dr. McCabe reported.
Median event-free survival was 16.8 months in 73 patients in the ifosfamide group versus 10.4 months for 73 patients in the TC group. Six-month event-free survival was 47% versus 37%, respectively. “Given the observed data, there is a 96% probability that ifosfamide is better than TC for event-free survival,” he said.
High-dose ifosfamide prolonged median event-free survival by 5.7 months, compared with 3.7 months for TC.
Notably, greater event-free survival and overall survival differences were observed for patients under age 14 years, compared with those aged 14 and older, Dr. McCabe noted.
As for toxicity, similar rates of neutropenic infections were seen in the two groups, but more severe renal and brain toxicity were observed with ifosfamide, with both occurring in less than 10% of patients, he said.
Despite the practice-changing results, Dr. McCabe stressed that the “differences [between treatments] are quite small, and what we actually need is better drugs to cure more patients.”
The rEEcur trial is continuing to recruit patients to the ifosfamide group, and a fifth chemotherapy group of carboplatin and etoposide has been added.
Later this year, investigators also plan to add a new group with a molecular targeted therapeutic.
Important global collaboration
Dr. Gralow emphasized the global collaboration that was behind this trial, which set out to answer important questions about how best to treat a rare disease. “In this really terrific collaboration ... there was an agreement to test all these regimens that are commonly used, and so we now have data on efficacy and toxicity.”
“It’s a really important concept in rare diseases: If we all work together, we actually can study them and get answers,” she said.
“I think pediatricians and oncologists are [now] better able to talk about the risks and benefits [of the regimens],” she added.
Vicki L. Keedy, MD, an ASCO Expert in sarcoma, concurred. The findings from the rEECur trial “could help physicians talk with patients and their families about the likelihood of response, survival, and toxicity for each regimen available for relapsed Ewing sarcoma based on objective, randomized data,” she commented in an ASCO press release.
A version of this article first appeared on Medscape.com.
AT ASCO 2022
Autism ‘elopement’ raises summer drowning risk
It happens quickly: A child on the autism spectrum bolts from supervision and disappears – an emergency called “autism elopement.” While any child can wander off, children on the autism spectrum face particular risks. These include the lure of water and the risk of drowning.
Some youngsters on the spectrum will follow this strong attraction to water and head for a nearby pond, river, or swimming pool. Such circumstances have made drowning a leading cause of death for these missing youths.
Autism elopement can happen any time. Summer can be especially dangerous. When the weather warms, the risk of drowning death rises, says Lori McIlwain, cofounder of the National Autism Association.
“The fatality risk is higher in May, June, July for that child to exit the setting unnoticed, especially if there’s an outdoor gathering and then they go directly to water,” Ms. McIlwain says. For instance, she says children can dart away during outdoor play, barbecues, gatherings, and other activities. Or they might wander off while vacationing near a beach or hotel pool.
Autism elopement
Many people don’t know about this risk, including some families with youngsters on the autism spectrum. The National Center for Missing and Exploited Children is working to change that – and find solutions.
About 12 years ago, “we started noticing a very disturbing trend that children with autism were going missing and they were having grave results,” says John Bischoff, vice president of the Center’s Missing Children Division.
The Center analyzed a decade of data on accidental deaths of children on the autism spectrum. Drowning was the #1 cause, accounting for 84% of those deaths.
In 2012, researchers reported on autism and wandering in the journal Pediatrics. They analyzed answers from about 1,000 families to an online survey on the topic. Parents who had children on the spectrum and children not on the spectrum responded. Nearly half of the parents said their child with autism had tried to wander off after age 4, and 26% had gone missing long enough to cause concern.
“Of those who went missing, 24% were in danger of drowning and 65% were in danger of traffic injury,” the researchers wrote. Children on the spectrum might also be drawn to traffic signs, highways, fire trucks, and trains.
In comparison, brothers and sisters of all ages who were not on the spectrum were much less likely to have wandered off.
Seeking a quiet place
It’s not entirely clear why children with autism are so drawn to water, Ms. McIlwain says. But there are some clues.
“What we see is that these children exit settings that are usually bothersome,” Ms. McIlwain says. “[Those settings are] loud, with a high amount of stimuli or stress or commotion, and they go to a quiet place, usually water in a quiet area. It’s calm. It’s peaceful.”
Water isn’t the only dangerous draw. When autism elopement happens, “they also go to the woods, they go to abandoned vehicles,” she says. “So any quiet thing is usually where they will head.”
A family’s loss
Beth Dilg, a mother in Maryland, lost her 7-year-old daughter, Savannah Martin, who was on the autism spectrum, to drowning in 2011. Ms. Dilg had been living in Oklahoma and raising her three children alone after separating from her husband. On a chilly February day, Savannah and her 2-year-old brother left their house after Ms. Dilg had asked her 11-year-old son to keep watch while she went into the bathroom for a few minutes.
When Ms. Dilg realized the two younger kids had left, she searched the property frantically. She shouted Savannah’s name repeatedly, but the child, who had limited language, didn’t come when called. “I feel like she knew what her name was,” Ms. Dilg says, “but it wasn’t like you’d call her name and she’d come to you.”
Ms. Dilg ran to a pond near her property after her 11-year-old son said that the two siblings were in the water. Ms. Dilg entered the water and grabbed her toddler, who had survived after having been kept afloat by his bicycle helmet. But when Ms. Dilg reached Savannah, she was already unresponsive. A neighbor helped pull the children out.
It can happen in any family. Even when a parent takes precautions, a child can slip out in a moment, perhaps while the parent is asleep or taking care of personal needs or if the child is at school or elsewhere.
“It’s unrealistic to say that you’d never take your eyes off your kid,” Ms. Dilg says.
She had tried to protect Savannah by starting her on swimming lessons, installing high locks on the doors, and trying to teach her about how to stay safe.
Still, children can be skillful in finding ways to escape, Ms. Dilg says. “These kids with autism are so smart. They may not be verbal, but they have this level of intelligence,” she says. “You always have to stay a step ahead of them.”
Ms. Dilg has been a longtime volunteer with Team HOPE, a peer support group with the National Center for Missing and Exploited Children. She offers emotional support to parents whose children are missing or who have died, including the parents of youngsters with autism who have drowned.
Teaching first responders
If a child on the autism spectrum goes missing, searching for them can be complicated by their condition. For instance, some children cannot speak or aren’t able to respond to searchers calling their name. The National Center for Missing and Exploited Children offers training to law enforcement and provides search protocols for first responders.
The center has drawn on expertise from Laurie Reyes, an officer with Maryland’s Montgomery County Police Department. In 2005, Ms. Reyes created a special unit within the department to focus on safety for people at risk for wandering. They have conditions that include autism/intellectual and developmental disabilities, as well as Alzheimer’s and other forms of dementia.
“We have a culture of awareness here,” Ms. Reyes says. All Montgomery County recruits and officers receive training in how to interact with those on the autism spectrum, who may not respond to police commands. Police also learn how to search, including immediately checking bodies of water. “We’ve had many times where we’ve located individuals in bodies of water,” Ms. Reyes says.
Don’t wait to call 911. When a child goes missing, time matters. Ms. Reyes advises families not to search on their own. “Call 911 right away,” she says.
Top safety tips to help prevent autism elopement
Use these tips to help keep kids on the autism spectrum safe and prevent drownings.
Secure your home. Use window and door alarms to alert you if a door or window becomes ajar. “Those door alarms are essential,” Ms. McIlwain says.
You can buy alarms online or get them free from the National Autism Association through its Big Red Safety Box program.
You can also buy portable door alarms for travel and arrange to have door alarms at your child’s school.
Ms. McIlwain advises securing the home with adequate locks and using baby monitors. Installing visual prompts, such as a stop sign on the door, might also cue a child not to leave.
Use personal identification. Ms. McIlwain says that children with autism must wear identification, such as a wristband, that includes their name, autism diagnosis, and the name and phone number of a contact person.
If children won’t wear a wristband, IDs on shoelaces are an option, she says. But parents should be aware that kids might leave without shoes or take them off before entering water.
Parents can also weigh the pros and cons of using tracking and locater devices, Ms. McIlwain says.
Identify triggers. “What’s going to make the child want to leave the setting? Is it noise? Is it a certain thing that they fear?” Ms. McIlwain says. “There’s always a reason.”
If parents can identify particular triggers, they can use calming techniques, for example, or provide headphones to counteract bothersome noises.
Teach safety skills, such as swimming lessons. Swimming lessons are important, Ms. McIlwain says. However, children with autism are often bothered by noise and commotion. So a regular swim class might not work for them.
Instead, Ms. McIlwain encourages parents to ask their local YMCA about special-needs swimming lessons or to search for such lessons online. What usually turns out to be best is to give the child a few private swimming lessons “with somebody who understands autism.”
For the child’s final lesson, they should swim fully clothed and with shoes on, Ms. McIlwain says. “A lot of our kids go straight into water fully clothed, and they just need to be able to be familiar with how that feels and the weight of that and be able to swim like that as well.”
If a child is drawn to water, discuss a scheduled time to go so that the youngster can wait, Ms. McIlwain says. “They can see that they’re going to get that water time. They’re going to be able to go to that place. They’re going to wait instead of trying to go on their own.”
Keep a close watch and team up. “When there is a family gathering or an outdoor barbecue, a lot of times, we all think, there are more adults here, so there are going to be more eyes on all the kids. And that always ends up being opposite, right?” Ms. McIlwain says.
Be specific about who is monitoring the child’s safety.
“We encourage parents to do the ‘Tag, you’re it’ game with one another. So you basically tag an adult who is responsible for keeping an eye on that child for a period of time so that there’s always supervision.”
Be prepared
There are a few things you can do now to be ready in case your child slips away. These measures may help find the child quickly.
Take photos today. Keep a full-length shot and a head shot of your child and store them electronically. If your child wanders away, you can immediately send the images to law enforcement to help them search.
Write a 911 script. Have this document ready in case your child wanders. It describes, among other things, points of interest that might draw your child, as well as locations of nearby bodies of water. By having it all written down, you’ll be able to share the information quickly with first responders. The Montgomery County Police Department has a “Wandering 911 Script” that you can download and use.
A version of this article first appeared on Webmd.com.
It happens quickly: A child on the autism spectrum bolts from supervision and disappears – an emergency called “autism elopement.” While any child can wander off, children on the autism spectrum face particular risks. These include the lure of water and the risk of drowning.
Some youngsters on the spectrum will follow this strong attraction to water and head for a nearby pond, river, or swimming pool. Such circumstances have made drowning a leading cause of death for these missing youths.
Autism elopement can happen any time. Summer can be especially dangerous. When the weather warms, the risk of drowning death rises, says Lori McIlwain, cofounder of the National Autism Association.
“The fatality risk is higher in May, June, July for that child to exit the setting unnoticed, especially if there’s an outdoor gathering and then they go directly to water,” Ms. McIlwain says. For instance, she says children can dart away during outdoor play, barbecues, gatherings, and other activities. Or they might wander off while vacationing near a beach or hotel pool.
Autism elopement
Many people don’t know about this risk, including some families with youngsters on the autism spectrum. The National Center for Missing and Exploited Children is working to change that – and find solutions.
About 12 years ago, “we started noticing a very disturbing trend that children with autism were going missing and they were having grave results,” says John Bischoff, vice president of the Center’s Missing Children Division.
The Center analyzed a decade of data on accidental deaths of children on the autism spectrum. Drowning was the #1 cause, accounting for 84% of those deaths.
In 2012, researchers reported on autism and wandering in the journal Pediatrics. They analyzed answers from about 1,000 families to an online survey on the topic. Parents who had children on the spectrum and children not on the spectrum responded. Nearly half of the parents said their child with autism had tried to wander off after age 4, and 26% had gone missing long enough to cause concern.
“Of those who went missing, 24% were in danger of drowning and 65% were in danger of traffic injury,” the researchers wrote. Children on the spectrum might also be drawn to traffic signs, highways, fire trucks, and trains.
In comparison, brothers and sisters of all ages who were not on the spectrum were much less likely to have wandered off.
Seeking a quiet place
It’s not entirely clear why children with autism are so drawn to water, Ms. McIlwain says. But there are some clues.
“What we see is that these children exit settings that are usually bothersome,” Ms. McIlwain says. “[Those settings are] loud, with a high amount of stimuli or stress or commotion, and they go to a quiet place, usually water in a quiet area. It’s calm. It’s peaceful.”
Water isn’t the only dangerous draw. When autism elopement happens, “they also go to the woods, they go to abandoned vehicles,” she says. “So any quiet thing is usually where they will head.”
A family’s loss
Beth Dilg, a mother in Maryland, lost her 7-year-old daughter, Savannah Martin, who was on the autism spectrum, to drowning in 2011. Ms. Dilg had been living in Oklahoma and raising her three children alone after separating from her husband. On a chilly February day, Savannah and her 2-year-old brother left their house after Ms. Dilg had asked her 11-year-old son to keep watch while she went into the bathroom for a few minutes.
When Ms. Dilg realized the two younger kids had left, she searched the property frantically. She shouted Savannah’s name repeatedly, but the child, who had limited language, didn’t come when called. “I feel like she knew what her name was,” Ms. Dilg says, “but it wasn’t like you’d call her name and she’d come to you.”
Ms. Dilg ran to a pond near her property after her 11-year-old son said that the two siblings were in the water. Ms. Dilg entered the water and grabbed her toddler, who had survived after having been kept afloat by his bicycle helmet. But when Ms. Dilg reached Savannah, she was already unresponsive. A neighbor helped pull the children out.
It can happen in any family. Even when a parent takes precautions, a child can slip out in a moment, perhaps while the parent is asleep or taking care of personal needs or if the child is at school or elsewhere.
“It’s unrealistic to say that you’d never take your eyes off your kid,” Ms. Dilg says.
She had tried to protect Savannah by starting her on swimming lessons, installing high locks on the doors, and trying to teach her about how to stay safe.
Still, children can be skillful in finding ways to escape, Ms. Dilg says. “These kids with autism are so smart. They may not be verbal, but they have this level of intelligence,” she says. “You always have to stay a step ahead of them.”
Ms. Dilg has been a longtime volunteer with Team HOPE, a peer support group with the National Center for Missing and Exploited Children. She offers emotional support to parents whose children are missing or who have died, including the parents of youngsters with autism who have drowned.
Teaching first responders
If a child on the autism spectrum goes missing, searching for them can be complicated by their condition. For instance, some children cannot speak or aren’t able to respond to searchers calling their name. The National Center for Missing and Exploited Children offers training to law enforcement and provides search protocols for first responders.
The center has drawn on expertise from Laurie Reyes, an officer with Maryland’s Montgomery County Police Department. In 2005, Ms. Reyes created a special unit within the department to focus on safety for people at risk for wandering. They have conditions that include autism/intellectual and developmental disabilities, as well as Alzheimer’s and other forms of dementia.
“We have a culture of awareness here,” Ms. Reyes says. All Montgomery County recruits and officers receive training in how to interact with those on the autism spectrum, who may not respond to police commands. Police also learn how to search, including immediately checking bodies of water. “We’ve had many times where we’ve located individuals in bodies of water,” Ms. Reyes says.
Don’t wait to call 911. When a child goes missing, time matters. Ms. Reyes advises families not to search on their own. “Call 911 right away,” she says.
Top safety tips to help prevent autism elopement
Use these tips to help keep kids on the autism spectrum safe and prevent drownings.
Secure your home. Use window and door alarms to alert you if a door or window becomes ajar. “Those door alarms are essential,” Ms. McIlwain says.
You can buy alarms online or get them free from the National Autism Association through its Big Red Safety Box program.
You can also buy portable door alarms for travel and arrange to have door alarms at your child’s school.
Ms. McIlwain advises securing the home with adequate locks and using baby monitors. Installing visual prompts, such as a stop sign on the door, might also cue a child not to leave.
Use personal identification. Ms. McIlwain says that children with autism must wear identification, such as a wristband, that includes their name, autism diagnosis, and the name and phone number of a contact person.
If children won’t wear a wristband, IDs on shoelaces are an option, she says. But parents should be aware that kids might leave without shoes or take them off before entering water.
Parents can also weigh the pros and cons of using tracking and locater devices, Ms. McIlwain says.
Identify triggers. “What’s going to make the child want to leave the setting? Is it noise? Is it a certain thing that they fear?” Ms. McIlwain says. “There’s always a reason.”
If parents can identify particular triggers, they can use calming techniques, for example, or provide headphones to counteract bothersome noises.
Teach safety skills, such as swimming lessons. Swimming lessons are important, Ms. McIlwain says. However, children with autism are often bothered by noise and commotion. So a regular swim class might not work for them.
Instead, Ms. McIlwain encourages parents to ask their local YMCA about special-needs swimming lessons or to search for such lessons online. What usually turns out to be best is to give the child a few private swimming lessons “with somebody who understands autism.”
For the child’s final lesson, they should swim fully clothed and with shoes on, Ms. McIlwain says. “A lot of our kids go straight into water fully clothed, and they just need to be able to be familiar with how that feels and the weight of that and be able to swim like that as well.”
If a child is drawn to water, discuss a scheduled time to go so that the youngster can wait, Ms. McIlwain says. “They can see that they’re going to get that water time. They’re going to be able to go to that place. They’re going to wait instead of trying to go on their own.”
Keep a close watch and team up. “When there is a family gathering or an outdoor barbecue, a lot of times, we all think, there are more adults here, so there are going to be more eyes on all the kids. And that always ends up being opposite, right?” Ms. McIlwain says.
Be specific about who is monitoring the child’s safety.
“We encourage parents to do the ‘Tag, you’re it’ game with one another. So you basically tag an adult who is responsible for keeping an eye on that child for a period of time so that there’s always supervision.”
Be prepared
There are a few things you can do now to be ready in case your child slips away. These measures may help find the child quickly.
Take photos today. Keep a full-length shot and a head shot of your child and store them electronically. If your child wanders away, you can immediately send the images to law enforcement to help them search.
Write a 911 script. Have this document ready in case your child wanders. It describes, among other things, points of interest that might draw your child, as well as locations of nearby bodies of water. By having it all written down, you’ll be able to share the information quickly with first responders. The Montgomery County Police Department has a “Wandering 911 Script” that you can download and use.
A version of this article first appeared on Webmd.com.
It happens quickly: A child on the autism spectrum bolts from supervision and disappears – an emergency called “autism elopement.” While any child can wander off, children on the autism spectrum face particular risks. These include the lure of water and the risk of drowning.
Some youngsters on the spectrum will follow this strong attraction to water and head for a nearby pond, river, or swimming pool. Such circumstances have made drowning a leading cause of death for these missing youths.
Autism elopement can happen any time. Summer can be especially dangerous. When the weather warms, the risk of drowning death rises, says Lori McIlwain, cofounder of the National Autism Association.
“The fatality risk is higher in May, June, July for that child to exit the setting unnoticed, especially if there’s an outdoor gathering and then they go directly to water,” Ms. McIlwain says. For instance, she says children can dart away during outdoor play, barbecues, gatherings, and other activities. Or they might wander off while vacationing near a beach or hotel pool.
Autism elopement
Many people don’t know about this risk, including some families with youngsters on the autism spectrum. The National Center for Missing and Exploited Children is working to change that – and find solutions.
About 12 years ago, “we started noticing a very disturbing trend that children with autism were going missing and they were having grave results,” says John Bischoff, vice president of the Center’s Missing Children Division.
The Center analyzed a decade of data on accidental deaths of children on the autism spectrum. Drowning was the #1 cause, accounting for 84% of those deaths.
In 2012, researchers reported on autism and wandering in the journal Pediatrics. They analyzed answers from about 1,000 families to an online survey on the topic. Parents who had children on the spectrum and children not on the spectrum responded. Nearly half of the parents said their child with autism had tried to wander off after age 4, and 26% had gone missing long enough to cause concern.
“Of those who went missing, 24% were in danger of drowning and 65% were in danger of traffic injury,” the researchers wrote. Children on the spectrum might also be drawn to traffic signs, highways, fire trucks, and trains.
In comparison, brothers and sisters of all ages who were not on the spectrum were much less likely to have wandered off.
Seeking a quiet place
It’s not entirely clear why children with autism are so drawn to water, Ms. McIlwain says. But there are some clues.
“What we see is that these children exit settings that are usually bothersome,” Ms. McIlwain says. “[Those settings are] loud, with a high amount of stimuli or stress or commotion, and they go to a quiet place, usually water in a quiet area. It’s calm. It’s peaceful.”
Water isn’t the only dangerous draw. When autism elopement happens, “they also go to the woods, they go to abandoned vehicles,” she says. “So any quiet thing is usually where they will head.”
A family’s loss
Beth Dilg, a mother in Maryland, lost her 7-year-old daughter, Savannah Martin, who was on the autism spectrum, to drowning in 2011. Ms. Dilg had been living in Oklahoma and raising her three children alone after separating from her husband. On a chilly February day, Savannah and her 2-year-old brother left their house after Ms. Dilg had asked her 11-year-old son to keep watch while she went into the bathroom for a few minutes.
When Ms. Dilg realized the two younger kids had left, she searched the property frantically. She shouted Savannah’s name repeatedly, but the child, who had limited language, didn’t come when called. “I feel like she knew what her name was,” Ms. Dilg says, “but it wasn’t like you’d call her name and she’d come to you.”
Ms. Dilg ran to a pond near her property after her 11-year-old son said that the two siblings were in the water. Ms. Dilg entered the water and grabbed her toddler, who had survived after having been kept afloat by his bicycle helmet. But when Ms. Dilg reached Savannah, she was already unresponsive. A neighbor helped pull the children out.
It can happen in any family. Even when a parent takes precautions, a child can slip out in a moment, perhaps while the parent is asleep or taking care of personal needs or if the child is at school or elsewhere.
“It’s unrealistic to say that you’d never take your eyes off your kid,” Ms. Dilg says.
She had tried to protect Savannah by starting her on swimming lessons, installing high locks on the doors, and trying to teach her about how to stay safe.
Still, children can be skillful in finding ways to escape, Ms. Dilg says. “These kids with autism are so smart. They may not be verbal, but they have this level of intelligence,” she says. “You always have to stay a step ahead of them.”
Ms. Dilg has been a longtime volunteer with Team HOPE, a peer support group with the National Center for Missing and Exploited Children. She offers emotional support to parents whose children are missing or who have died, including the parents of youngsters with autism who have drowned.
Teaching first responders
If a child on the autism spectrum goes missing, searching for them can be complicated by their condition. For instance, some children cannot speak or aren’t able to respond to searchers calling their name. The National Center for Missing and Exploited Children offers training to law enforcement and provides search protocols for first responders.
The center has drawn on expertise from Laurie Reyes, an officer with Maryland’s Montgomery County Police Department. In 2005, Ms. Reyes created a special unit within the department to focus on safety for people at risk for wandering. They have conditions that include autism/intellectual and developmental disabilities, as well as Alzheimer’s and other forms of dementia.
“We have a culture of awareness here,” Ms. Reyes says. All Montgomery County recruits and officers receive training in how to interact with those on the autism spectrum, who may not respond to police commands. Police also learn how to search, including immediately checking bodies of water. “We’ve had many times where we’ve located individuals in bodies of water,” Ms. Reyes says.
Don’t wait to call 911. When a child goes missing, time matters. Ms. Reyes advises families not to search on their own. “Call 911 right away,” she says.
Top safety tips to help prevent autism elopement
Use these tips to help keep kids on the autism spectrum safe and prevent drownings.
Secure your home. Use window and door alarms to alert you if a door or window becomes ajar. “Those door alarms are essential,” Ms. McIlwain says.
You can buy alarms online or get them free from the National Autism Association through its Big Red Safety Box program.
You can also buy portable door alarms for travel and arrange to have door alarms at your child’s school.
Ms. McIlwain advises securing the home with adequate locks and using baby monitors. Installing visual prompts, such as a stop sign on the door, might also cue a child not to leave.
Use personal identification. Ms. McIlwain says that children with autism must wear identification, such as a wristband, that includes their name, autism diagnosis, and the name and phone number of a contact person.
If children won’t wear a wristband, IDs on shoelaces are an option, she says. But parents should be aware that kids might leave without shoes or take them off before entering water.
Parents can also weigh the pros and cons of using tracking and locater devices, Ms. McIlwain says.
Identify triggers. “What’s going to make the child want to leave the setting? Is it noise? Is it a certain thing that they fear?” Ms. McIlwain says. “There’s always a reason.”
If parents can identify particular triggers, they can use calming techniques, for example, or provide headphones to counteract bothersome noises.
Teach safety skills, such as swimming lessons. Swimming lessons are important, Ms. McIlwain says. However, children with autism are often bothered by noise and commotion. So a regular swim class might not work for them.
Instead, Ms. McIlwain encourages parents to ask their local YMCA about special-needs swimming lessons or to search for such lessons online. What usually turns out to be best is to give the child a few private swimming lessons “with somebody who understands autism.”
For the child’s final lesson, they should swim fully clothed and with shoes on, Ms. McIlwain says. “A lot of our kids go straight into water fully clothed, and they just need to be able to be familiar with how that feels and the weight of that and be able to swim like that as well.”
If a child is drawn to water, discuss a scheduled time to go so that the youngster can wait, Ms. McIlwain says. “They can see that they’re going to get that water time. They’re going to be able to go to that place. They’re going to wait instead of trying to go on their own.”
Keep a close watch and team up. “When there is a family gathering or an outdoor barbecue, a lot of times, we all think, there are more adults here, so there are going to be more eyes on all the kids. And that always ends up being opposite, right?” Ms. McIlwain says.
Be specific about who is monitoring the child’s safety.
“We encourage parents to do the ‘Tag, you’re it’ game with one another. So you basically tag an adult who is responsible for keeping an eye on that child for a period of time so that there’s always supervision.”
Be prepared
There are a few things you can do now to be ready in case your child slips away. These measures may help find the child quickly.
Take photos today. Keep a full-length shot and a head shot of your child and store them electronically. If your child wanders away, you can immediately send the images to law enforcement to help them search.
Write a 911 script. Have this document ready in case your child wanders. It describes, among other things, points of interest that might draw your child, as well as locations of nearby bodies of water. By having it all written down, you’ll be able to share the information quickly with first responders. The Montgomery County Police Department has a “Wandering 911 Script” that you can download and use.
A version of this article first appeared on Webmd.com.
The power of napping
As a physician who has had a career-long obsession with the underappreciated value of sleep, a recent study published in the journal Child Development caught my eye. The findings presented by a group of Australian-based psychologists and educators suggest a positive association between napping and learning by preschool children. While the study itself relied on a very small sample and may not prove to be repeatable, the authors included in their introduction an excellent discussion of a large collection of recent studies supporting the educational benefit of sleep in general and napping in particular.
Although sleep seems to finally be receiving some of the attention it deserves, I am still concerned that as a profession we are failing to give it the appropriate weight at our health maintenance visits. This is particularly true of napping. Understandably, napping doesn’t feel urgent to parents in those turbulent first 4 or 5 months of night wakings and erratic settling. However, as a child approaches the 6-month milestone, napping is a topic ripe for well-considered anticipatory guidance.
When the recurrent cycles of awake-eat-sleep begin to develop into a somewhat predictable pattern and solid food is introduced, it’s time to suggest to parents a strategy that will encourage a napping pattern that will hopefully habituate into toddlerhood and beyond.
It can begin simply as a matter of defining the feeding in the middle of the day as lunch and then programming the period immediately following that meal as a siesta – a segment of the day completely reserved for rest. Many warm-weather countries have been using this strategy for centuries. Try to go to the pharmacy to pick up a prescription at 2 o’clock in the afternoon in rural Spain. It just ain’t gonna happen.
Most adults and children I know seem to be sleepy during this midday postprandial period. It makes more than a little sense to harness this natural drowsiness into creating a napping habit. However, the challenge for many young families is controlling their schedule to create a period of time when nothing else is going on in the child’s environment, leaving sleep as the only option. For some parents this requires the discipline to pause their own lives long enough so that the children realize that they aren’t missing out on something fun. This means no TV, no phone conversations, no visitors. Obviously, it also means not scheduling any appointments during this siesta period. Skilled day care providers have been doing this for years. But the message hasn’t seeped into the general population and sadly I occasionally see mothers with toddlers in the grocery store at 1 in the afternoon.
Once the nap/siesta is firmly welded to lunch, this gives the parent the ability to make minor adjustments that reflect the child’s stamina. If the child seems to be tiring/getting grumpy, serve up lunch a bit early and the restorative nap follows. As the child gets older and his or her stamina improves he or she may not be sleepy but the siesta remains as a quiet time. Some days it may be a nap, some days just a rest for an hour. By counseling parents to define the period after lunch as a siesta you will be helping them avoid that dreaded transition period called “giving up the nap.”
You may already be including this strategy in your anticipatory guidance. It may help to add to your advice the accumulating evidence that napping may play an important role in the child’s development and education.
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].
As a physician who has had a career-long obsession with the underappreciated value of sleep, a recent study published in the journal Child Development caught my eye. The findings presented by a group of Australian-based psychologists and educators suggest a positive association between napping and learning by preschool children. While the study itself relied on a very small sample and may not prove to be repeatable, the authors included in their introduction an excellent discussion of a large collection of recent studies supporting the educational benefit of sleep in general and napping in particular.
Although sleep seems to finally be receiving some of the attention it deserves, I am still concerned that as a profession we are failing to give it the appropriate weight at our health maintenance visits. This is particularly true of napping. Understandably, napping doesn’t feel urgent to parents in those turbulent first 4 or 5 months of night wakings and erratic settling. However, as a child approaches the 6-month milestone, napping is a topic ripe for well-considered anticipatory guidance.
When the recurrent cycles of awake-eat-sleep begin to develop into a somewhat predictable pattern and solid food is introduced, it’s time to suggest to parents a strategy that will encourage a napping pattern that will hopefully habituate into toddlerhood and beyond.
It can begin simply as a matter of defining the feeding in the middle of the day as lunch and then programming the period immediately following that meal as a siesta – a segment of the day completely reserved for rest. Many warm-weather countries have been using this strategy for centuries. Try to go to the pharmacy to pick up a prescription at 2 o’clock in the afternoon in rural Spain. It just ain’t gonna happen.
Most adults and children I know seem to be sleepy during this midday postprandial period. It makes more than a little sense to harness this natural drowsiness into creating a napping habit. However, the challenge for many young families is controlling their schedule to create a period of time when nothing else is going on in the child’s environment, leaving sleep as the only option. For some parents this requires the discipline to pause their own lives long enough so that the children realize that they aren’t missing out on something fun. This means no TV, no phone conversations, no visitors. Obviously, it also means not scheduling any appointments during this siesta period. Skilled day care providers have been doing this for years. But the message hasn’t seeped into the general population and sadly I occasionally see mothers with toddlers in the grocery store at 1 in the afternoon.
Once the nap/siesta is firmly welded to lunch, this gives the parent the ability to make minor adjustments that reflect the child’s stamina. If the child seems to be tiring/getting grumpy, serve up lunch a bit early and the restorative nap follows. As the child gets older and his or her stamina improves he or she may not be sleepy but the siesta remains as a quiet time. Some days it may be a nap, some days just a rest for an hour. By counseling parents to define the period after lunch as a siesta you will be helping them avoid that dreaded transition period called “giving up the nap.”
You may already be including this strategy in your anticipatory guidance. It may help to add to your advice the accumulating evidence that napping may play an important role in the child’s development and education.
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].
As a physician who has had a career-long obsession with the underappreciated value of sleep, a recent study published in the journal Child Development caught my eye. The findings presented by a group of Australian-based psychologists and educators suggest a positive association between napping and learning by preschool children. While the study itself relied on a very small sample and may not prove to be repeatable, the authors included in their introduction an excellent discussion of a large collection of recent studies supporting the educational benefit of sleep in general and napping in particular.
Although sleep seems to finally be receiving some of the attention it deserves, I am still concerned that as a profession we are failing to give it the appropriate weight at our health maintenance visits. This is particularly true of napping. Understandably, napping doesn’t feel urgent to parents in those turbulent first 4 or 5 months of night wakings and erratic settling. However, as a child approaches the 6-month milestone, napping is a topic ripe for well-considered anticipatory guidance.
When the recurrent cycles of awake-eat-sleep begin to develop into a somewhat predictable pattern and solid food is introduced, it’s time to suggest to parents a strategy that will encourage a napping pattern that will hopefully habituate into toddlerhood and beyond.
It can begin simply as a matter of defining the feeding in the middle of the day as lunch and then programming the period immediately following that meal as a siesta – a segment of the day completely reserved for rest. Many warm-weather countries have been using this strategy for centuries. Try to go to the pharmacy to pick up a prescription at 2 o’clock in the afternoon in rural Spain. It just ain’t gonna happen.
Most adults and children I know seem to be sleepy during this midday postprandial period. It makes more than a little sense to harness this natural drowsiness into creating a napping habit. However, the challenge for many young families is controlling their schedule to create a period of time when nothing else is going on in the child’s environment, leaving sleep as the only option. For some parents this requires the discipline to pause their own lives long enough so that the children realize that they aren’t missing out on something fun. This means no TV, no phone conversations, no visitors. Obviously, it also means not scheduling any appointments during this siesta period. Skilled day care providers have been doing this for years. But the message hasn’t seeped into the general population and sadly I occasionally see mothers with toddlers in the grocery store at 1 in the afternoon.
Once the nap/siesta is firmly welded to lunch, this gives the parent the ability to make minor adjustments that reflect the child’s stamina. If the child seems to be tiring/getting grumpy, serve up lunch a bit early and the restorative nap follows. As the child gets older and his or her stamina improves he or she may not be sleepy but the siesta remains as a quiet time. Some days it may be a nap, some days just a rest for an hour. By counseling parents to define the period after lunch as a siesta you will be helping them avoid that dreaded transition period called “giving up the nap.”
You may already be including this strategy in your anticipatory guidance. It may help to add to your advice the accumulating evidence that napping may play an important role in the child’s development and education.
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].
Childhood cardiovascular risks and longevity
Now hot off the press from the “always-guessed-it-was-true-but-now-you-know-it” department comes a multinational study that looked at childhood cardiovascular risk factors and longevity.
Using data collected from individuals in Finland, Australia, and the United States the International Childhood Cardiovascular Cohorts Consortium Outcomes Study investigators sought links between subjects’ body mass index, systolic blood pressure, total cholesterol, blood triglyceride level, and smoking in childhood with cardiovascular disease and outcomes as they aged into adulthood.
The children were initially enrolled in the 1970s and 1980s. The adult evaluations were done in 2015-2019 when the subjects’ average age was 46. Of the 40,000 individuals who originally entered the study, 800 were found to have cardiovascular events of which over 300 had resulted in death. I found these numbers a bit surprising given the relatively young age at which the follow-up data were collected.
What was less surprising is that people with higher than normal values for all five risk factors as children had nearly three times the risk of cardiovascular disease as adults. Researchers found that smoking at a young age was biggest risk factor with body mass index, systolic blood pressure, blood triglycerides, and cholesterol following in descending order. They also found that adults who were obese as children had triple the risk of cardiovascular disease as adults. High blood pressure in childhood doubled the risk.
It will be interesting to see if and how these trends change as the study population ages. It could be that the effect of these childhood risk factors is blunted as the those segments at the highest risk die off and/or risk- associated behaviors adopted in adulthood become more prominent. But, it feels more likely that the childhood risk factors will remain as major contributors.
Is this just another ho-hum-told-you-so study or does it have some special relevance for us as pediatricians? At a minimum these findings should inspire us to stick with our calling to commit ourselves to the health of children. A healthy adult population is clearly our legacy.
Of course the two individual risk factors in childhood that appear to be the most potent in adulthood, obesity and smoking, are also the most frustrating for pediatricians to address. However, the study suggests that we should rejoice in those few successes when we achieve them. Childhood obesity has been a tough nut to crack. On the other hand, the societal change that has made great strides in adult smoking over the last half century should encourage us that our work with the pediatric population will eventually bring rewards.
Smoking and obesity can include components of both patient and parental behavior. Monitoring cholesterol, triglycerides, and blood pressure hinges on our behavior as providers. Although there have been recent recommendations that we be more attentive, we don’t have a strong history when it comes to detecting and addressing high blood pressure in children. This study should serve as an another reminder to take blood pressure more seriously.
I was surprised and somewhat disappointed that I first learned about the results of this study in an email newsletter from the medical school I attended. I would have hoped that a paper like this from a well known peer-reviewed journal with a clear message about the relationship of childhood health and longevity should have been picked up quickly by the lay press. Again, this leaves it to us to promote the message that the health of children is important in and of itself but plays a critical role in the health of adults.
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].
Now hot off the press from the “always-guessed-it-was-true-but-now-you-know-it” department comes a multinational study that looked at childhood cardiovascular risk factors and longevity.
Using data collected from individuals in Finland, Australia, and the United States the International Childhood Cardiovascular Cohorts Consortium Outcomes Study investigators sought links between subjects’ body mass index, systolic blood pressure, total cholesterol, blood triglyceride level, and smoking in childhood with cardiovascular disease and outcomes as they aged into adulthood.
The children were initially enrolled in the 1970s and 1980s. The adult evaluations were done in 2015-2019 when the subjects’ average age was 46. Of the 40,000 individuals who originally entered the study, 800 were found to have cardiovascular events of which over 300 had resulted in death. I found these numbers a bit surprising given the relatively young age at which the follow-up data were collected.
What was less surprising is that people with higher than normal values for all five risk factors as children had nearly three times the risk of cardiovascular disease as adults. Researchers found that smoking at a young age was biggest risk factor with body mass index, systolic blood pressure, blood triglycerides, and cholesterol following in descending order. They also found that adults who were obese as children had triple the risk of cardiovascular disease as adults. High blood pressure in childhood doubled the risk.
It will be interesting to see if and how these trends change as the study population ages. It could be that the effect of these childhood risk factors is blunted as the those segments at the highest risk die off and/or risk- associated behaviors adopted in adulthood become more prominent. But, it feels more likely that the childhood risk factors will remain as major contributors.
Is this just another ho-hum-told-you-so study or does it have some special relevance for us as pediatricians? At a minimum these findings should inspire us to stick with our calling to commit ourselves to the health of children. A healthy adult population is clearly our legacy.
Of course the two individual risk factors in childhood that appear to be the most potent in adulthood, obesity and smoking, are also the most frustrating for pediatricians to address. However, the study suggests that we should rejoice in those few successes when we achieve them. Childhood obesity has been a tough nut to crack. On the other hand, the societal change that has made great strides in adult smoking over the last half century should encourage us that our work with the pediatric population will eventually bring rewards.
Smoking and obesity can include components of both patient and parental behavior. Monitoring cholesterol, triglycerides, and blood pressure hinges on our behavior as providers. Although there have been recent recommendations that we be more attentive, we don’t have a strong history when it comes to detecting and addressing high blood pressure in children. This study should serve as an another reminder to take blood pressure more seriously.
I was surprised and somewhat disappointed that I first learned about the results of this study in an email newsletter from the medical school I attended. I would have hoped that a paper like this from a well known peer-reviewed journal with a clear message about the relationship of childhood health and longevity should have been picked up quickly by the lay press. Again, this leaves it to us to promote the message that the health of children is important in and of itself but plays a critical role in the health of adults.
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].
Now hot off the press from the “always-guessed-it-was-true-but-now-you-know-it” department comes a multinational study that looked at childhood cardiovascular risk factors and longevity.
Using data collected from individuals in Finland, Australia, and the United States the International Childhood Cardiovascular Cohorts Consortium Outcomes Study investigators sought links between subjects’ body mass index, systolic blood pressure, total cholesterol, blood triglyceride level, and smoking in childhood with cardiovascular disease and outcomes as they aged into adulthood.
The children were initially enrolled in the 1970s and 1980s. The adult evaluations were done in 2015-2019 when the subjects’ average age was 46. Of the 40,000 individuals who originally entered the study, 800 were found to have cardiovascular events of which over 300 had resulted in death. I found these numbers a bit surprising given the relatively young age at which the follow-up data were collected.
What was less surprising is that people with higher than normal values for all five risk factors as children had nearly three times the risk of cardiovascular disease as adults. Researchers found that smoking at a young age was biggest risk factor with body mass index, systolic blood pressure, blood triglycerides, and cholesterol following in descending order. They also found that adults who were obese as children had triple the risk of cardiovascular disease as adults. High blood pressure in childhood doubled the risk.
It will be interesting to see if and how these trends change as the study population ages. It could be that the effect of these childhood risk factors is blunted as the those segments at the highest risk die off and/or risk- associated behaviors adopted in adulthood become more prominent. But, it feels more likely that the childhood risk factors will remain as major contributors.
Is this just another ho-hum-told-you-so study or does it have some special relevance for us as pediatricians? At a minimum these findings should inspire us to stick with our calling to commit ourselves to the health of children. A healthy adult population is clearly our legacy.
Of course the two individual risk factors in childhood that appear to be the most potent in adulthood, obesity and smoking, are also the most frustrating for pediatricians to address. However, the study suggests that we should rejoice in those few successes when we achieve them. Childhood obesity has been a tough nut to crack. On the other hand, the societal change that has made great strides in adult smoking over the last half century should encourage us that our work with the pediatric population will eventually bring rewards.
Smoking and obesity can include components of both patient and parental behavior. Monitoring cholesterol, triglycerides, and blood pressure hinges on our behavior as providers. Although there have been recent recommendations that we be more attentive, we don’t have a strong history when it comes to detecting and addressing high blood pressure in children. This study should serve as an another reminder to take blood pressure more seriously.
I was surprised and somewhat disappointed that I first learned about the results of this study in an email newsletter from the medical school I attended. I would have hoped that a paper like this from a well known peer-reviewed journal with a clear message about the relationship of childhood health and longevity should have been picked up quickly by the lay press. Again, this leaves it to us to promote the message that the health of children is important in and of itself but plays a critical role in the health of adults.
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].
Trans teens less likely to commit acts of sexual violence, says new study
Transgender and nonbinary adolescents are twice as likely to experience sexual violence as their cisgendered peers but are less likely to attempt rape or commit sexual assault, researchers have found.
The study, which was published online in JAMA Network Open, is among the first on the sexual violence that trans, nonbinary, and other gender nonconforming adolescents experience. Previous studies have focused on adults.
“In the busy world of clinical care, it is essential that clinicians be aware of potential disparities their patients are navigating,” said Michele Ybarra, PhD, MPH, president and research director of the Center for Innovative Public Health Research, San Clemente, California, who led the study. “This includes sexual violence victimization for gender minority youth and the need to talk about consent and boundaries for youth of all genders.”
Dr. Ybarra said that while clinicians may be aware that transgender young people face stigma, discrimination, and bullying, they may not be aware that trans youth are also the targets of sexual violence.
Studies indicate that health care providers and communities have significant misconceptions about sexually explicit behavior among trans and nonbinary teens. Misconceptions can lead to discrimination, resulting in higher rates of drug abuse, dropping out of school, suicide, and homelessness.
Dr. Ybarra and her colleagues surveyed 911 trans, nonbinary, or questioning youth on Instagram and Facebook through a collaboration with Growing Up With Media, a national longitudinal survey designed to investigate sexual violence during adolescence.
They also surveyed 3,282 cisgender persons aged 14-16 years who were recruited to the study between June 2018 and March 2020. The term “cisgender” refers to youth who identify with their gender at birth.
The questionnaires asked teens about gender identity, race, economic status, and support systems at home. Factors associated with not experiencing sexual violence included having a strong network of friends, family, and educators; involvement in the community; and having people close who affirm their gender identity.
More than three-fourths (78%) of youth surveyed identified as cisgender, 13.9% identified as questioning, and 7.9% identified as transgender.
Roughly two-thirds (67%) of transgender adolescents said they had experienced serious sexual violence, 73% reported experiencing violence in their communities, and 63% said they had been exposed to aggressive behavior. In contrast, 6.7% of trans youth said they had ever committed sexual violence, while 7.4% of cisgender teens surveyed, or 243 students, said they had done so.
“The relative lack of visibility of gender minority youth in sexual violence research is unacceptable,” Dr. Ybarra told this news organization. “To be counted, one needs to be seen. We aimed to start addressing this exclusion with the current study.”
The findings provide a lens into the levels of sexual violence that LGBTQIA+ youth experience and an opportunity to provide more inclusive care, according to Elizabeth Miller, MD, PhD, FSAHM, Distinguished Professor of Pediatrics, director of the Division of Adolescent and Young Adult Medicine, and medical director of community and population health at UPMC Children’s Hospital of Pittsburgh, who was not involved in the study.
“There are unfortunately pervasive and harmful stereotypes in our society about the ‘sexual deviancy’ attributed to LGBTQIA+ individuals,” Dr. Miller told this news organization. “This study adds to the research literature that counters and challenges these harmful – and inaccurate – perceptions.”
Dr. Miller said clinicians can help this population by offering youth accurate information about relevant support and services, including how to help a friend.
Programs that providers could incorporate include gender transformative approaches, which guide youth to examine gender norms and inequities and that develop leadership skills.
Such programs are more common outside the United States and have been shown to decrease LGBTQIA+ youth exposure to sexual violence, she said.
Dr. Miller said more research is needed to understand the contexts in which gender minority youth experience sexual violence to guide prevention efforts: “We need to move beyond individual-focused interventions to considering community-level interventions to create safer and more inclusive spaces for all youth.”
Dr. Miller has received royalties for writing content for UptoDate Wolters Kluwer outside of the current study. Dr. Ybarra has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Transgender and nonbinary adolescents are twice as likely to experience sexual violence as their cisgendered peers but are less likely to attempt rape or commit sexual assault, researchers have found.
The study, which was published online in JAMA Network Open, is among the first on the sexual violence that trans, nonbinary, and other gender nonconforming adolescents experience. Previous studies have focused on adults.
“In the busy world of clinical care, it is essential that clinicians be aware of potential disparities their patients are navigating,” said Michele Ybarra, PhD, MPH, president and research director of the Center for Innovative Public Health Research, San Clemente, California, who led the study. “This includes sexual violence victimization for gender minority youth and the need to talk about consent and boundaries for youth of all genders.”
Dr. Ybarra said that while clinicians may be aware that transgender young people face stigma, discrimination, and bullying, they may not be aware that trans youth are also the targets of sexual violence.
Studies indicate that health care providers and communities have significant misconceptions about sexually explicit behavior among trans and nonbinary teens. Misconceptions can lead to discrimination, resulting in higher rates of drug abuse, dropping out of school, suicide, and homelessness.
Dr. Ybarra and her colleagues surveyed 911 trans, nonbinary, or questioning youth on Instagram and Facebook through a collaboration with Growing Up With Media, a national longitudinal survey designed to investigate sexual violence during adolescence.
They also surveyed 3,282 cisgender persons aged 14-16 years who were recruited to the study between June 2018 and March 2020. The term “cisgender” refers to youth who identify with their gender at birth.
The questionnaires asked teens about gender identity, race, economic status, and support systems at home. Factors associated with not experiencing sexual violence included having a strong network of friends, family, and educators; involvement in the community; and having people close who affirm their gender identity.
More than three-fourths (78%) of youth surveyed identified as cisgender, 13.9% identified as questioning, and 7.9% identified as transgender.
Roughly two-thirds (67%) of transgender adolescents said they had experienced serious sexual violence, 73% reported experiencing violence in their communities, and 63% said they had been exposed to aggressive behavior. In contrast, 6.7% of trans youth said they had ever committed sexual violence, while 7.4% of cisgender teens surveyed, or 243 students, said they had done so.
“The relative lack of visibility of gender minority youth in sexual violence research is unacceptable,” Dr. Ybarra told this news organization. “To be counted, one needs to be seen. We aimed to start addressing this exclusion with the current study.”
The findings provide a lens into the levels of sexual violence that LGBTQIA+ youth experience and an opportunity to provide more inclusive care, according to Elizabeth Miller, MD, PhD, FSAHM, Distinguished Professor of Pediatrics, director of the Division of Adolescent and Young Adult Medicine, and medical director of community and population health at UPMC Children’s Hospital of Pittsburgh, who was not involved in the study.
“There are unfortunately pervasive and harmful stereotypes in our society about the ‘sexual deviancy’ attributed to LGBTQIA+ individuals,” Dr. Miller told this news organization. “This study adds to the research literature that counters and challenges these harmful – and inaccurate – perceptions.”
Dr. Miller said clinicians can help this population by offering youth accurate information about relevant support and services, including how to help a friend.
Programs that providers could incorporate include gender transformative approaches, which guide youth to examine gender norms and inequities and that develop leadership skills.
Such programs are more common outside the United States and have been shown to decrease LGBTQIA+ youth exposure to sexual violence, she said.
Dr. Miller said more research is needed to understand the contexts in which gender minority youth experience sexual violence to guide prevention efforts: “We need to move beyond individual-focused interventions to considering community-level interventions to create safer and more inclusive spaces for all youth.”
Dr. Miller has received royalties for writing content for UptoDate Wolters Kluwer outside of the current study. Dr. Ybarra has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Transgender and nonbinary adolescents are twice as likely to experience sexual violence as their cisgendered peers but are less likely to attempt rape or commit sexual assault, researchers have found.
The study, which was published online in JAMA Network Open, is among the first on the sexual violence that trans, nonbinary, and other gender nonconforming adolescents experience. Previous studies have focused on adults.
“In the busy world of clinical care, it is essential that clinicians be aware of potential disparities their patients are navigating,” said Michele Ybarra, PhD, MPH, president and research director of the Center for Innovative Public Health Research, San Clemente, California, who led the study. “This includes sexual violence victimization for gender minority youth and the need to talk about consent and boundaries for youth of all genders.”
Dr. Ybarra said that while clinicians may be aware that transgender young people face stigma, discrimination, and bullying, they may not be aware that trans youth are also the targets of sexual violence.
Studies indicate that health care providers and communities have significant misconceptions about sexually explicit behavior among trans and nonbinary teens. Misconceptions can lead to discrimination, resulting in higher rates of drug abuse, dropping out of school, suicide, and homelessness.
Dr. Ybarra and her colleagues surveyed 911 trans, nonbinary, or questioning youth on Instagram and Facebook through a collaboration with Growing Up With Media, a national longitudinal survey designed to investigate sexual violence during adolescence.
They also surveyed 3,282 cisgender persons aged 14-16 years who were recruited to the study between June 2018 and March 2020. The term “cisgender” refers to youth who identify with their gender at birth.
The questionnaires asked teens about gender identity, race, economic status, and support systems at home. Factors associated with not experiencing sexual violence included having a strong network of friends, family, and educators; involvement in the community; and having people close who affirm their gender identity.
More than three-fourths (78%) of youth surveyed identified as cisgender, 13.9% identified as questioning, and 7.9% identified as transgender.
Roughly two-thirds (67%) of transgender adolescents said they had experienced serious sexual violence, 73% reported experiencing violence in their communities, and 63% said they had been exposed to aggressive behavior. In contrast, 6.7% of trans youth said they had ever committed sexual violence, while 7.4% of cisgender teens surveyed, or 243 students, said they had done so.
“The relative lack of visibility of gender minority youth in sexual violence research is unacceptable,” Dr. Ybarra told this news organization. “To be counted, one needs to be seen. We aimed to start addressing this exclusion with the current study.”
The findings provide a lens into the levels of sexual violence that LGBTQIA+ youth experience and an opportunity to provide more inclusive care, according to Elizabeth Miller, MD, PhD, FSAHM, Distinguished Professor of Pediatrics, director of the Division of Adolescent and Young Adult Medicine, and medical director of community and population health at UPMC Children’s Hospital of Pittsburgh, who was not involved in the study.
“There are unfortunately pervasive and harmful stereotypes in our society about the ‘sexual deviancy’ attributed to LGBTQIA+ individuals,” Dr. Miller told this news organization. “This study adds to the research literature that counters and challenges these harmful – and inaccurate – perceptions.”
Dr. Miller said clinicians can help this population by offering youth accurate information about relevant support and services, including how to help a friend.
Programs that providers could incorporate include gender transformative approaches, which guide youth to examine gender norms and inequities and that develop leadership skills.
Such programs are more common outside the United States and have been shown to decrease LGBTQIA+ youth exposure to sexual violence, she said.
Dr. Miller said more research is needed to understand the contexts in which gender minority youth experience sexual violence to guide prevention efforts: “We need to move beyond individual-focused interventions to considering community-level interventions to create safer and more inclusive spaces for all youth.”
Dr. Miller has received royalties for writing content for UptoDate Wolters Kluwer outside of the current study. Dr. Ybarra has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Encouraging’ results of baricitinib in juvenile idiopathic arthritis
COPENHAGEN – Baricitinib (Olumiant), a Janus kinase (JAK) inhibitor, significantly increases time to disease flare and decreases frequency of flares in patients with juvenile idiopathic arthritis (JIA), according to the results of a phase 3, placebo-controlled study.
The results support use of baricitinib when biologic or conventional synthetic disease-modifying antirheumatic drugs (DMARDs) fail.
The difference in the proportion of patients who flared between baricitinib and placebo was seen as soon as 4 weeks after half of the patients switched from active drug to placebo, at 3.7% versus 23.5% respectively, reported Athimalaipet Ramanan, MD, from the University of Bristol (England) who presented the findings of the withdrawal, efficacy, and safety study at the annual European Congress of Rheumatology.
“Our patients and parents have been waiting for alternative drugs for JIA, so JAK inhibitors have come at the right time,” he said. “These are really very encouraging findings for families, caregivers, and patients with JIA, to have an effective oral JAK inhibitor for managing these children.”
In reporting the key findings, Dr. Ramanan added that the majority of patients (76%) achieved a JIA-ACR (American College of Rheumatology) 30 score during the 12-week open-label phase and went on to enter the double-blind withdrawal phase of the trial.
Baricitinib 2-mg tablets are already Food and Drug Administration approved for the treatment of adults with moderately to severely active rheumatoid arthritis. This study, sponsored by the drug manufacturer Eli Lilly, aimed to investigate the efficacy and safety in pediatric patients with JIA who have shown an inadequate response to conventional synthetic or biologic DMARDs.
“For juvenile patients we need to make a dose adjustment [from the adult dosing], especially because we don’t have long-term safety data from JAK inhibitors in general,” said Osama Elfayad, MD, rheumatologist from Mouwasat Hospital, Dammam, Saudi Arabia who attended the presentation and commented on the findings.
He emphasized that safety was of primary concern in the pediatric population who have a long life expectancy. “For me it is essential to have good long-term safety data in juvenile patients. If we start with 4 mg and if the patient is controlled, we should shift to 2 mg which will be much better. I understand some clinicians are asking for 1 mg.”
Study details
The study population included patients aged from 2 to 17 years old with extended oligo- or polyarticular JIA, enthesitis-related juvenile idiopathic arthritis (ERA) and juvenile psoriatic arthritis.
The trial was divided into three periods: a 2-week safety assessment, a 12-week open-label lead-in phase, and an up-to 32-week double-blind withdrawal phase. After confirmation of dose and safety, children were enrolled in the open-label phase receiving age-based, oral, once daily doses of baricitinib.
“The primary endpoint is really concerned with the next phase of the study [double-blind withdrawal phase] looking at the proportion of patients who have shown a response at week 12 [achieved JIA-ACR30] but when switched from active drug to placebo have a flare,” explained Dr. Ramanan.
Patients were randomized 1:1 to continuing baricitinib or newly starting placebo until disease flare or up to week 32. The time to flare during the double-blind phase was the primary endpoint, while secondary endpoints included JIA-ACR30/50/70/90 response rates at week 12, and the proportion of patients with a flare during the double-blind phase.
“These secondary endpoints are more relevant to the clinic,” noted Dr. Ramanan.
A total of 219 patients entered the open-label phase, and of these, 163 achieved a JIA-ACR 30. These 163 children entered the double-blind stage and were randomized to baricitinib four times a day (56 completed), or placebo (32 completed).
Two-thirds of patients were female, which is typical of the disease, explained Dr. Ramanan, and over two-thirds were White. “Most patients had had disease for around 4 years, and about half had had prior biologic therapy. About half were on baseline methotrexate and almost one-third had used corticosteroids although at doses of under 0.2mg/kg.
“It’s gratifying to see that over 75% achieved a JIA-ACR 30 [76.3%]. More importantly, two-thirds of the patients have a JIA-ACR 50 [63.5%], and almost half of the patients have a JIA-ACR 70 [46.1%]. This is pretty significant at 12 weeks only,” he remarked.
The key finding, however, was in the withdrawal phase, said Dr. Ramanan. “We see that those patients who had a response at week 12 and were then switched to placebo, about half [50.6%] flared on placebo, compared to only 17% of those who continued with baricitinib. So not only do those who switch to placebo have a higher frequency of flares but they are more likely to flare quickly, as early as 4 weeks.”
With respect to safety, he said: “This shows short-term safety, but what we really need is medium and long-term safety data. It is no surprise that most of the events seen were as expected in children including nasopharyngitis, upper respiratory tract infections, and nausea.”
In the baricitinib versus placebo phase, 4.9% had serious adverse events in the baricitinib group compared to 3.7% in the placebo group. “There was nothing we didn’t expect to see which was mainly infection,” said Dr. Ramanan.
Dr. Elfayad has no disclosures. Professor Ramanan is a consultant for Eli Lilly, Abbvie, Roche, UCB, Novartis, Pfizer, and Sobi. He has received grant/research support from Eli Lilly.
COPENHAGEN – Baricitinib (Olumiant), a Janus kinase (JAK) inhibitor, significantly increases time to disease flare and decreases frequency of flares in patients with juvenile idiopathic arthritis (JIA), according to the results of a phase 3, placebo-controlled study.
The results support use of baricitinib when biologic or conventional synthetic disease-modifying antirheumatic drugs (DMARDs) fail.
The difference in the proportion of patients who flared between baricitinib and placebo was seen as soon as 4 weeks after half of the patients switched from active drug to placebo, at 3.7% versus 23.5% respectively, reported Athimalaipet Ramanan, MD, from the University of Bristol (England) who presented the findings of the withdrawal, efficacy, and safety study at the annual European Congress of Rheumatology.
“Our patients and parents have been waiting for alternative drugs for JIA, so JAK inhibitors have come at the right time,” he said. “These are really very encouraging findings for families, caregivers, and patients with JIA, to have an effective oral JAK inhibitor for managing these children.”
In reporting the key findings, Dr. Ramanan added that the majority of patients (76%) achieved a JIA-ACR (American College of Rheumatology) 30 score during the 12-week open-label phase and went on to enter the double-blind withdrawal phase of the trial.
Baricitinib 2-mg tablets are already Food and Drug Administration approved for the treatment of adults with moderately to severely active rheumatoid arthritis. This study, sponsored by the drug manufacturer Eli Lilly, aimed to investigate the efficacy and safety in pediatric patients with JIA who have shown an inadequate response to conventional synthetic or biologic DMARDs.
“For juvenile patients we need to make a dose adjustment [from the adult dosing], especially because we don’t have long-term safety data from JAK inhibitors in general,” said Osama Elfayad, MD, rheumatologist from Mouwasat Hospital, Dammam, Saudi Arabia who attended the presentation and commented on the findings.
He emphasized that safety was of primary concern in the pediatric population who have a long life expectancy. “For me it is essential to have good long-term safety data in juvenile patients. If we start with 4 mg and if the patient is controlled, we should shift to 2 mg which will be much better. I understand some clinicians are asking for 1 mg.”
Study details
The study population included patients aged from 2 to 17 years old with extended oligo- or polyarticular JIA, enthesitis-related juvenile idiopathic arthritis (ERA) and juvenile psoriatic arthritis.
The trial was divided into three periods: a 2-week safety assessment, a 12-week open-label lead-in phase, and an up-to 32-week double-blind withdrawal phase. After confirmation of dose and safety, children were enrolled in the open-label phase receiving age-based, oral, once daily doses of baricitinib.
“The primary endpoint is really concerned with the next phase of the study [double-blind withdrawal phase] looking at the proportion of patients who have shown a response at week 12 [achieved JIA-ACR30] but when switched from active drug to placebo have a flare,” explained Dr. Ramanan.
Patients were randomized 1:1 to continuing baricitinib or newly starting placebo until disease flare or up to week 32. The time to flare during the double-blind phase was the primary endpoint, while secondary endpoints included JIA-ACR30/50/70/90 response rates at week 12, and the proportion of patients with a flare during the double-blind phase.
“These secondary endpoints are more relevant to the clinic,” noted Dr. Ramanan.
A total of 219 patients entered the open-label phase, and of these, 163 achieved a JIA-ACR 30. These 163 children entered the double-blind stage and were randomized to baricitinib four times a day (56 completed), or placebo (32 completed).
Two-thirds of patients were female, which is typical of the disease, explained Dr. Ramanan, and over two-thirds were White. “Most patients had had disease for around 4 years, and about half had had prior biologic therapy. About half were on baseline methotrexate and almost one-third had used corticosteroids although at doses of under 0.2mg/kg.
“It’s gratifying to see that over 75% achieved a JIA-ACR 30 [76.3%]. More importantly, two-thirds of the patients have a JIA-ACR 50 [63.5%], and almost half of the patients have a JIA-ACR 70 [46.1%]. This is pretty significant at 12 weeks only,” he remarked.
The key finding, however, was in the withdrawal phase, said Dr. Ramanan. “We see that those patients who had a response at week 12 and were then switched to placebo, about half [50.6%] flared on placebo, compared to only 17% of those who continued with baricitinib. So not only do those who switch to placebo have a higher frequency of flares but they are more likely to flare quickly, as early as 4 weeks.”
With respect to safety, he said: “This shows short-term safety, but what we really need is medium and long-term safety data. It is no surprise that most of the events seen were as expected in children including nasopharyngitis, upper respiratory tract infections, and nausea.”
In the baricitinib versus placebo phase, 4.9% had serious adverse events in the baricitinib group compared to 3.7% in the placebo group. “There was nothing we didn’t expect to see which was mainly infection,” said Dr. Ramanan.
Dr. Elfayad has no disclosures. Professor Ramanan is a consultant for Eli Lilly, Abbvie, Roche, UCB, Novartis, Pfizer, and Sobi. He has received grant/research support from Eli Lilly.
COPENHAGEN – Baricitinib (Olumiant), a Janus kinase (JAK) inhibitor, significantly increases time to disease flare and decreases frequency of flares in patients with juvenile idiopathic arthritis (JIA), according to the results of a phase 3, placebo-controlled study.
The results support use of baricitinib when biologic or conventional synthetic disease-modifying antirheumatic drugs (DMARDs) fail.
The difference in the proportion of patients who flared between baricitinib and placebo was seen as soon as 4 weeks after half of the patients switched from active drug to placebo, at 3.7% versus 23.5% respectively, reported Athimalaipet Ramanan, MD, from the University of Bristol (England) who presented the findings of the withdrawal, efficacy, and safety study at the annual European Congress of Rheumatology.
“Our patients and parents have been waiting for alternative drugs for JIA, so JAK inhibitors have come at the right time,” he said. “These are really very encouraging findings for families, caregivers, and patients with JIA, to have an effective oral JAK inhibitor for managing these children.”
In reporting the key findings, Dr. Ramanan added that the majority of patients (76%) achieved a JIA-ACR (American College of Rheumatology) 30 score during the 12-week open-label phase and went on to enter the double-blind withdrawal phase of the trial.
Baricitinib 2-mg tablets are already Food and Drug Administration approved for the treatment of adults with moderately to severely active rheumatoid arthritis. This study, sponsored by the drug manufacturer Eli Lilly, aimed to investigate the efficacy and safety in pediatric patients with JIA who have shown an inadequate response to conventional synthetic or biologic DMARDs.
“For juvenile patients we need to make a dose adjustment [from the adult dosing], especially because we don’t have long-term safety data from JAK inhibitors in general,” said Osama Elfayad, MD, rheumatologist from Mouwasat Hospital, Dammam, Saudi Arabia who attended the presentation and commented on the findings.
He emphasized that safety was of primary concern in the pediatric population who have a long life expectancy. “For me it is essential to have good long-term safety data in juvenile patients. If we start with 4 mg and if the patient is controlled, we should shift to 2 mg which will be much better. I understand some clinicians are asking for 1 mg.”
Study details
The study population included patients aged from 2 to 17 years old with extended oligo- or polyarticular JIA, enthesitis-related juvenile idiopathic arthritis (ERA) and juvenile psoriatic arthritis.
The trial was divided into three periods: a 2-week safety assessment, a 12-week open-label lead-in phase, and an up-to 32-week double-blind withdrawal phase. After confirmation of dose and safety, children were enrolled in the open-label phase receiving age-based, oral, once daily doses of baricitinib.
“The primary endpoint is really concerned with the next phase of the study [double-blind withdrawal phase] looking at the proportion of patients who have shown a response at week 12 [achieved JIA-ACR30] but when switched from active drug to placebo have a flare,” explained Dr. Ramanan.
Patients were randomized 1:1 to continuing baricitinib or newly starting placebo until disease flare or up to week 32. The time to flare during the double-blind phase was the primary endpoint, while secondary endpoints included JIA-ACR30/50/70/90 response rates at week 12, and the proportion of patients with a flare during the double-blind phase.
“These secondary endpoints are more relevant to the clinic,” noted Dr. Ramanan.
A total of 219 patients entered the open-label phase, and of these, 163 achieved a JIA-ACR 30. These 163 children entered the double-blind stage and were randomized to baricitinib four times a day (56 completed), or placebo (32 completed).
Two-thirds of patients were female, which is typical of the disease, explained Dr. Ramanan, and over two-thirds were White. “Most patients had had disease for around 4 years, and about half had had prior biologic therapy. About half were on baseline methotrexate and almost one-third had used corticosteroids although at doses of under 0.2mg/kg.
“It’s gratifying to see that over 75% achieved a JIA-ACR 30 [76.3%]. More importantly, two-thirds of the patients have a JIA-ACR 50 [63.5%], and almost half of the patients have a JIA-ACR 70 [46.1%]. This is pretty significant at 12 weeks only,” he remarked.
The key finding, however, was in the withdrawal phase, said Dr. Ramanan. “We see that those patients who had a response at week 12 and were then switched to placebo, about half [50.6%] flared on placebo, compared to only 17% of those who continued with baricitinib. So not only do those who switch to placebo have a higher frequency of flares but they are more likely to flare quickly, as early as 4 weeks.”
With respect to safety, he said: “This shows short-term safety, but what we really need is medium and long-term safety data. It is no surprise that most of the events seen were as expected in children including nasopharyngitis, upper respiratory tract infections, and nausea.”
In the baricitinib versus placebo phase, 4.9% had serious adverse events in the baricitinib group compared to 3.7% in the placebo group. “There was nothing we didn’t expect to see which was mainly infection,” said Dr. Ramanan.
Dr. Elfayad has no disclosures. Professor Ramanan is a consultant for Eli Lilly, Abbvie, Roche, UCB, Novartis, Pfizer, and Sobi. He has received grant/research support from Eli Lilly.
AT THE EULAR 2022 CONGRESS
Pfizer asks FDA to authorize COVID vaccine for children younger than 5
The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.
Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.
Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.
Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.
If the FDA gives them the green light, the CDC will then weigh in.
“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”
States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.
“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”
Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.
The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.
Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.
Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.
A version of this article first appeared on Medscape.com.
The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.
Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.
Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.
Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.
If the FDA gives them the green light, the CDC will then weigh in.
“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”
States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.
“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”
Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.
The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.
Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.
Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.
A version of this article first appeared on Medscape.com.
The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.
Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.
Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.
Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.
If the FDA gives them the green light, the CDC will then weigh in.
“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”
States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.
“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”
Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.
The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.
Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.
Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.
A version of this article first appeared on Medscape.com.
White children more likely to get imaging in EDs: Study
Non-Hispanic White children were more likely to receive diagnostic imaging at children’s hospitals’ emergency departments across the United States than were Hispanic children and non-Hispanic Black children, according to a large study published in JAMA Network Open.
Researchers found that, the more the percentage of children from minority groups cared for by a hospital increased, the wider the imaging gap between those children and non-Hispanic White children.
The cross-sectional study, led by Margaret E. Samuels-Kalow, MD, MPhil, MSHP, with the department of emergency medicine, Massachusetts General Hospital and Harvard Medical School in Boston, included 38 children’s hospitals and more than 12 million ED visits.
“These findings emphasize the urgent need for interventions at the hospital level to improve equity in imaging in pediatric emergency medicine,” the authors write.
Patients included in the study were younger than 18 and visited an ED from January 2016 through December 2019. Data were pulled from the Pediatric Health Information System.
Of the more than 12 million visits in this study, 3.5 million (28.7%) involved at least one diagnostic imaging test.
Diagnostic imaging was performed in 1.5 million visits (34.2%) for non-Hispanic White children; 790,961 (24.6%) for non-Hispanic Black children; and 907,222 (26.1%) for Hispanic children (P < .001).
Non-Hispanic Black children were consistently less likely to get diagnostic imaging than non-Hispanic White counterparts at every hospital in the study, no matter the imaging modality: radiography, ultrasonography, computed tomography, or magnetic resonance imaging.
Hispanic patients were generally less likely to get imaging than non-Hispanic White patients, though results were less consistent for ultrasound and MRI.
In a sensitivity analysis, when looking at imaging from patients’ first visit across the study cohort, non-Hispanic Black children were significantly less likely to get imaging than non-Hispanic White children (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.79).
“This remained significant even after adjustment for a priori specified confounders including hospital propensity to image,” the authors write.
Authors acknowledge that it is possible that some of the differences may be attributable to the patient mix regarding severity of cases or indications for imaging by hospital, but they note that all models were adjusted for diagnosis-related group and other potential confounders.
This study did not assess whether one group is being overtested. Researchers also note that higher rates of imaging do not necessarily indicate higher quality of care.
However, the authors note, previous research has suggested overtesting of non-Hispanic White patients for head CT and chest pain, as well as patterns of overtreatment of non-Hispanic White patients who have bronchiolitis or viral upper respiratory tract infections.
Medell Briggs-Malonson, MD, MPH, chief of health equity, diversity and inclusion for the University of California, Los Angeles, Hospital and Clinic System, who was not part of the study, said in an interview “this all rings true.”
“This is not the first study we have had in either the pediatric or adult populations that shows disparate levels of care as well as health outcomes. Now we are starting to be able to measure it,” she said.
This study is further evidence of medical racism, she says, and highlights that it’s not the hospital choice or the insurance type affecting the numbers, she said.
“When you control for those factors, it looks to be it’s only due to race and that’s because of the very deep levels of implicit bias as well as explicit bias that we still have in our health systems and even in our providers,” said Dr. Briggs-Malonson, who is also an associate professor of emergency medicine at UCLA. “It’s incredibly important to identify and immediately address.”
What can be done?
Changing these patterns starts with knowing the numbers, the authors write.
“Hospitals should measure their own differences in imaging rates and increase awareness of existing areas of differential treatment as a starting point for improvement,” Dr. Samuels-Kalow and coauthors say.
Dr. Briggs-Malonson added that guidelines are very clear about when children should get imaging. Adhering to evidence-based guidelines can help avoid variations in care from external factors.
“If children are not receiving the absolute best comprehensive evaluation in the emergency department that they deserve, we can miss many different illnesses, which can lead to worse outcomes,” she noted.
As for what might motivate lack of imaging, Dr. Briggs-Malonson pointed to longstanding trends of providers thinking complaints raised by minority patients may not be as severe as they report. Conversely, in caring for White patients there may be a feeling that more tests and imaging may be better out of more fear of missing something, she said.
At UCLA, she says, dashboards have been developed to track statistics on care by age, race, ethnicity, language, insurance type, etc., though not specifically in pediatric imaging, to assess and address any care inequities.
Summer L. Kaplan, MD, MS, director of emergency radiology at Children’s Hospital of Philadelphia, who also was not part of the study, said the finding of racial disparities in pediatric ED imaging provides evidence that gaps still exist in providing the best care to all children and families seeking emergency care.
“However, it is important to recognize that more imaging does not equal better care,” she said. “More imaging may be associated with unnecessary, low-value tests that may add radiation and other risks but do not improve care.”
She said higher rates of imaging may occur when patients present early in the course of a disease, when the differential diagnosis remains broad.
If families have delayed seeking care because of time constraints, transportation problems, cost of care, or mistrust of the health system, children may present later in the course of a disease and require less imaging for a diagnosis, she explained.
“This paper offers a valuable look at the inequities that exist in pediatric emergency imaging use, and further research will be essential to understand and address the causes of these differences,” Dr. Kaplan said.
A coauthor reported compensation as a member of a Medical Review Committee for Highmark. Other coauthors reported grants from the U.S. Agency for Healthcare Research and Quality outside the submitted work. Dr. Briggs-Malonson and Dr. Kaplan reported no relevant financial relationships.
Non-Hispanic White children were more likely to receive diagnostic imaging at children’s hospitals’ emergency departments across the United States than were Hispanic children and non-Hispanic Black children, according to a large study published in JAMA Network Open.
Researchers found that, the more the percentage of children from minority groups cared for by a hospital increased, the wider the imaging gap between those children and non-Hispanic White children.
The cross-sectional study, led by Margaret E. Samuels-Kalow, MD, MPhil, MSHP, with the department of emergency medicine, Massachusetts General Hospital and Harvard Medical School in Boston, included 38 children’s hospitals and more than 12 million ED visits.
“These findings emphasize the urgent need for interventions at the hospital level to improve equity in imaging in pediatric emergency medicine,” the authors write.
Patients included in the study were younger than 18 and visited an ED from January 2016 through December 2019. Data were pulled from the Pediatric Health Information System.
Of the more than 12 million visits in this study, 3.5 million (28.7%) involved at least one diagnostic imaging test.
Diagnostic imaging was performed in 1.5 million visits (34.2%) for non-Hispanic White children; 790,961 (24.6%) for non-Hispanic Black children; and 907,222 (26.1%) for Hispanic children (P < .001).
Non-Hispanic Black children were consistently less likely to get diagnostic imaging than non-Hispanic White counterparts at every hospital in the study, no matter the imaging modality: radiography, ultrasonography, computed tomography, or magnetic resonance imaging.
Hispanic patients were generally less likely to get imaging than non-Hispanic White patients, though results were less consistent for ultrasound and MRI.
In a sensitivity analysis, when looking at imaging from patients’ first visit across the study cohort, non-Hispanic Black children were significantly less likely to get imaging than non-Hispanic White children (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.79).
“This remained significant even after adjustment for a priori specified confounders including hospital propensity to image,” the authors write.
Authors acknowledge that it is possible that some of the differences may be attributable to the patient mix regarding severity of cases or indications for imaging by hospital, but they note that all models were adjusted for diagnosis-related group and other potential confounders.
This study did not assess whether one group is being overtested. Researchers also note that higher rates of imaging do not necessarily indicate higher quality of care.
However, the authors note, previous research has suggested overtesting of non-Hispanic White patients for head CT and chest pain, as well as patterns of overtreatment of non-Hispanic White patients who have bronchiolitis or viral upper respiratory tract infections.
Medell Briggs-Malonson, MD, MPH, chief of health equity, diversity and inclusion for the University of California, Los Angeles, Hospital and Clinic System, who was not part of the study, said in an interview “this all rings true.”
“This is not the first study we have had in either the pediatric or adult populations that shows disparate levels of care as well as health outcomes. Now we are starting to be able to measure it,” she said.
This study is further evidence of medical racism, she says, and highlights that it’s not the hospital choice or the insurance type affecting the numbers, she said.
“When you control for those factors, it looks to be it’s only due to race and that’s because of the very deep levels of implicit bias as well as explicit bias that we still have in our health systems and even in our providers,” said Dr. Briggs-Malonson, who is also an associate professor of emergency medicine at UCLA. “It’s incredibly important to identify and immediately address.”
What can be done?
Changing these patterns starts with knowing the numbers, the authors write.
“Hospitals should measure their own differences in imaging rates and increase awareness of existing areas of differential treatment as a starting point for improvement,” Dr. Samuels-Kalow and coauthors say.
Dr. Briggs-Malonson added that guidelines are very clear about when children should get imaging. Adhering to evidence-based guidelines can help avoid variations in care from external factors.
“If children are not receiving the absolute best comprehensive evaluation in the emergency department that they deserve, we can miss many different illnesses, which can lead to worse outcomes,” she noted.
As for what might motivate lack of imaging, Dr. Briggs-Malonson pointed to longstanding trends of providers thinking complaints raised by minority patients may not be as severe as they report. Conversely, in caring for White patients there may be a feeling that more tests and imaging may be better out of more fear of missing something, she said.
At UCLA, she says, dashboards have been developed to track statistics on care by age, race, ethnicity, language, insurance type, etc., though not specifically in pediatric imaging, to assess and address any care inequities.
Summer L. Kaplan, MD, MS, director of emergency radiology at Children’s Hospital of Philadelphia, who also was not part of the study, said the finding of racial disparities in pediatric ED imaging provides evidence that gaps still exist in providing the best care to all children and families seeking emergency care.
“However, it is important to recognize that more imaging does not equal better care,” she said. “More imaging may be associated with unnecessary, low-value tests that may add radiation and other risks but do not improve care.”
She said higher rates of imaging may occur when patients present early in the course of a disease, when the differential diagnosis remains broad.
If families have delayed seeking care because of time constraints, transportation problems, cost of care, or mistrust of the health system, children may present later in the course of a disease and require less imaging for a diagnosis, she explained.
“This paper offers a valuable look at the inequities that exist in pediatric emergency imaging use, and further research will be essential to understand and address the causes of these differences,” Dr. Kaplan said.
A coauthor reported compensation as a member of a Medical Review Committee for Highmark. Other coauthors reported grants from the U.S. Agency for Healthcare Research and Quality outside the submitted work. Dr. Briggs-Malonson and Dr. Kaplan reported no relevant financial relationships.
Non-Hispanic White children were more likely to receive diagnostic imaging at children’s hospitals’ emergency departments across the United States than were Hispanic children and non-Hispanic Black children, according to a large study published in JAMA Network Open.
Researchers found that, the more the percentage of children from minority groups cared for by a hospital increased, the wider the imaging gap between those children and non-Hispanic White children.
The cross-sectional study, led by Margaret E. Samuels-Kalow, MD, MPhil, MSHP, with the department of emergency medicine, Massachusetts General Hospital and Harvard Medical School in Boston, included 38 children’s hospitals and more than 12 million ED visits.
“These findings emphasize the urgent need for interventions at the hospital level to improve equity in imaging in pediatric emergency medicine,” the authors write.
Patients included in the study were younger than 18 and visited an ED from January 2016 through December 2019. Data were pulled from the Pediatric Health Information System.
Of the more than 12 million visits in this study, 3.5 million (28.7%) involved at least one diagnostic imaging test.
Diagnostic imaging was performed in 1.5 million visits (34.2%) for non-Hispanic White children; 790,961 (24.6%) for non-Hispanic Black children; and 907,222 (26.1%) for Hispanic children (P < .001).
Non-Hispanic Black children were consistently less likely to get diagnostic imaging than non-Hispanic White counterparts at every hospital in the study, no matter the imaging modality: radiography, ultrasonography, computed tomography, or magnetic resonance imaging.
Hispanic patients were generally less likely to get imaging than non-Hispanic White patients, though results were less consistent for ultrasound and MRI.
In a sensitivity analysis, when looking at imaging from patients’ first visit across the study cohort, non-Hispanic Black children were significantly less likely to get imaging than non-Hispanic White children (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.79).
“This remained significant even after adjustment for a priori specified confounders including hospital propensity to image,” the authors write.
Authors acknowledge that it is possible that some of the differences may be attributable to the patient mix regarding severity of cases or indications for imaging by hospital, but they note that all models were adjusted for diagnosis-related group and other potential confounders.
This study did not assess whether one group is being overtested. Researchers also note that higher rates of imaging do not necessarily indicate higher quality of care.
However, the authors note, previous research has suggested overtesting of non-Hispanic White patients for head CT and chest pain, as well as patterns of overtreatment of non-Hispanic White patients who have bronchiolitis or viral upper respiratory tract infections.
Medell Briggs-Malonson, MD, MPH, chief of health equity, diversity and inclusion for the University of California, Los Angeles, Hospital and Clinic System, who was not part of the study, said in an interview “this all rings true.”
“This is not the first study we have had in either the pediatric or adult populations that shows disparate levels of care as well as health outcomes. Now we are starting to be able to measure it,” she said.
This study is further evidence of medical racism, she says, and highlights that it’s not the hospital choice or the insurance type affecting the numbers, she said.
“When you control for those factors, it looks to be it’s only due to race and that’s because of the very deep levels of implicit bias as well as explicit bias that we still have in our health systems and even in our providers,” said Dr. Briggs-Malonson, who is also an associate professor of emergency medicine at UCLA. “It’s incredibly important to identify and immediately address.”
What can be done?
Changing these patterns starts with knowing the numbers, the authors write.
“Hospitals should measure their own differences in imaging rates and increase awareness of existing areas of differential treatment as a starting point for improvement,” Dr. Samuels-Kalow and coauthors say.
Dr. Briggs-Malonson added that guidelines are very clear about when children should get imaging. Adhering to evidence-based guidelines can help avoid variations in care from external factors.
“If children are not receiving the absolute best comprehensive evaluation in the emergency department that they deserve, we can miss many different illnesses, which can lead to worse outcomes,” she noted.
As for what might motivate lack of imaging, Dr. Briggs-Malonson pointed to longstanding trends of providers thinking complaints raised by minority patients may not be as severe as they report. Conversely, in caring for White patients there may be a feeling that more tests and imaging may be better out of more fear of missing something, she said.
At UCLA, she says, dashboards have been developed to track statistics on care by age, race, ethnicity, language, insurance type, etc., though not specifically in pediatric imaging, to assess and address any care inequities.
Summer L. Kaplan, MD, MS, director of emergency radiology at Children’s Hospital of Philadelphia, who also was not part of the study, said the finding of racial disparities in pediatric ED imaging provides evidence that gaps still exist in providing the best care to all children and families seeking emergency care.
“However, it is important to recognize that more imaging does not equal better care,” she said. “More imaging may be associated with unnecessary, low-value tests that may add radiation and other risks but do not improve care.”
She said higher rates of imaging may occur when patients present early in the course of a disease, when the differential diagnosis remains broad.
If families have delayed seeking care because of time constraints, transportation problems, cost of care, or mistrust of the health system, children may present later in the course of a disease and require less imaging for a diagnosis, she explained.
“This paper offers a valuable look at the inequities that exist in pediatric emergency imaging use, and further research will be essential to understand and address the causes of these differences,” Dr. Kaplan said.
A coauthor reported compensation as a member of a Medical Review Committee for Highmark. Other coauthors reported grants from the U.S. Agency for Healthcare Research and Quality outside the submitted work. Dr. Briggs-Malonson and Dr. Kaplan reported no relevant financial relationships.
FROM JAMA NETWORK OPEN
Are teenagers tone deaf?
I suspect that you have heard or read about the recent study in the Journal of Neuroscience that claims to have discovered evidence that as children become teenagers, their brains begin to tune out their mother’s voices. The story appeared in at least 10 Internet news sources including the American Academy of Pediatrics’ daily briefing.
Based on functional MRI studies by a group at Stanford (Calif.) University, the researchers found that while in general, teenagers became more attentive to all voices as they reached puberty, novel voices were favored over the maternal voices that had flooded their environment as younger children. Of course none of this comes as a surprise to anyone who has parented a teenager or spent any time trying to communicate with adolescents. Although we all must be a bit careful not to put too much stock in functional MRI studies, these findings do suggest a physiologic basis for the peer pressure that becomes one of the hallmarks of adolescence. I wouldn’t be surprised if some clever entrepreneur has already begun using MRI to search for just the right tonal qualities that will make the perfect Internet influencer.
But, will these MRI studies help parents who have already thrown up their arms and admitted defeat mumbling, “He’s stopped listening to me?” The more observant parents already realized long ago that their words were often the least effective tools in their tool kit when it comes to modifying behavior.
Just listen in any neighborhood playground or grocery store to how often you hear a parent trying to get a toddler or young child to correct a misbehavior using threats or promises that you and everyone else within earshot knows will never be followed by any consequence. How often do you see a parent modeling behaviors that they expect their children to avoid?
Some more “enlightened” parents will avoid threats and instead attempt to engage in a dialogue with their misbehaving child hoping that a rational discussion with a sleep-deprived toddler in full tantrum mode can convince the youngster to self-correct.
I’m sure you learned and may have even used the playground retort “sticks and stones may break my bones but words will never hurt me.” Of course more untrue words were never spoken. Words can hurt and they can scar. But words and threats can also be hollow and will fall on ears deafened by months and years during which there were no consequences. It is certainly nice to know that there is some physiologic correlation to what we all suspected. The good news is that teenagers are still listening to us, although they are increasingly more interested in what their peers and the rest of the world has to say.
What the study fails to point out is that while teenagers may still be listening to us their behavior is molded not so much by what we say but how we as parents and adults behave. Have we parented in a way in which our words are followed up with appropriate consequences? And, more importantly, have we modeled behavior that matches our words? We need to help parents realize that words can be important but parenting by example is the gold standard.
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 suspect that you have heard or read about the recent study in the Journal of Neuroscience that claims to have discovered evidence that as children become teenagers, their brains begin to tune out their mother’s voices. The story appeared in at least 10 Internet news sources including the American Academy of Pediatrics’ daily briefing.
Based on functional MRI studies by a group at Stanford (Calif.) University, the researchers found that while in general, teenagers became more attentive to all voices as they reached puberty, novel voices were favored over the maternal voices that had flooded their environment as younger children. Of course none of this comes as a surprise to anyone who has parented a teenager or spent any time trying to communicate with adolescents. Although we all must be a bit careful not to put too much stock in functional MRI studies, these findings do suggest a physiologic basis for the peer pressure that becomes one of the hallmarks of adolescence. I wouldn’t be surprised if some clever entrepreneur has already begun using MRI to search for just the right tonal qualities that will make the perfect Internet influencer.
But, will these MRI studies help parents who have already thrown up their arms and admitted defeat mumbling, “He’s stopped listening to me?” The more observant parents already realized long ago that their words were often the least effective tools in their tool kit when it comes to modifying behavior.
Just listen in any neighborhood playground or grocery store to how often you hear a parent trying to get a toddler or young child to correct a misbehavior using threats or promises that you and everyone else within earshot knows will never be followed by any consequence. How often do you see a parent modeling behaviors that they expect their children to avoid?
Some more “enlightened” parents will avoid threats and instead attempt to engage in a dialogue with their misbehaving child hoping that a rational discussion with a sleep-deprived toddler in full tantrum mode can convince the youngster to self-correct.
I’m sure you learned and may have even used the playground retort “sticks and stones may break my bones but words will never hurt me.” Of course more untrue words were never spoken. Words can hurt and they can scar. But words and threats can also be hollow and will fall on ears deafened by months and years during which there were no consequences. It is certainly nice to know that there is some physiologic correlation to what we all suspected. The good news is that teenagers are still listening to us, although they are increasingly more interested in what their peers and the rest of the world has to say.
What the study fails to point out is that while teenagers may still be listening to us their behavior is molded not so much by what we say but how we as parents and adults behave. Have we parented in a way in which our words are followed up with appropriate consequences? And, more importantly, have we modeled behavior that matches our words? We need to help parents realize that words can be important but parenting by example is the gold standard.
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 suspect that you have heard or read about the recent study in the Journal of Neuroscience that claims to have discovered evidence that as children become teenagers, their brains begin to tune out their mother’s voices. The story appeared in at least 10 Internet news sources including the American Academy of Pediatrics’ daily briefing.
Based on functional MRI studies by a group at Stanford (Calif.) University, the researchers found that while in general, teenagers became more attentive to all voices as they reached puberty, novel voices were favored over the maternal voices that had flooded their environment as younger children. Of course none of this comes as a surprise to anyone who has parented a teenager or spent any time trying to communicate with adolescents. Although we all must be a bit careful not to put too much stock in functional MRI studies, these findings do suggest a physiologic basis for the peer pressure that becomes one of the hallmarks of adolescence. I wouldn’t be surprised if some clever entrepreneur has already begun using MRI to search for just the right tonal qualities that will make the perfect Internet influencer.
But, will these MRI studies help parents who have already thrown up their arms and admitted defeat mumbling, “He’s stopped listening to me?” The more observant parents already realized long ago that their words were often the least effective tools in their tool kit when it comes to modifying behavior.
Just listen in any neighborhood playground or grocery store to how often you hear a parent trying to get a toddler or young child to correct a misbehavior using threats or promises that you and everyone else within earshot knows will never be followed by any consequence. How often do you see a parent modeling behaviors that they expect their children to avoid?
Some more “enlightened” parents will avoid threats and instead attempt to engage in a dialogue with their misbehaving child hoping that a rational discussion with a sleep-deprived toddler in full tantrum mode can convince the youngster to self-correct.
I’m sure you learned and may have even used the playground retort “sticks and stones may break my bones but words will never hurt me.” Of course more untrue words were never spoken. Words can hurt and they can scar. But words and threats can also be hollow and will fall on ears deafened by months and years during which there were no consequences. It is certainly nice to know that there is some physiologic correlation to what we all suspected. The good news is that teenagers are still listening to us, although they are increasingly more interested in what their peers and the rest of the world has to say.
What the study fails to point out is that while teenagers may still be listening to us their behavior is molded not so much by what we say but how we as parents and adults behave. Have we parented in a way in which our words are followed up with appropriate consequences? And, more importantly, have we modeled behavior that matches our words? We need to help parents realize that words can be important but parenting by example is the gold standard.
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].
