Reducing Unnecessary Antibiotics for Conjunctivitis

Article Type
Changed
Tue, 07/02/2024 - 11:17

 

TOPLINE:

More than two thirds of children with conjunctivitis received antibiotics within a day of their initial ambulatory care visit; however, follow-up visits and new antibiotic dispensations were rare regardless of treatment, suggesting that not receiving antibiotics may not lead to additional health care use.

METHODOLOGY:

  • Researchers evaluated the frequency of topical antibiotic treatment and its association with subsequent health care use among commercially insured children with acute infectious conjunctivitis in the United States.
  • This cohort study analyzed data from the 2021 MarketScan Commercial Claims and Encounters Database, including 44,793 children with conjunctivitis (median age, 5 years; 47% girls) and ambulatory care encounters.
  • The primary exposure was a topical antibiotic prescription dispensed within 1 day of an ambulatory care visit, with outcomes assessed 2-14 days after the visit.
  • The primary outcomes were ambulatory care revisits for conjunctivitis and same-day dispensation of a new topical antibiotic, and secondary outcomes included emergency department revisits and hospitalizations.

TAKEAWAY:

  • Topical antibiotics were dispensed within a day of an ambulatory care visit in 69% of the cases; however, they were less frequently dispensed following visits to eye clinics (34%), for children aged 6-11 years (66%), and for those with viral conjunctivitis (28%).
  • Ambulatory care revisits for conjunctivitis within 2 weeks occurred in only 3.2% of children who had received antibiotics (adjusted odds ratio [aOR], 1.11; 95% CI, 0.99-1.25).
  • Similarly, revisits with same-day dispensation of a new antibiotic were also rare (1.4%), with no significant association between antibiotic treatment and revisits (aOR, 1.10; 95% CI, 0.92-1.33).
  • Hospitalizations for conjunctivitis occurred in 0.03% of cases, and emergency department revisits occurred in 0.12%, with no differences between children who received antibiotics and those who did not.

IN PRACTICE:

“Given that antibiotics may not be associated with improved outcomes or change in subsequent health care use and are associated with adverse effects and antibiotic resistance, efforts to reduce overtreatment of acute infectious conjunctivitis are warranted,” the authors wrote.

SOURCE:

The study was led by Daniel J. Shapiro, MD, MPH, of the Department of Emergency Medicine at the University of California, San Francisco, and published online on June 27, 2024, in JAMA Ophthalmology.

LIMITATIONS:

The major limitations of the study included the inability to distinguish scheduled visits from unscheduled revisits, incomplete clinical data such as rare complications of conjunctivitis, and the inability to confirm the accuracy of the coded diagnosis of infectious conjunctivitis, especially in children who did not receive a thorough eye examination.

DISCLOSURES:

This study did not declare receiving funding from any sources. One author reported receiving grants from several sources outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

 

TOPLINE:

More than two thirds of children with conjunctivitis received antibiotics within a day of their initial ambulatory care visit; however, follow-up visits and new antibiotic dispensations were rare regardless of treatment, suggesting that not receiving antibiotics may not lead to additional health care use.

METHODOLOGY:

  • Researchers evaluated the frequency of topical antibiotic treatment and its association with subsequent health care use among commercially insured children with acute infectious conjunctivitis in the United States.
  • This cohort study analyzed data from the 2021 MarketScan Commercial Claims and Encounters Database, including 44,793 children with conjunctivitis (median age, 5 years; 47% girls) and ambulatory care encounters.
  • The primary exposure was a topical antibiotic prescription dispensed within 1 day of an ambulatory care visit, with outcomes assessed 2-14 days after the visit.
  • The primary outcomes were ambulatory care revisits for conjunctivitis and same-day dispensation of a new topical antibiotic, and secondary outcomes included emergency department revisits and hospitalizations.

TAKEAWAY:

  • Topical antibiotics were dispensed within a day of an ambulatory care visit in 69% of the cases; however, they were less frequently dispensed following visits to eye clinics (34%), for children aged 6-11 years (66%), and for those with viral conjunctivitis (28%).
  • Ambulatory care revisits for conjunctivitis within 2 weeks occurred in only 3.2% of children who had received antibiotics (adjusted odds ratio [aOR], 1.11; 95% CI, 0.99-1.25).
  • Similarly, revisits with same-day dispensation of a new antibiotic were also rare (1.4%), with no significant association between antibiotic treatment and revisits (aOR, 1.10; 95% CI, 0.92-1.33).
  • Hospitalizations for conjunctivitis occurred in 0.03% of cases, and emergency department revisits occurred in 0.12%, with no differences between children who received antibiotics and those who did not.

IN PRACTICE:

“Given that antibiotics may not be associated with improved outcomes or change in subsequent health care use and are associated with adverse effects and antibiotic resistance, efforts to reduce overtreatment of acute infectious conjunctivitis are warranted,” the authors wrote.

SOURCE:

The study was led by Daniel J. Shapiro, MD, MPH, of the Department of Emergency Medicine at the University of California, San Francisco, and published online on June 27, 2024, in JAMA Ophthalmology.

LIMITATIONS:

The major limitations of the study included the inability to distinguish scheduled visits from unscheduled revisits, incomplete clinical data such as rare complications of conjunctivitis, and the inability to confirm the accuracy of the coded diagnosis of infectious conjunctivitis, especially in children who did not receive a thorough eye examination.

DISCLOSURES:

This study did not declare receiving funding from any sources. One author reported receiving grants from several sources outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

More than two thirds of children with conjunctivitis received antibiotics within a day of their initial ambulatory care visit; however, follow-up visits and new antibiotic dispensations were rare regardless of treatment, suggesting that not receiving antibiotics may not lead to additional health care use.

METHODOLOGY:

  • Researchers evaluated the frequency of topical antibiotic treatment and its association with subsequent health care use among commercially insured children with acute infectious conjunctivitis in the United States.
  • This cohort study analyzed data from the 2021 MarketScan Commercial Claims and Encounters Database, including 44,793 children with conjunctivitis (median age, 5 years; 47% girls) and ambulatory care encounters.
  • The primary exposure was a topical antibiotic prescription dispensed within 1 day of an ambulatory care visit, with outcomes assessed 2-14 days after the visit.
  • The primary outcomes were ambulatory care revisits for conjunctivitis and same-day dispensation of a new topical antibiotic, and secondary outcomes included emergency department revisits and hospitalizations.

TAKEAWAY:

  • Topical antibiotics were dispensed within a day of an ambulatory care visit in 69% of the cases; however, they were less frequently dispensed following visits to eye clinics (34%), for children aged 6-11 years (66%), and for those with viral conjunctivitis (28%).
  • Ambulatory care revisits for conjunctivitis within 2 weeks occurred in only 3.2% of children who had received antibiotics (adjusted odds ratio [aOR], 1.11; 95% CI, 0.99-1.25).
  • Similarly, revisits with same-day dispensation of a new antibiotic were also rare (1.4%), with no significant association between antibiotic treatment and revisits (aOR, 1.10; 95% CI, 0.92-1.33).
  • Hospitalizations for conjunctivitis occurred in 0.03% of cases, and emergency department revisits occurred in 0.12%, with no differences between children who received antibiotics and those who did not.

IN PRACTICE:

“Given that antibiotics may not be associated with improved outcomes or change in subsequent health care use and are associated with adverse effects and antibiotic resistance, efforts to reduce overtreatment of acute infectious conjunctivitis are warranted,” the authors wrote.

SOURCE:

The study was led by Daniel J. Shapiro, MD, MPH, of the Department of Emergency Medicine at the University of California, San Francisco, and published online on June 27, 2024, in JAMA Ophthalmology.

LIMITATIONS:

The major limitations of the study included the inability to distinguish scheduled visits from unscheduled revisits, incomplete clinical data such as rare complications of conjunctivitis, and the inability to confirm the accuracy of the coded diagnosis of infectious conjunctivitis, especially in children who did not receive a thorough eye examination.

DISCLOSURES:

This study did not declare receiving funding from any sources. One author reported receiving grants from several sources outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168591</fileName> <TBEID>0C050D21.SIG</TBEID> <TBUniqueIdentifier>MD_0C050D21</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240702T094045</QCDate> <firstPublished>20240702T111341</firstPublished> <LastPublished>20240702T111341</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240702T111341</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Shrabasti Bhattacharya</byline> <bylineText>EDITED SHRABASTI BHATTACHARYA AND LISA GILLESPIE</bylineText> <bylineFull>EDITED SHRABASTI BHATTACHARYA AND LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>follow-up visits and new antibiotic dispensations were rare regardless of treatment, suggesting that not receiving antibiotics may not lead to additional health</metaDescription> <articlePDF/> <teaserImage/> <teaser>Study: Additional antibiotics or follow-up care was uncommon in pink eye, suggesting initial antibiotics may not be needed.</teaser> <title>Reducing Unnecessary Antibiotics for Conjunctivitis</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">20</term> <term>15</term> <term>21</term> <term>25</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">271</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Reducing Unnecessary Antibiotics for Conjunctivitis</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p>More than two thirds of children with conjunctivitis received antibiotics within a day of their initial ambulatory care visit; however, <span class="tag metaDescription">follow-up visits and new antibiotic dispensations were rare regardless of treatment, suggesting that not receiving antibiotics may not lead to additional health care use.</span></p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>Researchers evaluated the frequency of topical antibiotic treatment and its association with subsequent health care use among commercially insured children with acute infectious conjunctivitis in the United States.</li> <li>This cohort study analyzed data from the 2021 MarketScan Commercial Claims and Encounters Database, including 44,793 children with conjunctivitis (median age, 5 years; 47% girls) and ambulatory care encounters.</li> <li>The primary exposure was a topical antibiotic prescription dispensed within 1 day of an ambulatory care visit, with outcomes assessed 2-14 days after the visit.</li> <li>The primary outcomes were ambulatory care revisits for conjunctivitis and same-day dispensation of a new topical antibiotic, and secondary outcomes included emergency department revisits and hospitalizations.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>Topical antibiotics were dispensed within a day of an ambulatory care visit in 69% of the cases; however, they were less frequently dispensed following visits to eye clinics (34%), for children aged 6-11 years (66%), and for those with viral conjunctivitis (28%).</li> <li>Ambulatory care revisits for conjunctivitis within 2 weeks occurred in only 3.2% of children who had received antibiotics (adjusted odds ratio [aOR], 1.11; 95% CI, 0.99-1.25).</li> <li>Similarly, revisits with same-day dispensation of a new antibiotic were also rare (1.4%), with no significant association between antibiotic treatment and revisits (aOR, 1.10; 95% CI, 0.92-1.33).</li> <li>Hospitalizations for conjunctivitis occurred in 0.03% of cases, and emergency department revisits occurred in 0.12%, with no differences between children who received antibiotics and those who did not.</li> </ul> <h2>IN PRACTICE:</h2> <p>“Given that antibiotics may not be associated with improved outcomes or change in subsequent health care use and are associated with adverse effects and antibiotic resistance, efforts to reduce overtreatment of acute infectious conjunctivitis are warranted,” the authors wrote.</p> <h2>SOURCE:</h2> <p>The study was led by Daniel J. Shapiro, MD, MPH, of the Department of Emergency Medicine at the University of California, San Francisco, and <a href="https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2820326?utm_campaign=articlePDF&amp;utm_medium=articlePDFlink&amp;utm_source=articlePDF&amp;utm_content=jamaophthalmol.2024.2211">published online</a> on June 27, 2024, in <em>JAMA Ophthalmology</em>.</p> <h2>LIMITATIONS:</h2> <p>The major limitations of the study included the inability to distinguish scheduled visits from unscheduled revisits, incomplete clinical data such as rare complications of conjunctivitis, and the inability to confirm the accuracy of the coded diagnosis of infectious conjunctivitis, especially in children who did not receive a thorough eye examination.</p> <h2>DISCLOSURES:</h2> <p>This study did not declare receiving funding from any sources. One author reported receiving grants from several sources outside the submitted work.</p> <p> <em>This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/cutting-down-unnecessary-antibiotics-pink-eye-2024a1000c5p">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Is Measuring How Many Times Patients Get Screened for Depression Really a Reflection of Good Clinical Care?

Article Type
Changed
Fri, 04/05/2024 - 15:37

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

 

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

 

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

 

 

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

 

Suggestions From ACP for Improvement in MDD Metrics

  • Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
  • Add methods for clinicians to measure and indicate severity of MDD.
  • Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
  • Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

 

 

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

 

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

 

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

 

 

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

 

Suggestions From ACP for Improvement in MDD Metrics

  • Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
  • Add methods for clinicians to measure and indicate severity of MDD.
  • Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
  • Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

 

 

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

 

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

 

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

 

 

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

 

Suggestions From ACP for Improvement in MDD Metrics

  • Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
  • Add methods for clinicians to measure and indicate severity of MDD.
  • Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
  • Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

 

 

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167578</fileName> <TBEID>0C04F6B5.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F6B5</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240405T152643</QCDate> <firstPublished>20240405T153303</firstPublished> <LastPublished>20240405T153303</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240405T153303</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Lisa Gillespie</byline> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.</metaDescription> <articlePDF/> <teaserImage/> <teaser>Providing a screening may not be appropriate at every visit, especially those that are not routine check-ups or where time is limited.</teaser> <title>Is Measuring How Many Times Patients Get Screened for Depression Really a Reflection of Good Clinical Care?</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">15</term> <term>21</term> <term>25</term> </publications> <sections> <term>27980</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">248</term> <term>38029</term> <term>176</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Is Measuring How Many Times Patients Get Screened for Depression Really a Reflection of Good Clinical Care?</title> <deck/> </itemMeta> <itemContent> <p>Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a <a href="https://journals.lww.com/lww-medicalcare/abstract/2022/02000/the_2018_merit_based_incentive_payment_system_.9.aspx">2017 rule</a> which mandates such assessments.</p> <p><a href="https://qpp.cms.gov/docs/QPP_quality_measure_specifications/Claims-Registry-Measures/2024_Measure_134_MedicarePartBClaims.pdf">Providing a screening and, if needed, a follow-up plan</a> means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — <a href="https://www.medscape.com/viewarticle/929230">and others like it</a> that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.<br/><br/>For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.<br/><br/>“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”<br/><br/>A recent report from the <a href="https://www.acponline.org/clinical-information/performance-measures">American College of Physicians (ACP) </a>supported Dr. Connelly’s view. The body looked at <a href="https://www.acpjournals.org/doi/10.7326/M23-3077">eight quality measures</a> in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.<br/><br/>The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”<br/><br/>The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.</p> <h2>Necessary Evil or Burdensome Time Suck?</h2> <p>The Centers for Medicare &amp; Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.</p> <p>Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in <a href="https://www.medscape.com/viewarticle/883531">primary care</a> for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.</p> <h2>Standards ACP Used for Validating Depression Measurement</h2> <p>A committee with ACP used a modified appropriateness method from RAND and UCLA.</p> <p>They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.<br/><br/>They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.<br/><br/>A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.<br/><br/>“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.<br/><br/>Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the <a href="https://www.medscape.com/courses/section/903494?icd=login_success_email_match_norm">Merit-Based Incentive Payment System</a>. Health systems <a href="https://www.medscape.com/viewarticle/985427">choose six measures of quality to tie to their reimbursement</a> — along with assessments of costs and use of technology.<br/><br/>In turn, Medicare adjusts its <a href="https://www.medscape.com/courses/section/903496">reimbursement based</a> on how well a <a href="https://www.medscape.com/viewarticle/916056">clinician’s numbers</a> turn out and if they improved over time.<br/><br/>“<a href="https://www.medscape.com/viewarticle/923512">You don’t get the benefit of the upside if you don’t meet the measure</a>, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”<br/><br/>The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.</p> <h2>Implementing Measurement</h2> <p>At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for <a href="https://bphc.hrsa.gov/initiatives/advancing-health-center-excellence/hrsa-accreditation-patient-centered-medical-home-recognition-initiative">certification from the </a>Health Resources and Services Administration <a href="https://bphc.hrsa.gov/initiatives/advancing-health-center-excellence/hrsa-accreditation-patient-centered-medical-home-recognition-initiative">as a patient-centered medical home</a>, which the company uses in part to market itself to patients.</p> <p>Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.<br/><br/>“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.</p> <h2>Suggestions From ACP for Improvement in MDD Metrics</h2> <ul class="body"> <li>Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.</li> <li>Add methods for clinicians to measure and indicate severity of MDD.</li> <li>Enable use of a wider array of evidence-based tools and screenings to screen for MDD.</li> <li>Allow clinicians to document changes in treatment plan.</li> </ul> <p>Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.<br/><br/>Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.<br/><br/>“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.<br/><br/>Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.<br/><br/>Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.<br/><br/>At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.<br/><br/>“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”</p> <h2>Takeaways for Depression Screening and Follow-Up in Clinical Settings</h2> <p>Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.</p> <p>Patients have the right to refuse a screener and their wishes should be respected.<br/><br/>Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.<br/><br/>Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/measuring-how-many-times-patients-get-screened-depression-2024a10006d1">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

High school students using less tobacco, vape products, CDC report shows

Article Type
Changed
Fri, 11/03/2023 - 11:34

 

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

  • The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
  • The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
  • The overall response rate was 30.5%.
  • “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
  • The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

  • The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
  • From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
  • Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
  • Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

Publications
Topics
Sections

 

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

  • The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
  • The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
  • The overall response rate was 30.5%.
  • “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
  • The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

  • The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
  • From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
  • Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
  • Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

 

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

  • The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
  • The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
  • The overall response rate was 30.5%.
  • “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
  • The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

  • The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
  • From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
  • Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
  • Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>165801</fileName> <TBEID>0C04D0E5.SIG</TBEID> <TBUniqueIdentifier>MD_0C04D0E5</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20231103T111055</QCDate> <firstPublished>20231103T113126</firstPublished> <LastPublished>20231103T113126</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20231103T113126</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth stil</metaDescription> <articlePDF/> <teaserImage/> <teaser>“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use.”</teaser> <title>High school students using less tobacco, vape products, CDC report shows</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>cpn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">25</term> <term>6</term> <term>15</term> <term>9</term> </publications> <sections> <term>39313</term> <term canonical="true">27979</term> </sections> <topics> <term canonical="true">284</term> <term>271</term> <term>174</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>High school students using less tobacco, vape products, CDC report shows</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p><span class="tag metaDescription">Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, <a href="https://www.cdc.gov/mmwr/volumes/72/wr/mm7244a1.htm?s_cid=mm7244a1_w">government figures show</a>, but the majority of these youth still used flavored products,</span> which have been shown to both <a href="https://publications.aap.org/pediatrics/article/144/5/e20190789/76993/Flavored-E-cigarette-Use-and-Progression-of-Vaping?autologincheck=redirected">entice teens and keep them vaping</a>.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.</li> <li>The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.</li> <li>The overall response rate was 30.5%.</li> <li>“Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.</li> <li>The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).</li> <li>From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.</li> <li>Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).</li> <li>Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.</li> </ul> <h2>IN PRACTICE:</h2> <p>“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.</p> <h2>SOURCE:</h2> <p>The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.</p> <h2>LIMITATIONS:</h2> <p>Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.</p> <h2>DISCLOSURES:</h2> <p>No potential conflicts of interest were disclosed.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/998026">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

FDA approves RSV monoclonal antibody for all infants

Article Type
Changed
Mon, 07/17/2023 - 17:59

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

FDA_icon3_web.jpg

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

Publications
Topics
Sections

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

FDA_icon3_web.jpg

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

FDA_icon3_web.jpg

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>164339</fileName> <TBEID>0C04B339.SIG</TBEID> <TBUniqueIdentifier>MD_0C04B339</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20230717T174925</QCDate> <firstPublished>20230717T175411</firstPublished> <LastPublished>20230717T175411</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20230717T175411</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).</metaDescription> <articlePDF/> <teaserImage>170371</teaserImage> <teaser>The long-acting antibody is given as a single intramuscular injection.</teaser> <title>RSV monoclonal antibody approved by FDA for all infants</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">25</term> <term>15</term> <term>20</term> <term>6</term> </publications> <sections> <term canonical="true">27979</term> <term>39313</term> </sections> <topics> <term canonical="true">311</term> <term>284</term> <term>234</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24005fb2.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>RSV monoclonal antibody approved by FDA for all infants</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).</span> </p> <p>The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.<br/><br/>[[{"fid":"170371","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"FDA icon","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]As many as <a href="https://www.cdc.gov/rsv/high-risk/infants-young-children.html">80,000 children</a> under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.<br/><br/>The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.<br/><br/>Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.<br/><br/>Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; <em>P</em> &lt; .001).<br/><br/>The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.<br/><br/>“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/994444">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

‘Deprescribing’: Should some older adults shed their meds?

Article Type
Changed
Tue, 06/20/2023 - 10:14

Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.

Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.

“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.

For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.

Many adults over age 65 with chronic conditions may be on too many medications and could benefit from a medication review with their primary care doctor. Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.

About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.

An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.

“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”

Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
 

Finding the ‘right balance’

Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.

“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.

“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”

Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.

By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.

“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.

Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.

But doctors often need prompting from patients to start a review.

“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
 

 

 

Ask questions

Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.

“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”

She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.

“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said. 

The primary care doctor discontinued the anticholesterol drug.

Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said. 

“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”

Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.

With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.

Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.

Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.

“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”

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

Publications
Topics
Sections

Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.

Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.

“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.

For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.

Many adults over age 65 with chronic conditions may be on too many medications and could benefit from a medication review with their primary care doctor. Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.

About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.

An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.

“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”

Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
 

Finding the ‘right balance’

Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.

“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.

“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”

Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.

By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.

“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.

Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.

But doctors often need prompting from patients to start a review.

“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
 

 

 

Ask questions

Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.

“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”

She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.

“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said. 

The primary care doctor discontinued the anticholesterol drug.

Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said. 

“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”

Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.

With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.

Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.

Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.

“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”

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

Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.

Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.

“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.

For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.

Many adults over age 65 with chronic conditions may be on too many medications and could benefit from a medication review with their primary care doctor. Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.

About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.

An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.

“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”

Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
 

Finding the ‘right balance’

Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.

“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.

“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”

Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.

By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.

“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.

Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.

But doctors often need prompting from patients to start a review.

“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
 

 

 

Ask questions

Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.

“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”

She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.

“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said. 

The primary care doctor discontinued the anticholesterol drug.

Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said. 

“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”

Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.

With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.

Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.

Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.

“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”

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

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>163975</fileName> <TBEID>0C04AC0A.SIG</TBEID> <TBUniqueIdentifier>MD_0C04AC0A</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20230619T095927</QCDate> <firstPublished>20230619T103338</firstPublished> <LastPublished>20230619T103338</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20230619T103337</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Lisa Gillespie</byline> <bylineText>LISA GILLESPIE AND LARA SALAHI</bylineText> <bylineFull>LISA GILLESPIE AND LARA SALAHI</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Many adults over age 65 with chronic conditions may be on too many medications and could benefit from a medication review with their primary care doctor.</metaDescription> <articlePDF/> <teaserImage/> <teaser>“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations.”</teaser> <title>‘Deprescribing’: Should some older adults shed their meds?</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">21</term> <term>15</term> </publications> <sections> <term canonical="true">27980</term> <term>39313</term> </sections> <topics> <term canonical="true">215</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>‘Deprescribing’: Should some older adults shed their meds?</title> <deck/> </itemMeta> <itemContent> <p>Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.</p> <p>Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names. <br/><br/>“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death. <br/><br/>For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said. <br/><br/><span class="tag metaDescription">Many adults over age 65 with chronic conditions may be on too many medications and could benefit from a medication review with their primary care doctor. </span>Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed. <br/><br/>About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, <a href="https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/jgs.16743">a study published in 2020 in the Journal of the American Geriatrics Society shows.</a> While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications. <br/><br/>An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said. <br/><br/>“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”<br/><br/>Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.<br/><br/></p> <h2>Finding the ‘right balance’</h2> <p>Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the <a href="https://www.healthyagingpoll.org/reports-more/report/views-medication-deprescribing-among-adults-age-50-80">University of Michigan</a>, Ann Arbor. </p> <p>“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the <a href="https://deprescribingresearch.org/">U.S. Deprescribing Research Network</a>, a doctor group focused on improving medication use for older adults.<br/><br/>“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”<br/><br/>Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor <a href="https://www.healthinaging.org/medications-older-adults/what-older-adults-can-do-manage-medications">for a review of medications</a> that have multiplied over time. <br/><br/>By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor. <br/><br/>“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.<br/><br/>Patients and caregivers can ask for an honest conversation with their doctor. The <a href="https://www.healthyagingpoll.org/reports-more/report/views-medication-deprescribing-among-adults-age-50-80">University of Michigan poll</a> found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit. <br/><br/>But doctors often need prompting from patients to start a review. <br/><br/>“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.<br/><br/></p> <h2>Ask questions</h2> <p>Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.</p> <p>“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”<br/><br/>She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack. <br/><br/>“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said. <br/><br/>The primary care doctor discontinued the anticholesterol drug. <br/><br/>Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. <a href="https://naspa.us/resource/swp/">In states that allow for pharmacists</a> to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said. <br/><br/>“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”<br/><br/>Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.<br/><br/>With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.<br/><br/>Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, <a href="https://www.medicare.gov/drug-coverage-part-d/what-medicare-part-d-drug-plans-cover/medication-therapy-management-programs-for-complex-health-needs">Medicare plans</a> offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.<br/><br/>Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists. <br/><br/>“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”</p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.webmd.com/healthy-aging/news/20230616/deprescribing-should-some-older-adults-shed-their-meds">WebMD.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Forgotten but not gone: EVALI epidemic continues 

Article Type
Changed
Mon, 04/24/2023 - 14:19

Rashelle Bernal vaped and ended up in an induced coma for a week. She was one of almost 3,000 people who were hospitalized during 2019 and early 2020 with severe lung damage from vaping and became part of what is now known as the epidemic of e-cigarette, or vaping, product use–associated lung injury (EVALI).

For many, the EVALI epidemic is a distant, pre-COVID memory.

But the vaping-related injuries are still happening. And for Ms. Bernal, the aftermath is her reality. Her pulmonologist from that time described the harm from the vape ingredients as an oil spill in her lungs. Eventually, the toxins would probably clear. But she will likely wrestle with the injuries for a very long time.

More than 3 years later, she frequently finds herself in the emergency department.

“If I get sick, if there’s anything that irritates my lungs – it could be something as simple as pollen in the air – it will cause me to get like a bacterial infection or other issues, and I can’t breathe,” Ms. Ms. Bernal, now 30, said in a recent interview. “I get really winded, to the point where I’ll walk up the stairs and I feel like I just ran a mile.”

In 2019 and 2020, a media firestorm erupted as hospitals notified the public of outbreaks of vaping-related lung injuries. News headlines reported e-cigarettes were killing teens from Texas to the Bronx. Investigators at the U.S. Centers for Disease Control and Prevention tracked most of the cases to vitamin E acetate, an additive in illicit cannabis vaping products intended to promote the metabolism of tetrahydrocannabinol (THC). The agency stopped tracking EVALI in February 2020.

But 2 months later, in April 2020, the agency’s National Center for Health Statistics implemented a diagnostic code, U07.0, for health care professionals in the United States to diagnose EVALI for the first time. The code is also used for lung damage related to use of electronic cigarettes and “dabbing” – a method of inhaling cannabis. Damage could include inflammation of the lungs, pulmonary hemorrhage, and eosinophilic pneumonia.

The incidence of these diagnoses appears to have risen sharply since 2020. In the last three months of 2020, a total of 11,300 medical claims included the U07.0 code. That figure rose to 22,000 in 2021 and hit 31,600 in 2022, according to data compiled for and provided to Medscape by Komodo Health, a health care technology company that holds a database of more than 330 million U.S. patients from Medicare, Medicaid, and commercial insurers’ medical, pharmacy, and laboratory claims.

Harm from vaping, including EVALI, has continued.

“We’re still seeing a number of patients diagnosed with vaping disorders, but it’s not top of mind,” said Usha Periyanayagam, MD, MPH, head of clinic product and real-world evidence for Komodo and a former emergency medicine physician.
 

Where it started

Devika Rao, MD, a pediatric pulmonology specialist at UT Southwestern Medical Center, Dallas, has cared for most of her EVALI patients in the hospital, with the most recent case in early 2023. But in January, for the first time, she saw an EVALI patient in an outpatient clinic. The person had not been admitted to the hospital – like most were pre-pandemic. And like most who were seen during the pandemic, this patient had milder symptoms, not requiring intubation or take-home oxygen.

In 2019 and the beginning of 2020, many EVALI patients who were eventually hospitalized first sought help at urgent care centers or with primary care doctors and were presumed to have pneumonia or gastroenteritis and sent home.

“But they got worse, and they would present to our emergency room; their chest X-rays and CT scans showed extensive lung disease,” Dr. Rao said, adding that the damage was striking among patients all under age 18. “They were short of breath. Their oxygen levels were low. They had diminished lung function. And they had a lot of GI issues like abdominal pain and weight loss from nausea and vomiting.”

“These overwhelming inflammatory reactions that we see with EVALI,” said Karen M. Wilson, MD, MPH, a pediatric hospitalist at the University of Rochester (N.Y.) Medical Center and a tobacco use researcher. “You might find some microvascular changes with normal inhaling of smoke or aerosol, but you’re not going to find macro changes like we see with the EVALI.”

In late 2019, images of the CT scans of patients with EVALI were published, grabbing the attention of Arun Kannappan, MD, an assistant professor of pulmonary sciences and critical care at the University of Colorado Anschutz School of Medicine, Aurora. Dr. Kannappan knew a patient with such severe lung damage could develop acute respiratory distress syndrome, which means a patient would be put on a ventilator because their inflamed lungs could not oxygenate blood.

“That confers within somewhere between 30% to 50% chance of dying; it made all of the pulmonary specialists really turn their heads to make sure that we keep a lookout for it,” said Dr. Kannappan.

CT scans of lungs proved to be a critical diagnostic tool for doctors. Most of the images from patients showed acute inflammation and diffuse lung damage. Ehab Ali, MD, a critical care and pulmonary disease medicine specialist in Louisville, Ky., said the damage was often spread across both lungs in many areas and appeared opaque and hazy, known as “ground glass.” COVID-19, meanwhile, appeared differently in lung scans, often with damage that was more isolated.

But many diseases carry a “ground glass” appearance, with many potential causes, like infections, cigarette smoke, or an autoimmune condition.

“Before you even talk to the patient, you can immediately put it in your mind that ‘I’m going to ask this patient if they vape,’ when I see the distribution of ground glass appearance,” Dr. Ali said.

Dr. Ali said other factors, like the age of the patient – about three-quarters of EVALI patients are under age 34, according to the CDC – would spur him to ask about vaping. But because so many patients were young, discerning vape usage wasn’t always easy.  

“When you’re talking to teenagers, if you ask them upon admission, with the parents in the room, they’re going say ‘no,’ ” said Rachel Boykan, MD, a pediatric hospitalist at Stony Brook (N.Y.) Children’s. She added that her hospital is still seeing cases.

Dr. Rao said it often takes two to three people asking a patient about any vape usage before they confess.

Ms. Bernal, who was 27 at the time of her hospital admission for EVALI, said she bought vapes with THC at a retail shop in California. She’d been a traditional marijuana smoker, using the leaf product, but switched when someone told her it was healthier to vape THC than inhale smoke from burned marijuana leaves into her lungs. “I thought this was safe.”

Dr. Rao and her colleagues recently published a study of 41 teenage patients with EVALI who were seen at Children’s Medical Center Dallas between December 2018 and July 2021. All but one reported using e-cigarettes containing THC, and the CDC in its most recent report from February 2020 said about 80% of patients had used vapes containing THC.

The CDC also found that vitamin E acetate, an oily substance that allows THC to travel from the lungs to the brain quickly and an ingredient used in the food and cosmetics industries, was found in many of the lungs of EVALI patients, though not all.
 

 

 

The aftermath

The outcomes of the thousands of patients who had EVALI – and those who may still be developing it – are largely untracked.

Bonnie Halpern-Felsher, PhD, director at the Stanford (Calif.) Reach Lab that bears her name and a researcher on tobacco in youth, said she and many of her colleagues are frustrated that the CDC is not continuing to collect data on EVALI.

“I know a lot of colleagues who’ve said that they’re still seeing EVALI, but because of COVID-19 they stopped collecting the data. And that’s been very frustrating because it’s hard to say whether the kinds of lung issues you’re having are related to e-cigarettes, generally, or EVALI,” Dr. Halpern-Felsher said.

Researchers and doctors affiliated with the American Thoracic Society published a report with solutions on how to better track EVALI. They recommended that a national case registry and biorepository be created.

Doctors also worry that many cases were missed. Dr. Boykan said that while protocol dictated nurses and other clinicians ask about a history of vaping – a key part of EVALI diagnosis – many did not. Dr. Ali, the Louisville critical care physician, said EVALI symptoms of nausea, cough, and fever are associated with viral infections.

“I’m sure that some of these cases might be discharged from the emergency room as a virus,” Dr. Ali said. “Most of the time patients would get prescribed steroids for viral infections, which may help EVALI patients even though it’s never been studied.”

Dr. Rao also said the treatment regimen at Children’s MC Dallas, which included high doses of intravenous steroids, seemed to help. But the best management approach for treatment, or long-term follow up care, has not been studied.

The report in the Annals of the American Thoracic Society said prospective studies are showing that a significant portion of patients with EVALI experience prolonged respiratory issues and cognitive and mood impairment. Dr. Rao said a common thread for many of her EVALI patients has been significant stress in their lives with school or family, which led them to vape in an attempt to reduce stress.

That was certainly the case for Ms. Bernal before her hospital admission. She had recently moved across the country for her husband’s job, was trying to buy a house, and had spent months in a hotel with three children. She vaped to cope.

But she said her mental and cognitive health has worsened. Back in Louisville, she saw a neurologist, who told her that her brain had shrunk, she said. She hasn’t found a new neurologist in Portland, Ore., where her family moved a year after the EVALI episode.

But she often finds herself overwhelmed and overstimulated with tasks that she said she never had problems with before. She tears up while talking about the newfound limitations. She struggled to find a primary care physician who could medically manage her mental health and a counselor who can understand what she’s been through with EVALI.

But, “a lot of doctors aren’t educated in it, and they don’t know how to respond or they don’t know what to do,” Ms. Bernal said. “And that makes me feel like, I guess, what I had wasn’t important.”

Ms. Bernal does have a new pulmonologist and is going in for a round of pulmonary tests soon because she often finds herself unable to breathe while completing simple tasks. She is tired of rushing to the ER. She wants answers, or some kind of treatment to help her feel normal again.

“I feel like this is my fault,” Ms. Bernal said. “Had I not smoked, I would be fine, and that’s hard to live with. Every day. Telling yourself, ‘It’s your fault.’ It’s been how many years now? And I still haven’t found peace yet. I don’t know if ever will.”

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

Publications
Topics
Sections

Rashelle Bernal vaped and ended up in an induced coma for a week. She was one of almost 3,000 people who were hospitalized during 2019 and early 2020 with severe lung damage from vaping and became part of what is now known as the epidemic of e-cigarette, or vaping, product use–associated lung injury (EVALI).

For many, the EVALI epidemic is a distant, pre-COVID memory.

But the vaping-related injuries are still happening. And for Ms. Bernal, the aftermath is her reality. Her pulmonologist from that time described the harm from the vape ingredients as an oil spill in her lungs. Eventually, the toxins would probably clear. But she will likely wrestle with the injuries for a very long time.

More than 3 years later, she frequently finds herself in the emergency department.

“If I get sick, if there’s anything that irritates my lungs – it could be something as simple as pollen in the air – it will cause me to get like a bacterial infection or other issues, and I can’t breathe,” Ms. Ms. Bernal, now 30, said in a recent interview. “I get really winded, to the point where I’ll walk up the stairs and I feel like I just ran a mile.”

In 2019 and 2020, a media firestorm erupted as hospitals notified the public of outbreaks of vaping-related lung injuries. News headlines reported e-cigarettes were killing teens from Texas to the Bronx. Investigators at the U.S. Centers for Disease Control and Prevention tracked most of the cases to vitamin E acetate, an additive in illicit cannabis vaping products intended to promote the metabolism of tetrahydrocannabinol (THC). The agency stopped tracking EVALI in February 2020.

But 2 months later, in April 2020, the agency’s National Center for Health Statistics implemented a diagnostic code, U07.0, for health care professionals in the United States to diagnose EVALI for the first time. The code is also used for lung damage related to use of electronic cigarettes and “dabbing” – a method of inhaling cannabis. Damage could include inflammation of the lungs, pulmonary hemorrhage, and eosinophilic pneumonia.

The incidence of these diagnoses appears to have risen sharply since 2020. In the last three months of 2020, a total of 11,300 medical claims included the U07.0 code. That figure rose to 22,000 in 2021 and hit 31,600 in 2022, according to data compiled for and provided to Medscape by Komodo Health, a health care technology company that holds a database of more than 330 million U.S. patients from Medicare, Medicaid, and commercial insurers’ medical, pharmacy, and laboratory claims.

Harm from vaping, including EVALI, has continued.

“We’re still seeing a number of patients diagnosed with vaping disorders, but it’s not top of mind,” said Usha Periyanayagam, MD, MPH, head of clinic product and real-world evidence for Komodo and a former emergency medicine physician.
 

Where it started

Devika Rao, MD, a pediatric pulmonology specialist at UT Southwestern Medical Center, Dallas, has cared for most of her EVALI patients in the hospital, with the most recent case in early 2023. But in January, for the first time, she saw an EVALI patient in an outpatient clinic. The person had not been admitted to the hospital – like most were pre-pandemic. And like most who were seen during the pandemic, this patient had milder symptoms, not requiring intubation or take-home oxygen.

In 2019 and the beginning of 2020, many EVALI patients who were eventually hospitalized first sought help at urgent care centers or with primary care doctors and were presumed to have pneumonia or gastroenteritis and sent home.

“But they got worse, and they would present to our emergency room; their chest X-rays and CT scans showed extensive lung disease,” Dr. Rao said, adding that the damage was striking among patients all under age 18. “They were short of breath. Their oxygen levels were low. They had diminished lung function. And they had a lot of GI issues like abdominal pain and weight loss from nausea and vomiting.”

“These overwhelming inflammatory reactions that we see with EVALI,” said Karen M. Wilson, MD, MPH, a pediatric hospitalist at the University of Rochester (N.Y.) Medical Center and a tobacco use researcher. “You might find some microvascular changes with normal inhaling of smoke or aerosol, but you’re not going to find macro changes like we see with the EVALI.”

In late 2019, images of the CT scans of patients with EVALI were published, grabbing the attention of Arun Kannappan, MD, an assistant professor of pulmonary sciences and critical care at the University of Colorado Anschutz School of Medicine, Aurora. Dr. Kannappan knew a patient with such severe lung damage could develop acute respiratory distress syndrome, which means a patient would be put on a ventilator because their inflamed lungs could not oxygenate blood.

“That confers within somewhere between 30% to 50% chance of dying; it made all of the pulmonary specialists really turn their heads to make sure that we keep a lookout for it,” said Dr. Kannappan.

CT scans of lungs proved to be a critical diagnostic tool for doctors. Most of the images from patients showed acute inflammation and diffuse lung damage. Ehab Ali, MD, a critical care and pulmonary disease medicine specialist in Louisville, Ky., said the damage was often spread across both lungs in many areas and appeared opaque and hazy, known as “ground glass.” COVID-19, meanwhile, appeared differently in lung scans, often with damage that was more isolated.

But many diseases carry a “ground glass” appearance, with many potential causes, like infections, cigarette smoke, or an autoimmune condition.

“Before you even talk to the patient, you can immediately put it in your mind that ‘I’m going to ask this patient if they vape,’ when I see the distribution of ground glass appearance,” Dr. Ali said.

Dr. Ali said other factors, like the age of the patient – about three-quarters of EVALI patients are under age 34, according to the CDC – would spur him to ask about vaping. But because so many patients were young, discerning vape usage wasn’t always easy.  

“When you’re talking to teenagers, if you ask them upon admission, with the parents in the room, they’re going say ‘no,’ ” said Rachel Boykan, MD, a pediatric hospitalist at Stony Brook (N.Y.) Children’s. She added that her hospital is still seeing cases.

Dr. Rao said it often takes two to three people asking a patient about any vape usage before they confess.

Ms. Bernal, who was 27 at the time of her hospital admission for EVALI, said she bought vapes with THC at a retail shop in California. She’d been a traditional marijuana smoker, using the leaf product, but switched when someone told her it was healthier to vape THC than inhale smoke from burned marijuana leaves into her lungs. “I thought this was safe.”

Dr. Rao and her colleagues recently published a study of 41 teenage patients with EVALI who were seen at Children’s Medical Center Dallas between December 2018 and July 2021. All but one reported using e-cigarettes containing THC, and the CDC in its most recent report from February 2020 said about 80% of patients had used vapes containing THC.

The CDC also found that vitamin E acetate, an oily substance that allows THC to travel from the lungs to the brain quickly and an ingredient used in the food and cosmetics industries, was found in many of the lungs of EVALI patients, though not all.
 

 

 

The aftermath

The outcomes of the thousands of patients who had EVALI – and those who may still be developing it – are largely untracked.

Bonnie Halpern-Felsher, PhD, director at the Stanford (Calif.) Reach Lab that bears her name and a researcher on tobacco in youth, said she and many of her colleagues are frustrated that the CDC is not continuing to collect data on EVALI.

“I know a lot of colleagues who’ve said that they’re still seeing EVALI, but because of COVID-19 they stopped collecting the data. And that’s been very frustrating because it’s hard to say whether the kinds of lung issues you’re having are related to e-cigarettes, generally, or EVALI,” Dr. Halpern-Felsher said.

Researchers and doctors affiliated with the American Thoracic Society published a report with solutions on how to better track EVALI. They recommended that a national case registry and biorepository be created.

Doctors also worry that many cases were missed. Dr. Boykan said that while protocol dictated nurses and other clinicians ask about a history of vaping – a key part of EVALI diagnosis – many did not. Dr. Ali, the Louisville critical care physician, said EVALI symptoms of nausea, cough, and fever are associated with viral infections.

“I’m sure that some of these cases might be discharged from the emergency room as a virus,” Dr. Ali said. “Most of the time patients would get prescribed steroids for viral infections, which may help EVALI patients even though it’s never been studied.”

Dr. Rao also said the treatment regimen at Children’s MC Dallas, which included high doses of intravenous steroids, seemed to help. But the best management approach for treatment, or long-term follow up care, has not been studied.

The report in the Annals of the American Thoracic Society said prospective studies are showing that a significant portion of patients with EVALI experience prolonged respiratory issues and cognitive and mood impairment. Dr. Rao said a common thread for many of her EVALI patients has been significant stress in their lives with school or family, which led them to vape in an attempt to reduce stress.

That was certainly the case for Ms. Bernal before her hospital admission. She had recently moved across the country for her husband’s job, was trying to buy a house, and had spent months in a hotel with three children. She vaped to cope.

But she said her mental and cognitive health has worsened. Back in Louisville, she saw a neurologist, who told her that her brain had shrunk, she said. She hasn’t found a new neurologist in Portland, Ore., where her family moved a year after the EVALI episode.

But she often finds herself overwhelmed and overstimulated with tasks that she said she never had problems with before. She tears up while talking about the newfound limitations. She struggled to find a primary care physician who could medically manage her mental health and a counselor who can understand what she’s been through with EVALI.

But, “a lot of doctors aren’t educated in it, and they don’t know how to respond or they don’t know what to do,” Ms. Bernal said. “And that makes me feel like, I guess, what I had wasn’t important.”

Ms. Bernal does have a new pulmonologist and is going in for a round of pulmonary tests soon because she often finds herself unable to breathe while completing simple tasks. She is tired of rushing to the ER. She wants answers, or some kind of treatment to help her feel normal again.

“I feel like this is my fault,” Ms. Bernal said. “Had I not smoked, I would be fine, and that’s hard to live with. Every day. Telling yourself, ‘It’s your fault.’ It’s been how many years now? And I still haven’t found peace yet. I don’t know if ever will.”

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

Rashelle Bernal vaped and ended up in an induced coma for a week. She was one of almost 3,000 people who were hospitalized during 2019 and early 2020 with severe lung damage from vaping and became part of what is now known as the epidemic of e-cigarette, or vaping, product use–associated lung injury (EVALI).

For many, the EVALI epidemic is a distant, pre-COVID memory.

But the vaping-related injuries are still happening. And for Ms. Bernal, the aftermath is her reality. Her pulmonologist from that time described the harm from the vape ingredients as an oil spill in her lungs. Eventually, the toxins would probably clear. But she will likely wrestle with the injuries for a very long time.

More than 3 years later, she frequently finds herself in the emergency department.

“If I get sick, if there’s anything that irritates my lungs – it could be something as simple as pollen in the air – it will cause me to get like a bacterial infection or other issues, and I can’t breathe,” Ms. Ms. Bernal, now 30, said in a recent interview. “I get really winded, to the point where I’ll walk up the stairs and I feel like I just ran a mile.”

In 2019 and 2020, a media firestorm erupted as hospitals notified the public of outbreaks of vaping-related lung injuries. News headlines reported e-cigarettes were killing teens from Texas to the Bronx. Investigators at the U.S. Centers for Disease Control and Prevention tracked most of the cases to vitamin E acetate, an additive in illicit cannabis vaping products intended to promote the metabolism of tetrahydrocannabinol (THC). The agency stopped tracking EVALI in February 2020.

But 2 months later, in April 2020, the agency’s National Center for Health Statistics implemented a diagnostic code, U07.0, for health care professionals in the United States to diagnose EVALI for the first time. The code is also used for lung damage related to use of electronic cigarettes and “dabbing” – a method of inhaling cannabis. Damage could include inflammation of the lungs, pulmonary hemorrhage, and eosinophilic pneumonia.

The incidence of these diagnoses appears to have risen sharply since 2020. In the last three months of 2020, a total of 11,300 medical claims included the U07.0 code. That figure rose to 22,000 in 2021 and hit 31,600 in 2022, according to data compiled for and provided to Medscape by Komodo Health, a health care technology company that holds a database of more than 330 million U.S. patients from Medicare, Medicaid, and commercial insurers’ medical, pharmacy, and laboratory claims.

Harm from vaping, including EVALI, has continued.

“We’re still seeing a number of patients diagnosed with vaping disorders, but it’s not top of mind,” said Usha Periyanayagam, MD, MPH, head of clinic product and real-world evidence for Komodo and a former emergency medicine physician.
 

Where it started

Devika Rao, MD, a pediatric pulmonology specialist at UT Southwestern Medical Center, Dallas, has cared for most of her EVALI patients in the hospital, with the most recent case in early 2023. But in January, for the first time, she saw an EVALI patient in an outpatient clinic. The person had not been admitted to the hospital – like most were pre-pandemic. And like most who were seen during the pandemic, this patient had milder symptoms, not requiring intubation or take-home oxygen.

In 2019 and the beginning of 2020, many EVALI patients who were eventually hospitalized first sought help at urgent care centers or with primary care doctors and were presumed to have pneumonia or gastroenteritis and sent home.

“But they got worse, and they would present to our emergency room; their chest X-rays and CT scans showed extensive lung disease,” Dr. Rao said, adding that the damage was striking among patients all under age 18. “They were short of breath. Their oxygen levels were low. They had diminished lung function. And they had a lot of GI issues like abdominal pain and weight loss from nausea and vomiting.”

“These overwhelming inflammatory reactions that we see with EVALI,” said Karen M. Wilson, MD, MPH, a pediatric hospitalist at the University of Rochester (N.Y.) Medical Center and a tobacco use researcher. “You might find some microvascular changes with normal inhaling of smoke or aerosol, but you’re not going to find macro changes like we see with the EVALI.”

In late 2019, images of the CT scans of patients with EVALI were published, grabbing the attention of Arun Kannappan, MD, an assistant professor of pulmonary sciences and critical care at the University of Colorado Anschutz School of Medicine, Aurora. Dr. Kannappan knew a patient with such severe lung damage could develop acute respiratory distress syndrome, which means a patient would be put on a ventilator because their inflamed lungs could not oxygenate blood.

“That confers within somewhere between 30% to 50% chance of dying; it made all of the pulmonary specialists really turn their heads to make sure that we keep a lookout for it,” said Dr. Kannappan.

CT scans of lungs proved to be a critical diagnostic tool for doctors. Most of the images from patients showed acute inflammation and diffuse lung damage. Ehab Ali, MD, a critical care and pulmonary disease medicine specialist in Louisville, Ky., said the damage was often spread across both lungs in many areas and appeared opaque and hazy, known as “ground glass.” COVID-19, meanwhile, appeared differently in lung scans, often with damage that was more isolated.

But many diseases carry a “ground glass” appearance, with many potential causes, like infections, cigarette smoke, or an autoimmune condition.

“Before you even talk to the patient, you can immediately put it in your mind that ‘I’m going to ask this patient if they vape,’ when I see the distribution of ground glass appearance,” Dr. Ali said.

Dr. Ali said other factors, like the age of the patient – about three-quarters of EVALI patients are under age 34, according to the CDC – would spur him to ask about vaping. But because so many patients were young, discerning vape usage wasn’t always easy.  

“When you’re talking to teenagers, if you ask them upon admission, with the parents in the room, they’re going say ‘no,’ ” said Rachel Boykan, MD, a pediatric hospitalist at Stony Brook (N.Y.) Children’s. She added that her hospital is still seeing cases.

Dr. Rao said it often takes two to three people asking a patient about any vape usage before they confess.

Ms. Bernal, who was 27 at the time of her hospital admission for EVALI, said she bought vapes with THC at a retail shop in California. She’d been a traditional marijuana smoker, using the leaf product, but switched when someone told her it was healthier to vape THC than inhale smoke from burned marijuana leaves into her lungs. “I thought this was safe.”

Dr. Rao and her colleagues recently published a study of 41 teenage patients with EVALI who were seen at Children’s Medical Center Dallas between December 2018 and July 2021. All but one reported using e-cigarettes containing THC, and the CDC in its most recent report from February 2020 said about 80% of patients had used vapes containing THC.

The CDC also found that vitamin E acetate, an oily substance that allows THC to travel from the lungs to the brain quickly and an ingredient used in the food and cosmetics industries, was found in many of the lungs of EVALI patients, though not all.
 

 

 

The aftermath

The outcomes of the thousands of patients who had EVALI – and those who may still be developing it – are largely untracked.

Bonnie Halpern-Felsher, PhD, director at the Stanford (Calif.) Reach Lab that bears her name and a researcher on tobacco in youth, said she and many of her colleagues are frustrated that the CDC is not continuing to collect data on EVALI.

“I know a lot of colleagues who’ve said that they’re still seeing EVALI, but because of COVID-19 they stopped collecting the data. And that’s been very frustrating because it’s hard to say whether the kinds of lung issues you’re having are related to e-cigarettes, generally, or EVALI,” Dr. Halpern-Felsher said.

Researchers and doctors affiliated with the American Thoracic Society published a report with solutions on how to better track EVALI. They recommended that a national case registry and biorepository be created.

Doctors also worry that many cases were missed. Dr. Boykan said that while protocol dictated nurses and other clinicians ask about a history of vaping – a key part of EVALI diagnosis – many did not. Dr. Ali, the Louisville critical care physician, said EVALI symptoms of nausea, cough, and fever are associated with viral infections.

“I’m sure that some of these cases might be discharged from the emergency room as a virus,” Dr. Ali said. “Most of the time patients would get prescribed steroids for viral infections, which may help EVALI patients even though it’s never been studied.”

Dr. Rao also said the treatment regimen at Children’s MC Dallas, which included high doses of intravenous steroids, seemed to help. But the best management approach for treatment, or long-term follow up care, has not been studied.

The report in the Annals of the American Thoracic Society said prospective studies are showing that a significant portion of patients with EVALI experience prolonged respiratory issues and cognitive and mood impairment. Dr. Rao said a common thread for many of her EVALI patients has been significant stress in their lives with school or family, which led them to vape in an attempt to reduce stress.

That was certainly the case for Ms. Bernal before her hospital admission. She had recently moved across the country for her husband’s job, was trying to buy a house, and had spent months in a hotel with three children. She vaped to cope.

But she said her mental and cognitive health has worsened. Back in Louisville, she saw a neurologist, who told her that her brain had shrunk, she said. She hasn’t found a new neurologist in Portland, Ore., where her family moved a year after the EVALI episode.

But she often finds herself overwhelmed and overstimulated with tasks that she said she never had problems with before. She tears up while talking about the newfound limitations. She struggled to find a primary care physician who could medically manage her mental health and a counselor who can understand what she’s been through with EVALI.

But, “a lot of doctors aren’t educated in it, and they don’t know how to respond or they don’t know what to do,” Ms. Bernal said. “And that makes me feel like, I guess, what I had wasn’t important.”

Ms. Bernal does have a new pulmonologist and is going in for a round of pulmonary tests soon because she often finds herself unable to breathe while completing simple tasks. She is tired of rushing to the ER. She wants answers, or some kind of treatment to help her feel normal again.

“I feel like this is my fault,” Ms. Bernal said. “Had I not smoked, I would be fine, and that’s hard to live with. Every day. Telling yourself, ‘It’s your fault.’ It’s been how many years now? And I still haven’t found peace yet. I don’t know if ever will.”

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

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>163105</fileName> <TBEID>0C049A27.SIG</TBEID> <TBUniqueIdentifier>MD_0C049A27</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20230418T142031</QCDate> <firstPublished>20230418T150307</firstPublished> <LastPublished>20230418T150307</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20230418T150307</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Lisa Gillespie</byline> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>“We’re still seeing a number of patients diagnosed with vaping disorders, but it’s not top of mind,”</metaDescription> <articlePDF/> <teaserImage/> <teaser>For many, the EVALI epidemic is a distant, pre-COVID memory.</teaser> <title>Forgotten but not gone: EVALI epidemic continues </title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">6</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">27980</term> <term>39313</term> </sections> <topics> <term canonical="true">284</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Forgotten but not gone: EVALI epidemic continues </title> <deck/> </itemMeta> <itemContent> <p>Rashelle Bernal vaped and ended up in an induced coma for a week. She was one of almost 3,000 people who were hospitalized during 2019 and early 2020 with severe lung damage from vaping and became part of what is now known as the epidemic of e-cigarette, or vaping, product use–associated lung injury (EVALI).</p> <p>For many, the EVALI epidemic is a distant, pre-COVID memory.<br/><br/>But the vaping-related injuries are still happening. And for Ms. Bernal, the aftermath is her reality. Her pulmonologist from that time described the harm from the vape ingredients as an oil spill in her lungs. Eventually, the toxins would probably clear. But she will likely wrestle with the injuries for a very long time.<br/><br/>More than 3 years later, she frequently finds herself in the emergency department.<br/><br/>“If I get sick, if there’s anything that irritates my lungs – it could be something as simple as pollen in the air – it will cause me to get like a bacterial infection or other issues, and I can’t breathe,” Ms. Ms. Bernal, now 30, said in a recent interview. “I get really winded, to the point where I’ll walk up the stairs and I feel like I just ran a mile.”<br/><br/>In 2019 and 2020, a media firestorm erupted as hospitals notified the public of outbreaks of vaping-related lung injuries. News headlines reported e-cigarettes were killing teens from Texas to the Bronx. Investigators at the U.S. <a href="https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html">Centers for Disease Control and Prevention</a> tracked most of the cases to vitamin E acetate, an additive in illicit cannabis vaping products intended to promote the metabolism of tetrahydrocannabinol (THC). The agency stopped tracking EVALI in February 2020.<br/><br/>But 2 months later, in April 2020, the agency’s <a href="https://www.cdc.gov/nchs/data/icd/vaping-announcement-final-12-09-19.pdf">National Center for Health Statistics</a> implemented a diagnostic code, U07.0, for health care professionals in the United States to diagnose EVALI for the first time. The code is also used for lung damage related to use of electronic cigarettes and “dabbing” – a method of inhaling cannabis. Damage could include inflammation of the lungs, pulmonary hemorrhage, and eosinophilic pneumonia.<br/><br/>The incidence of these diagnoses appears to have risen sharply since 2020. In the last three months of 2020, a total of 11,300 medical claims included the U07.0 code. That figure rose to 22,000 in 2021 and hit 31,600 in 2022, according to data compiled for and provided to Medscape by Komodo Health, a health care technology company that holds a database of more than 330 million U.S. patients from Medicare, Medicaid, and commercial insurers’ medical, pharmacy, and laboratory claims.<br/><br/>Harm from vaping, including EVALI, has continued.<br/><br/><span class="tag metaDescription">“We’re still seeing a number of patients diagnosed with vaping disorders, but it’s not top of mind,”</span> said Usha Periyanayagam, MD, MPH, head of clinic product and real-world evidence for Komodo and a former emergency medicine physician.<br/><br/></p> <h2>Where it started </h2> <p>Devika Rao, MD, a pediatric pulmonology specialist at UT Southwestern Medical Center, Dallas, has cared for most of her EVALI patients in the hospital, with the most recent case in early 2023. But in January, for the first time, she saw an EVALI patient in an outpatient clinic. The person had not been admitted to the hospital – like most were pre-pandemic. And like most who were seen during the pandemic, this patient had milder symptoms, not requiring intubation or take-home oxygen.</p> <p>In 2019 and the beginning of 2020, many EVALI patients who were eventually hospitalized first sought help at urgent care centers or with primary care doctors and were presumed to have pneumonia or gastroenteritis and sent home.<br/><br/>“But they got worse, and they would present to our emergency room; their chest X-rays and CT scans showed extensive lung disease,” Dr. Rao said, adding that the damage was striking among patients all under age 18. “They were short of breath. Their oxygen levels were low. They had diminished lung function. And they had a lot of GI issues like abdominal pain and weight loss from nausea and vomiting.”<br/><br/>“These overwhelming inflammatory reactions that we see with EVALI,” said Karen M. Wilson, MD, MPH, a pediatric hospitalist at the University of Rochester (N.Y.) Medical Center and a tobacco use researcher. “You might find some microvascular changes with normal inhaling of smoke or aerosol, but you’re not going to find macro changes like we see with the EVALI.”<br/><br/>In late 2019, images of the CT scans of patients with EVALI were published, grabbing the attention of Arun Kannappan, MD, an assistant professor of pulmonary sciences and critical care at the University of Colorado Anschutz School of Medicine, Aurora. Dr. Kannappan knew a patient with such severe lung damage could develop acute respiratory distress syndrome, which means a patient would be put on a ventilator because their inflamed lungs could not oxygenate blood.<br/><br/>“That confers within somewhere between 30% to 50% chance of dying; it made all of the pulmonary specialists really turn their heads to make sure that we keep a lookout for it,” said Dr. Kannappan.<br/><br/>CT scans of lungs proved to be a critical diagnostic tool for doctors. Most of the images from patients showed acute inflammation and diffuse lung damage. Ehab Ali, MD, a critical care and pulmonary disease medicine specialist in Louisville, Ky., said the damage was often spread across both lungs in many areas and appeared opaque and hazy, known as “ground glass.” COVID-19, meanwhile, appeared differently in lung scans, often with damage that was more isolated.<br/><br/>But many diseases carry a “ground glass” appearance, with many potential causes, like infections, cigarette smoke, or an autoimmune condition.<br/><br/>“Before you even talk to the patient, you can immediately put it in your mind that ‘I’m going to ask this patient if they vape,’ when I see the distribution of ground glass appearance,” Dr. Ali said.<br/><br/>Dr. Ali said other factors, like the age of the patient – about three-quarters of EVALI patients are under age 34, according to the CDC – would spur him to ask about vaping. But because so many patients were young, discerning vape usage wasn’t always easy.  <br/><br/>“When you’re talking to teenagers, if you ask them upon admission, with the parents in the room, they’re going say ‘no,’ ” said Rachel Boykan, MD, a pediatric hospitalist at Stony Brook (N.Y.) Children’s. She added that her hospital is still seeing cases.<br/><br/>Dr. Rao said it often takes two to three people asking a patient about any vape usage before they confess.<br/><br/>Ms. Bernal, who was 27 at the time of her hospital admission for EVALI, said she bought vapes with THC at a retail shop in California. She’d been a traditional marijuana smoker, using the leaf product, but switched when someone told her it was healthier to vape THC than inhale smoke from burned marijuana leaves into her lungs. “I thought this was safe.”<br/><br/>Dr. Rao and her colleagues <a href="https://onlinelibrary.wiley.com/doi/10.1002/ppul.26283">recently published a study</a> of 41 teenage patients with EVALI who were seen at Children’s Medical Center Dallas between December 2018 and July 2021. All but one reported using e-cigarettes containing THC, and the CDC in its most recent report from February 2020 said about 80% of patients had used vapes containing THC.<br/><br/>The CDC also found that vitamin E acetate, an oily substance that allows THC to travel from the lungs to the brain quickly and an ingredient used in the food and cosmetics industries, was found in many of the lungs of EVALI patients, though not all.<br/><br/></p> <h2>The aftermath </h2> <p>The outcomes of the thousands of patients who had EVALI – and those who may still be developing it – are largely untracked.</p> <p>Bonnie Halpern-Felsher, PhD, director at the Stanford (Calif.) Reach Lab that bears her name and a researcher on tobacco in youth, said she and many of her colleagues are frustrated that the CDC is not continuing to collect data on EVALI.<br/><br/>“I know a lot of colleagues who’ve said that they’re still seeing EVALI, but because of COVID-19 they stopped collecting the data. And that’s been very frustrating because it’s hard to say whether the kinds of lung issues you’re having are related to e-cigarettes, generally, or EVALI,” Dr. Halpern-Felsher said.<br/><br/>Researchers and doctors affiliated with the American Thoracic Society <span class="Hyperlink"><a href="https://www.atsjournals.org/doi/full/10.1513/AnnalsATS.202209-796ST">published a report</a></span> with solutions on how to better track EVALI. They recommended that a national case registry and biorepository be created.<br/><br/>Doctors also worry that many cases were missed. Dr. Boykan said that while protocol dictated nurses and other clinicians ask about a history of vaping – a key part of EVALI diagnosis – many did not. Dr. Ali, the Louisville critical care physician, said EVALI symptoms of nausea, cough, and fever are associated with viral infections.<br/><br/>“I’m sure that some of these cases might be discharged from the emergency room as a virus,” Dr. Ali said. “Most of the time patients would get prescribed steroids for viral infections, which may help EVALI patients even though it’s never been studied.”<br/><br/>Dr. Rao also said the treatment regimen at Children’s MC Dallas, which included high doses of intravenous steroids, seemed to help. But the best management approach for treatment, or long-term follow up care, has not been studied.<br/><br/>The report in the Annals of the American Thoracic Society said prospective studies are showing that a significant portion of patients with EVALI experience prolonged respiratory issues and cognitive and mood impairment. Dr. Rao said a common thread for many of her EVALI patients has been significant stress in their lives with school or family, which led them to vape in an attempt to reduce stress.<br/><br/>That was certainly the case for Ms. Bernal before her hospital admission. She had recently moved across the country for her husband’s job, was trying to buy a house, and had spent months in a hotel with three children. She vaped to cope.<br/><br/>But she said her mental and cognitive health has worsened. Back in Louisville, she saw a neurologist, who told her that her brain had shrunk, she said. She hasn’t found a new neurologist in Portland, Ore., where her family moved a year after the EVALI episode.<br/><br/>But she often finds herself overwhelmed and overstimulated with tasks that she said she never had problems with before. She tears up while talking about the newfound limitations. She struggled to find a primary care physician who could medically manage her mental health and a counselor who can understand what she’s been through with EVALI.<br/><br/>But, “a lot of doctors aren’t educated in it, and they don’t know how to respond or they don’t know what to do,” Ms. Bernal said. “And that makes me feel like, I guess, what I had wasn’t important.”<br/><br/>Ms. Bernal does have a new pulmonologist and is going in for a round of pulmonary tests soon because she often finds herself unable to breathe while completing simple tasks. She is tired of rushing to the ER. She wants answers, or some kind of treatment to help her feel normal again.<br/><br/>“I feel like this is my fault,” Ms. Bernal said. “Had I not smoked, I would be fine, and that’s hard to live with. Every day. Telling yourself, ‘It’s your fault.’ It’s been how many years now? And I still haven’t found peace yet. I don’t know if ever will.”<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/990888">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

FDA: Newborns protected by whooping cough vaccine

Article Type
Changed
Mon, 10/10/2022 - 09:35

The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.

The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old. The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.

FDA_icon3_web.jpg

“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”

Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.

The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.

Boostrix is administered as a single 0.5-mL dose.

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

Publications
Topics
Sections

The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.

The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old. The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.

FDA_icon3_web.jpg

“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”

Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.

The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.

Boostrix is administered as a single 0.5-mL dose.

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

The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.

The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old. The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.

FDA_icon3_web.jpg

“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”

Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.

The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.

Boostrix is administered as a single 0.5-mL dose.

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

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>160414</fileName> <TBEID>0C045C02.SIG</TBEID> <TBUniqueIdentifier>MD_0C045C02</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20221010T092446</QCDate> <firstPublished>20221010T092939</firstPublished> <LastPublished>20221010T092939</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20221010T092939</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Lisa Gillespie</byline> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old.</metaDescription> <articlePDF/> <teaserImage>170371</teaserImage> <teaser>“This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.</teaser> <title>FDA: Newborns protected by whooping cough vaccine</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">23</term> <term>25</term> <term>15</term> <term>20</term> <term>6</term> </publications> <sections> <term canonical="true">27979</term> <term>39313</term> </sections> <topics> <term canonical="true">262</term> <term>280</term> <term>322</term> <term>311</term> <term>271</term> <term>284</term> <term>50347</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24005fb2.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA: Newborns protected by whooping cough vaccine</title> <deck/> </itemMeta> <itemContent> <p>The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.</p> <p><span class="tag metaDescription">The federal agency on Oct. 7 approved Boostrix for use during the last 3 months of pregnancy to prevent pertussis in infants under 2 months old.</span> The vaccine, manufactured by GlaxoSmithKline, was previously approved among pregnant people for their own protection.<br/><br/>[[{"fid":"170371","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"FDA icon","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”<br/><br/>Pertussis is a highly contagious respiratory tract infection caused by the bacterium <em>Bordetella pertussis</em>. Most cases that result in hospitalizations and death are among infants within 2 months of birth.<br/><br/>The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.<br/><br/>Boostrix is administered as a single 0.5-mL dose.</p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/982107">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Reduced-lactose infant formula related to higher risk of obesity later

Article Type
Changed
Wed, 09/07/2022 - 07:37

Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.

Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.

Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.

“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”

Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.

“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.

Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.

Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.

Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).

Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.

Williams_Tara_FL_web.jpg
%3Cp%3EDr.%20Tara%20Williams%3C%2Fp%3E


She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.

“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.

Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.

In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.

Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.

“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.

Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.

“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”

Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.

Publications
Topics
Sections

Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.

Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.

Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.

“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”

Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.

“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.

Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.

Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.

Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).

Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.

Williams_Tara_FL_web.jpg
%3Cp%3EDr.%20Tara%20Williams%3C%2Fp%3E


She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.

“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.

Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.

In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.

Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.

“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.

Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.

“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”

Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.

Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.

Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.

Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.

“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”

Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.

“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.

Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.

Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.

Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).

Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.

Williams_Tara_FL_web.jpg
%3Cp%3EDr.%20Tara%20Williams%3C%2Fp%3E


She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.

“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.

Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.

In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.

Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.

“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.

Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.

“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”

Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>159802</fileName> <TBEID>0C044FEF.SIG</TBEID> <TBUniqueIdentifier>MD_0C044FEF</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20220906T123706</QCDate> <firstPublished>20220906T164350</firstPublished> <LastPublished>20220906T164350</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20220906T164350</CMSDate> <articleSource>FROM AMERICAN JOURNAL OF CLINICAL NUTRITION</articleSource> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText>MDedge News </bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babi</metaDescription> <articlePDF/> <teaserImage/> <teaser>“This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”</teaser> <title>Reduced-lactose infant formula related to higher risk of obesity later</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FP</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement>Copyright 2017 Frontline Medical News</copyrightStatement> </publicationData> <publicationData> <publicationCode>PN</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">25</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> </sections> <topics> <term canonical="true">261</term> <term>271</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Reduced-lactose infant formula related to higher risk of obesity later</title> <deck/> </itemMeta> <itemContent> <p>Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new <span class="Hyperlink"><a href="https://academic.oup.com/ajcn/advance-article-abstract/doi/10.1093/ajcn/nqac173/6673129?redirectedFrom=fulltext">research</a></span> shows. </p> <p>Infants who drink <span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6121544/">infant formula</a></span> instead of <span class="Hyperlink"><a href="https://pubmed.ncbi.nlm.nih.gov/28398851/">breast milk</a></span> already carry an <span class="Hyperlink"><a href="https://publications.aap.org/pediatrics/article/129/3/e827/31785/Breastfeeding-and-the-Use-of-Human-Milk?autologincheck=redirected?nfToken=00000000-0000-0000-0000-000000000000">increased risk</a></span> of obesity. But the new study, published in The <span class="Hyperlink">American Journal of Clinical Nutrition</span>, found a difference in types of formula and obesity outcomes for children. <br/><br/>Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; <em>P</em> = .02) of being obese by age 2 than infants who received regular cow’s milk formula. <br/><br/>“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”<br/><br/>Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.<br/><br/>“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is <span class="Hyperlink">lactose intolerant</span>, but they are not,” Dr. Corkins said. <br/><br/>Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC. <br/><br/>Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic. <br/><br/>Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; <em>P</em> = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; <em>P</em> = .01).<br/><br/>Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain. <br/><br/>She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity. <br/><br/>“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood. <br/><br/>Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized. <br/><br/>In addition, emerging research shows corn syrup may act differently from other sugars in the <span class="Hyperlink"><a href="https://physoc.onlinelibrary.wiley.com/doi/full/10.1113/JP280034">gut microbiome</a></span> and as it is metabolized in the liver, leading to <span class="Hyperlink"><a href="https://www.princeton.edu/news/2010/03/22/sweet-problem-princeton-researchers-find-high-fructose-corn-syrup-prompts">weight gain</a></span>. <br/><br/>Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for <span class="Hyperlink"><a href="https://www.fns.usda.gov/wic/eligibility-and-coverage-rates-2018">WIC</a></span>, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents. <br/><br/>“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study. <br/><br/>Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula. <br/><br/>“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”<br/><br/>Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.<span class="end"/> </p> <p class="email">pdnews@mdedge.com</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM AMERICAN JOURNAL OF CLINICAL NUTRITION

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

How racist is your algorithm?

Article Type
Changed
Wed, 07/06/2022 - 14:42

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

 

 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

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

Publications
Topics
Sections

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

 

 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

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

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

 

 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

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

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>158859</fileName> <TBEID>0C043B17.SIG</TBEID> <TBUniqueIdentifier>MD_0C043B17</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20220705T161135</QCDate> <firstPublished>20220706T094134</firstPublished> <LastPublished>20220706T094134</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20220706T094134</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank</metaDescription> <articlePDF/> <teaserImage/> <teaser>The AAP recently published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy.</teaser> <title>How racist is your algorithm?</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FP</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement>Copyright 2017 Frontline Medical News</copyrightStatement> </publicationData> <publicationData> <publicationCode>IM</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> <publicationData> <publicationCode>PN</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term>15</term> <term>21</term> <term canonical="true">25</term> </publications> <sections> <term canonical="true">39313</term> <term>27980</term> </sections> <topics> <term canonical="true">66772</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>How racist is your algorithm?</title> <deck/> </itemMeta> <itemContent> <p>Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.</p> <p>Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.<br/><br/>“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.<br/><br/>Dr. Chomilo is referring to the <a href="https://www.medscape.com/answers/984358-200083/how-is-the-glomerular-filtration-rate-gfr-calculated-in-the-workup-for-chronic-kidney-disease-ckd-in-children">estimated glomerular filtration rate</a> (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.<br/><br/>The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.<br/><br/>The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.<br/><br/>“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.<br/><br/>Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.<br/><br/>In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.<br/><br/>The eGFR is perhaps the best example of a calculator that’s gone through <a href="https://www.nejm.org/doi/full/10.1056/NEJMms2004740">the process</a>: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.<br/><br/>But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, <a href="https://www.kff.org/racial-equity-and-health-policy/issue-brief/use-of-race-in-clinical-diagnosis-and-decision-making-overview-and-implications/">race</a> does not equal <a href="https://www.medscape.com/viewarticle/584366_12">genetics</a> or any other <a href="https://www.nejm.org/doi/full/10.1056/NEJMms2029562">measurable</a> <a href="https://www.medscape.com/viewarticle/926549">datapoint</a>.<br/><br/>In a study <a href="https://jamanetwork.com/journals/jamapediatrics/article-abstract/2792739?utm_campaign=articlePDF&amp;utm_medium=articlePDFlink&amp;utm_source=articlePDF&amp;utm_content=jamapediatrics.2022.1641">published</a> in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.<br/><br/></p> <h2>Waiting for alternatives</h2> <p>The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.</p> <p>Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.<br/><br/>“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.<br/><br/>The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.<br/><br/>The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.<br/><br/>“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”<br/><br/>Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.<br/><br/>Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.<br/><br/>“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.<br/><br/>Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.<br/><br/>In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.<br/><br/>“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”<br/><br/>For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.<br/><br/>“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”<br/><br/>Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.<br/><br/>For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.<br/><br/>“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/976520?src=#vp_1">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Roe v. Wade reversal would rock ob.gyn. residencies

Article Type
Changed
Thu, 05/05/2022 - 12:27
Display Headline
Roe v. Wade reversal would rock ob.gyn. residencies

A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.

On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.

Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.

Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”

The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”

Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.

Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.

Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
 

A glimpse at the future

The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.

The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.

“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”

But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”

She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available. 
 

 

 

Spillover effect

Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.

“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”

Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.

“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.

Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.

“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”

Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.

Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
 

A looming ‘pipeline problem’

There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.

Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.

Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.

“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”

States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.

As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”

 

 

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

Publications
Topics
Sections

A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.

On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.

Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.

Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”

The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”

Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.

Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.

Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
 

A glimpse at the future

The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.

The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.

“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”

But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”

She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available. 
 

 

 

Spillover effect

Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.

“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”

Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.

“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.

Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.

“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”

Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.

Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
 

A looming ‘pipeline problem’

There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.

Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.

Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.

“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”

States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.

As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”

 

 

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

A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.

On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.

Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.

Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”

The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”

Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.

Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.

Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
 

A glimpse at the future

The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.

The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.

“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”

But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”

She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available. 
 

 

 

Spillover effect

Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.

“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”

Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.

“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.

Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.

“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”

Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.

Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
 

A looming ‘pipeline problem’

There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.

Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.

Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.

“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”

States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.

As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”

 

 

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

Publications
Publications
Topics
Article Type
Display Headline
Roe v. Wade reversal would rock ob.gyn. residencies
Display Headline
Roe v. Wade reversal would rock ob.gyn. residencies
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>157756</fileName> <TBEID>0C0424CF.SIG</TBEID> <TBUniqueIdentifier>MD_0C0424CF</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20220505T121451</QCDate> <firstPublished>20220505T121538</firstPublished> <LastPublished>20220505T121538</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20220505T121538</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Lisa Gillespie</byline> <bylineText>LISA GILLESPIE</bylineText> <bylineFull>LISA GILLESPIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from l</metaDescription> <articlePDF/> <teaserImage/> <teaser>The loss of <em>Roe</em> “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training.”</teaser> <title>Roe v. Wade reversal would rock ob.gyn. residencies</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FP</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement>Copyright 2017 Frontline Medical News</copyrightStatement> </publicationData> <publicationData> <publicationCode>OB</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">23</term> </publications> <sections> <term>27980</term> <term canonical="true">39313</term> </sections> <topics> <term>38029</term> <term>322</term> <term canonical="true">262</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Roe v. Wade reversal would rock ob.gyn. residencies</title> <deck/> </itemMeta> <itemContent> <p>A decision by the U.S. Supreme Court to overturn <em>Roe v. Wade</em> could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.</p> <p>On Monday, Politico <a href="https://www.politico.com/news/2022/05/02/supreme-court-abortion-draft-opinion-00029473">published a leaked initial draft</a> majority opinion written by Justice Samuel Alito, which declares <em>Roe</em> unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the <a href="https://www.guttmacher.org/article/2021/10/26-states-are-certain-or-likely-ban-abortion-without-roe-heres-which-ones-and-why">procedure before viability</a>, which is defined as 24-26 weeks into a pregnancy.<br/><br/>Loss of federal protections provided by <em>Roe</em> would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.<br/><br/>Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”<br/><br/>The loss of <em>Roe</em> “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”<br/><br/>Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of <em>Roe</em>. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the <a href="https://www.guttmacher.org/article/2021/10/26-states-are-certain-or-likely-ban-abortion-without-roe-heres-which-ones-and-why">Guttmacher</a> Institute.<br/><br/>Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling <a href="https://journals.lww.com/greenjournal/Abstract/9900/Projected_Implications_of_Overturning_Roe_v_Wade.449.aspx">2,638 residents as of 2022,</a> according to a study published in <a href="https://journals.lww.com/greenjournal/Abstract/9900/Projected_Implications_of_Overturning_Roe_v_Wade.449.aspx">April</a> by researchers at the UCLA.<br/><br/>Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.<br/><br/></p> <h2>A glimpse at the future </h2> <p>The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.</p> <p><a href="https://ryanprogram.org/home/ryan-program-technical-assistance/">The Ryan Program</a> has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.<br/><br/>“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”<br/><br/>But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”<br/><br/>She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available. <br/><br/></p> <h2>Spillover effect </h2> <p>Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and <a href="https://www.medscape.com/viewarticle/971319">Arizona</a> – states that have <a href="https://www.npr.org/2022/05/03/1096504251/oklahoma-governor-texas-style-abortion-ban">severely restricted abortion rights</a>.</p> <p>“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”<br/><br/>Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.<br/><br/>“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.<br/><br/>Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.<br/><br/>“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”<br/><br/>Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.<br/><br/>Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.<br/><br/></p> <h2>A looming ‘pipeline problem’</h2> <p>There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790325?appid=scweb">published</a></span> in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.</p> <p>Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.<br/><br/>Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.<br/><br/>“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”<br/><br/>States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.<br/><br/>As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/973411">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article