Medicare Advantage Plans Not Always Advantageous

Article Type
Changed
Tue, 06/25/2024 - 09:23

While Medicare Advantage (MA) plans are marketed as providing more generous benefits than traditional Medicare (TM), differences in the financial burden between beneficiaries switching to MA and staying with TM, are minimal, a longitudinal cohort analysis found.

In fact, according to a study by Sungchul Park, PhD, a health economist at Korea University in Seoul, and colleagues, the estimated annual out-of-pocket spending when switching to MA was $168 higher than staying in TM. That amounted to a 10.5% relative increase based on baseline out-of-pocket spending of $1597 annually among switchers, ranging widely, however, from a $133 decrease to a $469 increase. And for some, MA enrollment was associated with a higher likelihood of catastrophic financial burden.

“Our findings contrast with the notion that MA’s apparently more generous health insurance benefits lead to financial savings for enrollees,” Dr. Park and associates wrote in Annals of Internal Medicine.
 

The study

The analysis looked at costs for 7054 TM stayers and 1544 TM-to-MA switchers from the 2014-2020 Medical Expenditure Panel Survey, focusing on a cohort in which 18% of TM-covered individuals in year 1 switched to MA in year 2.

Comparative financial outcome measures included individual healthcare costs (out-of-pocket spending/cost sharing), financial burden (high/catastrophic), and subjective financial hardship (difficulty paying medical bills).

Although the overall out-of-pocket differences for MA were minimal and amounted to less than 1% of total healthcare expenses, MA was associated with a greater financial burden in vulnerable, especially in low-income populations. For every 100 beneficiaries with family incomes below 200% of the federal poverty level, one to six more switchers faced a catastrophic financial burden, with their out-of-pocket costs consuming more than 40% of household income in the year after switching.

The gap between the perception of lower costs and reality may be caused by a substantially heavier cost-sharing burden for certain services in MA plans, Dr. Park and associates pointed out. While MA enrollees generally paid less in some studies than the Part A hospital deductible for TM for inpatient stays of 3 days, they were more likely to face higher cost sharing for stays exceeding 7 days

Furthermore, whereas TM covers home health services without cost sharing, some MA plans have copayments. In addition, out-of-network health services can cost more. MA enrollees paid an average of $9 more for mental health services than for other in-network services and often encountered limited access to in-network providers. According to a 2021 study, only 18.2% of mental health professionals, 34.4% of cardiologists, 50.0% of psychiatrists, and 57.9% of primary care providers were included in MA networks,

An accompanying editorial noted that private MA plans will reap $83 billion in overpayments from U.S. taxpayers this year, according to Congress’s Medicare Payment Advisory Commission.

And as the data from Dr. Park and colleagues reveal, switchers don’t get much financial protection, according to primary care physician and healthcare researcher Steffi J. Woolhandler, MD, MPH, and internist David U. Himmelstein, MD, both of City University of New York at Hunter College in New York City.

“Medicare Advantage looks good when you’re healthy and don’t need much care. But when you need coverage, it often fails, leaving you with big bills and narrow choices for care,” Dr. Woolhandler said in an interview.

So how do these findings square with insurers’ hard-sell claims and enrollees’ perceptions that MA cuts out-of-pocket costs? “The likeliest explanation is that MA insurers have structured their benefits to advantage low-cost (that is, profitable) enrollees and disadvantage those requiring expensive care,” the editorial commentators wrote. For beneficiaries on inexpensive medications, MA plans would be a financial win. “But for patients requiring expensive chemotherapies, the 20% coinsurance that most MA plans charge could be financially ruinous.”

Commenting on the study but not involved in it, David A. Lipschutz, JD, LLB, associate director of the Center for Medicare Advocacy in Washington, DC, called the study an important one that provides more evidence that significant overpayments to MA plans don’t translate to better financial protections for plan enrollees, particularly lower-income individuals. “While there has been some recent movement to hold plans more accountable for providing necessary care, much more impactful action by policymakers is required to mitigate the harms of the growing privatization of the Medicare program,” he said. “MA overpayments could be redistributed to traditional Medicare in order to enrich all Medicare beneficiaries instead of just insurance companies.”

This study was supported by the National Research Foundation of Korea. Dr. Park disclosed no competing interests. One study coauthor reported support from government and not-for-profit research-funding bodies. Editorialists Dr. Woolhandler and Dr. Himmelstein had no competing interests to declare. Dr. Lipschutz disclosed Medicare advocacy work.

Publications
Topics
Sections

While Medicare Advantage (MA) plans are marketed as providing more generous benefits than traditional Medicare (TM), differences in the financial burden between beneficiaries switching to MA and staying with TM, are minimal, a longitudinal cohort analysis found.

In fact, according to a study by Sungchul Park, PhD, a health economist at Korea University in Seoul, and colleagues, the estimated annual out-of-pocket spending when switching to MA was $168 higher than staying in TM. That amounted to a 10.5% relative increase based on baseline out-of-pocket spending of $1597 annually among switchers, ranging widely, however, from a $133 decrease to a $469 increase. And for some, MA enrollment was associated with a higher likelihood of catastrophic financial burden.

“Our findings contrast with the notion that MA’s apparently more generous health insurance benefits lead to financial savings for enrollees,” Dr. Park and associates wrote in Annals of Internal Medicine.
 

The study

The analysis looked at costs for 7054 TM stayers and 1544 TM-to-MA switchers from the 2014-2020 Medical Expenditure Panel Survey, focusing on a cohort in which 18% of TM-covered individuals in year 1 switched to MA in year 2.

Comparative financial outcome measures included individual healthcare costs (out-of-pocket spending/cost sharing), financial burden (high/catastrophic), and subjective financial hardship (difficulty paying medical bills).

Although the overall out-of-pocket differences for MA were minimal and amounted to less than 1% of total healthcare expenses, MA was associated with a greater financial burden in vulnerable, especially in low-income populations. For every 100 beneficiaries with family incomes below 200% of the federal poverty level, one to six more switchers faced a catastrophic financial burden, with their out-of-pocket costs consuming more than 40% of household income in the year after switching.

The gap between the perception of lower costs and reality may be caused by a substantially heavier cost-sharing burden for certain services in MA plans, Dr. Park and associates pointed out. While MA enrollees generally paid less in some studies than the Part A hospital deductible for TM for inpatient stays of 3 days, they were more likely to face higher cost sharing for stays exceeding 7 days

Furthermore, whereas TM covers home health services without cost sharing, some MA plans have copayments. In addition, out-of-network health services can cost more. MA enrollees paid an average of $9 more for mental health services than for other in-network services and often encountered limited access to in-network providers. According to a 2021 study, only 18.2% of mental health professionals, 34.4% of cardiologists, 50.0% of psychiatrists, and 57.9% of primary care providers were included in MA networks,

An accompanying editorial noted that private MA plans will reap $83 billion in overpayments from U.S. taxpayers this year, according to Congress’s Medicare Payment Advisory Commission.

And as the data from Dr. Park and colleagues reveal, switchers don’t get much financial protection, according to primary care physician and healthcare researcher Steffi J. Woolhandler, MD, MPH, and internist David U. Himmelstein, MD, both of City University of New York at Hunter College in New York City.

“Medicare Advantage looks good when you’re healthy and don’t need much care. But when you need coverage, it often fails, leaving you with big bills and narrow choices for care,” Dr. Woolhandler said in an interview.

So how do these findings square with insurers’ hard-sell claims and enrollees’ perceptions that MA cuts out-of-pocket costs? “The likeliest explanation is that MA insurers have structured their benefits to advantage low-cost (that is, profitable) enrollees and disadvantage those requiring expensive care,” the editorial commentators wrote. For beneficiaries on inexpensive medications, MA plans would be a financial win. “But for patients requiring expensive chemotherapies, the 20% coinsurance that most MA plans charge could be financially ruinous.”

Commenting on the study but not involved in it, David A. Lipschutz, JD, LLB, associate director of the Center for Medicare Advocacy in Washington, DC, called the study an important one that provides more evidence that significant overpayments to MA plans don’t translate to better financial protections for plan enrollees, particularly lower-income individuals. “While there has been some recent movement to hold plans more accountable for providing necessary care, much more impactful action by policymakers is required to mitigate the harms of the growing privatization of the Medicare program,” he said. “MA overpayments could be redistributed to traditional Medicare in order to enrich all Medicare beneficiaries instead of just insurance companies.”

This study was supported by the National Research Foundation of Korea. Dr. Park disclosed no competing interests. One study coauthor reported support from government and not-for-profit research-funding bodies. Editorialists Dr. Woolhandler and Dr. Himmelstein had no competing interests to declare. Dr. Lipschutz disclosed Medicare advocacy work.

While Medicare Advantage (MA) plans are marketed as providing more generous benefits than traditional Medicare (TM), differences in the financial burden between beneficiaries switching to MA and staying with TM, are minimal, a longitudinal cohort analysis found.

In fact, according to a study by Sungchul Park, PhD, a health economist at Korea University in Seoul, and colleagues, the estimated annual out-of-pocket spending when switching to MA was $168 higher than staying in TM. That amounted to a 10.5% relative increase based on baseline out-of-pocket spending of $1597 annually among switchers, ranging widely, however, from a $133 decrease to a $469 increase. And for some, MA enrollment was associated with a higher likelihood of catastrophic financial burden.

“Our findings contrast with the notion that MA’s apparently more generous health insurance benefits lead to financial savings for enrollees,” Dr. Park and associates wrote in Annals of Internal Medicine.
 

The study

The analysis looked at costs for 7054 TM stayers and 1544 TM-to-MA switchers from the 2014-2020 Medical Expenditure Panel Survey, focusing on a cohort in which 18% of TM-covered individuals in year 1 switched to MA in year 2.

Comparative financial outcome measures included individual healthcare costs (out-of-pocket spending/cost sharing), financial burden (high/catastrophic), and subjective financial hardship (difficulty paying medical bills).

Although the overall out-of-pocket differences for MA were minimal and amounted to less than 1% of total healthcare expenses, MA was associated with a greater financial burden in vulnerable, especially in low-income populations. For every 100 beneficiaries with family incomes below 200% of the federal poverty level, one to six more switchers faced a catastrophic financial burden, with their out-of-pocket costs consuming more than 40% of household income in the year after switching.

The gap between the perception of lower costs and reality may be caused by a substantially heavier cost-sharing burden for certain services in MA plans, Dr. Park and associates pointed out. While MA enrollees generally paid less in some studies than the Part A hospital deductible for TM for inpatient stays of 3 days, they were more likely to face higher cost sharing for stays exceeding 7 days

Furthermore, whereas TM covers home health services without cost sharing, some MA plans have copayments. In addition, out-of-network health services can cost more. MA enrollees paid an average of $9 more for mental health services than for other in-network services and often encountered limited access to in-network providers. According to a 2021 study, only 18.2% of mental health professionals, 34.4% of cardiologists, 50.0% of psychiatrists, and 57.9% of primary care providers were included in MA networks,

An accompanying editorial noted that private MA plans will reap $83 billion in overpayments from U.S. taxpayers this year, according to Congress’s Medicare Payment Advisory Commission.

And as the data from Dr. Park and colleagues reveal, switchers don’t get much financial protection, according to primary care physician and healthcare researcher Steffi J. Woolhandler, MD, MPH, and internist David U. Himmelstein, MD, both of City University of New York at Hunter College in New York City.

“Medicare Advantage looks good when you’re healthy and don’t need much care. But when you need coverage, it often fails, leaving you with big bills and narrow choices for care,” Dr. Woolhandler said in an interview.

So how do these findings square with insurers’ hard-sell claims and enrollees’ perceptions that MA cuts out-of-pocket costs? “The likeliest explanation is that MA insurers have structured their benefits to advantage low-cost (that is, profitable) enrollees and disadvantage those requiring expensive care,” the editorial commentators wrote. For beneficiaries on inexpensive medications, MA plans would be a financial win. “But for patients requiring expensive chemotherapies, the 20% coinsurance that most MA plans charge could be financially ruinous.”

Commenting on the study but not involved in it, David A. Lipschutz, JD, LLB, associate director of the Center for Medicare Advocacy in Washington, DC, called the study an important one that provides more evidence that significant overpayments to MA plans don’t translate to better financial protections for plan enrollees, particularly lower-income individuals. “While there has been some recent movement to hold plans more accountable for providing necessary care, much more impactful action by policymakers is required to mitigate the harms of the growing privatization of the Medicare program,” he said. “MA overpayments could be redistributed to traditional Medicare in order to enrich all Medicare beneficiaries instead of just insurance companies.”

This study was supported by the National Research Foundation of Korea. Dr. Park disclosed no competing interests. One study coauthor reported support from government and not-for-profit research-funding bodies. Editorialists Dr. Woolhandler and Dr. Himmelstein had no competing interests to declare. Dr. Lipschutz disclosed Medicare advocacy work.

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>168513</fileName> <TBEID>0C050B40.SIG</TBEID> <TBUniqueIdentifier>MD_0C050B40</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Medicare Advantage can cost more</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240624T115958</QCDate> <firstPublished>20240624T120138</firstPublished> <LastPublished>20240624T120138</LastPublished> <pubStatus qcode="stat:"/> <embargoDate>20240624T170000</embargoDate> <killDate/> <CMSDate>20240624T170000</CMSDate> <articleSource>FROM ANNALS OF INTERNAL MEDICINE</articleSource> <facebookInfo/> <meetingNumber>na</meetingNumber> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</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>While Medicare Advantage (MA) plans are marketed as providing more generous benefits than traditional Medicare (TM), differences in the financial burden between</metaDescription> <articlePDF/> <teaserImage/> <teaser>Enrollees who switched from traditional Medicare to Medicare Advantage saw little savings and reduced accessibility of specialty care.</teaser> <title>Medicare Advantage Plans Not Always Advantageous</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>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>cpn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>skin</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>hemn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>5</term> <term>6</term> <term>34</term> <term>9</term> <term>13</term> <term>15</term> <term canonical="true">21</term> <term>18</term> <term>23</term> <term>31</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">38029</term> <term>278</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Medicare Advantage Plans Not Always Advantageous</title> <deck/> </itemMeta> <itemContent> <p>While Medicare Advantage (MA) plans are marketed as providing more generous benefits than traditional Medicare (TM), differences in the financial burden between beneficiaries switching to MA and staying with TM, are minimal, a longitudinal cohort analysis found. </p> <p>In fact, according to a study by Sungchul Park, PhD, a health economist at Korea University in Seoul, and colleagues, the estimated annual out-of-pocket spending when switching to MA was $168 higher than staying in TM. That amounted to a 10.5% relative increase based on baseline out-of-pocket spending of $1597 annually among switchers, ranging widely, however, from a $133 decrease to a $469 increase. And for some, MA enrollment was associated with a higher likelihood of catastrophic financial burden. <br/><br/>“Our findings contrast with the notion that MA’s apparently more generous health insurance benefits lead to financial savings for enrollees,” Dr. Park and associates wrote in <em>Annals of Internal Medicine</em>. <br/><br/></p> <h2>The study</h2> <p>The analysis looked at costs for 7054 TM stayers and 1544 TM-to-MA switchers from the 2014-2020 Medical Expenditure Panel Survey, focusing on a cohort in which 18% of TM-covered individuals in year 1 switched to MA in year 2.</p> <p>Comparative financial outcome measures included individual healthcare costs (out-of-pocket spending/cost sharing), financial burden (high/catastrophic), and subjective financial hardship (difficulty paying medical bills). <br/><br/>Although the overall out-of-pocket differences for MA were minimal and amounted to less than 1% of total healthcare expenses, MA was associated with a greater financial burden in vulnerable, especially in low-income populations. For every 100 beneficiaries with family incomes below 200% of the federal poverty level, one to six more switchers faced a catastrophic financial burden, with their out-of-pocket costs consuming more than 40% of household income in the year after switching.<br/><br/>The gap between the perception of lower costs and reality may be caused by a substantially heavier cost-sharing burden for certain services in MA plans, Dr. Park and associates pointed out. While MA enrollees generally paid less in some studies than the Part A hospital deductible for TM for inpatient stays of 3 days, they were more likely to face higher cost sharing for stays exceeding 7 days <br/><br/>Furthermore, whereas TM covers home health services without cost sharing, some MA plans have copayments. In addition, out-of-network health services can cost more. MA enrollees paid an average of $9 more for mental health services than for other in-network services and often encountered limited access to in-network providers. According to a <span class="Hyperlink"><a href="https://link.springer.com/article/10.1007/s11606-020-06534-2">2021 study</a>,</span> only 18.2% of mental health professionals, 34.4% of cardiologists, 50.0% of psychiatrists, and 57.9% of primary care providers were included in MA networks, <br/><br/>An accompanying editorial noted that private MA plans will reap $83 billion in overpayments from U.S. taxpayers this year, according to Congress’s <a href="https://www.medpac.gov/document/march-2024-report-to-the-congress-medicare-payment-policy/">Medicare Payment Advisory Commission</a>.<br/><br/>And as the data from Dr. Park and colleagues reveal, switchers don’t get much financial protection, according to primary care physician and healthcare researcher Steffi J. Woolhandler, MD, MPH, and internist David U. Himmelstein, MD, both of City University of New York at Hunter College in New York City. <br/><br/>“Medicare Advantage looks good when you’re healthy and don’t need much care. But when you need coverage, it often fails, leaving you with big bills and narrow choices for care,” Dr. Woolhandler said in an interview.<br/><br/>So how do these findings square with insurers’ hard-sell claims and enrollees’ perceptions that MA cuts out-of-pocket costs? “The likeliest explanation is that MA insurers have structured their benefits to advantage low-cost (that is, profitable) enrollees and disadvantage those requiring expensive care,” the editorial commentators wrote. For beneficiaries on inexpensive medications, MA plans would be a financial win. “But for patients requiring expensive chemotherapies, the 20% coinsurance that most MA plans charge could be financially ruinous.”<br/><br/>Commenting on the study but not involved in it, David A. Lipschutz, JD, LLB, associate director of the Center for Medicare Advocacy in Washington, DC, called the study an important one that provides more evidence that significant overpayments to MA plans don’t translate to better financial protections for plan enrollees, particularly lower-income individuals. “While there has been some recent movement to hold plans more accountable for providing necessary care, much more impactful action by policymakers is required to mitigate the harms of the growing privatization of the Medicare program,” he said. “MA overpayments could be redistributed to traditional Medicare in order to enrich all Medicare beneficiaries instead of just insurance companies.”<br/><br/>This study was supported by the National Research Foundation of Korea. Dr. Park disclosed no competing interests. One study coauthor reported support from government and not-for-profit research-funding bodies. Editorialists Dr. Woolhandler and Dr. Himmelstein had no competing interests to declare. Dr. Lipschutz disclosed Medicare advocacy work.<span class="end"/> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM ANNALS OF INTERNAL MEDICINE

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

Metformin Gets a Reproductive Reprieve — For Diabetic Moms and Dads Alike

Article Type
Changed
Fri, 06/21/2024 - 11:47

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

heprogaswethedrovutagivespinophakufrawuvokishethaslocowospubruwraslekobroprubrephohe
Dr. Yu-Han Chiu


“On the one hand, metformin can cross the placenta and might directly affect the fetus. On the other hand, poor blood sugar control is a risk factor for birth defects,” she continued. “Insulin in combination with metformin might control blood sugar better than using insulin alone, which may lower the risk of birth defects.”

Switched to insulin monotherapy or prescribed additional insulin within 90 days of their last menstrual period, mothers were assessed for nonchromosomal fetal malformations and nonlive births, spontaneous abortion, and termination. Continuing metformin or adding insulin to metformin in early pregnancy resulted in little to no increased risk for major malformations in infants.

The estimated risk for nonlive birth was 32.7% with insulin monotherapy and 34.3% with insulin plus metformin polytherapy, for a risk ratio (RR) of 1.02 (95% confidence interval (CI), 1.01-1.04).

In addition, the estimated risk for live birth with congenital malformations was 8.0% (5.70-10.2) under insulin monotherapy and 5.7% under insulin plus metformin (95% CI, 4.5-7.3), amounting to a risk ratio of 0.72 (0.51-1.09).

While the results may involve residual confounding by participants’ glycemic control and body mass index, Dr. Chiu said, “Our findings suggest that the current clinical recommendations to switch from metformin to insulin before pregnancy, due to concerns about birth defects, may require reconsideration.”

She noted that previous trials showed adding metformin to insulin in mid-late pregnancy also improved blood sugar control with no increase in risk of birth defects. “However, most of these studies started treatment too late — between 10 and 34 weeks of pregnancy — to determine if metformin could cause birth defects.”

Observational studies found that women with pregestational diabetes who used noninsulin antidiabetics (mainly metformin) in the first trimester had a lower risk of birth defects, compared with those who used insulin, Dr. Chiu added. “However, comparing metformin with insulin may have some biases because women who used metformin generally have less severe diabetes than those who used insulin.”

Aligning with these reassuring findings, a randomized, placebo-controlled trial reported that adding metformin to insulin did not lead to a higher incidence of neonatal morbidity and mortality and was associated with better maternal glycemic control and reduced maternal weight gain. Metformin-exposed offspring, however, had lower birth weights and a higher incidence of being small for gestational age.

Similarly, a recent Nordic register study of more than 3.7 million infants also found no evidence of an increased risk of major defects with the use of metformin vs insulin in the first trimester.

Despite such reassuring findings, however, Dr. Chiu stressed the need to study other pregnancy and infant outcomes as well as the safety of other oral antidiabetics during pregnancy.
 

 

 

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

kaniswekouufrudospacesestovemuvawurinogushiles
Dr. Ran S. Rotem


The prevalence of MCMs in the cohort was 4.7% in children of fathers unexposed to diabetes medications (n = 381,041), compared with 6.2% in children of fathers exposed during preconception spermatogenesis to metformin (n = 1730).

By these crude numbers, children with preconception paternal metformin exposure had a nearly 30% increased odds of MCMs. But whereas the crude odds ratio (OR) for MCMs with paternal metformin exposure in all formulations was 1.28 (95% CI, 1.01-1.64), the adjusted OR was 1.00 (95% CI, 0.76 -1.31). Within specific regimens, the adjusted OR was 0.86 (95% CI, 0.60-1.23) for metformin in monotherapy and 1.36 (95% CI, 1.00-1.85) for metformin in polytherapy.

At the outset, Dr. Rotem’s group hypothesized that any crude associations between metformin in polytherapy and birth defects could potentially be explained by poorer underlying parental cardiometabolic risk profiles in those taking multiple diabetes medications. Compared with that of unexposed fathers, the prevalence of cardiometabolic morbidity was indeed substantially higher among both fathers who used metformin during spermatogenesis and their spouses.

In addition, these fathers were more likely to be older, to be smokers, and to have fertility problems. Similarly, mothers were more likely to have cardiovascular comorbidity and to have had fertility problems when the father used metformin.

Moreover, children born to men who used diabetes medications before conception were much more likely to have mothers who also had diabetes and other metabolic conditions, Dr. Rotem noted. “This makes sense since we know that many of these conditions are affected by diet and lifestyle factors that are probably shared across individuals living in the same household.”

Recent research has shown that paternal health and behavior before conception can affect offspring development and long-term health. Characteristics including obesity, diabetes, and metabolic syndrome are seen to affect offspring via complex indirect and direct mechanisms, both genetic and nongenetic.

Doing little to dispel safety concerns, a recent Danish national study reported a link between preconception paternal metformin and major birth defects, particularly genital birth defects in boys. That study, however, lacked data on medication adherence and glycemic control.

“These are well-conducted studies, but it would be useful to see them replicated in different populations, as the sample sizes eligible for analysis are relatively small and some of the confidence intervals are wide,” said Robert W. Platt, PhD, a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada. “However, the results suggest that type 2 diabetics can focus on the most effective treatment pathway for their condition. Metformin does not appear to confer an increased risk of congenital malformations.”

spitadrotepasepotaphoshohephasleviuosuuijutrushafrakonechesespiueshiprecranogishuphedraswipraswudakiwrachodrechaspacroraswap
Dr. Robert W. Platt


According to an accompanying editorial by Sarah Martins da Silva. MBChB, MD, a reproductive medicine specialist at the University of Dundee in Scotland, the Israeli findings highlight the importance of factoring the sometimes overlooked issue of paternal health into reproductive planning and prenatal care. She stressed that individual risks and benefits should always be carefully considered and results interpreted with caution since such studies lack information on glycemic control. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for T2D for men and women trying to conceive as well as for managing hyperglycemia in pregnant women in the first trimester,” she wrote and agreed that it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy.

slepojifrohacledrichavadacrawajoclibropesludrojabrewrujupravathipeclunacrusheshiswaspuslubruphephulusacramishoslajosw
Dr. Sarah Martins da Silva


The studies by Dr. Chiu and Dr. Rotem were funded by the National Institutes of Health. Dr. Chiu and Dr. Rotem had no competing interests to declare. Dr. Hernandez Diaz, a coauthor on both studies, reported funding from Takeda and consulting for Moderna, Johnson & Johnson, and UCB. Several authors reported support from government and not-for-profit research funding agencies. Dr. Platt disclosed no competing interests. Editorial commentator Dr. Martins da Silva disclosed consulting, speaking, travel, and advisory fees from, variously, Dyneval, Ferring Pharmaceutical, Merck, IBSA, and Gedeon Richer.

Publications
Topics
Sections

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

heprogaswethedrovutagivespinophakufrawuvokishethaslocowospubruwraslekobroprubrephohe
Dr. Yu-Han Chiu


“On the one hand, metformin can cross the placenta and might directly affect the fetus. On the other hand, poor blood sugar control is a risk factor for birth defects,” she continued. “Insulin in combination with metformin might control blood sugar better than using insulin alone, which may lower the risk of birth defects.”

Switched to insulin monotherapy or prescribed additional insulin within 90 days of their last menstrual period, mothers were assessed for nonchromosomal fetal malformations and nonlive births, spontaneous abortion, and termination. Continuing metformin or adding insulin to metformin in early pregnancy resulted in little to no increased risk for major malformations in infants.

The estimated risk for nonlive birth was 32.7% with insulin monotherapy and 34.3% with insulin plus metformin polytherapy, for a risk ratio (RR) of 1.02 (95% confidence interval (CI), 1.01-1.04).

In addition, the estimated risk for live birth with congenital malformations was 8.0% (5.70-10.2) under insulin monotherapy and 5.7% under insulin plus metformin (95% CI, 4.5-7.3), amounting to a risk ratio of 0.72 (0.51-1.09).

While the results may involve residual confounding by participants’ glycemic control and body mass index, Dr. Chiu said, “Our findings suggest that the current clinical recommendations to switch from metformin to insulin before pregnancy, due to concerns about birth defects, may require reconsideration.”

She noted that previous trials showed adding metformin to insulin in mid-late pregnancy also improved blood sugar control with no increase in risk of birth defects. “However, most of these studies started treatment too late — between 10 and 34 weeks of pregnancy — to determine if metformin could cause birth defects.”

Observational studies found that women with pregestational diabetes who used noninsulin antidiabetics (mainly metformin) in the first trimester had a lower risk of birth defects, compared with those who used insulin, Dr. Chiu added. “However, comparing metformin with insulin may have some biases because women who used metformin generally have less severe diabetes than those who used insulin.”

Aligning with these reassuring findings, a randomized, placebo-controlled trial reported that adding metformin to insulin did not lead to a higher incidence of neonatal morbidity and mortality and was associated with better maternal glycemic control and reduced maternal weight gain. Metformin-exposed offspring, however, had lower birth weights and a higher incidence of being small for gestational age.

Similarly, a recent Nordic register study of more than 3.7 million infants also found no evidence of an increased risk of major defects with the use of metformin vs insulin in the first trimester.

Despite such reassuring findings, however, Dr. Chiu stressed the need to study other pregnancy and infant outcomes as well as the safety of other oral antidiabetics during pregnancy.
 

 

 

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

kaniswekouufrudospacesestovemuvawurinogushiles
Dr. Ran S. Rotem


The prevalence of MCMs in the cohort was 4.7% in children of fathers unexposed to diabetes medications (n = 381,041), compared with 6.2% in children of fathers exposed during preconception spermatogenesis to metformin (n = 1730).

By these crude numbers, children with preconception paternal metformin exposure had a nearly 30% increased odds of MCMs. But whereas the crude odds ratio (OR) for MCMs with paternal metformin exposure in all formulations was 1.28 (95% CI, 1.01-1.64), the adjusted OR was 1.00 (95% CI, 0.76 -1.31). Within specific regimens, the adjusted OR was 0.86 (95% CI, 0.60-1.23) for metformin in monotherapy and 1.36 (95% CI, 1.00-1.85) for metformin in polytherapy.

At the outset, Dr. Rotem’s group hypothesized that any crude associations between metformin in polytherapy and birth defects could potentially be explained by poorer underlying parental cardiometabolic risk profiles in those taking multiple diabetes medications. Compared with that of unexposed fathers, the prevalence of cardiometabolic morbidity was indeed substantially higher among both fathers who used metformin during spermatogenesis and their spouses.

In addition, these fathers were more likely to be older, to be smokers, and to have fertility problems. Similarly, mothers were more likely to have cardiovascular comorbidity and to have had fertility problems when the father used metformin.

Moreover, children born to men who used diabetes medications before conception were much more likely to have mothers who also had diabetes and other metabolic conditions, Dr. Rotem noted. “This makes sense since we know that many of these conditions are affected by diet and lifestyle factors that are probably shared across individuals living in the same household.”

Recent research has shown that paternal health and behavior before conception can affect offspring development and long-term health. Characteristics including obesity, diabetes, and metabolic syndrome are seen to affect offspring via complex indirect and direct mechanisms, both genetic and nongenetic.

Doing little to dispel safety concerns, a recent Danish national study reported a link between preconception paternal metformin and major birth defects, particularly genital birth defects in boys. That study, however, lacked data on medication adherence and glycemic control.

“These are well-conducted studies, but it would be useful to see them replicated in different populations, as the sample sizes eligible for analysis are relatively small and some of the confidence intervals are wide,” said Robert W. Platt, PhD, a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada. “However, the results suggest that type 2 diabetics can focus on the most effective treatment pathway for their condition. Metformin does not appear to confer an increased risk of congenital malformations.”

spitadrotepasepotaphoshohephasleviuosuuijutrushafrakonechesespiueshiprecranogishuphedraswipraswudakiwrachodrechaspacroraswap
Dr. Robert W. Platt


According to an accompanying editorial by Sarah Martins da Silva. MBChB, MD, a reproductive medicine specialist at the University of Dundee in Scotland, the Israeli findings highlight the importance of factoring the sometimes overlooked issue of paternal health into reproductive planning and prenatal care. She stressed that individual risks and benefits should always be carefully considered and results interpreted with caution since such studies lack information on glycemic control. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for T2D for men and women trying to conceive as well as for managing hyperglycemia in pregnant women in the first trimester,” she wrote and agreed that it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy.

slepojifrohacledrichavadacrawajoclibropesludrojabrewrujupravathipeclunacrusheshiswaspuslubruphephulusacramishoslajosw
Dr. Sarah Martins da Silva


The studies by Dr. Chiu and Dr. Rotem were funded by the National Institutes of Health. Dr. Chiu and Dr. Rotem had no competing interests to declare. Dr. Hernandez Diaz, a coauthor on both studies, reported funding from Takeda and consulting for Moderna, Johnson & Johnson, and UCB. Several authors reported support from government and not-for-profit research funding agencies. Dr. Platt disclosed no competing interests. Editorial commentator Dr. Martins da Silva disclosed consulting, speaking, travel, and advisory fees from, variously, Dyneval, Ferring Pharmaceutical, Merck, IBSA, and Gedeon Richer.

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

heprogaswethedrovutagivespinophakufrawuvokishethaslocowospubruwraslekobroprubrephohe
Dr. Yu-Han Chiu


“On the one hand, metformin can cross the placenta and might directly affect the fetus. On the other hand, poor blood sugar control is a risk factor for birth defects,” she continued. “Insulin in combination with metformin might control blood sugar better than using insulin alone, which may lower the risk of birth defects.”

Switched to insulin monotherapy or prescribed additional insulin within 90 days of their last menstrual period, mothers were assessed for nonchromosomal fetal malformations and nonlive births, spontaneous abortion, and termination. Continuing metformin or adding insulin to metformin in early pregnancy resulted in little to no increased risk for major malformations in infants.

The estimated risk for nonlive birth was 32.7% with insulin monotherapy and 34.3% with insulin plus metformin polytherapy, for a risk ratio (RR) of 1.02 (95% confidence interval (CI), 1.01-1.04).

In addition, the estimated risk for live birth with congenital malformations was 8.0% (5.70-10.2) under insulin monotherapy and 5.7% under insulin plus metformin (95% CI, 4.5-7.3), amounting to a risk ratio of 0.72 (0.51-1.09).

While the results may involve residual confounding by participants’ glycemic control and body mass index, Dr. Chiu said, “Our findings suggest that the current clinical recommendations to switch from metformin to insulin before pregnancy, due to concerns about birth defects, may require reconsideration.”

She noted that previous trials showed adding metformin to insulin in mid-late pregnancy also improved blood sugar control with no increase in risk of birth defects. “However, most of these studies started treatment too late — between 10 and 34 weeks of pregnancy — to determine if metformin could cause birth defects.”

Observational studies found that women with pregestational diabetes who used noninsulin antidiabetics (mainly metformin) in the first trimester had a lower risk of birth defects, compared with those who used insulin, Dr. Chiu added. “However, comparing metformin with insulin may have some biases because women who used metformin generally have less severe diabetes than those who used insulin.”

Aligning with these reassuring findings, a randomized, placebo-controlled trial reported that adding metformin to insulin did not lead to a higher incidence of neonatal morbidity and mortality and was associated with better maternal glycemic control and reduced maternal weight gain. Metformin-exposed offspring, however, had lower birth weights and a higher incidence of being small for gestational age.

Similarly, a recent Nordic register study of more than 3.7 million infants also found no evidence of an increased risk of major defects with the use of metformin vs insulin in the first trimester.

Despite such reassuring findings, however, Dr. Chiu stressed the need to study other pregnancy and infant outcomes as well as the safety of other oral antidiabetics during pregnancy.
 

 

 

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

kaniswekouufrudospacesestovemuvawurinogushiles
Dr. Ran S. Rotem


The prevalence of MCMs in the cohort was 4.7% in children of fathers unexposed to diabetes medications (n = 381,041), compared with 6.2% in children of fathers exposed during preconception spermatogenesis to metformin (n = 1730).

By these crude numbers, children with preconception paternal metformin exposure had a nearly 30% increased odds of MCMs. But whereas the crude odds ratio (OR) for MCMs with paternal metformin exposure in all formulations was 1.28 (95% CI, 1.01-1.64), the adjusted OR was 1.00 (95% CI, 0.76 -1.31). Within specific regimens, the adjusted OR was 0.86 (95% CI, 0.60-1.23) for metformin in monotherapy and 1.36 (95% CI, 1.00-1.85) for metformin in polytherapy.

At the outset, Dr. Rotem’s group hypothesized that any crude associations between metformin in polytherapy and birth defects could potentially be explained by poorer underlying parental cardiometabolic risk profiles in those taking multiple diabetes medications. Compared with that of unexposed fathers, the prevalence of cardiometabolic morbidity was indeed substantially higher among both fathers who used metformin during spermatogenesis and their spouses.

In addition, these fathers were more likely to be older, to be smokers, and to have fertility problems. Similarly, mothers were more likely to have cardiovascular comorbidity and to have had fertility problems when the father used metformin.

Moreover, children born to men who used diabetes medications before conception were much more likely to have mothers who also had diabetes and other metabolic conditions, Dr. Rotem noted. “This makes sense since we know that many of these conditions are affected by diet and lifestyle factors that are probably shared across individuals living in the same household.”

Recent research has shown that paternal health and behavior before conception can affect offspring development and long-term health. Characteristics including obesity, diabetes, and metabolic syndrome are seen to affect offspring via complex indirect and direct mechanisms, both genetic and nongenetic.

Doing little to dispel safety concerns, a recent Danish national study reported a link between preconception paternal metformin and major birth defects, particularly genital birth defects in boys. That study, however, lacked data on medication adherence and glycemic control.

“These are well-conducted studies, but it would be useful to see them replicated in different populations, as the sample sizes eligible for analysis are relatively small and some of the confidence intervals are wide,” said Robert W. Platt, PhD, a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada. “However, the results suggest that type 2 diabetics can focus on the most effective treatment pathway for their condition. Metformin does not appear to confer an increased risk of congenital malformations.”

spitadrotepasepotaphoshohephasleviuosuuijutrushafrakonechesespiueshiprecranogishuphedraswipraswudakiwrachodrechaspacroraswap
Dr. Robert W. Platt


According to an accompanying editorial by Sarah Martins da Silva. MBChB, MD, a reproductive medicine specialist at the University of Dundee in Scotland, the Israeli findings highlight the importance of factoring the sometimes overlooked issue of paternal health into reproductive planning and prenatal care. She stressed that individual risks and benefits should always be carefully considered and results interpreted with caution since such studies lack information on glycemic control. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for T2D for men and women trying to conceive as well as for managing hyperglycemia in pregnant women in the first trimester,” she wrote and agreed that it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy.

slepojifrohacledrichavadacrawajoclibropesludrojabrewrujupravathipeclunacrusheshiswaspuslubruphephulusacramishoslajosw
Dr. Sarah Martins da Silva


The studies by Dr. Chiu and Dr. Rotem were funded by the National Institutes of Health. Dr. Chiu and Dr. Rotem had no competing interests to declare. Dr. Hernandez Diaz, a coauthor on both studies, reported funding from Takeda and consulting for Moderna, Johnson & Johnson, and UCB. Several authors reported support from government and not-for-profit research funding agencies. Dr. Platt disclosed no competing interests. Editorial commentator Dr. Martins da Silva disclosed consulting, speaking, travel, and advisory fees from, variously, Dyneval, Ferring Pharmaceutical, Merck, IBSA, and Gedeon Richer.

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>168481</fileName> <TBEID>0C050A5E.SIG</TBEID> <TBUniqueIdentifier>MD_0C050A5E</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240621T113341</QCDate> <firstPublished>20240621T114405</firstPublished> <LastPublished>20240621T114405</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240621T114405</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Diana Swift</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</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>For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including</metaDescription> <articlePDF/> <teaserImage>301953</teaserImage> <teaser>Physicians can reassure parents with diabetes about the safety of metformin use before conception and in early pregnancy.</teaser> <title>Metformin Gets a Reproductive Reprieve — For Diabetic Moms and Dads Alike</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>endo</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>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>34</term> <term canonical="true">15</term> <term>21</term> <term>23</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> </sections> <topics> <term canonical="true">205</term> <term>206</term> <term>322</term> <term>287</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012a4e.jpg</altRep> <description role="drol:caption">Dr. Yu-Han Chiu</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012a4f.jpg</altRep> <description role="drol:caption">Dr. Ran S. Rotem</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012a50.jpg</altRep> <description role="drol:caption">Dr. Robert W. Platt</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012a51.jpg</altRep> <description role="drol:caption">Dr. Sarah Martins da Silva</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Metformin Gets a Reproductive Reprieve — For Diabetic Moms and Dads Alike</title> <deck/> </itemMeta> <itemContent> <p>For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.</p> <p>Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — <span class="Hyperlink"><a href="https://www.acpjournals.org/doi/10.7326/M23-2038">one in mothers</a></span>, the <span class="Hyperlink"><a href="https://www.acpjournals.org/doi/10.7326/M23-1405">other in fathers</a></span> — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in <em>Annals of Internal Medicine</em>.<br/><br/>The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy, <br/><br/>In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.[[{"fid":"301953","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Chiu is an epidemiologist at the Harvard School of Public Health","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Yu-Han Chiu"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]] <br/><br/>“On the one hand, metformin can cross the placenta and might directly affect the fetus. On the other hand, poor blood sugar control is a risk factor for birth defects,” she continued. “Insulin in combination with metformin might control blood sugar better than using insulin alone, which may lower the risk of birth defects.” <br/><br/>Switched to insulin monotherapy or prescribed additional insulin within 90 days of their last menstrual period, mothers were assessed for nonchromosomal fetal malformations and nonlive births, spontaneous abortion, and termination. Continuing metformin or adding insulin to metformin in early pregnancy resulted in little to no increased risk for major malformations in infants.<br/><br/>The estimated risk for nonlive birth was 32.7% with insulin monotherapy and 34.3% with insulin plus metformin polytherapy, for a risk ratio (RR) of 1.02 (95% confidence interval (CI), 1.01-1.04).<br/><br/>In addition, the estimated risk for live birth with congenital malformations was 8.0% (5.70-10.2) under insulin monotherapy and 5.7% under insulin plus metformin (95% CI, 4.5-7.3), amounting to a risk ratio of 0.72 (0.51-1.09).<br/><br/>While the results may involve residual confounding by participants’ glycemic control and body mass index, Dr. Chiu said, “Our findings suggest that the current clinical recommendations to switch from metformin to insulin before pregnancy, due to concerns about birth defects, may require reconsideration.” <br/><br/>She noted that previous trials showed adding metformin to insulin in mid-late pregnancy also improved blood sugar control with no increase in risk of birth defects. “However, most of these studies started treatment too late — between 10 and 34 weeks of pregnancy — to determine if metformin could cause birth defects.”<br/><br/>Observational studies found that women with pregestational diabetes who used noninsulin antidiabetics (mainly metformin) in the first trimester had a lower risk of birth defects, compared with those who used insulin, Dr. Chiu added. “However, comparing metformin with insulin may have some biases because women who used metformin generally have less severe diabetes than those who used insulin.”<br/><br/>Aligning with these reassuring findings, a randomized, <span class="Hyperlink"><a href="https://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30310-7/abstract">placebo-controlled trial</a></span> reported that adding metformin to insulin did not lead to a higher incidence of neonatal morbidity and mortality and was associated with better maternal glycemic control and reduced maternal weight gain. Metformin-exposed offspring, however, had lower birth weights and a higher incidence of being small for gestational age. <br/><br/>Similarly, a recent Nordic <span class="Hyperlink"><a href="https://diabetesjournals.org/care/article/46/8/1556/151609/Metformin-Versus-Insulin-and-Risk-of-Major">register study</a></span> of more than 3.7 million infants also found no evidence of an increased risk of major defects with the use of metformin vs insulin in the first trimester.<br/><br/>Despite such reassuring findings, however, Dr. Chiu stressed the need to study other pregnancy and infant outcomes as well as the safety of other oral antidiabetics during pregnancy.<br/><br/></p> <h2>Metformin in Fathers</h2> <p>Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe. </p> <p>The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns. <br/><br/>“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”[[{"fid":"301954","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Rotem is a neuroepidemiologist at the Harvard School of Public Health, Boston, Massachusetts","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Ran S. Rotem"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>The prevalence of MCMs in the cohort was 4.7% in children of fathers unexposed to diabetes medications (n = 381,041), compared with 6.2% in children of fathers exposed during preconception spermatogenesis to metformin (n = 1730).<br/><br/>By these crude numbers, children with preconception paternal metformin exposure had a nearly 30% increased odds of MCMs. But whereas the crude odds ratio (OR) for MCMs with paternal metformin exposure in all formulations was 1.28 (95% CI, 1.01-1.64), the adjusted OR was 1.00 (95% CI, 0.76 -1.31). Within specific regimens, the adjusted OR was 0.86 (95% CI, 0.60-1.23) for metformin in monotherapy and 1.36 (95% CI, 1.00-1.85) for metformin in polytherapy. <br/><br/>At the outset, Dr. Rotem’s group hypothesized that any crude associations between metformin in polytherapy and birth defects could potentially be explained by poorer underlying parental cardiometabolic risk profiles in those taking multiple diabetes medications. Compared with that of unexposed fathers, the prevalence of cardiometabolic morbidity was indeed substantially higher among both fathers who used metformin during spermatogenesis and their spouses.<br/><br/>In addition, these fathers were more likely to be older, to be smokers, and to have fertility problems. Similarly, mothers were more likely to have cardiovascular comorbidity and to have had fertility problems when the father used metformin.<br/><br/>Moreover, children born to men who used diabetes medications before conception were much more likely to have mothers who also had diabetes and other metabolic conditions, Dr. Rotem noted. “This makes sense since we know that many of these conditions are affected by diet and lifestyle factors that are probably shared across individuals living in the same household.”<br/><br/>Recent <span class="Hyperlink"><a href="https://link.springer.com/article/10.1007/s00125-019-4919-9">research</a> </span>has shown that paternal health and behavior before conception can affect offspring development and long-term health. Characteristics including obesity, diabetes, and metabolic syndrome are seen to affect offspring via complex indirect and direct mechanisms, both genetic and nongenetic. <br/><br/>Doing little to dispel safety concerns, a recent <span class="Hyperlink"><a href="https://www.acpjournals.org/doi/10.7326/M21-4389">Danish national study</a> </span>reported a link between preconception paternal metformin and major birth defects, particularly genital birth defects in boys. That study, however, lacked data on medication adherence and glycemic control.<br/><br/>“These are well-conducted studies, but it would be useful to see them replicated in different populations, as the sample sizes eligible for analysis are relatively small and some of the confidence intervals are wide,” said Robert W. Platt, PhD, a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada. “However, the results suggest that type 2 diabetics can focus on the most effective treatment pathway for their condition. Metformin does not appear to confer an increased risk of congenital malformations.”[[{"fid":"301956","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Platt is a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada.","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Robert W. Platt"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>According to an <span class="Hyperlink"><a href="https://www.acpjournals.org/doi/10.7326/M24-0883">accompanying editorial</a></span> by Sarah Martins da Silva. MBChB, MD, a reproductive medicine specialist at the University of Dundee in Scotland, the Israeli findings highlight the importance of factoring the sometimes overlooked issue of paternal health into reproductive planning and prenatal care. She stressed that individual risks and benefits should always be carefully considered and results interpreted with caution since such studies lack information on glycemic control. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for T2D for men and women trying to conceive as well as for managing hyperglycemia in pregnant women in the first trimester,” she wrote and agreed that it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy.[[{"fid":"301957","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Martins da Silva is a reproductive medicine specialist at the University of Dundee in Scotland","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Sarah Martins da Silva"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]] <br/><br/>The studies by Dr. Chiu and Dr. Rotem were funded by the National Institutes of Health. Dr. Chiu and Dr. Rotem had no competing interests to declare. Dr. Hernandez Diaz, a coauthor on both studies, reported funding from Takeda and consulting for Moderna, Johnson &amp; Johnson, and UCB. Several authors reported support from government and not-for-profit research funding agencies. Dr. Platt disclosed no competing interests. Editorial commentator Dr. Martins da Silva disclosed consulting, speaking, travel, and advisory fees from, variously, Dyneval, Ferring Pharmaceutical, Merck, IBSA, and Gedeon Richer.<span class="end"/></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

Nonanemic Iron Deficiency Underdiagnosed in Women

Article Type
Changed
Fri, 06/07/2024 - 12:04

Three different definitions of nonanemic iron deficiency (ID), a common disorder causing substantial morbidity in women, were significantly associated with different population prevalence estimates, a data analysis of the cross-sectional Hemochromatosis and Iron Overload Screening Study (HEIRS) study found.

These differences held, regardless of self-reported age, pregnancy, or race and ethnicity, according to HEIRS researchers led by James C. Barton, MD, professor of hematology at the University of Alabama at Birmingham.

“Using higher serum ferritin thresholds to define ID could lead to diagnosis and treatment of more women with ID and greater reduction of related morbidity,” the investigators wrote. The study was published in JAMA Network Open.

The authors noted that ID affects about 2 billion people worldwide, mainly women and children, increasing risks of fatigue, impaired muscular performance, cold intolerance, mucosal and epithelial abnormalities, pica, disturbances of menstruation, and adverse pregnancy outcomes.

Manifestations of ID, including anemia, are less prevalent or less severe in adults with higher serum ferritin (SF), and the three definitions correspond, in sequence, to ID of increasing prevalence and decreasing severity, they explained.
 

The Study

HEIRS conducted multiethnic, primary care–based screening for iron disorders during 2001-2003 at four field centers in the United States and one in Canada at primary care venues.

In data for the current study analyzed from June to December, 2023, the three ID definitions were: combined transferrin saturation less than 10% and SF less than 15 ng/mL (HEIRS); SF less than 15 ng/mL (World Health Organization [WHO]); and SF less than 25 ng/mL, the threshold for ID-deficient erythropoiesis [IDE).

Among the cohort’s 62,685 women (mean age, 49.58 years, 27,072 White, 17,272 Black), the estimated prevalence of ID emerged as follows across the different definitions:

  • 1957 (3.12%) according to HEIRS
  • 4659 (7.43%) according to WHO
  • 9611 (15.33%) according to IDE

Those figures translated to an increased relative ID prevalence of 2.4-fold (95% CI, 2.3-2.5; P < .001) according to the WHO standard and 4.9-fold (95% CI, 4.7-5.2; P < .001) according IDEs.

In addition, prevalence was higher in younger women, and within each racial and ethnic subgroup of participants aged 25-54 years, prevalence rose significantly from the HEIRS definition to the WHO and IDE definitions.

Notably, ID was significantly higher among Black and Hispanic participants than Asian and White participants.

An accompanying editorial pointed to gender-based health equity issues raised by the HEIRS analysis and argued that a similar passive acceptance of laboratory definitions of a debilitating but correctable condition in White males would be “frankly unimaginable.”

“Iron deficiency is the leading cause of years lived with disability among women of reproductive age,” wrote hematologist Michelle Sholzberg, MDCM, MSc, and Grace H. Tang, MSc, of St. Michael’s Hospital in Toronto, Canada. “It is a factor clearly associated with maternal death and morbidity (including diminished IQ), and it is correctable, and, thus, unnecessary, in high-income, middle-income, and low-income geographic settings.”

The authors listed no specific funding for this analysis of HEIRS data. Dr. Barton reported contracts from the National Institutes of Health, National Human Genome Research Institute, outside of the submitted work. A coauthor reported grants from the National Heart, Lung, and Blood Institute and the National Human Genome Research Institute outside of the submitted work. Dr. Sholzberg reported unrestricted research funding to her institution from Octapharma and Pfizer and speakers’ honoraria from Takeda, Sobi, and Medison outside of the submitted work.

Publications
Topics
Sections

Three different definitions of nonanemic iron deficiency (ID), a common disorder causing substantial morbidity in women, were significantly associated with different population prevalence estimates, a data analysis of the cross-sectional Hemochromatosis and Iron Overload Screening Study (HEIRS) study found.

These differences held, regardless of self-reported age, pregnancy, or race and ethnicity, according to HEIRS researchers led by James C. Barton, MD, professor of hematology at the University of Alabama at Birmingham.

“Using higher serum ferritin thresholds to define ID could lead to diagnosis and treatment of more women with ID and greater reduction of related morbidity,” the investigators wrote. The study was published in JAMA Network Open.

The authors noted that ID affects about 2 billion people worldwide, mainly women and children, increasing risks of fatigue, impaired muscular performance, cold intolerance, mucosal and epithelial abnormalities, pica, disturbances of menstruation, and adverse pregnancy outcomes.

Manifestations of ID, including anemia, are less prevalent or less severe in adults with higher serum ferritin (SF), and the three definitions correspond, in sequence, to ID of increasing prevalence and decreasing severity, they explained.
 

The Study

HEIRS conducted multiethnic, primary care–based screening for iron disorders during 2001-2003 at four field centers in the United States and one in Canada at primary care venues.

In data for the current study analyzed from June to December, 2023, the three ID definitions were: combined transferrin saturation less than 10% and SF less than 15 ng/mL (HEIRS); SF less than 15 ng/mL (World Health Organization [WHO]); and SF less than 25 ng/mL, the threshold for ID-deficient erythropoiesis [IDE).

Among the cohort’s 62,685 women (mean age, 49.58 years, 27,072 White, 17,272 Black), the estimated prevalence of ID emerged as follows across the different definitions:

  • 1957 (3.12%) according to HEIRS
  • 4659 (7.43%) according to WHO
  • 9611 (15.33%) according to IDE

Those figures translated to an increased relative ID prevalence of 2.4-fold (95% CI, 2.3-2.5; P < .001) according to the WHO standard and 4.9-fold (95% CI, 4.7-5.2; P < .001) according IDEs.

In addition, prevalence was higher in younger women, and within each racial and ethnic subgroup of participants aged 25-54 years, prevalence rose significantly from the HEIRS definition to the WHO and IDE definitions.

Notably, ID was significantly higher among Black and Hispanic participants than Asian and White participants.

An accompanying editorial pointed to gender-based health equity issues raised by the HEIRS analysis and argued that a similar passive acceptance of laboratory definitions of a debilitating but correctable condition in White males would be “frankly unimaginable.”

“Iron deficiency is the leading cause of years lived with disability among women of reproductive age,” wrote hematologist Michelle Sholzberg, MDCM, MSc, and Grace H. Tang, MSc, of St. Michael’s Hospital in Toronto, Canada. “It is a factor clearly associated with maternal death and morbidity (including diminished IQ), and it is correctable, and, thus, unnecessary, in high-income, middle-income, and low-income geographic settings.”

The authors listed no specific funding for this analysis of HEIRS data. Dr. Barton reported contracts from the National Institutes of Health, National Human Genome Research Institute, outside of the submitted work. A coauthor reported grants from the National Heart, Lung, and Blood Institute and the National Human Genome Research Institute outside of the submitted work. Dr. Sholzberg reported unrestricted research funding to her institution from Octapharma and Pfizer and speakers’ honoraria from Takeda, Sobi, and Medison outside of the submitted work.

Three different definitions of nonanemic iron deficiency (ID), a common disorder causing substantial morbidity in women, were significantly associated with different population prevalence estimates, a data analysis of the cross-sectional Hemochromatosis and Iron Overload Screening Study (HEIRS) study found.

These differences held, regardless of self-reported age, pregnancy, or race and ethnicity, according to HEIRS researchers led by James C. Barton, MD, professor of hematology at the University of Alabama at Birmingham.

“Using higher serum ferritin thresholds to define ID could lead to diagnosis and treatment of more women with ID and greater reduction of related morbidity,” the investigators wrote. The study was published in JAMA Network Open.

The authors noted that ID affects about 2 billion people worldwide, mainly women and children, increasing risks of fatigue, impaired muscular performance, cold intolerance, mucosal and epithelial abnormalities, pica, disturbances of menstruation, and adverse pregnancy outcomes.

Manifestations of ID, including anemia, are less prevalent or less severe in adults with higher serum ferritin (SF), and the three definitions correspond, in sequence, to ID of increasing prevalence and decreasing severity, they explained.
 

The Study

HEIRS conducted multiethnic, primary care–based screening for iron disorders during 2001-2003 at four field centers in the United States and one in Canada at primary care venues.

In data for the current study analyzed from June to December, 2023, the three ID definitions were: combined transferrin saturation less than 10% and SF less than 15 ng/mL (HEIRS); SF less than 15 ng/mL (World Health Organization [WHO]); and SF less than 25 ng/mL, the threshold for ID-deficient erythropoiesis [IDE).

Among the cohort’s 62,685 women (mean age, 49.58 years, 27,072 White, 17,272 Black), the estimated prevalence of ID emerged as follows across the different definitions:

  • 1957 (3.12%) according to HEIRS
  • 4659 (7.43%) according to WHO
  • 9611 (15.33%) according to IDE

Those figures translated to an increased relative ID prevalence of 2.4-fold (95% CI, 2.3-2.5; P < .001) according to the WHO standard and 4.9-fold (95% CI, 4.7-5.2; P < .001) according IDEs.

In addition, prevalence was higher in younger women, and within each racial and ethnic subgroup of participants aged 25-54 years, prevalence rose significantly from the HEIRS definition to the WHO and IDE definitions.

Notably, ID was significantly higher among Black and Hispanic participants than Asian and White participants.

An accompanying editorial pointed to gender-based health equity issues raised by the HEIRS analysis and argued that a similar passive acceptance of laboratory definitions of a debilitating but correctable condition in White males would be “frankly unimaginable.”

“Iron deficiency is the leading cause of years lived with disability among women of reproductive age,” wrote hematologist Michelle Sholzberg, MDCM, MSc, and Grace H. Tang, MSc, of St. Michael’s Hospital in Toronto, Canada. “It is a factor clearly associated with maternal death and morbidity (including diminished IQ), and it is correctable, and, thus, unnecessary, in high-income, middle-income, and low-income geographic settings.”

The authors listed no specific funding for this analysis of HEIRS data. Dr. Barton reported contracts from the National Institutes of Health, National Human Genome Research Institute, outside of the submitted work. A coauthor reported grants from the National Heart, Lung, and Blood Institute and the National Human Genome Research Institute outside of the submitted work. Dr. Sholzberg reported unrestricted research funding to her institution from Octapharma and Pfizer and speakers’ honoraria from Takeda, Sobi, and Medison outside of the submitted work.

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>168335</fileName> <TBEID>0C050742.SIG</TBEID> <TBUniqueIdentifier>MD_0C050742</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Iron Deficiency underdiagnosed</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240607T112242</QCDate> <firstPublished>20240607T120046</firstPublished> <LastPublished>20240607T120046</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240607T120046</CMSDate> <articleSource>FROM JAMA NETWORK OPEN</articleSource> <facebookInfo/> <meetingNumber>na</meetingNumber> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</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>Three different definitions of nonanemic iron deficiency (ID), a common disorder causing substantial morbidity in women, were significantly associated with diff</metaDescription> <articlePDF/> <teaserImage/> <teaser>“Using higher serum ferritin thresholds to define iron deficiency could lead to diagnosis and treatment of more women with iron deficiency and greater reduction of related morbidity,”</teaser> <title>Nonanemic Iron Deficiency Underdiagnosed in Women</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>hemn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">18</term> <term>21</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term>225</term> <term>322</term> <term canonical="true">182</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Nonanemic Iron Deficiency Underdiagnosed in Women</title> <deck/> </itemMeta> <itemContent> <p>Three different definitions of nonanemic iron deficiency (ID), a common disorder causing substantial morbidity in women, were significantly associated with different population prevalence estimates, a data analysis of the cross-sectional Hemochromatosis and Iron Overload Screening Study (HEIRS) <span class="Hyperlink">study found</span>. </p> <p>These differences held, regardless of self-reported age, pregnancy, or race and ethnicity, according to HEIRS researchers led by James C. Barton, MD, professor of hematology at the University of Alabama at Birmingham. <br/><br/>“Using higher serum ferritin thresholds to define ID could lead to diagnosis and treatment of more women with ID and greater reduction of related morbidity,” the investigators wrote. The <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2819707?utm_campaign=articlePDF&amp;utm_medium=articlePDFlink&amp;utm_source=articlePDF&amp;utm_content=jamanetworkopen.2024.13967">study was published</a></span> in <em>JAMA Network Open</em>.<br/><br/>The authors noted that ID affects about 2 billion people worldwide, mainly women and children, increasing risks of fatigue, impaired muscular performance, cold intolerance, mucosal and epithelial abnormalities, pica, disturbances of menstruation, and adverse pregnancy outcomes.<br/><br/>Manifestations of ID, including anemia, are less prevalent or less severe in adults with higher serum ferritin (SF), and the three definitions correspond, in sequence, to ID of increasing prevalence and decreasing severity, they explained.<br/><br/></p> <h2>The Study</h2> <p>HEIRS conducted multiethnic, primary care–based screening for iron disorders during 2001-2003 at four field centers in the United States and one in Canada at primary care venues.</p> <p>In data for the current study analyzed from June to December, 2023, the three ID definitions were: combined transferrin saturation less than 10% and SF less than 15 ng/mL (HEIRS); SF less than 15 ng/mL (World Health Organization [WHO]); and SF less than 25 ng/mL, the threshold for ID-deficient erythropoiesis [IDE).<br/><br/>Among the cohort’s 62,685 women (mean age, 49.58 years, 27,072 White, 17,272 Black), the estimated prevalence of ID emerged as follows across the different definitions:</p> <ul class="body"> <li>1957 (3.12%) according to HEIRS </li> <li>4659 (7.43%) according to WHO </li> <li>9611 (15.33%) according to IDE</li> </ul> <p>Those figures translated to an increased relative ID prevalence of 2.4-fold (95% CI, 2.3-2.5; <em>P</em> &lt; .001) according to the WHO standard and 4.9-fold (95% CI, 4.7-5.2; <em>P</em> &lt; .001) according IDEs.<br/><br/>In addition, prevalence was higher in younger women, and within each racial and ethnic subgroup of participants aged 25-54 years, prevalence rose significantly from the HEIRS definition to the WHO and IDE definitions. <br/><br/>Notably, ID was significantly higher among Black and Hispanic participants than Asian and White participants.<br/><br/>An accompanying <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2819710?utm_campaign=articlePDF&amp;utm_medium=articlePDFlink&amp;utm_source=articlePDF&amp;utm_content=jamanetworkopen.2024.13928">editorial</a></span> pointed to gender-based health equity issues raised by the HEIRS analysis and argued that a similar passive acceptance of laboratory definitions of a debilitating but correctable condition in White males would be “frankly unimaginable.” <br/><br/>“Iron deficiency is the leading cause of years lived with disability among women of reproductive age,” wrote hematologist Michelle Sholzberg, MDCM, MSc, and Grace H. Tang, MSc, of St. Michael’s Hospital in Toronto, Canada. “It is a factor clearly associated with maternal death and morbidity (including diminished IQ), and it is correctable, and, thus, unnecessary, in high-income, middle-income, and low-income geographic settings.” <br/><br/>The authors listed no specific funding for this analysis of HEIRS data. Dr. Barton reported contracts from the National Institutes of Health, National Human Genome Research Institute, outside of the submitted work. A coauthor reported grants from the National Heart, Lung, and Blood Institute and the National Human Genome Research Institute outside of the submitted work. Dr. Sholzberg reported unrestricted research funding to her institution from Octapharma and Pfizer and speakers’ honoraria from Takeda, Sobi, and Medison outside of the submitted work. </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM JAMA NETWORK OPEN

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

5 Vaccinations Adults Need Beyond COVID and Flu

Article Type
Changed
Wed, 06/05/2024 - 15:22

Many adults are complacent about vaccinations, believing that annual COVID and flu shots aside, they had all the immunizations they need as children and teens. But adults need vaccines as well, especially if they have missed earlier doses. And older and health-compromised adults, in particular, can benefit from newer vaccines that were not part of the childhood schedule.

“The question is whether adults had the vaccinations they need in the first place,” Sandra Adamson Fryhofer, MD, an internist in Atlanta and the American Medical Association’s liaison to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, said in an interview. “Many do not even have reliable records of vaccination.”

drisadrikadiradaslilivavabophothiduchimehispuhovadekibusiuiuachochocropacrodethoroviprejebrukestipruuochecejaphecromoshaspesta
Dr. Sandra Adamson Fryhofer

Primary care physicians are ideally positioned to get adult patients to update their vaccination status on older vaccines and obtain newer ones as needed. “ACIP recommendations for adult vaccines are getting longer and more complicated and the way they’re administered is more complex, too, in that they’re not all given in the primary care office but sometimes in pharmacies,” Dr. Fryhofer said.

Not all adult patients want to update their vaccinations. “Vaccine hesitancy among many adults is accelerated by the several new vaccines that have been recommended in recent years,” Lauren Block, MD, MPH, an internist at Northwell Health and assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research in metropolitan New York City, said in an interview.

Physicians are rightly concerned about the lagging rates of adult vaccination, Dr. Block said. “Given the prevalence of conditions like pneumonia and shingles and the morbidity associated with them, healthcare providers should take every opportunity to discuss vaccination with patients, from well visits to hospital visits,” Dr. Block added. 

clushaclejuueshiprototiminiluspufrichoprathespeswuthocehilispapholufroswomadrichamuuoredipethesecacrastelospocrouemisogaslabrochuphasichasweshavojukibrovowrophojibebrecrorethelabemaswishanabuswatiphiwafruuaslesathudrocuchobostevechetreshidrures
Dr. Lauren Block

She pointed to several obstacles to broader uptake, including product shortages, financial barriers, and, increasingly, the negative vocal messaging from media outlets and social media.
 

Current Recommendations

The main vaccines recommended for adults, besides flu and COVID shots, are for respiratory syncytial virus (RVS); shingles; pneumococcal disease; measles, mumps, and rubella (MMR); and tetanus, diphtheria, and pertussis (Tdap). Less commonly, booster vaccines for MM, and hepatitis are recommended when titers are proven to be low.

ACIP’s updated 2024 Adult Immunization Schedule can be downloaded from the website of the CDC.

The newest additions to the schedule include RSV vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of updated COVID vaccines (both mRNA and protein-based adjuvanted versions).
 

1. Respiratory Syncytial Virus Vaccines

There are two licensed RSV vaccines, Arexvy and Abrysvo. The CDC schedule recommends a single-dose RSV vaccine for adults age 60 years and older, especially those at high risk of contracting the virus — but after shared decision-making based on a discussion of the risk-harm balance since this vaccine carries a small increased chance of developing the neurological symptoms of Guillain-Barré syndrome.

Chronic health conditions associated with a higher risk of severe RVS include cardiopulmonary disease, diabetes, and kidney, liver, and hematologic disorders, as well as compromised immunity, older age, and frailty.
 

2. Shingles Vaccines

This painful disease carries the potential complication of postherpetic neuralgia (PHN), which leads to long-term nerve pain in 10%-18% of patients, especially those over age 40. ACIP recommends two doses of the recombinant zoster vaccine (Shingrix) for individuals 50 years and older. Those 19 years and older with weakened immune systems due to disease or medical treatments should get two doses of the recombinant vaccine, as they have a higher risk of getting shingles and its complications, including neurological problems and skin and eye infections.

3 Pneumococcal Vaccines

There are three approved pneumococcal vaccines: PCV15 (Vaxneuvance), PCV20 (Prevnar20), and PPSV23 (Pneumovax23).

“The pneumococcal vaccine schedule is the most complicated one as higher-valent products continue to become available,” Dr. Fryhofer said.

The two types are pneumococcal conjugate vaccines (PCVs, specifically PCV15 and PCV20) and the pneumococcal polysaccharide vaccine (PPSV23). “While PPSV23 covers 23 strains, it doesn’t give the long-term immunity of the conjugate vaccine,” said Dr. Fryhofer. “A patient may have completed their vaccination with the polysaccharide vaccine but 5 years out may no longer be protected. So we offer the option of getting a dose of PCV20 to round out the protection and confer greater immune memory.”

The ACIP schedule recommends immunization against the Streptococcus pneumoniae pathogen for all older and all at-risk adults. Routine administration of PCV15 or PCV20 is advised for those 65 years or older who have never received any pneumococcal conjugate vaccine or whose previous vaccination history is unknown. If PCV15 is used, it should be followed by PPSV23. Those 65 years or older should get PPSV23 even if they already had one or more doses of pneumococcal vaccine before turning 65.

Further vaccination is recommended for younger at-risk adults aged 19-64 years who have received both PCV13 and PPSV23 but have incomplete vaccination status. These individuals are advised to complete their pneumococcal series by receiving either a single dose of PCV20 at an interval of at least 5 years after the last pneumococcal vaccine dose or more than one dose of PPSV23.

See Pneumococcal Vaccination: Summary of Who and When to Vaccinate for CDC guidance on vaccination options for adults who have previously received a pneumococcal conjugate vaccine. Or, to sort out quickly who gets what and when based on their age, concurrent conditions, and vaccination history, the CDC offers a type-in app called the PneumoRecs VaxAdvisor.
 

4. Measles, Mumps, and Rubella, and Varicella Vaccines

The two approved MMR vaccines are M-M-R II and PRIORIX. A third vaccine, ProQuad, adds varicella.

Adults lacking presumptive evidence of immunity should get at least one dose of the MMR combination vaccine.

Those born before 1957 are deemed to be immune, Dr. Fryhofer noted.

Two doses are recommended for adults entering high-risk settings for measles or mumps transmission such as healthcare personnel, students away at college, and international travelers. The two doses should be separated by at least 28 days. It’s no secret that measles, though preventable, is making a comeback, with 146 reported cases (48 in adults) across 21 states as of May 31 — most linked to international travel.

Women who plan to get pregnant should be vaccinated before but not during each pregnancy. (The vaccine is safe during lactation.) And those of childbearing age with no presumptive evidence of immunity are advised to get at least one dose of the MMR vaccine.
 

 

 

5. Tetanus, Diphtheria, and Pertussis Vaccine

Adults with no previous Tdap vaccination should receive a single dose of Adacel or Boostrix followed by a booster every 10 years. Boostrix is recommended for adults over 64 years.

During every pregnancy, women should have a single dose of Tdap, preferably in gestational weeks 27 through 36.

As to the immediate postpartum period, Tdap is recommended only for mothers who did not receive it during their current pregnancy and never received a prior dose. If a woman did not receive Tdap during her current pregnancy but did receive a prior dose of Tdap, she does not need Tdap postpartum.
 

The Challenges

According to Dr. Fryhofer, widespread disinformation about the risks of immunization against vaccine-preventable diseases has brought us to a flashpoint. “It’s now more important than ever to keep telling patients that vaccination is one of the most effective tools for preventing individual illness and protecting public health.”

She recommends that doctors follow the National Institutes of Health’s AIMS method to broach the subject of adult vaccination and increase participation in an inquiring, reassuring, and low-pressure way. Standing for Announce, Inquire, Mirror, and Secure, AIMS structures a nonjudgmental, patient-friendly conversation around immunization to elicit and acknowledge the reasons for hesitancy while explaining the safety and efficacy of vaccines.

Dr. Fryhofer frequently uses AIMS to bring inoculation-averse patients around. “Keep the conversation open with reluctant patients but leave them where they are. They need to see you as a reliable source and nonjudgmental source of information,” she said.

Dr. Block recommends outlining the diseases that have been eliminated through vaccines, from polio to measles, as well as the dangers of vaccine refusal, as indicated by recent outbreaks of vaccine-preventable diseases in areas with low immunization rates. “This approach highlights the opportunity we all have to get vaccinated to protect ourselves and our communities,”  she said.

In Dr. Fryhofer’s view, the situation is urgent and doctors need to be proactive. “We’re now at a public-health tipping point where we may see a sliding back and a reversing of many years of progress.”

Dr. Fryhofer and Dr. Block disclosed no competing interests relevant to their comments.

Publications
Topics
Sections

Many adults are complacent about vaccinations, believing that annual COVID and flu shots aside, they had all the immunizations they need as children and teens. But adults need vaccines as well, especially if they have missed earlier doses. And older and health-compromised adults, in particular, can benefit from newer vaccines that were not part of the childhood schedule.

“The question is whether adults had the vaccinations they need in the first place,” Sandra Adamson Fryhofer, MD, an internist in Atlanta and the American Medical Association’s liaison to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, said in an interview. “Many do not even have reliable records of vaccination.”

drisadrikadiradaslilivavabophothiduchimehispuhovadekibusiuiuachochocropacrodethoroviprejebrukestipruuochecejaphecromoshaspesta
Dr. Sandra Adamson Fryhofer

Primary care physicians are ideally positioned to get adult patients to update their vaccination status on older vaccines and obtain newer ones as needed. “ACIP recommendations for adult vaccines are getting longer and more complicated and the way they’re administered is more complex, too, in that they’re not all given in the primary care office but sometimes in pharmacies,” Dr. Fryhofer said.

Not all adult patients want to update their vaccinations. “Vaccine hesitancy among many adults is accelerated by the several new vaccines that have been recommended in recent years,” Lauren Block, MD, MPH, an internist at Northwell Health and assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research in metropolitan New York City, said in an interview.

Physicians are rightly concerned about the lagging rates of adult vaccination, Dr. Block said. “Given the prevalence of conditions like pneumonia and shingles and the morbidity associated with them, healthcare providers should take every opportunity to discuss vaccination with patients, from well visits to hospital visits,” Dr. Block added. 

clushaclejuueshiprototiminiluspufrichoprathespeswuthocehilispapholufroswomadrichamuuoredipethesecacrastelospocrouemisogaslabrochuphasichasweshavojukibrovowrophojibebrecrorethelabemaswishanabuswatiphiwafruuaslesathudrocuchobostevechetreshidrures
Dr. Lauren Block

She pointed to several obstacles to broader uptake, including product shortages, financial barriers, and, increasingly, the negative vocal messaging from media outlets and social media.
 

Current Recommendations

The main vaccines recommended for adults, besides flu and COVID shots, are for respiratory syncytial virus (RVS); shingles; pneumococcal disease; measles, mumps, and rubella (MMR); and tetanus, diphtheria, and pertussis (Tdap). Less commonly, booster vaccines for MM, and hepatitis are recommended when titers are proven to be low.

ACIP’s updated 2024 Adult Immunization Schedule can be downloaded from the website of the CDC.

The newest additions to the schedule include RSV vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of updated COVID vaccines (both mRNA and protein-based adjuvanted versions).
 

1. Respiratory Syncytial Virus Vaccines

There are two licensed RSV vaccines, Arexvy and Abrysvo. The CDC schedule recommends a single-dose RSV vaccine for adults age 60 years and older, especially those at high risk of contracting the virus — but after shared decision-making based on a discussion of the risk-harm balance since this vaccine carries a small increased chance of developing the neurological symptoms of Guillain-Barré syndrome.

Chronic health conditions associated with a higher risk of severe RVS include cardiopulmonary disease, diabetes, and kidney, liver, and hematologic disorders, as well as compromised immunity, older age, and frailty.
 

2. Shingles Vaccines

This painful disease carries the potential complication of postherpetic neuralgia (PHN), which leads to long-term nerve pain in 10%-18% of patients, especially those over age 40. ACIP recommends two doses of the recombinant zoster vaccine (Shingrix) for individuals 50 years and older. Those 19 years and older with weakened immune systems due to disease or medical treatments should get two doses of the recombinant vaccine, as they have a higher risk of getting shingles and its complications, including neurological problems and skin and eye infections.

3 Pneumococcal Vaccines

There are three approved pneumococcal vaccines: PCV15 (Vaxneuvance), PCV20 (Prevnar20), and PPSV23 (Pneumovax23).

“The pneumococcal vaccine schedule is the most complicated one as higher-valent products continue to become available,” Dr. Fryhofer said.

The two types are pneumococcal conjugate vaccines (PCVs, specifically PCV15 and PCV20) and the pneumococcal polysaccharide vaccine (PPSV23). “While PPSV23 covers 23 strains, it doesn’t give the long-term immunity of the conjugate vaccine,” said Dr. Fryhofer. “A patient may have completed their vaccination with the polysaccharide vaccine but 5 years out may no longer be protected. So we offer the option of getting a dose of PCV20 to round out the protection and confer greater immune memory.”

The ACIP schedule recommends immunization against the Streptococcus pneumoniae pathogen for all older and all at-risk adults. Routine administration of PCV15 or PCV20 is advised for those 65 years or older who have never received any pneumococcal conjugate vaccine or whose previous vaccination history is unknown. If PCV15 is used, it should be followed by PPSV23. Those 65 years or older should get PPSV23 even if they already had one or more doses of pneumococcal vaccine before turning 65.

Further vaccination is recommended for younger at-risk adults aged 19-64 years who have received both PCV13 and PPSV23 but have incomplete vaccination status. These individuals are advised to complete their pneumococcal series by receiving either a single dose of PCV20 at an interval of at least 5 years after the last pneumococcal vaccine dose or more than one dose of PPSV23.

See Pneumococcal Vaccination: Summary of Who and When to Vaccinate for CDC guidance on vaccination options for adults who have previously received a pneumococcal conjugate vaccine. Or, to sort out quickly who gets what and when based on their age, concurrent conditions, and vaccination history, the CDC offers a type-in app called the PneumoRecs VaxAdvisor.
 

4. Measles, Mumps, and Rubella, and Varicella Vaccines

The two approved MMR vaccines are M-M-R II and PRIORIX. A third vaccine, ProQuad, adds varicella.

Adults lacking presumptive evidence of immunity should get at least one dose of the MMR combination vaccine.

Those born before 1957 are deemed to be immune, Dr. Fryhofer noted.

Two doses are recommended for adults entering high-risk settings for measles or mumps transmission such as healthcare personnel, students away at college, and international travelers. The two doses should be separated by at least 28 days. It’s no secret that measles, though preventable, is making a comeback, with 146 reported cases (48 in adults) across 21 states as of May 31 — most linked to international travel.

Women who plan to get pregnant should be vaccinated before but not during each pregnancy. (The vaccine is safe during lactation.) And those of childbearing age with no presumptive evidence of immunity are advised to get at least one dose of the MMR vaccine.
 

 

 

5. Tetanus, Diphtheria, and Pertussis Vaccine

Adults with no previous Tdap vaccination should receive a single dose of Adacel or Boostrix followed by a booster every 10 years. Boostrix is recommended for adults over 64 years.

During every pregnancy, women should have a single dose of Tdap, preferably in gestational weeks 27 through 36.

As to the immediate postpartum period, Tdap is recommended only for mothers who did not receive it during their current pregnancy and never received a prior dose. If a woman did not receive Tdap during her current pregnancy but did receive a prior dose of Tdap, she does not need Tdap postpartum.
 

The Challenges

According to Dr. Fryhofer, widespread disinformation about the risks of immunization against vaccine-preventable diseases has brought us to a flashpoint. “It’s now more important than ever to keep telling patients that vaccination is one of the most effective tools for preventing individual illness and protecting public health.”

She recommends that doctors follow the National Institutes of Health’s AIMS method to broach the subject of adult vaccination and increase participation in an inquiring, reassuring, and low-pressure way. Standing for Announce, Inquire, Mirror, and Secure, AIMS structures a nonjudgmental, patient-friendly conversation around immunization to elicit and acknowledge the reasons for hesitancy while explaining the safety and efficacy of vaccines.

Dr. Fryhofer frequently uses AIMS to bring inoculation-averse patients around. “Keep the conversation open with reluctant patients but leave them where they are. They need to see you as a reliable source and nonjudgmental source of information,” she said.

Dr. Block recommends outlining the diseases that have been eliminated through vaccines, from polio to measles, as well as the dangers of vaccine refusal, as indicated by recent outbreaks of vaccine-preventable diseases in areas with low immunization rates. “This approach highlights the opportunity we all have to get vaccinated to protect ourselves and our communities,”  she said.

In Dr. Fryhofer’s view, the situation is urgent and doctors need to be proactive. “We’re now at a public-health tipping point where we may see a sliding back and a reversing of many years of progress.”

Dr. Fryhofer and Dr. Block disclosed no competing interests relevant to their comments.

Many adults are complacent about vaccinations, believing that annual COVID and flu shots aside, they had all the immunizations they need as children and teens. But adults need vaccines as well, especially if they have missed earlier doses. And older and health-compromised adults, in particular, can benefit from newer vaccines that were not part of the childhood schedule.

“The question is whether adults had the vaccinations they need in the first place,” Sandra Adamson Fryhofer, MD, an internist in Atlanta and the American Medical Association’s liaison to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, said in an interview. “Many do not even have reliable records of vaccination.”

drisadrikadiradaslilivavabophothiduchimehispuhovadekibusiuiuachochocropacrodethoroviprejebrukestipruuochecejaphecromoshaspesta
Dr. Sandra Adamson Fryhofer

Primary care physicians are ideally positioned to get adult patients to update their vaccination status on older vaccines and obtain newer ones as needed. “ACIP recommendations for adult vaccines are getting longer and more complicated and the way they’re administered is more complex, too, in that they’re not all given in the primary care office but sometimes in pharmacies,” Dr. Fryhofer said.

Not all adult patients want to update their vaccinations. “Vaccine hesitancy among many adults is accelerated by the several new vaccines that have been recommended in recent years,” Lauren Block, MD, MPH, an internist at Northwell Health and assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research in metropolitan New York City, said in an interview.

Physicians are rightly concerned about the lagging rates of adult vaccination, Dr. Block said. “Given the prevalence of conditions like pneumonia and shingles and the morbidity associated with them, healthcare providers should take every opportunity to discuss vaccination with patients, from well visits to hospital visits,” Dr. Block added. 

clushaclejuueshiprototiminiluspufrichoprathespeswuthocehilispapholufroswomadrichamuuoredipethesecacrastelospocrouemisogaslabrochuphasichasweshavojukibrovowrophojibebrecrorethelabemaswishanabuswatiphiwafruuaslesathudrocuchobostevechetreshidrures
Dr. Lauren Block

She pointed to several obstacles to broader uptake, including product shortages, financial barriers, and, increasingly, the negative vocal messaging from media outlets and social media.
 

Current Recommendations

The main vaccines recommended for adults, besides flu and COVID shots, are for respiratory syncytial virus (RVS); shingles; pneumococcal disease; measles, mumps, and rubella (MMR); and tetanus, diphtheria, and pertussis (Tdap). Less commonly, booster vaccines for MM, and hepatitis are recommended when titers are proven to be low.

ACIP’s updated 2024 Adult Immunization Schedule can be downloaded from the website of the CDC.

The newest additions to the schedule include RSV vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of updated COVID vaccines (both mRNA and protein-based adjuvanted versions).
 

1. Respiratory Syncytial Virus Vaccines

There are two licensed RSV vaccines, Arexvy and Abrysvo. The CDC schedule recommends a single-dose RSV vaccine for adults age 60 years and older, especially those at high risk of contracting the virus — but after shared decision-making based on a discussion of the risk-harm balance since this vaccine carries a small increased chance of developing the neurological symptoms of Guillain-Barré syndrome.

Chronic health conditions associated with a higher risk of severe RVS include cardiopulmonary disease, diabetes, and kidney, liver, and hematologic disorders, as well as compromised immunity, older age, and frailty.
 

2. Shingles Vaccines

This painful disease carries the potential complication of postherpetic neuralgia (PHN), which leads to long-term nerve pain in 10%-18% of patients, especially those over age 40. ACIP recommends two doses of the recombinant zoster vaccine (Shingrix) for individuals 50 years and older. Those 19 years and older with weakened immune systems due to disease or medical treatments should get two doses of the recombinant vaccine, as they have a higher risk of getting shingles and its complications, including neurological problems and skin and eye infections.

3 Pneumococcal Vaccines

There are three approved pneumococcal vaccines: PCV15 (Vaxneuvance), PCV20 (Prevnar20), and PPSV23 (Pneumovax23).

“The pneumococcal vaccine schedule is the most complicated one as higher-valent products continue to become available,” Dr. Fryhofer said.

The two types are pneumococcal conjugate vaccines (PCVs, specifically PCV15 and PCV20) and the pneumococcal polysaccharide vaccine (PPSV23). “While PPSV23 covers 23 strains, it doesn’t give the long-term immunity of the conjugate vaccine,” said Dr. Fryhofer. “A patient may have completed their vaccination with the polysaccharide vaccine but 5 years out may no longer be protected. So we offer the option of getting a dose of PCV20 to round out the protection and confer greater immune memory.”

The ACIP schedule recommends immunization against the Streptococcus pneumoniae pathogen for all older and all at-risk adults. Routine administration of PCV15 or PCV20 is advised for those 65 years or older who have never received any pneumococcal conjugate vaccine or whose previous vaccination history is unknown. If PCV15 is used, it should be followed by PPSV23. Those 65 years or older should get PPSV23 even if they already had one or more doses of pneumococcal vaccine before turning 65.

Further vaccination is recommended for younger at-risk adults aged 19-64 years who have received both PCV13 and PPSV23 but have incomplete vaccination status. These individuals are advised to complete their pneumococcal series by receiving either a single dose of PCV20 at an interval of at least 5 years after the last pneumococcal vaccine dose or more than one dose of PPSV23.

See Pneumococcal Vaccination: Summary of Who and When to Vaccinate for CDC guidance on vaccination options for adults who have previously received a pneumococcal conjugate vaccine. Or, to sort out quickly who gets what and when based on their age, concurrent conditions, and vaccination history, the CDC offers a type-in app called the PneumoRecs VaxAdvisor.
 

4. Measles, Mumps, and Rubella, and Varicella Vaccines

The two approved MMR vaccines are M-M-R II and PRIORIX. A third vaccine, ProQuad, adds varicella.

Adults lacking presumptive evidence of immunity should get at least one dose of the MMR combination vaccine.

Those born before 1957 are deemed to be immune, Dr. Fryhofer noted.

Two doses are recommended for adults entering high-risk settings for measles or mumps transmission such as healthcare personnel, students away at college, and international travelers. The two doses should be separated by at least 28 days. It’s no secret that measles, though preventable, is making a comeback, with 146 reported cases (48 in adults) across 21 states as of May 31 — most linked to international travel.

Women who plan to get pregnant should be vaccinated before but not during each pregnancy. (The vaccine is safe during lactation.) And those of childbearing age with no presumptive evidence of immunity are advised to get at least one dose of the MMR vaccine.
 

 

 

5. Tetanus, Diphtheria, and Pertussis Vaccine

Adults with no previous Tdap vaccination should receive a single dose of Adacel or Boostrix followed by a booster every 10 years. Boostrix is recommended for adults over 64 years.

During every pregnancy, women should have a single dose of Tdap, preferably in gestational weeks 27 through 36.

As to the immediate postpartum period, Tdap is recommended only for mothers who did not receive it during their current pregnancy and never received a prior dose. If a woman did not receive Tdap during her current pregnancy but did receive a prior dose of Tdap, she does not need Tdap postpartum.
 

The Challenges

According to Dr. Fryhofer, widespread disinformation about the risks of immunization against vaccine-preventable diseases has brought us to a flashpoint. “It’s now more important than ever to keep telling patients that vaccination is one of the most effective tools for preventing individual illness and protecting public health.”

She recommends that doctors follow the National Institutes of Health’s AIMS method to broach the subject of adult vaccination and increase participation in an inquiring, reassuring, and low-pressure way. Standing for Announce, Inquire, Mirror, and Secure, AIMS structures a nonjudgmental, patient-friendly conversation around immunization to elicit and acknowledge the reasons for hesitancy while explaining the safety and efficacy of vaccines.

Dr. Fryhofer frequently uses AIMS to bring inoculation-averse patients around. “Keep the conversation open with reluctant patients but leave them where they are. They need to see you as a reliable source and nonjudgmental source of information,” she said.

Dr. Block recommends outlining the diseases that have been eliminated through vaccines, from polio to measles, as well as the dangers of vaccine refusal, as indicated by recent outbreaks of vaccine-preventable diseases in areas with low immunization rates. “This approach highlights the opportunity we all have to get vaccinated to protect ourselves and our communities,”  she said.

In Dr. Fryhofer’s view, the situation is urgent and doctors need to be proactive. “We’re now at a public-health tipping point where we may see a sliding back and a reversing of many years of progress.”

Dr. Fryhofer and Dr. Block disclosed no competing interests relevant to their comments.

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>168291</fileName> <TBEID>0C050663.SIG</TBEID> <TBUniqueIdentifier>MD_0C050663</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Adult vaccines</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240605T111316</QCDate> <firstPublished>20240605T120954</firstPublished> <LastPublished>20240605T120954</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240605T120954</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber>na</meetingNumber> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</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>Many adults are complacent about vaccinations, believing that annual COVID and flu shots aside, they had all the immunizations they need as children and teens. </metaDescription> <articlePDF/> <teaserImage>301859</teaserImage> <teaser>“It’s now more important than ever to keep telling patients that vaccination is one of the most effective tools for preventing individual illness and protecting public health.”</teaser> <title>5 Vaccinations Adults Need Beyond COVID and Flu</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> </publications_g> <publications> <term>15</term> <term canonical="true">21</term> </publications> <sections> <term>27980</term> <term canonical="true">39313</term> <term>75</term> </sections> <topics> <term>234</term> <term canonical="true">311</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240129d2.jpg</altRep> <description role="drol:caption">Dr. Sandra Adamson Fryhofer</description> <description role="drol:credit">Mary Jane Starke</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240129d3.jpg</altRep> <description role="drol:caption">Dr. Lauren Block</description> <description role="drol:credit">Feinstein Institute for Medical Research</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>5 Vaccinations Adults Need Beyond COVID and Flu</title> <deck/> </itemMeta> <itemContent> <p>Many adults are complacent about vaccinations, believing that annual COVID and flu shots aside, they had all the immunizations they need as children and teens. But adults need vaccines as well, especially if they have missed earlier doses. And older and health-compromised adults, in particular, can benefit from newer vaccines that were not part of the childhood schedule.</p> <p>“The question is whether adults had the vaccinations they need in the first place,” Sandra Adamson Fryhofer, MD, an internist in Atlanta and the American Medical Association’s liaison to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, said in an interview. “Many do not even have reliable records of vaccination.”<br/><br/>[[{"fid":"301859","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Sandra Adamson Fryhofer, an internist in Atlanta and the American Medical Association's liaison to the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention","field_file_image_credit[und][0][value]":"Mary Jane Starke","field_file_image_caption[und][0][value]":"Dr. Sandra Adamson Fryhofer"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]Primary care physicians are ideally positioned to get adult patients to update their vaccination status on older vaccines and obtain newer ones as needed. “ACIP recommendations for adult vaccines are getting longer and more complicated and the way they’re administered is more complex, too, in that they’re not all given in the primary care office but sometimes in pharmacies,” Dr. Fryhofer said.<br/><br/>Not all adult patients want to update their vaccinations. “Vaccine hesitancy among many adults is accelerated by the several new vaccines that have been recommended in recent years,” Lauren Block, MD, MPH, an internist at Northwell Health and assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research in metropolitan New York City, said in an interview.<br/><br/>Physicians are rightly concerned about the lagging rates of adult vaccination, Dr. Block said. “Given the prevalence of conditions like pneumonia and shingles and the morbidity associated with them, healthcare providers should take every opportunity to discuss vaccination with patients, from well visits to hospital visits,” Dr. Block added. <br/><br/>[[{"fid":"301860","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Lauren Block is an internist at Northwell Health and assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research, New York City","field_file_image_credit[und][0][value]":"Feinstein Institute for Medical Research","field_file_image_caption[und][0][value]":"Dr. Lauren Block"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]She pointed to several obstacles to broader uptake, including product shortages, financial barriers, and, increasingly, the negative vocal messaging from media outlets and social media. <br/><br/></p> <h2>Current Recommendations</h2> <p>The main vaccines recommended for adults, besides flu and COVID shots, are for respiratory syncytial virus (RVS); shingles; pneumococcal disease; measles, mumps, and rubella (MMR); and tetanus, diphtheria, and pertussis (Tdap). Less commonly, booster vaccines for MM, and hepatitis are recommended when titers are proven to be low.</p> <p>ACIP’s updated 2024 <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/schedules/hcp/imz/adult-index.html">Adult Immunization Schedule</a> </span>can be downloaded from the <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html">website </a></span>of the CDC. <br/><br/>The newest additions to the schedule include RSV vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of updated COVID vaccines (both mRNA and protein-based adjuvanted versions).<br/><br/></p> <h2>1. Respiratory Syncytial Virus Vaccines</h2> <p>There are two licensed RSV vaccines, Arexvy and Abrysvo. The CDC schedule recommends a single-dose <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html#:~:text=CDC%20recommends%20that%20adults%2060,RSV%20vaccination%20will%20be%20beneficial">RSV vaccine</a></span> for adults age 60 years and older, especially those at high risk of contracting the virus — but after shared decision-making based on a discussion of the risk-harm balance since this vaccine carries a small <span class="Hyperlink"><a href="https://www.ninds.nih.gov/health-information/disorders/guillain-barre-syndrome#toc-what-is-guillain-barr-syndrome">increased chance</a></span> of developing the neurological symptoms of Guillain-Barré syndrome.</p> <p>Chronic health conditions associated with a higher risk of severe RVS include cardiopulmonary disease, diabetes, and kidney, liver, and hematologic disorders, as well as compromised immunity, older age, and frailty.<br/><br/></p> <h2>2. Shingles Vaccines</h2> <p>This <span class="Hyperlink"><a href="https://www.cdc.gov/shingles/signs-symptoms/index.html">painful disease</a></span> carries the potential complication of postherpetic neuralgia (PHN), which leads to long-term nerve pain in 10%-18% of patients, especially those over age 40. <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html#:~:text=CDC%20recommends%20two%20doses%20of,prior%20episode%20of%20herpes%20zoster">ACIP recommends</a></span> two doses of the recombinant zoster vaccine (Shingrix) for individuals 50 years and older. Those 19 years and older with <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/vpd/shingles/hcp/immunocompromised-adults.html">weakened immune systems</a></span> due to disease or medical treatments should get two doses of the recombinant vaccine, as they have a higher risk of getting shingles and its complications, including neurological problems and skin and eye infections.</p> <h2>3 Pneumococcal Vaccines</h2> <p>There are three approved pneumococcal vaccines: PCV15 (Vaxneuvance), PCV20 (Prevnar20), and PPSV23 (Pneumovax23).</p> <p>“The pneumococcal vaccine schedule is the most complicated one as higher-valent products continue to become available,” Dr. Fryhofer said.<br/><br/>The two types are pneumococcal conjugate vaccines (PCVs, specifically PCV15 and PCV20) and the pneumococcal polysaccharide vaccine (PPSV23). “While PPSV23 covers 23 strains, it doesn’t give the long-term immunity of the conjugate vaccine,” said Dr. Fryhofer. “A patient may have completed their vaccination with the polysaccharide vaccine but 5 years out may no longer be protected. So we offer the option of getting a dose of PCV20 to round out the protection and confer greater immune memory.”<br/><br/>The ACIP schedule recommends immunization against the <em>Streptococcus pneumoniae</em> pathogen for all older and all at-risk adults. <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/vpd/shingles/hcp/immunocompromised-adults.html">Routine administration</a></span> of PCV15 or PCV20 is advised for those 65 years or older who have never received any pneumococcal conjugate vaccine or whose previous vaccination history is unknown. If PCV15 is used, it should be followed by PPSV23. Those 65 years or older should get PPSV23 even if they already had one or more doses of pneumococcal vaccine before turning 65. <br/><br/>Further vaccination is recommended for <span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10495181/#:~:text=Adults%20aged%20%E2%89%A519%20years%20with%20an%20immunocompromising%20condition%2C%20a,5%20years%20after%20the%20last">younger at-risk adults</a></span> aged 19-64 years who have received both PCV13 and PPSV23 but have incomplete vaccination status. These individuals are advised to complete their pneumococcal series by receiving either a single dose of PCV20 at an interval of at least 5 years after the last pneumococcal vaccine dose or more than one dose of PPSV23.<br/><br/>See <a href="https://www.cdc.gov/vaccines/vpd/pneumo/hcp/who-when-to-vaccinate.html">Pneumococcal Vaccination: Summary of Who and When to Vaccinate</a> for CDC guidance on vaccination options for adults who have previously received a pneumococcal conjugate vaccine. Or, to sort out quickly who gets what and when based on their age, concurrent conditions, and vaccination history, the CDC offers a type-in app called the <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/vpd/pneumo/hcp/pneumoapp.html">PneumoRecs VaxAdvisor</a></span>.<br/><br/></p> <h2>4. Measles, Mumps, and Rubella, and Varicella Vaccines</h2> <p>The two approved MMR vaccines are M-M-R II and PRIORIX. A third vaccine, ProQuad, adds varicella. </p> <p>Adults lacking <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/vpd/mmr/hcp/recommendations.html#:~:text=Presumptive%20evidence%20of%20immunity%20can,adults%20not%20considered%20high%20risk">presumptive evidence of immunity</a></span> should get at least one dose of the MMR combination vaccine. <br/><br/>Those born before 1957 are deemed to be immune, Dr. Fryhofer noted.<br/><br/>Two doses are recommended for adults entering high-risk settings for measles or mumps transmission such as healthcare personnel, students away at college, and international travelers. The two doses should be separated by at least 28 days. It’s no secret that measles, though preventable, is <span class="Hyperlink"><a href="https://www.cdc.gov/measles/data-research/index.html">making a comeback</a></span>, with 146 reported cases (48 in adults) across 21 states as of May 31 — most linked to international travel. <br/><br/>Women who plan to get pregnant should be vaccinated before but not during each pregnancy. (The vaccine is safe during lactation.) And those of childbearing age with no presumptive evidence of immunity are advised to get at least one dose of the MMR vaccine.<br/><br/></p> <h2>5. Tetanus, Diphtheria, and Pertussis Vaccine</h2> <p>Adults with no previous <span class="Hyperlink"><a href="https://www.cdc.gov/vaccines/vpd/dtap-tdap-td/public/index.html">Tdap vaccination</a></span> should receive a single dose of Adacel or Boostrix followed by a booster every 10 years. Boostrix is recommended for adults over 64 years. </p> <p>During every pregnancy, women should have a single dose of Tdap, preferably in gestational weeks 27 through 36.<br/><br/>As to the immediate postpartum period, Tdap is recommended only for mothers who did not receive it during their current pregnancy and never received a prior dose. If a woman did not receive Tdap during her current pregnancy but did receive a prior dose of Tdap, she does not need Tdap postpartum.<br/><br/></p> <h2>The Challenges</h2> <p>According to Dr. Fryhofer, widespread disinformation about the risks of immunization against vaccine-preventable diseases has brought us to a flashpoint. “It’s now more important than ever to keep telling patients that vaccination is one of the most effective tools for preventing individual illness and protecting public health.”</p> <p>She recommends that doctors follow the National Institutes of Health’s<span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10273204/#:~:text=An%20acronym%20for%20the%20structure,into%20their%20most%20receptive%20mode"> AIMS method</a></span> to broach the subject of adult vaccination and increase participation in an inquiring, reassuring, and low-pressure way. Standing for Announce, Inquire, Mirror, and Secure, AIMS structures a nonjudgmental, patient-friendly conversation around immunization to elicit and acknowledge the reasons for hesitancy while explaining the safety and efficacy of vaccines.<br/><br/>Dr. Fryhofer frequently uses AIMS to bring inoculation-averse patients around. “Keep the conversation open with reluctant patients but leave them where they are. They need to see you as a reliable source and nonjudgmental source of information,” she said. <br/><br/>Dr. Block recommends outlining the diseases that have been eliminated through vaccines, from polio to measles, as well as the dangers of vaccine refusal, as indicated by recent outbreaks of vaccine-preventable diseases in areas with low immunization rates. “This approach highlights the opportunity we all have to get vaccinated to protect ourselves and our communities,”  she said.<br/><br/>In Dr. Fryhofer’s view, the situation is urgent and doctors need to be proactive. “We’re now at a public-health tipping point where we may see a sliding back and a reversing of many years of progress.”<br/><br/>Dr. Fryhofer and Dr. Block disclosed no competing interests relevant to their comments.</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

Culture of Sexual Harassment, Bullying Plagues Ob.Gyn.

Article Type
Changed
Fri, 05/24/2024 - 12:25

Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominated field, a systematic evidence review found.

Published in JAMA Network Open, by Ankita Gupta, MD, MPH, a urogynecology and reconstructive pelvic surgery specialist at the University of Louisville in Kentucky, and colleagues, the analysis found rates as high as 71% for sexual harassment, coercion, or unwanted advances. It also noted high rates of bullying, gender bias, and microaggressions. “We were struck by the continued high rates of harassment,” Dr. Gupta said in an interview. “Much of the literature within academic medicine has suggested the unequal distribution of women among medical specialties is the cause of sexual and gender harassment, but despite ob.gyns. being overwhelmingly female, we found that gender bias continues to occur at alarmingly high rates.”

Furthermore, among studies where this was reported, almost 25% of respondents had experienced sexual coercion. Not unexpectedly, this mistreatment often went unreported to institutional leadership out of fear of retaliation.

“We were also surprised to find a high rate of 51% for sexual harassment among male respondents as well, suggesting that both gender and power dynamics play a role in harassment,” Dr. Gupta said.

The primary perpetrators of unwanted behaviors were other doctors, overwhelmingly attending physicians, although residents and fellows were also identified as perpetrators, especially when harassment was reported by medical students, she added. “This once again points to the underreported abuse of professional power.” Women were rarely the perpetrators — just 10% — although they were the perpetrators in 57.7% of cases when the victim was male.

“Another interesting aspect of this is gender bias and microaggressions in the operating room,” she continued. While female surgeons often experience bias coming from OR staff, the review found that 94.4% of female ob.gyns. had been mistaken for non-physicians, 88.9% had pre-apologized for asking for something from a surgical technician or nurse, and 83.3% needed to make such requests multiple times. “These instances demonstrate gender bias in both male and female operating room staff toward female ob.gyns.”

Undermining and bullying behaviors are common in surgical specialties, Dr. Gupta explained, and the tantrums, swearing, and humiliation of trainees may be considered as much a rite of passage as the long hours. “As a trainee, you are taught to ignore such behavior as reporting it comes with fear of repercussions.”

This review bore this out, with only 8%-12% of respondents across studies reporting harassment and then predominantly to another trainee. “Sexual harassment and microaggressions can further lead to loss of career opportunities and burnout and I have come across many ob.gyns. who have chosen alternate paths owing to negative experiences,” Dr. Gupta said.

The Analysis

A joint effort by the Society of Gynecologic Surgeons and the and Society of Gynecologic Oncology, the analysis looked at existing literature from inception through June 2023.

A total of 10 eligible studies with 5852 participants addressed prevalence and 12 eligible studies in 2906 participants addressed interventions. Among the findings across different studies:

  • Sexual harassment was noted by 250 of 907 physicians (27.6%) and 181 of 255 female gynecologic oncologists (70.9%).
  • Workplace discrimination ranged from 142 of 249 female gynecologic oncologists (57.0%) to 354 of 527 female gynecologic oncologists (67.2%); among male gynecologic oncologists 138 of 358 (38.5%) reported discrimination.
  • Bullying was reported by 131 of 248 female gynecologic oncologists (52.8%).
  • Ob.gyn. trainees commonly experienced sexual harassment: 253 of 366 respondents (69.1%); this included gender harassment, unwanted sexual attention, and sexual coercion.
  • Mistreatment of medical students during ob.gyn. rotation was indicated by 168 of 668 (25.1%).
  • Perpetrators of harassment included physicians (30.1%), other trainees (13.1%), and OR staff (7.7%).

These findings are consistent with those of other recent investigations. A systematic review from 2022 found that 25% of ob.gyn., 32% of general surgery, and 21% of medical interns and students reported bullying .

In another 2022 review, in which ob.gyn. program directors were mainly women and department chairs mainly men, the prevalence of sexual harassment did not differ based on the gender of program directors and chairs.

A study from 2021 reported that 27% of academic surgical trainees, including ob.gyns., reported sexual harassment.

Going back to 2004, a study across multiple medical specialties found that ob.gyn. was second only to general surgery as the specialty associated with the highest rates of sexual harassment.

Despite institutional anti-discrimination policies, real-life interventions seem ineffective. “Disappointingly, we found that most interventions to address harassment had not been appropriately evaluated and did not show a decrease in sexual harassment,” Dr. Gupta said. “Interventions that were successful in reducing mistreatment of trainees required institutional buy-in at multiple levels, including leadership, management, and administration,” she said.

Multi-pronged strategies might include providing tools to educate healthcare staff about harassment and empowering bystanders to intervene when encountering such situations. “Further, independent offices where all complaints are evaluated by an intermediary third party and requiring professionalism to be a criterion for promotion criterion can be useful strategies,” she said.

She noted that residents may model harassing behavior perpetrated by senior attending physicians, thereby creating a cycle of mistreatment. “Equipping clinicians to be better surgical educators, providing clinical support, and modeling positive behavior may help disrupt the culture of harassment.” While the best solutions may be unclear, it is clear that much work remains to be done before the ob.gyn. working environment catches up to official institutional anti-discrimination policies.

This study was supported by the Society of Gynecologic Surgeons. Dr. Gupta disclosed no competing interests. Several coauthors disclosed relationships with multiple pharmaceutical or biomedical companies.

Publications
Topics
Sections

Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominated field, a systematic evidence review found.

Published in JAMA Network Open, by Ankita Gupta, MD, MPH, a urogynecology and reconstructive pelvic surgery specialist at the University of Louisville in Kentucky, and colleagues, the analysis found rates as high as 71% for sexual harassment, coercion, or unwanted advances. It also noted high rates of bullying, gender bias, and microaggressions. “We were struck by the continued high rates of harassment,” Dr. Gupta said in an interview. “Much of the literature within academic medicine has suggested the unequal distribution of women among medical specialties is the cause of sexual and gender harassment, but despite ob.gyns. being overwhelmingly female, we found that gender bias continues to occur at alarmingly high rates.”

Furthermore, among studies where this was reported, almost 25% of respondents had experienced sexual coercion. Not unexpectedly, this mistreatment often went unreported to institutional leadership out of fear of retaliation.

“We were also surprised to find a high rate of 51% for sexual harassment among male respondents as well, suggesting that both gender and power dynamics play a role in harassment,” Dr. Gupta said.

The primary perpetrators of unwanted behaviors were other doctors, overwhelmingly attending physicians, although residents and fellows were also identified as perpetrators, especially when harassment was reported by medical students, she added. “This once again points to the underreported abuse of professional power.” Women were rarely the perpetrators — just 10% — although they were the perpetrators in 57.7% of cases when the victim was male.

“Another interesting aspect of this is gender bias and microaggressions in the operating room,” she continued. While female surgeons often experience bias coming from OR staff, the review found that 94.4% of female ob.gyns. had been mistaken for non-physicians, 88.9% had pre-apologized for asking for something from a surgical technician or nurse, and 83.3% needed to make such requests multiple times. “These instances demonstrate gender bias in both male and female operating room staff toward female ob.gyns.”

Undermining and bullying behaviors are common in surgical specialties, Dr. Gupta explained, and the tantrums, swearing, and humiliation of trainees may be considered as much a rite of passage as the long hours. “As a trainee, you are taught to ignore such behavior as reporting it comes with fear of repercussions.”

This review bore this out, with only 8%-12% of respondents across studies reporting harassment and then predominantly to another trainee. “Sexual harassment and microaggressions can further lead to loss of career opportunities and burnout and I have come across many ob.gyns. who have chosen alternate paths owing to negative experiences,” Dr. Gupta said.

The Analysis

A joint effort by the Society of Gynecologic Surgeons and the and Society of Gynecologic Oncology, the analysis looked at existing literature from inception through June 2023.

A total of 10 eligible studies with 5852 participants addressed prevalence and 12 eligible studies in 2906 participants addressed interventions. Among the findings across different studies:

  • Sexual harassment was noted by 250 of 907 physicians (27.6%) and 181 of 255 female gynecologic oncologists (70.9%).
  • Workplace discrimination ranged from 142 of 249 female gynecologic oncologists (57.0%) to 354 of 527 female gynecologic oncologists (67.2%); among male gynecologic oncologists 138 of 358 (38.5%) reported discrimination.
  • Bullying was reported by 131 of 248 female gynecologic oncologists (52.8%).
  • Ob.gyn. trainees commonly experienced sexual harassment: 253 of 366 respondents (69.1%); this included gender harassment, unwanted sexual attention, and sexual coercion.
  • Mistreatment of medical students during ob.gyn. rotation was indicated by 168 of 668 (25.1%).
  • Perpetrators of harassment included physicians (30.1%), other trainees (13.1%), and OR staff (7.7%).

These findings are consistent with those of other recent investigations. A systematic review from 2022 found that 25% of ob.gyn., 32% of general surgery, and 21% of medical interns and students reported bullying .

In another 2022 review, in which ob.gyn. program directors were mainly women and department chairs mainly men, the prevalence of sexual harassment did not differ based on the gender of program directors and chairs.

A study from 2021 reported that 27% of academic surgical trainees, including ob.gyns., reported sexual harassment.

Going back to 2004, a study across multiple medical specialties found that ob.gyn. was second only to general surgery as the specialty associated with the highest rates of sexual harassment.

Despite institutional anti-discrimination policies, real-life interventions seem ineffective. “Disappointingly, we found that most interventions to address harassment had not been appropriately evaluated and did not show a decrease in sexual harassment,” Dr. Gupta said. “Interventions that were successful in reducing mistreatment of trainees required institutional buy-in at multiple levels, including leadership, management, and administration,” she said.

Multi-pronged strategies might include providing tools to educate healthcare staff about harassment and empowering bystanders to intervene when encountering such situations. “Further, independent offices where all complaints are evaluated by an intermediary third party and requiring professionalism to be a criterion for promotion criterion can be useful strategies,” she said.

She noted that residents may model harassing behavior perpetrated by senior attending physicians, thereby creating a cycle of mistreatment. “Equipping clinicians to be better surgical educators, providing clinical support, and modeling positive behavior may help disrupt the culture of harassment.” While the best solutions may be unclear, it is clear that much work remains to be done before the ob.gyn. working environment catches up to official institutional anti-discrimination policies.

This study was supported by the Society of Gynecologic Surgeons. Dr. Gupta disclosed no competing interests. Several coauthors disclosed relationships with multiple pharmaceutical or biomedical companies.

Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominated field, a systematic evidence review found.

Published in JAMA Network Open, by Ankita Gupta, MD, MPH, a urogynecology and reconstructive pelvic surgery specialist at the University of Louisville in Kentucky, and colleagues, the analysis found rates as high as 71% for sexual harassment, coercion, or unwanted advances. It also noted high rates of bullying, gender bias, and microaggressions. “We were struck by the continued high rates of harassment,” Dr. Gupta said in an interview. “Much of the literature within academic medicine has suggested the unequal distribution of women among medical specialties is the cause of sexual and gender harassment, but despite ob.gyns. being overwhelmingly female, we found that gender bias continues to occur at alarmingly high rates.”

Furthermore, among studies where this was reported, almost 25% of respondents had experienced sexual coercion. Not unexpectedly, this mistreatment often went unreported to institutional leadership out of fear of retaliation.

“We were also surprised to find a high rate of 51% for sexual harassment among male respondents as well, suggesting that both gender and power dynamics play a role in harassment,” Dr. Gupta said.

The primary perpetrators of unwanted behaviors were other doctors, overwhelmingly attending physicians, although residents and fellows were also identified as perpetrators, especially when harassment was reported by medical students, she added. “This once again points to the underreported abuse of professional power.” Women were rarely the perpetrators — just 10% — although they were the perpetrators in 57.7% of cases when the victim was male.

“Another interesting aspect of this is gender bias and microaggressions in the operating room,” she continued. While female surgeons often experience bias coming from OR staff, the review found that 94.4% of female ob.gyns. had been mistaken for non-physicians, 88.9% had pre-apologized for asking for something from a surgical technician or nurse, and 83.3% needed to make such requests multiple times. “These instances demonstrate gender bias in both male and female operating room staff toward female ob.gyns.”

Undermining and bullying behaviors are common in surgical specialties, Dr. Gupta explained, and the tantrums, swearing, and humiliation of trainees may be considered as much a rite of passage as the long hours. “As a trainee, you are taught to ignore such behavior as reporting it comes with fear of repercussions.”

This review bore this out, with only 8%-12% of respondents across studies reporting harassment and then predominantly to another trainee. “Sexual harassment and microaggressions can further lead to loss of career opportunities and burnout and I have come across many ob.gyns. who have chosen alternate paths owing to negative experiences,” Dr. Gupta said.

The Analysis

A joint effort by the Society of Gynecologic Surgeons and the and Society of Gynecologic Oncology, the analysis looked at existing literature from inception through June 2023.

A total of 10 eligible studies with 5852 participants addressed prevalence and 12 eligible studies in 2906 participants addressed interventions. Among the findings across different studies:

  • Sexual harassment was noted by 250 of 907 physicians (27.6%) and 181 of 255 female gynecologic oncologists (70.9%).
  • Workplace discrimination ranged from 142 of 249 female gynecologic oncologists (57.0%) to 354 of 527 female gynecologic oncologists (67.2%); among male gynecologic oncologists 138 of 358 (38.5%) reported discrimination.
  • Bullying was reported by 131 of 248 female gynecologic oncologists (52.8%).
  • Ob.gyn. trainees commonly experienced sexual harassment: 253 of 366 respondents (69.1%); this included gender harassment, unwanted sexual attention, and sexual coercion.
  • Mistreatment of medical students during ob.gyn. rotation was indicated by 168 of 668 (25.1%).
  • Perpetrators of harassment included physicians (30.1%), other trainees (13.1%), and OR staff (7.7%).

These findings are consistent with those of other recent investigations. A systematic review from 2022 found that 25% of ob.gyn., 32% of general surgery, and 21% of medical interns and students reported bullying .

In another 2022 review, in which ob.gyn. program directors were mainly women and department chairs mainly men, the prevalence of sexual harassment did not differ based on the gender of program directors and chairs.

A study from 2021 reported that 27% of academic surgical trainees, including ob.gyns., reported sexual harassment.

Going back to 2004, a study across multiple medical specialties found that ob.gyn. was second only to general surgery as the specialty associated with the highest rates of sexual harassment.

Despite institutional anti-discrimination policies, real-life interventions seem ineffective. “Disappointingly, we found that most interventions to address harassment had not been appropriately evaluated and did not show a decrease in sexual harassment,” Dr. Gupta said. “Interventions that were successful in reducing mistreatment of trainees required institutional buy-in at multiple levels, including leadership, management, and administration,” she said.

Multi-pronged strategies might include providing tools to educate healthcare staff about harassment and empowering bystanders to intervene when encountering such situations. “Further, independent offices where all complaints are evaluated by an intermediary third party and requiring professionalism to be a criterion for promotion criterion can be useful strategies,” she said.

She noted that residents may model harassing behavior perpetrated by senior attending physicians, thereby creating a cycle of mistreatment. “Equipping clinicians to be better surgical educators, providing clinical support, and modeling positive behavior may help disrupt the culture of harassment.” While the best solutions may be unclear, it is clear that much work remains to be done before the ob.gyn. working environment catches up to official institutional anti-discrimination policies.

This study was supported by the Society of Gynecologic Surgeons. Dr. Gupta disclosed no competing interests. Several coauthors disclosed relationships with multiple pharmaceutical or biomedical companies.

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>168168</fileName> <TBEID>0C0503C7.SIG</TBEID> <TBUniqueIdentifier>MD_0C0503C7</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Culture of harassment in ObGyn</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240524T121908</QCDate> <firstPublished>20240524T122114</firstPublished> <LastPublished>20240524T122114</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240524T122114</CMSDate> <articleSource>FROM JAMA NETWORK OPEN</articleSource> <facebookInfo/> <meetingNumber>na</meetingNumber> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</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>Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominat</metaDescription> <articlePDF/> <teaserImage/> <teaser>Even in this female-dominated field, a systematic evidence review found harassment by other physicians and even operating room staff to be common. </teaser> <title>Culture of Sexual Harassment, Bullying Plagues Ob.Gyn.</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>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">23</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">38029</term> <term>66772</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Culture of Sexual Harassment, Bullying Plagues Ob.Gyn.</title> <deck/> </itemMeta> <itemContent> <p>Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominated field, a systematic evidence review found.</p> <p><span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2818407">Published</a></span> in <em>JAMA Network Open</em>, by Ankita Gupta, MD, MPH, a urogynecology and reconstructive pelvic surgery specialist at the University of Louisville in Kentucky, and colleagues, the analysis found rates as high as 71% for sexual harassment, coercion, or unwanted advances. It also noted high rates of bullying, gender bias, and microaggressions. “We were struck by the continued high rates of harassment,” Dr. Gupta said in an interview. “Much of the literature within academic medicine has suggested the unequal distribution of women among medical specialties is the cause of sexual and gender harassment, but despite ob.gyns. being overwhelmingly female, we found that gender bias continues to occur at alarmingly high rates.”<br/><br/>Furthermore, among studies where this was reported, almost 25% of respondents had experienced sexual coercion. Not unexpectedly, this mistreatment often went unreported to institutional leadership out of fear of retaliation. <br/><br/>“We were also surprised to find a high rate of 51% for sexual harassment among male respondents as well, suggesting that both gender and power dynamics play a role in harassment,” Dr. Gupta said.<br/><br/>The primary perpetrators of unwanted behaviors were other doctors, overwhelmingly attending physicians, although residents and fellows were also identified as perpetrators, especially when harassment was reported by medical students, she added. “This once again points to the underreported abuse of professional power.” Women were rarely the perpetrators — just 10% — although they were the perpetrators in 57.7% of cases when the victim was male. <br/><br/>“Another interesting aspect of this is gender bias and microaggressions in the operating room,” she continued. While female surgeons often experience bias coming from OR staff, the review found that 94.4% of female ob.gyns. had been mistaken for non-physicians, 88.9% had pre-apologized for asking for something from a surgical technician or nurse, and 83.3% needed to make such requests multiple times. “These instances demonstrate gender bias in both male and female operating room staff toward female ob.gyns.” <br/><br/>Undermining and bullying behaviors are common in surgical specialties, Dr. Gupta explained, and the tantrums, swearing, and humiliation of trainees may be considered as much a rite of passage as the long hours. “As a trainee, you are taught to ignore such behavior as reporting it comes with fear of repercussions.” <br/><br/>This review bore this out, with only 8%-12% of respondents across studies reporting harassment and then predominantly to another trainee. “Sexual harassment and microaggressions can further lead to loss of career opportunities and burnout and I have come across many ob.gyns. who have chosen alternate paths owing to negative experiences,” Dr. Gupta said.</p> <h2>The Analysis</h2> <p>A joint effort by the Society of Gynecologic Surgeons and the and Society of Gynecologic Oncology, the analysis looked at existing literature from inception through June 2023.</p> <p>A total of 10 eligible studies with 5852 participants addressed prevalence and 12 eligible studies in 2906 participants addressed interventions. Among the findings across different studies:</p> <ul class="body"> <li>Sexual harassment was noted by 250 of 907 physicians (27.6%) and 181 of 255 female gynecologic oncologists (70.9%). </li> <li>Workplace discrimination ranged from 142 of 249 female gynecologic oncologists (57.0%) to 354 of 527 female gynecologic oncologists (67.2%); among male gynecologic oncologists 138 of 358 (38.5%) reported discrimination.</li> <li>Bullying was reported by 131 of 248 female gynecologic oncologists (52.8%).</li> <li>Ob.gyn. trainees commonly experienced sexual harassment: 253 of 366 respondents (69.1%); this included gender harassment, unwanted sexual attention, and sexual coercion. </li> <li>Mistreatment of medical students during ob.gyn. rotation was indicated by 168 of 668 (25.1%). </li> <li>Perpetrators of harassment included physicians (30.1%), other trainees (13.1%), and OR staff (7.7%). </li> </ul> <p>These findings are consistent with those of other recent investigations. A systematic <span class="Hyperlink"><a href="https://onlinelibrary.wiley.com/doi/10.1007/s00268-021-06432-6">review</a></span> from 2022 found that 25% of ob.gyn., 32% of general surgery, and 21% of medical interns and students reported bullying .</p> <p>In <span class="Hyperlink"><a href="https://www.sciencedirect.com/science/article/abs/pii/S193172042200068X?via%3Dihub">another 2022 review</a></span>, in which ob.gyn. program directors were mainly women and department chairs mainly men, the prevalence of sexual harassment did not differ based on the gender of program directors and chairs.<br/><br/>A <span class="Hyperlink"><a href="https://bmjopen.bmj.com/content/11/7/e043256">study from 2021</a></span> reported that 27% of academic surgical trainees, including ob.gyns., reported sexual harassment.<br/><br/>Going back to 2004, <span class="Hyperlink"><a href="https://journals.sagepub.com/doi/10.1177/1363459304038799">a study</a></span> across multiple medical specialties found that ob.gyn. was second only to general surgery as the specialty associated with the highest rates of sexual harassment.<br/><br/>Despite institutional anti-discrimination policies, real-life interventions seem ineffective. “Disappointingly, we found that most interventions to address harassment had not been appropriately evaluated and did not show a decrease in sexual harassment,” Dr. Gupta said. “Interventions that were successful in reducing mistreatment of trainees required institutional buy-in at multiple levels, including leadership, management, and administration,” she said.<br/><br/>Multi-pronged strategies might include providing tools to educate healthcare staff about harassment and empowering bystanders to intervene when encountering such situations. “Further, independent offices where all complaints are evaluated by an intermediary third party and requiring professionalism to be a criterion for promotion criterion can be useful strategies,” she said. <br/><br/>She noted that residents may model harassing behavior perpetrated by senior attending physicians, thereby creating a cycle of mistreatment. “Equipping clinicians to be better surgical educators, providing clinical support, and modeling positive behavior may help disrupt the culture of harassment.” While the best solutions may be unclear, it is clear that much work remains to be done before the ob.gyn. working environment catches up to official institutional anti-discrimination policies.<br/><br/>This study was supported by the Society of Gynecologic Surgeons. Dr. Gupta disclosed no competing interests. Several coauthors disclosed relationships with multiple pharmaceutical or biomedical companies. </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM JAMA NETWORK OPEN

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-Alcohol Intake in MASLD Increases Risk of Cirrhosis

Critical Need for Early Tx of High-Risk Alcohol Use
Article Type
Changed
Fri, 05/10/2024 - 13:41

One in nine patients with steatotic liver disease reported concurrent alcohol use, and more than 11% reported high-risk consumption, a national study of more than a million US veterans found.

Moreover, the combination of steatotic liver disease and high-risk alcohol intake carried a more than 43% higher long-term risk of liver cirrhosis compared with no alcohol use, according to researchers led by Robert J. Wong, MD, MS, of the Division of Gastroenterology and Hepatology, Veterans Affairs Healthcare System Palo Alto, at Stanford University School of Medicine in Palo Alto, California.

However, the study found that “reducing alcohol use lowers risk of cirrhosis, emphasizing the importance of timely alcohol use assessment and early interventions to address high-risk alcohol use in steatotic liver disease,” Dr. Wong and associates wrote in Gastroenterology.

Although concurrent moderate to heavy alcohol intake would be expected to lead more rapidly to liver disease progression, the existing literature has been conflicting, the authors noted. Several studies have even found moderate alcohol associated with a lower risk of advanced liver disease among MASLD patients, including that by Dunn et al. .
 

The Study

MASLD patients were identified through the US Veterans Affairs Corporate Data Warehouse from January 1, 2010, through December 31, 2017, with follow-up through December 31, 2022.

Alcohol use was assessed by Alcohol Use Disorders Identification Test–Concise (AUDIT-C) scores and was categorized as follows: no alcohol (AUDIT-C = 0), low-risk alcohol use (AUDIT-C 1-2 for women and 1–3 for men), and high-risk alcohol (AUDIT-C ≥ 3 for women and ≥ 4 for men).

Among the 1,156,189 veterans with MASLD, 54.2% reported no alcohol, 34.6% low-risk alcohol, and 11.2% high-risk alcohol use. In median follow-up of nine to 10 years, incidence rates of cirrhosis were .53 per 100 person-years for no use, .42 for low-risk use, and .76 for high-risk use.

In contrast to patients with baseline high-risk alcohol intake who reported no change in use, those who decreased their alcohol intake during follow-up experienced a 39% reduction in the long-term risk of cirrhosis, for a hazard ratio of .61 (95% CI, .45-.83, P < .01).

tusludastawushechuhauajarosuframachuslejurodrowraboslusibabofratrathijubraniphudeswopohokasajestusathodruswiphisliprodorastimuspasoslislauostesholephububraswugikitrebriwrostodoclislefruspotrecraslucugerecredrafrulephates
Dr. Robert J. Wong


About 70% of patients were non-Hispanic Whites and more than 90% were male in all consumption categories. The no-alcohol group was older than the high-risk alcohol group: 64 years vs 59.9 years (P < .0001). Compared with the high-risk alcohol group, the no-alcohol group had a significantly greater proportion of comorbid diabetes (62.3% vs 42.5%), hypertension (77.9% vs 69.1%), or cardiovascular disease (40.2% vs 25.9%, P < .0001 for all comparisons).

In a significant study observation, fewer than 5% of patients with high-risk use received behavioral or pharmacologic therapy and of those who did, most were referred for or received treatment at or near the time of cirrhosis diagnosis. “This highlights a major gap in linking patients with high-risk alcohol use to appropriate behavioral or pharmacologic therapy in a timely manner and may reflect missed opportunities to prevent further alcohol-related morbidity and mortality,” Dr. Wong and colleagues wrote.

They called for studies of novel interventions for timely assessment of alcohol use with linkage to addiction services. They cited the need to understand the interaction between levels of alcohol use and underlying MASLD, adding, “More research is also needed to understand whether this interaction varies across different populations.”

This study received no specific funding. Dr. Wong reported funding through his institution from Gilead Sciences, Exact Sciences, and Thera Technologies.

Body

 

Recent consensus in defining metabolic dysfunction-associated steatotic liver disease (MASLD) has raised awareness for the combined impact of cardiometabolic risk factors and alcohol consumption on liver disease progression. This study by Wong et al. highlights the undeniable influence of high-risk alcohol use on the development of advanced liver disease.

In a national cohort of over 1 million US veterans with steatotic liver disease (SLD), patients with high-risk alcohol use based on AUDIT-C assessment exhibited > 43% greater risk of cirrhosis compared to those with no alcohol use. The relationship between alcohol and liver severity in SLD was observed even after excluding patients meeting classification for predominant alcohol-associated liver disease. While increased alcohol use was associated with increased incidence of cirrhosis, decreased alcohol use led to a notable 39% reduction in cirrhosis risk over time.

Reducing alcohol consumption remains best practice guidelines for mitigating risk of progression in steatotic liver disease. However, results of this study emphasize the critical need for early identification and treatment of high-risk alcohol use in all patients with SLD. While universal recommendations for alcohol abstinence provides pragmatic implementation, there is a significant need to better understand the interaction of specific metabolic risk factors and patterns of alcohol use across the spectrum of MetALD to guide personalized recommendations for patient education and management.[[{"fid":"301427","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","field_file_image_credit[und][0][value]":"Mayo Clinic","field_file_image_caption[und][0][value]":"Dr. Tiffany Wu"},"type":"media","field_deltas":{"2":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","field_file_image_credit[und][0][value]":"Mayo Clinic","field_file_image_caption[und][0][value]":"Dr. Tiffany Wu"}},"attributes":{"alt":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","class":"media-element file-medstat-image-flush-right","data-delta":"2"}}]]

Further research using prospective clinical trial design is needed to evaluate the interplay of alcohol consumption and metabolic risk factors across variable age, sex, genetics, and environmental exposures that are increasingly being recognized as vital drivers of health and disease.

Tiffany Wu, MD, MS, is a fellow in Transplant Hepatology at Mayo Clinic in Rochester, Minnesota. She has no conflicts.

Publications
Topics
Sections
Body

 

Recent consensus in defining metabolic dysfunction-associated steatotic liver disease (MASLD) has raised awareness for the combined impact of cardiometabolic risk factors and alcohol consumption on liver disease progression. This study by Wong et al. highlights the undeniable influence of high-risk alcohol use on the development of advanced liver disease.

In a national cohort of over 1 million US veterans with steatotic liver disease (SLD), patients with high-risk alcohol use based on AUDIT-C assessment exhibited > 43% greater risk of cirrhosis compared to those with no alcohol use. The relationship between alcohol and liver severity in SLD was observed even after excluding patients meeting classification for predominant alcohol-associated liver disease. While increased alcohol use was associated with increased incidence of cirrhosis, decreased alcohol use led to a notable 39% reduction in cirrhosis risk over time.

Reducing alcohol consumption remains best practice guidelines for mitigating risk of progression in steatotic liver disease. However, results of this study emphasize the critical need for early identification and treatment of high-risk alcohol use in all patients with SLD. While universal recommendations for alcohol abstinence provides pragmatic implementation, there is a significant need to better understand the interaction of specific metabolic risk factors and patterns of alcohol use across the spectrum of MetALD to guide personalized recommendations for patient education and management.[[{"fid":"301427","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","field_file_image_credit[und][0][value]":"Mayo Clinic","field_file_image_caption[und][0][value]":"Dr. Tiffany Wu"},"type":"media","field_deltas":{"2":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","field_file_image_credit[und][0][value]":"Mayo Clinic","field_file_image_caption[und][0][value]":"Dr. Tiffany Wu"}},"attributes":{"alt":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","class":"media-element file-medstat-image-flush-right","data-delta":"2"}}]]

Further research using prospective clinical trial design is needed to evaluate the interplay of alcohol consumption and metabolic risk factors across variable age, sex, genetics, and environmental exposures that are increasingly being recognized as vital drivers of health and disease.

Tiffany Wu, MD, MS, is a fellow in Transplant Hepatology at Mayo Clinic in Rochester, Minnesota. She has no conflicts.

Body

 

Recent consensus in defining metabolic dysfunction-associated steatotic liver disease (MASLD) has raised awareness for the combined impact of cardiometabolic risk factors and alcohol consumption on liver disease progression. This study by Wong et al. highlights the undeniable influence of high-risk alcohol use on the development of advanced liver disease.

In a national cohort of over 1 million US veterans with steatotic liver disease (SLD), patients with high-risk alcohol use based on AUDIT-C assessment exhibited > 43% greater risk of cirrhosis compared to those with no alcohol use. The relationship between alcohol and liver severity in SLD was observed even after excluding patients meeting classification for predominant alcohol-associated liver disease. While increased alcohol use was associated with increased incidence of cirrhosis, decreased alcohol use led to a notable 39% reduction in cirrhosis risk over time.

Reducing alcohol consumption remains best practice guidelines for mitigating risk of progression in steatotic liver disease. However, results of this study emphasize the critical need for early identification and treatment of high-risk alcohol use in all patients with SLD. While universal recommendations for alcohol abstinence provides pragmatic implementation, there is a significant need to better understand the interaction of specific metabolic risk factors and patterns of alcohol use across the spectrum of MetALD to guide personalized recommendations for patient education and management.[[{"fid":"301427","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","field_file_image_credit[und][0][value]":"Mayo Clinic","field_file_image_caption[und][0][value]":"Dr. Tiffany Wu"},"type":"media","field_deltas":{"2":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","field_file_image_credit[und][0][value]":"Mayo Clinic","field_file_image_caption[und][0][value]":"Dr. Tiffany Wu"}},"attributes":{"alt":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","class":"media-element file-medstat-image-flush-right","data-delta":"2"}}]]

Further research using prospective clinical trial design is needed to evaluate the interplay of alcohol consumption and metabolic risk factors across variable age, sex, genetics, and environmental exposures that are increasingly being recognized as vital drivers of health and disease.

Tiffany Wu, MD, MS, is a fellow in Transplant Hepatology at Mayo Clinic in Rochester, Minnesota. She has no conflicts.

Title
Critical Need for Early Tx of High-Risk Alcohol Use
Critical Need for Early Tx of High-Risk Alcohol Use

One in nine patients with steatotic liver disease reported concurrent alcohol use, and more than 11% reported high-risk consumption, a national study of more than a million US veterans found.

Moreover, the combination of steatotic liver disease and high-risk alcohol intake carried a more than 43% higher long-term risk of liver cirrhosis compared with no alcohol use, according to researchers led by Robert J. Wong, MD, MS, of the Division of Gastroenterology and Hepatology, Veterans Affairs Healthcare System Palo Alto, at Stanford University School of Medicine in Palo Alto, California.

However, the study found that “reducing alcohol use lowers risk of cirrhosis, emphasizing the importance of timely alcohol use assessment and early interventions to address high-risk alcohol use in steatotic liver disease,” Dr. Wong and associates wrote in Gastroenterology.

Although concurrent moderate to heavy alcohol intake would be expected to lead more rapidly to liver disease progression, the existing literature has been conflicting, the authors noted. Several studies have even found moderate alcohol associated with a lower risk of advanced liver disease among MASLD patients, including that by Dunn et al. .
 

The Study

MASLD patients were identified through the US Veterans Affairs Corporate Data Warehouse from January 1, 2010, through December 31, 2017, with follow-up through December 31, 2022.

Alcohol use was assessed by Alcohol Use Disorders Identification Test–Concise (AUDIT-C) scores and was categorized as follows: no alcohol (AUDIT-C = 0), low-risk alcohol use (AUDIT-C 1-2 for women and 1–3 for men), and high-risk alcohol (AUDIT-C ≥ 3 for women and ≥ 4 for men).

Among the 1,156,189 veterans with MASLD, 54.2% reported no alcohol, 34.6% low-risk alcohol, and 11.2% high-risk alcohol use. In median follow-up of nine to 10 years, incidence rates of cirrhosis were .53 per 100 person-years for no use, .42 for low-risk use, and .76 for high-risk use.

In contrast to patients with baseline high-risk alcohol intake who reported no change in use, those who decreased their alcohol intake during follow-up experienced a 39% reduction in the long-term risk of cirrhosis, for a hazard ratio of .61 (95% CI, .45-.83, P < .01).

tusludastawushechuhauajarosuframachuslejurodrowraboslusibabofratrathijubraniphudeswopohokasajestusathodruswiphisliprodorastimuspasoslislauostesholephububraswugikitrebriwrostodoclislefruspotrecraslucugerecredrafrulephates
Dr. Robert J. Wong


About 70% of patients were non-Hispanic Whites and more than 90% were male in all consumption categories. The no-alcohol group was older than the high-risk alcohol group: 64 years vs 59.9 years (P < .0001). Compared with the high-risk alcohol group, the no-alcohol group had a significantly greater proportion of comorbid diabetes (62.3% vs 42.5%), hypertension (77.9% vs 69.1%), or cardiovascular disease (40.2% vs 25.9%, P < .0001 for all comparisons).

In a significant study observation, fewer than 5% of patients with high-risk use received behavioral or pharmacologic therapy and of those who did, most were referred for or received treatment at or near the time of cirrhosis diagnosis. “This highlights a major gap in linking patients with high-risk alcohol use to appropriate behavioral or pharmacologic therapy in a timely manner and may reflect missed opportunities to prevent further alcohol-related morbidity and mortality,” Dr. Wong and colleagues wrote.

They called for studies of novel interventions for timely assessment of alcohol use with linkage to addiction services. They cited the need to understand the interaction between levels of alcohol use and underlying MASLD, adding, “More research is also needed to understand whether this interaction varies across different populations.”

This study received no specific funding. Dr. Wong reported funding through his institution from Gilead Sciences, Exact Sciences, and Thera Technologies.

One in nine patients with steatotic liver disease reported concurrent alcohol use, and more than 11% reported high-risk consumption, a national study of more than a million US veterans found.

Moreover, the combination of steatotic liver disease and high-risk alcohol intake carried a more than 43% higher long-term risk of liver cirrhosis compared with no alcohol use, according to researchers led by Robert J. Wong, MD, MS, of the Division of Gastroenterology and Hepatology, Veterans Affairs Healthcare System Palo Alto, at Stanford University School of Medicine in Palo Alto, California.

However, the study found that “reducing alcohol use lowers risk of cirrhosis, emphasizing the importance of timely alcohol use assessment and early interventions to address high-risk alcohol use in steatotic liver disease,” Dr. Wong and associates wrote in Gastroenterology.

Although concurrent moderate to heavy alcohol intake would be expected to lead more rapidly to liver disease progression, the existing literature has been conflicting, the authors noted. Several studies have even found moderate alcohol associated with a lower risk of advanced liver disease among MASLD patients, including that by Dunn et al. .
 

The Study

MASLD patients were identified through the US Veterans Affairs Corporate Data Warehouse from January 1, 2010, through December 31, 2017, with follow-up through December 31, 2022.

Alcohol use was assessed by Alcohol Use Disorders Identification Test–Concise (AUDIT-C) scores and was categorized as follows: no alcohol (AUDIT-C = 0), low-risk alcohol use (AUDIT-C 1-2 for women and 1–3 for men), and high-risk alcohol (AUDIT-C ≥ 3 for women and ≥ 4 for men).

Among the 1,156,189 veterans with MASLD, 54.2% reported no alcohol, 34.6% low-risk alcohol, and 11.2% high-risk alcohol use. In median follow-up of nine to 10 years, incidence rates of cirrhosis were .53 per 100 person-years for no use, .42 for low-risk use, and .76 for high-risk use.

In contrast to patients with baseline high-risk alcohol intake who reported no change in use, those who decreased their alcohol intake during follow-up experienced a 39% reduction in the long-term risk of cirrhosis, for a hazard ratio of .61 (95% CI, .45-.83, P < .01).

tusludastawushechuhauajarosuframachuslejurodrowraboslusibabofratrathijubraniphudeswopohokasajestusathodruswiphisliprodorastimuspasoslislauostesholephububraswugikitrebriwrostodoclislefruspotrecraslucugerecredrafrulephates
Dr. Robert J. Wong


About 70% of patients were non-Hispanic Whites and more than 90% were male in all consumption categories. The no-alcohol group was older than the high-risk alcohol group: 64 years vs 59.9 years (P < .0001). Compared with the high-risk alcohol group, the no-alcohol group had a significantly greater proportion of comorbid diabetes (62.3% vs 42.5%), hypertension (77.9% vs 69.1%), or cardiovascular disease (40.2% vs 25.9%, P < .0001 for all comparisons).

In a significant study observation, fewer than 5% of patients with high-risk use received behavioral or pharmacologic therapy and of those who did, most were referred for or received treatment at or near the time of cirrhosis diagnosis. “This highlights a major gap in linking patients with high-risk alcohol use to appropriate behavioral or pharmacologic therapy in a timely manner and may reflect missed opportunities to prevent further alcohol-related morbidity and mortality,” Dr. Wong and colleagues wrote.

They called for studies of novel interventions for timely assessment of alcohol use with linkage to addiction services. They cited the need to understand the interaction between levels of alcohol use and underlying MASLD, adding, “More research is also needed to understand whether this interaction varies across different populations.”

This study received no specific funding. Dr. Wong reported funding through his institution from Gilead Sciences, Exact Sciences, and Thera Technologies.

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>167904</fileName> <TBEID>0C04FE2D.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FE2D</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Alcohol-cirrhosis in MASLD</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240510T132054</QCDate> <firstPublished>20240510T133724</firstPublished> <LastPublished>20240510T133724</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240510T133724</CMSDate> <articleSource>FROM GASTROENTEROLOGY </articleSource> <facebookInfo/> <meetingNumber/> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</bylineFull> <bylineTitleText>MDedge News</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>One in nine patients with steatotic liver disease reported concurrent alcohol use, and more than 11% reported high-risk consumption, a national study of more th</metaDescription> <articlePDF/> <teaserImage>301426</teaserImage> <teaser>In a significant study observation, fewer than 5% of US veterans with high-risk use received behavioral or pharmacologic therapy.</teaser> <title>High-Alcohol Intake in MASLD Increases Risk of Cirrhosis</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>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> </publications> <sections> <term canonical="true">69</term> <term>39313</term> <term>27970</term> </sections> <topics> <term canonical="true">346</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012918.jpg</altRep> <description role="drol:caption">Dr. Robert J. Wong</description> <description role="drol:credit">Dr. Wong</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012919.jpg</altRep> <description role="drol:caption">Dr. Tiffany Wu</description> <description role="drol:credit">Mayo Clinic</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>High-Alcohol Intake in MASLD Increases Risk of Cirrhosis</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">One in nine patients with steatotic liver disease reported concurrent alcohol use, and more than 11% reported high-risk consumption, a national study of more than a million US veterans found.</span> </p> <p>Moreover, the combination of steatotic liver disease and high-risk alcohol intake carried a more than 43% higher long-term risk of liver cirrhosis compared with no alcohol use, according to researchers led by Robert J. Wong, MD, MS, of the Division of Gastroenterology and Hepatology, Veterans Affairs Healthcare System Palo Alto, at Stanford University School of Medicine in Palo Alto, California.<br/><br/>However, <span class="Hyperlink"><a href="https://www.gastrojournal.org/article/S0016-5085(24)00238-5/abstract">the study</a></span> found that “reducing alcohol use lowers risk of cirrhosis, emphasizing the importance of timely alcohol use assessment and early interventions to address high-risk alcohol use in steatotic liver disease,” Dr. Wong and associates <span class="Hyperlink">wrote in </span><em>Gastroenterology</em>.<br/><br/>Although concurrent moderate to heavy alcohol intake would be expected to lead more rapidly to liver disease progression, the existing literature has been conflicting, the authors noted. Several studies have even found moderate alcohol associated with a lower risk of advanced liver disease among MASLD patients, including that <span class="Hyperlink"><a href="https://www.journal-of-hepatology.eu/article/S0168-8278(12)00279-6/abstract">by Dunn et al.</a></span> .<br/><br/></p> <h2>The Study</h2> <p>MASLD patients were identified through the US Veterans Affairs Corporate Data Warehouse from January 1, 2010, through December 31, 2017, with follow-up through December 31, 2022. </p> <p>Alcohol use was assessed by Alcohol Use Disorders Identification Test–Concise (AUDIT-C) scores and was categorized as follows: no alcohol (AUDIT-C = 0), low-risk alcohol use (AUDIT-C 1-2 for women and 1–3 for men), and high-risk alcohol (AUDIT-C ≥ 3 for women and ≥ 4 for men).<br/><br/>Among the 1,156,189 veterans with MASLD, 54.2% reported no alcohol, 34.6% low-risk alcohol, and 11.2% high-risk alcohol use. In median follow-up of nine to 10 years, incidence rates of cirrhosis were .53 per 100 person-years for no use, .42 for low-risk use, and .76 for high-risk use.<br/><br/>In contrast to patients with baseline high-risk alcohol intake who reported no change in use, those who decreased their alcohol intake during follow-up experienced a 39% reduction in the long-term risk of cirrhosis, for a hazard ratio of .61 (95% CI, .45-.83, <em>P</em> &lt; .01).[[{"fid":"301426","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Robert J. Wong, Division of Gastroenterology and Hepatology, Veterans Affairs Healthcare System Palo Alto, at Stanford University School of Medicine in Palo Alto, California","field_file_image_credit[und][0][value]":"Dr. Wong","field_file_image_caption[und][0][value]":"Dr. Robert J. Wong"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>About 70% of patients were non-Hispanic Whites and more than 90% were male in all consumption categories. The no-alcohol group was older than the high-risk alcohol group: 64 years vs 59.9 years (<em>P</em> &lt; .0001). Compared with the high-risk alcohol group, the no-alcohol group had a significantly greater proportion of comorbid diabetes (62.3% vs 42.5%), hypertension (77.9% vs 69.1%), or cardiovascular disease (40.2% vs 25.9%, <em>P</em> &lt; .0001 for all comparisons).<br/><br/>In a significant study observation, fewer than 5% of patients with high-risk use received behavioral or pharmacologic therapy and of those who did, most were referred for or received treatment at or near the time of cirrhosis diagnosis. “This highlights a major gap in linking patients with high-risk alcohol use to appropriate behavioral or pharmacologic therapy in a timely manner and may reflect missed opportunities to prevent further alcohol-related morbidity and mortality,” Dr. Wong and colleagues wrote.<br/><br/>They called for studies of novel interventions for timely assessment of alcohol use with linkage to addiction services. They cited the need to understand the interaction between levels of alcohol use and underlying MASLD, adding, “More research is also needed to understand whether this interaction varies across different populations.”<br/><br/>This study received no specific funding. Dr. Wong reported funding through his institution from Gilead Sciences, Exact Sciences, and Thera Technologies.<span class="end"/></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>views</itemRole> <itemClass>text</itemClass> <title>Critical Need for Early Tx of High-Risk Alcohol Use</title> <deck/> </itemMeta> <itemContent> <p>Recent consensus in defining metabolic dysfunction-associated steatotic liver disease (MASLD) has raised awareness for the combined impact of cardiometabolic risk factors and alcohol consumption on liver disease progression. This study by Wong et al. highlights the undeniable influence of high-risk alcohol use on the development of advanced liver disease. </p> <p>In a national cohort of over 1 million US veterans with steatotic liver disease (SLD), patients with high-risk alcohol use based on AUDIT-C assessment exhibited &gt; 43% greater risk of cirrhosis compared to those with no alcohol use. The relationship between alcohol and liver severity in SLD was observed even after excluding patients meeting classification for predominant alcohol-associated liver disease. While increased alcohol use was associated with increased incidence of cirrhosis, decreased alcohol use led to a notable 39% reduction in cirrhosis risk over time.<br/><br/>Reducing alcohol consumption remains best practice guidelines for mitigating risk of progression in steatotic liver disease. However, results of this study emphasize the critical need for early identification and treatment of high-risk alcohol use in all patients with SLD. While universal recommendations for alcohol abstinence provides pragmatic implementation, there is a significant need to better understand the interaction of specific metabolic risk factors and patterns of alcohol use across the spectrum of MetALD to guide personalized recommendations for patient education and management.[[{"fid":"301427","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Tiffany Wu, Transplant Hepatology at Mayo Clinic in Rochester, Minnesota","field_file_image_credit[und][0][value]":"Mayo Clinic","field_file_image_caption[und][0][value]":"Dr. Tiffany Wu"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>Further research using prospective clinical trial design is needed to evaluate the interplay of alcohol consumption and metabolic risk factors across variable age, sex, genetics, and environmental exposures that are increasingly being recognized as vital drivers of health and disease.</p> <p><em> <em>Tiffany Wu, MD, MS, is a fellow in Transplant Hepatology at Mayo Clinic in Rochester, Minnesota. She has no conflicts.</em> </em></p> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM GASTROENTEROLOGY

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

Genes May Govern Intestinal Sites of Pediatric Crohn’s

Article Type
Changed
Thu, 05/09/2024 - 16:43

Genetic predisposition likely directs intestinal disease location in pediatric Crohn’s disease (CD) — whether colon-predominant (C-CD) or small-bowel-predominant (SB-CD), a small analysis in Cellular and Molecular Gastroenterology and Hepatology suggests.

Richard Kellermayer, MD, PhD, professor of pediatrics in the Section of Pediatric Gastroenterology, Hepatology and Nutrition at Baylor College of Medicine in Houston, Texas, and colleagues compared the genetic makeup of patients based on their Crohn’s disease location — predominantly in the small bowel (L4) or predominantly in the colon (L2 and/or L3). They then generated bipartite networks of susceptibility genes to study the polygenic background of the disease subtypes. They hypothesize that such networks may govern where a patient develops Crohn’s disease.

gomugetrisadaclavuphuprospikehivotibothubauo
Dr. Richard Kellermayer

According to current understanding, as Dr. Kellermayer told GI & Hepatology News, most autoimmune disorders, CD included, develop in people with a genetic predisposition after serial environmental insults between conception and young adulthood. “As opposed to single-gene-associated genetic disorders, autoimmune diseases are linked to several hundred genes in which subtle anomalies can work in concert to predispose someone to a certain disorder,” he said. “We hope our findings will guide the development of personalized treatments based on the disease location at diagnosis to advance precision medicine.”
 

CD cases

Eight cases of SB-CD and 11 of C-CD met the inclusion criteria. Mean age at CD diagnosis was about 11 years for both subtypes, while 36.3% of patients with C-CD were female vs 25% of those with SB-CD. Ethnicity was 72.2% White in the C-CD group and 87.5% in the SB-CD group.

As to the main ileocolonic locations according to the Paris Classification of pediatric inflammatory bowel disease, 54.5% in the C-CD group had involvement at L2 and 45.5% at L3. In SB-CD cases, 100% had disease at L4b, 37.5% at L4, and 50% at L1.

The researchers identified 115 single-nucleotide polymorphisms (SNPs) with a combined annotation-dependent depletion (CADD) score on Phil’s Read Editor (PHRED) of >10 that was associated with 97 genes. PHRED is a computer program measuring the quality of the identification of nucleobases generated by automated DNA sequencing and scores the deleteriousness of single-nucleotide variants. The identified genes in this study had a significantly (P < .01) different allele variation between C-CD and SB-CD.

Among the top 28 candidates was an SNP in the EFNA3 gene with a CADD score > 20 for differentiating between the two phenotypically distinct CD groups. Furthermore, the EFNA3 rs17723260 (predicted to be deleterious) was found to have a significantly lower allele frequency (4.5%) in C-CD compared with its allele frequency of 37.5% in SB-CD (chi square P = .0097).

“This finding indicates that EFNA3 might play a role in modulating colonic inflammation, in which a deleterious genetic defect might provide protection against colitis (and direct autoimmunity against the proximal small bowel) in the polygenic background of CD,” the investigators wrote.

EFNA3 has been linked to both CD and ulcerative colitis. Another four genes associated with the top five SNP candidates had already been connected with IBD or mammalian intestinal inflammation. 

According to the authors, the biomedical literature and mouse model findings “implicate the translational relevance of our candidate gene compendium for directing colon- vs small-bowel–predominant CD development.” They hope the findings will be replicated in larger CD cohorts differentiated by disease location. “Our work may set the nidus for CD subtype–based precision medicine by guiding individualized treatment strategies,” they wrote.

This study was supported by the ProKIIDS Network of the Crohn’s and Colitis Foundation and the Public Health Service. It was also supported by the Wagner, Frugoni, and Klaasmeyer families’ Gutsy Kids Fund and by the DR and GL Laws Fund. The authors disclosed no conflicts of interest.

Publications
Topics
Sections

Genetic predisposition likely directs intestinal disease location in pediatric Crohn’s disease (CD) — whether colon-predominant (C-CD) or small-bowel-predominant (SB-CD), a small analysis in Cellular and Molecular Gastroenterology and Hepatology suggests.

Richard Kellermayer, MD, PhD, professor of pediatrics in the Section of Pediatric Gastroenterology, Hepatology and Nutrition at Baylor College of Medicine in Houston, Texas, and colleagues compared the genetic makeup of patients based on their Crohn’s disease location — predominantly in the small bowel (L4) or predominantly in the colon (L2 and/or L3). They then generated bipartite networks of susceptibility genes to study the polygenic background of the disease subtypes. They hypothesize that such networks may govern where a patient develops Crohn’s disease.

gomugetrisadaclavuphuprospikehivotibothubauo
Dr. Richard Kellermayer

According to current understanding, as Dr. Kellermayer told GI & Hepatology News, most autoimmune disorders, CD included, develop in people with a genetic predisposition after serial environmental insults between conception and young adulthood. “As opposed to single-gene-associated genetic disorders, autoimmune diseases are linked to several hundred genes in which subtle anomalies can work in concert to predispose someone to a certain disorder,” he said. “We hope our findings will guide the development of personalized treatments based on the disease location at diagnosis to advance precision medicine.”
 

CD cases

Eight cases of SB-CD and 11 of C-CD met the inclusion criteria. Mean age at CD diagnosis was about 11 years for both subtypes, while 36.3% of patients with C-CD were female vs 25% of those with SB-CD. Ethnicity was 72.2% White in the C-CD group and 87.5% in the SB-CD group.

As to the main ileocolonic locations according to the Paris Classification of pediatric inflammatory bowel disease, 54.5% in the C-CD group had involvement at L2 and 45.5% at L3. In SB-CD cases, 100% had disease at L4b, 37.5% at L4, and 50% at L1.

The researchers identified 115 single-nucleotide polymorphisms (SNPs) with a combined annotation-dependent depletion (CADD) score on Phil’s Read Editor (PHRED) of >10 that was associated with 97 genes. PHRED is a computer program measuring the quality of the identification of nucleobases generated by automated DNA sequencing and scores the deleteriousness of single-nucleotide variants. The identified genes in this study had a significantly (P < .01) different allele variation between C-CD and SB-CD.

Among the top 28 candidates was an SNP in the EFNA3 gene with a CADD score > 20 for differentiating between the two phenotypically distinct CD groups. Furthermore, the EFNA3 rs17723260 (predicted to be deleterious) was found to have a significantly lower allele frequency (4.5%) in C-CD compared with its allele frequency of 37.5% in SB-CD (chi square P = .0097).

“This finding indicates that EFNA3 might play a role in modulating colonic inflammation, in which a deleterious genetic defect might provide protection against colitis (and direct autoimmunity against the proximal small bowel) in the polygenic background of CD,” the investigators wrote.

EFNA3 has been linked to both CD and ulcerative colitis. Another four genes associated with the top five SNP candidates had already been connected with IBD or mammalian intestinal inflammation. 

According to the authors, the biomedical literature and mouse model findings “implicate the translational relevance of our candidate gene compendium for directing colon- vs small-bowel–predominant CD development.” They hope the findings will be replicated in larger CD cohorts differentiated by disease location. “Our work may set the nidus for CD subtype–based precision medicine by guiding individualized treatment strategies,” they wrote.

This study was supported by the ProKIIDS Network of the Crohn’s and Colitis Foundation and the Public Health Service. It was also supported by the Wagner, Frugoni, and Klaasmeyer families’ Gutsy Kids Fund and by the DR and GL Laws Fund. The authors disclosed no conflicts of interest.

Genetic predisposition likely directs intestinal disease location in pediatric Crohn’s disease (CD) — whether colon-predominant (C-CD) or small-bowel-predominant (SB-CD), a small analysis in Cellular and Molecular Gastroenterology and Hepatology suggests.

Richard Kellermayer, MD, PhD, professor of pediatrics in the Section of Pediatric Gastroenterology, Hepatology and Nutrition at Baylor College of Medicine in Houston, Texas, and colleagues compared the genetic makeup of patients based on their Crohn’s disease location — predominantly in the small bowel (L4) or predominantly in the colon (L2 and/or L3). They then generated bipartite networks of susceptibility genes to study the polygenic background of the disease subtypes. They hypothesize that such networks may govern where a patient develops Crohn’s disease.

gomugetrisadaclavuphuprospikehivotibothubauo
Dr. Richard Kellermayer

According to current understanding, as Dr. Kellermayer told GI & Hepatology News, most autoimmune disorders, CD included, develop in people with a genetic predisposition after serial environmental insults between conception and young adulthood. “As opposed to single-gene-associated genetic disorders, autoimmune diseases are linked to several hundred genes in which subtle anomalies can work in concert to predispose someone to a certain disorder,” he said. “We hope our findings will guide the development of personalized treatments based on the disease location at diagnosis to advance precision medicine.”
 

CD cases

Eight cases of SB-CD and 11 of C-CD met the inclusion criteria. Mean age at CD diagnosis was about 11 years for both subtypes, while 36.3% of patients with C-CD were female vs 25% of those with SB-CD. Ethnicity was 72.2% White in the C-CD group and 87.5% in the SB-CD group.

As to the main ileocolonic locations according to the Paris Classification of pediatric inflammatory bowel disease, 54.5% in the C-CD group had involvement at L2 and 45.5% at L3. In SB-CD cases, 100% had disease at L4b, 37.5% at L4, and 50% at L1.

The researchers identified 115 single-nucleotide polymorphisms (SNPs) with a combined annotation-dependent depletion (CADD) score on Phil’s Read Editor (PHRED) of >10 that was associated with 97 genes. PHRED is a computer program measuring the quality of the identification of nucleobases generated by automated DNA sequencing and scores the deleteriousness of single-nucleotide variants. The identified genes in this study had a significantly (P < .01) different allele variation between C-CD and SB-CD.

Among the top 28 candidates was an SNP in the EFNA3 gene with a CADD score > 20 for differentiating between the two phenotypically distinct CD groups. Furthermore, the EFNA3 rs17723260 (predicted to be deleterious) was found to have a significantly lower allele frequency (4.5%) in C-CD compared with its allele frequency of 37.5% in SB-CD (chi square P = .0097).

“This finding indicates that EFNA3 might play a role in modulating colonic inflammation, in which a deleterious genetic defect might provide protection against colitis (and direct autoimmunity against the proximal small bowel) in the polygenic background of CD,” the investigators wrote.

EFNA3 has been linked to both CD and ulcerative colitis. Another four genes associated with the top five SNP candidates had already been connected with IBD or mammalian intestinal inflammation. 

According to the authors, the biomedical literature and mouse model findings “implicate the translational relevance of our candidate gene compendium for directing colon- vs small-bowel–predominant CD development.” They hope the findings will be replicated in larger CD cohorts differentiated by disease location. “Our work may set the nidus for CD subtype–based precision medicine by guiding individualized treatment strategies,” they wrote.

This study was supported by the ProKIIDS Network of the Crohn’s and Colitis Foundation and the Public Health Service. It was also supported by the Wagner, Frugoni, and Klaasmeyer families’ Gutsy Kids Fund and by the DR and GL Laws Fund. The authors disclosed no conflicts of interest.

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>167921</fileName> <TBEID>0C04FE47.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FE47</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Location genes in pediatric CD</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240509T153928</QCDate> <firstPublished>20240509T163909</firstPublished> <LastPublished>20240509T163909</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240509T163909</CMSDate> <articleSource>FROM CELLULAR AND MOLECULAR GASTROENTEROLOGY AND HEPATOLOGY </articleSource> <facebookInfo/> <meetingNumber/> <byline>Diana Swift dianaswift@rpgers.cm</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</bylineFull> <bylineTitleText>MDedge News</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>Genetic predisposition likely directs intestinal disease location in pediatric Crohn’s disease (CD) — whether colon-predominant (C-CD) or small-bowel-predominan</metaDescription> <articlePDF/> <teaserImage>301415</teaserImage> <teaser>The researchers hope the findings will be replicated in larger CD cohorts differentiated by disease location.</teaser> <title>Genes May Govern Intestinal Sites of Pediatric Crohn’s</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>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> </publications> <sections> <term canonical="true">69</term> <term>27970</term> <term>39313</term> </sections> <topics> <term canonical="true">345</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/2401290c.jpg</altRep> <description role="drol:caption">Dr. Richard Kellermayer</description> <description role="drol:credit">Baylor College of Medicine</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Genes May Govern Intestinal Sites of Pediatric Crohn’s</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">Genetic predisposition likely directs intestinal disease location in pediatric Crohn’s disease (CD) — whether colon-predominant (C-CD) or small-bowel-predominant (SB-CD)</span>, <span class="Hyperlink"><a href="https://www.cmghjournal.org/article/S2352-345X(24)00038-9/fulltext">a small analysis</a></span> in <em>Cellular and Molecular Gastroenterology and Hepatology</em> suggests.</p> <p>Richard Kellermayer, MD, PhD, professor of pediatrics in the Section of Pediatric Gastroenterology, Hepatology and Nutrition at Baylor College of Medicine in Houston, Texas, and colleagues compared the genetic makeup of patients based on their Crohn’s disease location — predominantly in the small bowel (L4) or predominantly in the colon (L2 and/or L3). They then generated bipartite networks of susceptibility genes to study the polygenic background of the disease subtypes. They hypothesize that such networks may govern where a patient develops Crohn’s disease.<br/><br/>[[{"fid":"301415","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Richard Kellermayer, Section of Pediatric Gastroenterology, Hepatology and Nutrition at Baylor College of Medicine in Houston, Texas","field_file_image_credit[und][0][value]":"Baylor College of Medicine","field_file_image_caption[und][0][value]":"Dr. Richard Kellermayer"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]According to current understanding, as Dr. Kellermayer told <em>GI &amp; Hepatology News</em>, most autoimmune disorders, CD included, develop in people with a genetic predisposition after serial environmental insults between conception and young adulthood. “As opposed to single-gene-associated genetic disorders, autoimmune diseases are linked to several hundred genes in which subtle anomalies can work in concert to predispose someone to a certain disorder,” he said. “We hope our findings will guide the development of personalized treatments based on the disease location at diagnosis to advance precision medicine.”<br/><br/></p> <h2>CD cases</h2> <p>Eight cases of SB-CD and 11 of C-CD met the inclusion criteria. Mean age at CD diagnosis was about 11 years for both subtypes, while 36.3% of patients with C-CD were female vs 25% of those with SB-CD. Ethnicity was 72.2% White in the C-CD group and 87.5% in the SB-CD group.</p> <p>As to the main ileocolonic locations according to the <span class="Hyperlink"><a href="https://academic.oup.com/ibdjournal/article/17/6/1314/4631074">Paris Classification</a></span> of pediatric inflammatory bowel disease, 54.5% in the C-CD group had involvement at L2 and 45.5% at L3. In SB-CD cases, 100% had disease at L4b, 37.5% at L4, and 50% at L1.<br/><br/>The researchers identified 115 single-nucleotide polymorphisms (SNPs) with a combined annotation-dependent depletion (CADD) score on Phil’s Read Editor (<span class="Hyperlink"><a href="https://en.wikipedia.org/wiki/Phred_quality_score">PHRED</a></span>) of &gt;10 that was associated with 97 genes. PHRED is a computer program measuring the quality of the identification of nucleobases generated by automated DNA sequencing and scores the deleteriousness of single-nucleotide variants. The identified genes in this study had a significantly (<em>P</em> &lt; .01) different allele variation between C-CD and SB-CD. <br/><br/>Among the top 28 candidates was an SNP in the <em>EFNA3</em> gene with a CADD score &gt; 20 for differentiating between the two phenotypically distinct CD groups. Furthermore, the <em>EFNA3</em> rs17723260 (predicted to be deleterious) was found to have a significantly lower allele frequency (4.5%) in C-CD compared with its allele frequency of 37.5% in SB-CD (chi square <em>P</em> = .0097). <br/><br/>“This finding indicates that <em>EFNA3</em> might play a role in modulating colonic inflammation, in which a deleterious genetic defect might provide protection against colitis (and direct autoimmunity against the proximal small bowel) in the polygenic background of CD,” the investigators wrote.<br/><br/><em>EFNA3</em> has been linked to both CD and ulcerative colitis. Another four genes associated with the top five SNP candidates had already been connected with IBD or mammalian intestinal inflammation. <br/><br/>According to the authors, the biomedical literature and mouse model findings “implicate the translational relevance of our candidate gene compendium for directing colon- vs small-bowel–predominant CD development.” They hope the findings will be replicated in larger CD cohorts differentiated by disease location. “Our work may set the nidus for CD subtype–based precision medicine by guiding individualized treatment strategies,” they wrote.<br/><br/>This study was supported by the ProKIIDS Network of the Crohn’s and Colitis Foundation and the Public Health Service. It was also supported by the Wagner, Frugoni, and Klaasmeyer families’ Gutsy Kids Fund and by the DR and GL Laws Fund. The authors disclosed no conflicts of interest.<span class="end"/></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM CELLULAR AND MOLECULAR GASTROENTEROLOGY AND HEPATOLOGY

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

Composite Scale Better Gauges Mucosal Injury in Celiac Disease

Article Type
Changed
Thu, 05/09/2024 - 15:08

A new two-measure metric seems to improve accuracy and statistical precision in assessing celiac disease (CeD) histology compared with either of two components alone, according to a study in Clinical Gastroenterology and Hepatology.

The new morphometric duodenal biopsy mucosal scale joins together villous height-to-crypt depth ratio (Vh:Cd) and intraepithelial lymphocytes (IEL) — each key CeD histological measures of the small intestine — in a scale called VCIEL.

The authors believe the VCIEL will enable a broader and more accurate measurement of mucosal health in CeD. It will be particularly useful for population analysis in clinical trials and could improve the powering of trial design. “Use of VCIEL may lead to better outcome measures for potential new therapeutic treatments benefiting patients,” wrote Jocelyn A. Silvester, MD, PhD, a pediatrician at Boston Children’s Hospital and an assistant professor at Harvard Medical School, and colleagues.

chushosushachokinunudi
Dr. Jocelyn A. Silvester


This chronic enteropathy affects about 1% of the world’s population and requires a lifelong adherence to a gluten-free diet, the authors noted.

The authors pointed to weaknesses in the current quantitative and qualitative ways of measuring gluten-induced mucosal injury on biopsy for CeD. “Morphometry measures the injury continuum for architecture and inflammation, but these are used as separate outcomes,” they wrote. “The original Marsh-Oberhuber [M-O] classifications are rather contrived approaches to assess a biologic continuum, forcing the injury in categorical groups of unclear clinical relevance and where clinically significant changes may occur within one single category.”

Moreover, the quantitation of inflammation relies on binary assessment as normal or increased, which results in histology that is unscorable by M-O if villous atrophy persists without increased IELs, they added.
 

The Study

In the absence of a broadly accepted single measure of mucosal injury in CeD, the group assessed whether the composite metric could improve statistical precision for assessing histology.

Enter VCIEL, which combines the Vh:Cd and IEL for individual patients with equal weighting by converting each scale to a fraction of their standard deviation and summing the results.

The researchers applied the VCIEL formula in a reanalysis of four clinical gluten-challenge trials and compared the results for Vh:Cd and IEL separately with those for VCIEL for clinical significance (effect size) and statistical significance.

In reanalysis of the ALV003-1021 trial, for example, the researchers observed an effect size and P value (analysis of covariance) of 1.37 and .038 for a delta (difference) value of Vh:Cd 1.17 and .005 for IEL and 1.86 and .004 for VCIEL.

For the similar gluten-challenge IMGX003-NCCIH-1721 trial, the corresponding delta results were .76 and .057 for Vh:Cd, .98 and .018 for IEL, and 1.14 and .007 for VCIEL. Comparable improvements with VCIEL over individual Vh:Cd and IEL were observed for other studies, including a nontherapeutic gluten challenge study.

In NCT03409796 trial data, the computation of VCIEL values showed an improved statistical significance relative to the component values of Vh:Cd and IEL by the within-group paired 2-tailed t test P values from baseline to day 15, particularly at a 10-g gluten challenge dose: Vh:Cd, IEL, VCIEL = .0050, .0031, and .0014, respectively.

Little correlation emerged between baseline values and changes with intervention for Vh:Cd and IEL on an individual patient basis.

The greater accuracy and statistical precision of the VCIEL scale are presumably due to averaging over some of the measurement uncertainty in individual patient and timepoint Vh:Cd and IEL values and creating a composite of different histologic properties, the authors noted.

This study was funded by ImmunogenX, Inc. First author Jack A. Syage is a cofounder and shareholder in ImmunogenX Inc. Dr. Silvester has served on an advisory board for Takeda Pharmaceuticals and has received research funding from Biomedal S.L., Cour Pharmaceuticals, and Glutenostics LLC. Several coauthors disclosed various financial ties to multiple private-sector pharmaceutical and biomedical companies, including ImmunogenX.

Publications
Topics
Sections

A new two-measure metric seems to improve accuracy and statistical precision in assessing celiac disease (CeD) histology compared with either of two components alone, according to a study in Clinical Gastroenterology and Hepatology.

The new morphometric duodenal biopsy mucosal scale joins together villous height-to-crypt depth ratio (Vh:Cd) and intraepithelial lymphocytes (IEL) — each key CeD histological measures of the small intestine — in a scale called VCIEL.

The authors believe the VCIEL will enable a broader and more accurate measurement of mucosal health in CeD. It will be particularly useful for population analysis in clinical trials and could improve the powering of trial design. “Use of VCIEL may lead to better outcome measures for potential new therapeutic treatments benefiting patients,” wrote Jocelyn A. Silvester, MD, PhD, a pediatrician at Boston Children’s Hospital and an assistant professor at Harvard Medical School, and colleagues.

chushosushachokinunudi
Dr. Jocelyn A. Silvester


This chronic enteropathy affects about 1% of the world’s population and requires a lifelong adherence to a gluten-free diet, the authors noted.

The authors pointed to weaknesses in the current quantitative and qualitative ways of measuring gluten-induced mucosal injury on biopsy for CeD. “Morphometry measures the injury continuum for architecture and inflammation, but these are used as separate outcomes,” they wrote. “The original Marsh-Oberhuber [M-O] classifications are rather contrived approaches to assess a biologic continuum, forcing the injury in categorical groups of unclear clinical relevance and where clinically significant changes may occur within one single category.”

Moreover, the quantitation of inflammation relies on binary assessment as normal or increased, which results in histology that is unscorable by M-O if villous atrophy persists without increased IELs, they added.
 

The Study

In the absence of a broadly accepted single measure of mucosal injury in CeD, the group assessed whether the composite metric could improve statistical precision for assessing histology.

Enter VCIEL, which combines the Vh:Cd and IEL for individual patients with equal weighting by converting each scale to a fraction of their standard deviation and summing the results.

The researchers applied the VCIEL formula in a reanalysis of four clinical gluten-challenge trials and compared the results for Vh:Cd and IEL separately with those for VCIEL for clinical significance (effect size) and statistical significance.

In reanalysis of the ALV003-1021 trial, for example, the researchers observed an effect size and P value (analysis of covariance) of 1.37 and .038 for a delta (difference) value of Vh:Cd 1.17 and .005 for IEL and 1.86 and .004 for VCIEL.

For the similar gluten-challenge IMGX003-NCCIH-1721 trial, the corresponding delta results were .76 and .057 for Vh:Cd, .98 and .018 for IEL, and 1.14 and .007 for VCIEL. Comparable improvements with VCIEL over individual Vh:Cd and IEL were observed for other studies, including a nontherapeutic gluten challenge study.

In NCT03409796 trial data, the computation of VCIEL values showed an improved statistical significance relative to the component values of Vh:Cd and IEL by the within-group paired 2-tailed t test P values from baseline to day 15, particularly at a 10-g gluten challenge dose: Vh:Cd, IEL, VCIEL = .0050, .0031, and .0014, respectively.

Little correlation emerged between baseline values and changes with intervention for Vh:Cd and IEL on an individual patient basis.

The greater accuracy and statistical precision of the VCIEL scale are presumably due to averaging over some of the measurement uncertainty in individual patient and timepoint Vh:Cd and IEL values and creating a composite of different histologic properties, the authors noted.

This study was funded by ImmunogenX, Inc. First author Jack A. Syage is a cofounder and shareholder in ImmunogenX Inc. Dr. Silvester has served on an advisory board for Takeda Pharmaceuticals and has received research funding from Biomedal S.L., Cour Pharmaceuticals, and Glutenostics LLC. Several coauthors disclosed various financial ties to multiple private-sector pharmaceutical and biomedical companies, including ImmunogenX.

A new two-measure metric seems to improve accuracy and statistical precision in assessing celiac disease (CeD) histology compared with either of two components alone, according to a study in Clinical Gastroenterology and Hepatology.

The new morphometric duodenal biopsy mucosal scale joins together villous height-to-crypt depth ratio (Vh:Cd) and intraepithelial lymphocytes (IEL) — each key CeD histological measures of the small intestine — in a scale called VCIEL.

The authors believe the VCIEL will enable a broader and more accurate measurement of mucosal health in CeD. It will be particularly useful for population analysis in clinical trials and could improve the powering of trial design. “Use of VCIEL may lead to better outcome measures for potential new therapeutic treatments benefiting patients,” wrote Jocelyn A. Silvester, MD, PhD, a pediatrician at Boston Children’s Hospital and an assistant professor at Harvard Medical School, and colleagues.

chushosushachokinunudi
Dr. Jocelyn A. Silvester


This chronic enteropathy affects about 1% of the world’s population and requires a lifelong adherence to a gluten-free diet, the authors noted.

The authors pointed to weaknesses in the current quantitative and qualitative ways of measuring gluten-induced mucosal injury on biopsy for CeD. “Morphometry measures the injury continuum for architecture and inflammation, but these are used as separate outcomes,” they wrote. “The original Marsh-Oberhuber [M-O] classifications are rather contrived approaches to assess a biologic continuum, forcing the injury in categorical groups of unclear clinical relevance and where clinically significant changes may occur within one single category.”

Moreover, the quantitation of inflammation relies on binary assessment as normal or increased, which results in histology that is unscorable by M-O if villous atrophy persists without increased IELs, they added.
 

The Study

In the absence of a broadly accepted single measure of mucosal injury in CeD, the group assessed whether the composite metric could improve statistical precision for assessing histology.

Enter VCIEL, which combines the Vh:Cd and IEL for individual patients with equal weighting by converting each scale to a fraction of their standard deviation and summing the results.

The researchers applied the VCIEL formula in a reanalysis of four clinical gluten-challenge trials and compared the results for Vh:Cd and IEL separately with those for VCIEL for clinical significance (effect size) and statistical significance.

In reanalysis of the ALV003-1021 trial, for example, the researchers observed an effect size and P value (analysis of covariance) of 1.37 and .038 for a delta (difference) value of Vh:Cd 1.17 and .005 for IEL and 1.86 and .004 for VCIEL.

For the similar gluten-challenge IMGX003-NCCIH-1721 trial, the corresponding delta results were .76 and .057 for Vh:Cd, .98 and .018 for IEL, and 1.14 and .007 for VCIEL. Comparable improvements with VCIEL over individual Vh:Cd and IEL were observed for other studies, including a nontherapeutic gluten challenge study.

In NCT03409796 trial data, the computation of VCIEL values showed an improved statistical significance relative to the component values of Vh:Cd and IEL by the within-group paired 2-tailed t test P values from baseline to day 15, particularly at a 10-g gluten challenge dose: Vh:Cd, IEL, VCIEL = .0050, .0031, and .0014, respectively.

Little correlation emerged between baseline values and changes with intervention for Vh:Cd and IEL on an individual patient basis.

The greater accuracy and statistical precision of the VCIEL scale are presumably due to averaging over some of the measurement uncertainty in individual patient and timepoint Vh:Cd and IEL values and creating a composite of different histologic properties, the authors noted.

This study was funded by ImmunogenX, Inc. First author Jack A. Syage is a cofounder and shareholder in ImmunogenX Inc. Dr. Silvester has served on an advisory board for Takeda Pharmaceuticals and has received research funding from Biomedal S.L., Cour Pharmaceuticals, and Glutenostics LLC. Several coauthors disclosed various financial ties to multiple private-sector pharmaceutical and biomedical companies, including ImmunogenX.

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>167920</fileName> <TBEID>0C04FE6B.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FE6B</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Composite Celiac Scale</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240509T140639</QCDate> <firstPublished>20240509T150455</firstPublished> <LastPublished>20240509T150455</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240509T150455</CMSDate> <articleSource>FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY </articleSource> <facebookInfo/> <meetingNumber/> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</bylineFull> <bylineTitleText>MDedge News</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 new two-measure metric seems to improve accuracy and statistical precision in assessing celiac disease (CeD) histology compared with either of two components </metaDescription> <articlePDF/> <teaserImage>301388</teaserImage> <teaser>The new scale should be particularly useful for population analysis in clinical trials and could improve the powering of trial design.</teaser> <title>Composite Scale Better Gauges Mucosal Injury in Celiac Disease</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>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> </publications> <sections> <term canonical="true">69</term> <term>39313</term> <term>27970</term> </sections> <topics> <term canonical="true">345</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/2401290b.jpg</altRep> <description role="drol:caption">Dr. Jocelyn A. Silvester</description> <description role="drol:credit">Boston Children’s Hospital</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Composite Scale Better Gauges Mucosal Injury in Celiac Disease</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">A new two-measure metric seems to improve accuracy and statistical precision in assessing celiac disease (CeD) histology compared with either of two components alone</span>, according <span class="Hyperlink"><a href="https://doi.org/10.1016/j.cgh.2023.10.031">to a study</a></span> in <em>Clinical Gastroenterology and Hepatology</em>.</p> <p>The new morphometric duodenal biopsy mucosal scale joins together villous height-to-crypt depth ratio (Vh:Cd) and intraepithelial lymphocytes (IEL) — each key CeD histological measures of the small intestine — in a scale called VCIEL. <br/><br/>The authors believe the VCIEL will enable a broader and more accurate measurement of mucosal health in CeD. It will be particularly useful for population analysis in clinical trials and could improve the powering of trial design. “Use of VCIEL may lead to better outcome measures for potential new therapeutic treatments benefiting patients,” wrote Jocelyn A. Silvester, MD, PhD, a pediatrician at Boston Children’s Hospital and an assistant professor at Harvard Medical School, and colleagues.[[{"fid":"301388","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Jocelyn A. Silvester, Boston Children’s Hospital and Harvard Medical School","field_file_image_credit[und][0][value]":"Boston Children’s Hospital","field_file_image_caption[und][0][value]":"Dr. Jocelyn A. Silvester"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]<br/><br/>This chronic enteropathy affects about 1% of <span class="Hyperlink"><a href="https://journals.lww.com/ajg/abstract/2015/03000/trends_and_racial_ethnic_disparities_in.19.aspx">the world’s population</a></span> and requires a lifelong adherence to a gluten-free diet, the authors noted.<br/><br/>The authors pointed to weaknesses in the current quantitative and qualitative ways of measuring gluten-induced mucosal injury on biopsy for CeD. “Morphometry measures the injury continuum for architecture and inflammation, but these are used as separate outcomes,” they wrote. “The original <span class="Hyperlink"><a href="https://diagnosticpathology.biomedcentral.com/articles/10.1186/s13000-023-01412-x">Marsh-Oberhuber [M-O] classifications</a></span> are rather contrived approaches to assess a biologic continuum, forcing the injury in categorical groups of unclear clinical relevance and where clinically significant changes may occur within one single category.” <br/><br/>Moreover, the quantitation of inflammation relies on binary assessment as normal or increased, which results in histology that is unscorable by M-O if villous atrophy persists without increased IELs, they added.<br/><br/></p> <h2>The Study</h2> <p>In the absence of a broadly accepted single measure of mucosal injury in CeD, the group assessed whether the composite metric could improve statistical precision for assessing histology. </p> <p>Enter VCIEL, which combines the Vh:Cd and IEL for individual patients with equal weighting by converting each scale to a fraction of their standard deviation and summing the results. <br/><br/>The researchers applied the VCIEL formula in a reanalysis of four clinical gluten-challenge trials and compared the results for Vh:Cd and IEL separately with those for VCIEL for clinical significance (effect size) and statistical significance.<br/><br/>In reanalysis of the ALV003-1021 trial, for example, the researchers observed an effect size and <em>P</em> value (analysis of covariance) of 1.37 and .038 for a delta (difference) value of Vh:Cd 1.17 and .005 for IEL and 1.86 and .004 for VCIEL.<br/><br/>For the similar gluten-challenge IMGX003-NCCIH-1721 trial, the corresponding delta results were .76 and .057 for Vh:Cd, .98 and .018 for IEL, and 1.14 and .007 for VCIEL. Comparable improvements with VCIEL over individual Vh:Cd and IEL were observed for other studies, including a nontherapeutic gluten challenge study.<br/><br/>In NCT03409796 trial data, the computation of VCIEL values showed an improved statistical significance relative to the component values of Vh:Cd and IEL by the within-group paired 2-tailed t test <em>P</em> values from baseline to day 15, particularly at a 10-g gluten challenge dose: Vh:Cd, IEL, VCIEL = .0050, .0031, and .0014, respectively.<br/><br/>Little correlation emerged between baseline values and changes with intervention for Vh:Cd and IEL on an individual patient basis.<br/><br/>The greater accuracy and statistical precision of the VCIEL scale are presumably due to averaging over some of the measurement uncertainty in individual patient and timepoint Vh:Cd and IEL values and creating a composite of different histologic properties, the authors noted.<br/><br/>This study was funded by ImmunogenX, Inc. First author Jack A. Syage is a cofounder and shareholder in ImmunogenX Inc. Dr. Silvester has served on an advisory board for Takeda Pharmaceuticals and has received research funding from Biomedal S.L., Cour Pharmaceuticals, and Glutenostics LLC. Several coauthors disclosed various financial ties to multiple private-sector pharmaceutical and biomedical companies, including ImmunogenX.<span class="end"/></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

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-Quality Diet in Early Life May Ward Off Later IBD

Article Type
Changed
Tue, 05/07/2024 - 15:23

Children who ate a high-quality diet at 1 year of age were at a 25% reduced risk of developing inflammatory bowel disease (IBD) in later life, prospective pooled data from two Scandinavian birth cohorts suggested.

It appears important to feed children a quality diet at a very young age, in particular one rich in vegetables and fish, since by age three, only dietary fish intake had any impact on IBD risk.

Guo_Annie_SWE_web.jpg
Ms. Annie Guo

Although high intakes of these two food categories in very early life correlated with lower IBD risk, exposure to sugar-sweetened beverages (SSBs) was associated with an increased risk. “While non-causal explanations for our results cannot be ruled out, these novel findings are consistent with the hypothesis that early-life diet, possibly mediated through changes in the gut microbiome, may affect the risk of developing IBD,” wrote lead author Annie Guo, a PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden, and colleagues. The report was published in Gut.

“This is a population-based study investigating the risk for IBD, rather than the specific effect of diet,” Ms. Guo said in an interview. “Therefore, the results are not enough on their own to be translated into individual advice that can be applicable in the clinic. However, the study supports current dietary guidelines for small children, that is, the intake of sugar should be limited and a higher intake of fish and vegetables is beneficial for overall health.”
 

Two-Cohort Study

The investigators prospectively recorded food-group information on children (just under half were female) from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study to assess the diet quality using a Healthy Eating Index and intake frequency. Parents answered questions about their offspring’s diet at ages 12-18 months and 30-36 months. Quality of diet was measured by intake of meat, fish, fruit, vegetables, dairy, sweets, snacks, and drinks.

The Swedish cohort included 21,700 children born between October 1997 and October 1999, while the Norwegian analysis included 114,500 children, 95,200 mothers, and 75,200 fathers recruited from across Norway from 1999 to 2008. In 1,304,433 person-years of follow-up, the researchers tracked 81,280 participants from birth to childhood and adolescence, with median follow-ups in the two cohorts ranging from 1 year of age to 21.3 years (Sweden) and to 15.2 years of age (Norway). Of these children, 307 were diagnosed with IBD: Crohn’s disease (CD; n = 131); ulcerative colitis (UC; n = 97); and IBD unclassified (n = 79).

Adjusting for parental IBD history, sex, origin, education, and maternal comorbidities, the study found:

  • Compared with low-quality diet, both medium- and high-quality diets at 1 year were associated with a roughly 25% reduced risk for IBD (pooled adjusted hazard ratio [aHR], 0.75 [95% CI, 0.58-0.98] and 0.75 [0.56-1.0], respectively).
  • The pooled aHR per increase of category was 0.86 (95% CI, 0.74-0.99). The pooled aHR for IBD in 1-year-olds with high vs low fish intake was 0.70 (95% CI, 0.49-1.0), and this diet showed an association with a reduced risk for UC (pooled aHR, 0.46; 95% CI, 0.21-0.99). Higher vegetable intake at 1 year was also associated with a risk reduction in IBD (HR, 0.72; 95% CI, 0.55-0.95). It has been hypothesized that intake of vegetables and vegetable fibers may have programming effects on the immune system.
  • AutoWith 72% of children reportedly consuming SSBs at age 1, pooled aHRs showed that some vs no intake of SSBs was associated with an increased risk for later IBD (pooled aHR, 1.42; 95% CI, 1.05-1.90).
  • There were no obvious associations between overall IBD or CD/UC risk and meat, dairy, fruit, grains, potatoes, and foods high in sugar and/or fat. Diet at age 3 years was not associated with incident IBD (pooled aHR, 1.02; 95% CI, 0.76-1.37), suggesting that the risk impact of diet is greatest on very young and vulnerable microbiomes.
 

 

Ms. Guo noted that a Swedish national survey among 4-year-olds found a mean SSB consumption of 187 g/d with a mean frequency of once daily. The most desired changes in food habits are a lower intake of soft drinks, sweets, crisps, cakes, and biscuits and an increase in the intake of fruits and vegetables. A similar Norwegian survey among 2-year-olds showed that SSBs were consumed by 36% of all children with a mean intake of 40 g/d.

The exact mechanism by which sugar affects the intestinal microbiota is not established. “However, what we do know is that an excessive intake of sugar can disrupt the balance of the gut microbiome,” Ms. Guo said. “And if the child has a high intake of foods with high in sugar, that also increases the chances that the child’s overall diet has a lower intake of other foods that contribute to a diverse microbiome such as fruits and vegetables.”

An ‘Elegant’ Study

In an accompanying editorial, gastroenterologist Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, of Mass General Brigham and the Mass General Research Institute, Boston, cautioned that accurately measuring food intake in very young children is difficult, and dietary questionnaires in this study did not address food additives and emulsifiers common in commercial baby food, which may play a role in the pathogenesis of IBD.

Ananthakrishnan_Ashwin_Bosto_web.jpg
Dr. Ashwin N. Ananthakrishnan

Another study limitation is that the dietary questionnaire used has not been qualitatively or quantitatively validated against other more conventional methods, said Dr. Ananthakrishnan, who was not involved in the research.

Nevertheless, he called the study “elegant” and expanding of the data on the importance of this period in IBD development. “Although in the present study there was no association between diet at 3 years and development of IBD (in contrast to the association observed for dietary intake at 1 year), other prospective cohorts of adult-onset IBD have demonstrated an inverse association between vegetable or fish intake and reduced risk for CD while sugar-sweetened beverages have been linked to a higher risk for IBD.”

As to the question of recommending early preventive diet for IBD, “thus far, data on the impact of diet very early in childhood, outside of breastfeeding, on the risk for IBD has been lacking,” Dr. Ananthakrishnan said in an interview. “This important study highlights that diet as early as 1 year can modify subsequent risk for IBD. This raises the intriguing possibility of whether early changes in diet could be used, particularly in those at higher risk, to reduce or even prevent future development of IBD. Of course, more works needs to be done to define modifiability of diet as a risk factor, but this is an important supportive data.”

In his editorial, Dr. Ananthakrishnan stated that despite the absence of gold-standard interventional data demonstrating a benefit of dietary interventions, “in my opinion, it may still be reasonable to suggest such interventions to motivate individuals who incorporate several of the dietary patterns associated with lower risk for IBD from this and other studies. This includes ensuring adequate dietary fiber, particularly from fruits and vegetables, intake of fish, minimizing sugar-sweetened beverages and preferring fresh over processed and ultra-processed foods and snacks.” According to the study authors, their novel findings support further research on the role of childhood diet in the prevention of IBD.

The All Babies in Southeast Sweden Study is supported by Barndiabetesfonden (Swedish Child Diabetes Foundation), the Swedish Council for Working Life and Social Research, the Swedish Research Council, the Medical Research Council of Southeast Sweden, the JDRF Wallenberg Foundation, ALF and LFoU grants from Region Östergötland and Linköping University, and the Joanna Cocozza Foundation.

The Norwegian Mother, Father and Child Cohort Study is supported by the Norwegian Ministry of Health and Care Services and the Ministry of Education and Research.

Ms. Guo received grants from the Swedish Society for Medical Research and the Henning and Johan Throne-Holst Foundation to conduct this study. Co-author Karl Mårild has received funding from the Swedish Society for Medical Research, the Swedish Research Council, and ALF, Sweden’s medical research and education co-ordinating body. The authors declared no competing interests. Dr. Ananthakrishnan is supported by the National Institutes of Health, the Leona M. and Harry B. Helmsley Charitable Trust, and the Chleck Family Foundation. He has served on the scientific advisory board for Geneoscopy.

Publications
Topics
Sections

Children who ate a high-quality diet at 1 year of age were at a 25% reduced risk of developing inflammatory bowel disease (IBD) in later life, prospective pooled data from two Scandinavian birth cohorts suggested.

It appears important to feed children a quality diet at a very young age, in particular one rich in vegetables and fish, since by age three, only dietary fish intake had any impact on IBD risk.

Guo_Annie_SWE_web.jpg
Ms. Annie Guo

Although high intakes of these two food categories in very early life correlated with lower IBD risk, exposure to sugar-sweetened beverages (SSBs) was associated with an increased risk. “While non-causal explanations for our results cannot be ruled out, these novel findings are consistent with the hypothesis that early-life diet, possibly mediated through changes in the gut microbiome, may affect the risk of developing IBD,” wrote lead author Annie Guo, a PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden, and colleagues. The report was published in Gut.

“This is a population-based study investigating the risk for IBD, rather than the specific effect of diet,” Ms. Guo said in an interview. “Therefore, the results are not enough on their own to be translated into individual advice that can be applicable in the clinic. However, the study supports current dietary guidelines for small children, that is, the intake of sugar should be limited and a higher intake of fish and vegetables is beneficial for overall health.”
 

Two-Cohort Study

The investigators prospectively recorded food-group information on children (just under half were female) from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study to assess the diet quality using a Healthy Eating Index and intake frequency. Parents answered questions about their offspring’s diet at ages 12-18 months and 30-36 months. Quality of diet was measured by intake of meat, fish, fruit, vegetables, dairy, sweets, snacks, and drinks.

The Swedish cohort included 21,700 children born between October 1997 and October 1999, while the Norwegian analysis included 114,500 children, 95,200 mothers, and 75,200 fathers recruited from across Norway from 1999 to 2008. In 1,304,433 person-years of follow-up, the researchers tracked 81,280 participants from birth to childhood and adolescence, with median follow-ups in the two cohorts ranging from 1 year of age to 21.3 years (Sweden) and to 15.2 years of age (Norway). Of these children, 307 were diagnosed with IBD: Crohn’s disease (CD; n = 131); ulcerative colitis (UC; n = 97); and IBD unclassified (n = 79).

Adjusting for parental IBD history, sex, origin, education, and maternal comorbidities, the study found:

  • Compared with low-quality diet, both medium- and high-quality diets at 1 year were associated with a roughly 25% reduced risk for IBD (pooled adjusted hazard ratio [aHR], 0.75 [95% CI, 0.58-0.98] and 0.75 [0.56-1.0], respectively).
  • The pooled aHR per increase of category was 0.86 (95% CI, 0.74-0.99). The pooled aHR for IBD in 1-year-olds with high vs low fish intake was 0.70 (95% CI, 0.49-1.0), and this diet showed an association with a reduced risk for UC (pooled aHR, 0.46; 95% CI, 0.21-0.99). Higher vegetable intake at 1 year was also associated with a risk reduction in IBD (HR, 0.72; 95% CI, 0.55-0.95). It has been hypothesized that intake of vegetables and vegetable fibers may have programming effects on the immune system.
  • AutoWith 72% of children reportedly consuming SSBs at age 1, pooled aHRs showed that some vs no intake of SSBs was associated with an increased risk for later IBD (pooled aHR, 1.42; 95% CI, 1.05-1.90).
  • There were no obvious associations between overall IBD or CD/UC risk and meat, dairy, fruit, grains, potatoes, and foods high in sugar and/or fat. Diet at age 3 years was not associated with incident IBD (pooled aHR, 1.02; 95% CI, 0.76-1.37), suggesting that the risk impact of diet is greatest on very young and vulnerable microbiomes.
 

 

Ms. Guo noted that a Swedish national survey among 4-year-olds found a mean SSB consumption of 187 g/d with a mean frequency of once daily. The most desired changes in food habits are a lower intake of soft drinks, sweets, crisps, cakes, and biscuits and an increase in the intake of fruits and vegetables. A similar Norwegian survey among 2-year-olds showed that SSBs were consumed by 36% of all children with a mean intake of 40 g/d.

The exact mechanism by which sugar affects the intestinal microbiota is not established. “However, what we do know is that an excessive intake of sugar can disrupt the balance of the gut microbiome,” Ms. Guo said. “And if the child has a high intake of foods with high in sugar, that also increases the chances that the child’s overall diet has a lower intake of other foods that contribute to a diverse microbiome such as fruits and vegetables.”

An ‘Elegant’ Study

In an accompanying editorial, gastroenterologist Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, of Mass General Brigham and the Mass General Research Institute, Boston, cautioned that accurately measuring food intake in very young children is difficult, and dietary questionnaires in this study did not address food additives and emulsifiers common in commercial baby food, which may play a role in the pathogenesis of IBD.

Ananthakrishnan_Ashwin_Bosto_web.jpg
Dr. Ashwin N. Ananthakrishnan

Another study limitation is that the dietary questionnaire used has not been qualitatively or quantitatively validated against other more conventional methods, said Dr. Ananthakrishnan, who was not involved in the research.

Nevertheless, he called the study “elegant” and expanding of the data on the importance of this period in IBD development. “Although in the present study there was no association between diet at 3 years and development of IBD (in contrast to the association observed for dietary intake at 1 year), other prospective cohorts of adult-onset IBD have demonstrated an inverse association between vegetable or fish intake and reduced risk for CD while sugar-sweetened beverages have been linked to a higher risk for IBD.”

As to the question of recommending early preventive diet for IBD, “thus far, data on the impact of diet very early in childhood, outside of breastfeeding, on the risk for IBD has been lacking,” Dr. Ananthakrishnan said in an interview. “This important study highlights that diet as early as 1 year can modify subsequent risk for IBD. This raises the intriguing possibility of whether early changes in diet could be used, particularly in those at higher risk, to reduce or even prevent future development of IBD. Of course, more works needs to be done to define modifiability of diet as a risk factor, but this is an important supportive data.”

In his editorial, Dr. Ananthakrishnan stated that despite the absence of gold-standard interventional data demonstrating a benefit of dietary interventions, “in my opinion, it may still be reasonable to suggest such interventions to motivate individuals who incorporate several of the dietary patterns associated with lower risk for IBD from this and other studies. This includes ensuring adequate dietary fiber, particularly from fruits and vegetables, intake of fish, minimizing sugar-sweetened beverages and preferring fresh over processed and ultra-processed foods and snacks.” According to the study authors, their novel findings support further research on the role of childhood diet in the prevention of IBD.

The All Babies in Southeast Sweden Study is supported by Barndiabetesfonden (Swedish Child Diabetes Foundation), the Swedish Council for Working Life and Social Research, the Swedish Research Council, the Medical Research Council of Southeast Sweden, the JDRF Wallenberg Foundation, ALF and LFoU grants from Region Östergötland and Linköping University, and the Joanna Cocozza Foundation.

The Norwegian Mother, Father and Child Cohort Study is supported by the Norwegian Ministry of Health and Care Services and the Ministry of Education and Research.

Ms. Guo received grants from the Swedish Society for Medical Research and the Henning and Johan Throne-Holst Foundation to conduct this study. Co-author Karl Mårild has received funding from the Swedish Society for Medical Research, the Swedish Research Council, and ALF, Sweden’s medical research and education co-ordinating body. The authors declared no competing interests. Dr. Ananthakrishnan is supported by the National Institutes of Health, the Leona M. and Harry B. Helmsley Charitable Trust, and the Chleck Family Foundation. He has served on the scientific advisory board for Geneoscopy.

Children who ate a high-quality diet at 1 year of age were at a 25% reduced risk of developing inflammatory bowel disease (IBD) in later life, prospective pooled data from two Scandinavian birth cohorts suggested.

It appears important to feed children a quality diet at a very young age, in particular one rich in vegetables and fish, since by age three, only dietary fish intake had any impact on IBD risk.

Guo_Annie_SWE_web.jpg
Ms. Annie Guo

Although high intakes of these two food categories in very early life correlated with lower IBD risk, exposure to sugar-sweetened beverages (SSBs) was associated with an increased risk. “While non-causal explanations for our results cannot be ruled out, these novel findings are consistent with the hypothesis that early-life diet, possibly mediated through changes in the gut microbiome, may affect the risk of developing IBD,” wrote lead author Annie Guo, a PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden, and colleagues. The report was published in Gut.

“This is a population-based study investigating the risk for IBD, rather than the specific effect of diet,” Ms. Guo said in an interview. “Therefore, the results are not enough on their own to be translated into individual advice that can be applicable in the clinic. However, the study supports current dietary guidelines for small children, that is, the intake of sugar should be limited and a higher intake of fish and vegetables is beneficial for overall health.”
 

Two-Cohort Study

The investigators prospectively recorded food-group information on children (just under half were female) from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study to assess the diet quality using a Healthy Eating Index and intake frequency. Parents answered questions about their offspring’s diet at ages 12-18 months and 30-36 months. Quality of diet was measured by intake of meat, fish, fruit, vegetables, dairy, sweets, snacks, and drinks.

The Swedish cohort included 21,700 children born between October 1997 and October 1999, while the Norwegian analysis included 114,500 children, 95,200 mothers, and 75,200 fathers recruited from across Norway from 1999 to 2008. In 1,304,433 person-years of follow-up, the researchers tracked 81,280 participants from birth to childhood and adolescence, with median follow-ups in the two cohorts ranging from 1 year of age to 21.3 years (Sweden) and to 15.2 years of age (Norway). Of these children, 307 were diagnosed with IBD: Crohn’s disease (CD; n = 131); ulcerative colitis (UC; n = 97); and IBD unclassified (n = 79).

Adjusting for parental IBD history, sex, origin, education, and maternal comorbidities, the study found:

  • Compared with low-quality diet, both medium- and high-quality diets at 1 year were associated with a roughly 25% reduced risk for IBD (pooled adjusted hazard ratio [aHR], 0.75 [95% CI, 0.58-0.98] and 0.75 [0.56-1.0], respectively).
  • The pooled aHR per increase of category was 0.86 (95% CI, 0.74-0.99). The pooled aHR for IBD in 1-year-olds with high vs low fish intake was 0.70 (95% CI, 0.49-1.0), and this diet showed an association with a reduced risk for UC (pooled aHR, 0.46; 95% CI, 0.21-0.99). Higher vegetable intake at 1 year was also associated with a risk reduction in IBD (HR, 0.72; 95% CI, 0.55-0.95). It has been hypothesized that intake of vegetables and vegetable fibers may have programming effects on the immune system.
  • AutoWith 72% of children reportedly consuming SSBs at age 1, pooled aHRs showed that some vs no intake of SSBs was associated with an increased risk for later IBD (pooled aHR, 1.42; 95% CI, 1.05-1.90).
  • There were no obvious associations between overall IBD or CD/UC risk and meat, dairy, fruit, grains, potatoes, and foods high in sugar and/or fat. Diet at age 3 years was not associated with incident IBD (pooled aHR, 1.02; 95% CI, 0.76-1.37), suggesting that the risk impact of diet is greatest on very young and vulnerable microbiomes.
 

 

Ms. Guo noted that a Swedish national survey among 4-year-olds found a mean SSB consumption of 187 g/d with a mean frequency of once daily. The most desired changes in food habits are a lower intake of soft drinks, sweets, crisps, cakes, and biscuits and an increase in the intake of fruits and vegetables. A similar Norwegian survey among 2-year-olds showed that SSBs were consumed by 36% of all children with a mean intake of 40 g/d.

The exact mechanism by which sugar affects the intestinal microbiota is not established. “However, what we do know is that an excessive intake of sugar can disrupt the balance of the gut microbiome,” Ms. Guo said. “And if the child has a high intake of foods with high in sugar, that also increases the chances that the child’s overall diet has a lower intake of other foods that contribute to a diverse microbiome such as fruits and vegetables.”

An ‘Elegant’ Study

In an accompanying editorial, gastroenterologist Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, of Mass General Brigham and the Mass General Research Institute, Boston, cautioned that accurately measuring food intake in very young children is difficult, and dietary questionnaires in this study did not address food additives and emulsifiers common in commercial baby food, which may play a role in the pathogenesis of IBD.

Ananthakrishnan_Ashwin_Bosto_web.jpg
Dr. Ashwin N. Ananthakrishnan

Another study limitation is that the dietary questionnaire used has not been qualitatively or quantitatively validated against other more conventional methods, said Dr. Ananthakrishnan, who was not involved in the research.

Nevertheless, he called the study “elegant” and expanding of the data on the importance of this period in IBD development. “Although in the present study there was no association between diet at 3 years and development of IBD (in contrast to the association observed for dietary intake at 1 year), other prospective cohorts of adult-onset IBD have demonstrated an inverse association between vegetable or fish intake and reduced risk for CD while sugar-sweetened beverages have been linked to a higher risk for IBD.”

As to the question of recommending early preventive diet for IBD, “thus far, data on the impact of diet very early in childhood, outside of breastfeeding, on the risk for IBD has been lacking,” Dr. Ananthakrishnan said in an interview. “This important study highlights that diet as early as 1 year can modify subsequent risk for IBD. This raises the intriguing possibility of whether early changes in diet could be used, particularly in those at higher risk, to reduce or even prevent future development of IBD. Of course, more works needs to be done to define modifiability of diet as a risk factor, but this is an important supportive data.”

In his editorial, Dr. Ananthakrishnan stated that despite the absence of gold-standard interventional data demonstrating a benefit of dietary interventions, “in my opinion, it may still be reasonable to suggest such interventions to motivate individuals who incorporate several of the dietary patterns associated with lower risk for IBD from this and other studies. This includes ensuring adequate dietary fiber, particularly from fruits and vegetables, intake of fish, minimizing sugar-sweetened beverages and preferring fresh over processed and ultra-processed foods and snacks.” According to the study authors, their novel findings support further research on the role of childhood diet in the prevention of IBD.

The All Babies in Southeast Sweden Study is supported by Barndiabetesfonden (Swedish Child Diabetes Foundation), the Swedish Council for Working Life and Social Research, the Swedish Research Council, the Medical Research Council of Southeast Sweden, the JDRF Wallenberg Foundation, ALF and LFoU grants from Region Östergötland and Linköping University, and the Joanna Cocozza Foundation.

The Norwegian Mother, Father and Child Cohort Study is supported by the Norwegian Ministry of Health and Care Services and the Ministry of Education and Research.

Ms. Guo received grants from the Swedish Society for Medical Research and the Henning and Johan Throne-Holst Foundation to conduct this study. Co-author Karl Mårild has received funding from the Swedish Society for Medical Research, the Swedish Research Council, and ALF, Sweden’s medical research and education co-ordinating body. The authors declared no competing interests. Dr. Ananthakrishnan is supported by the National Institutes of Health, the Leona M. and Harry B. Helmsley Charitable Trust, and the Chleck Family Foundation. He has served on the scientific advisory board for Geneoscopy.

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>167825</fileName> <TBEID>0C04FBAC.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FBAC</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Early diet may cut IBD risk</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240507T150738</QCDate> <firstPublished>20240507T151749</firstPublished> <LastPublished>20240507T151749</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240507T151749</CMSDate> <articleSource>FROM GUT </articleSource> <facebookInfo/> <meetingNumber/> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</bylineFull> <bylineTitleText>MDedge News</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>Children who ate a high-quality diet at 1 year of age were at a 25% reduced risk of developing inflammatory bowel disease (IBD) in later life</metaDescription> <articlePDF/> <teaserImage>301202</teaserImage> <teaser>It appears important to feed children a quality diet at a very young age, in particular, one rich in vegetables and fish.</teaser> <title>High-Quality Diet in Early Life May Ward Off Later IBD</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>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> <term>21</term> <term>15</term> <term>25</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> </sections> <topics> <term canonical="true">345</term> <term>213</term> <term>271</term> <term>49620</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012891.jpg</altRep> <description role="drol:caption">Ms. Annie Guo</description> <description role="drol:credit">Ms. Guo</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24011402.jpg</altRep> <description role="drol:caption">Dr. Ashwin N. Ananthakrishnan</description> <description role="drol:credit">Mass General Brigham</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>High-Quality Diet in Early Life May Ward Off Later IBD</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">Children who ate a high-quality diet at 1 year of age were at a 25% reduced risk of developing inflammatory bowel disease (IBD) in later life</span>, prospective pooled data from two Scandinavian birth cohorts suggested.</p> <p>It appears important to feed children a quality diet at a very young age, in particular one rich in vegetables and fish, since by age three, only dietary fish intake had any impact on IBD risk.<br/><br/>[[{"fid":"301202","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Ms. Annie Guo, PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden","field_file_image_credit[und][0][value]":"Ms. Guo","field_file_image_caption[und][0][value]":"Ms. Annie Guo"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]Although high intakes of these two food categories in very early life correlated with lower IBD risk, exposure to sugar-sweetened beverages (SSBs) was associated with an increased risk. “While non-causal explanations for our results cannot be ruled out, these novel findings are consistent with the hypothesis that early-life diet, possibly mediated through changes in the gut microbiome, may affect the risk of developing IBD,” <span class="Hyperlink"><a href="https://gut.bmj.com/content/73/4/590">wrote</a></span> lead author Annie Guo, a PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden, and colleagues. The report was published <span class="Hyperlink">in</span><span class="Hyperlink"> </span><em>Gut</em>.<br/><br/>“This is a population-based study investigating the risk for IBD, rather than the specific effect of diet,” Ms. Guo said in an interview. “Therefore, the results are not enough on their own to be translated into individual advice that can be applicable in the clinic. However, the study supports current dietary guidelines for small children, that is, the intake of sugar should be limited and a higher intake of fish and vegetables is beneficial for overall health.”<br/><br/></p> <h2>Two-Cohort Study</h2> <p>The investigators prospectively recorded food-group information on children (just under half were female) from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study to assess the diet quality using a Healthy Eating Index and intake frequency. Parents answered questions about their offspring’s diet at ages 12-18 months and 30-36 months. Quality of diet was measured by intake of meat, fish, fruit, vegetables, dairy, sweets, snacks, and drinks.</p> <p>The Swedish cohort included 21,700 children born between October 1997 and October 1999, while the Norwegian analysis included 114,500 children, 95,200 mothers, and 75,200 fathers recruited from across Norway from 1999 to 2008. In 1,304,433 person-years of follow-up, the researchers tracked 81,280 participants from birth to childhood and adolescence, with median follow-ups in the two cohorts ranging from 1 year of age to 21.3 years (Sweden) and to 15.2 years of age (Norway). Of these children, 307 were diagnosed with IBD: Crohn’s disease (CD; n = 131); ulcerative colitis (UC; n = 97); and IBD unclassified (n = 79).<br/><br/>Adjusting for parental IBD history, sex, origin, education, and maternal comorbidities, the study found:</p> <ul class="body"> <li>Compared with low-quality diet, both medium- and high-quality diets at 1 year were associated with a roughly 25% reduced risk for IBD (pooled adjusted hazard ratio [aHR], 0.75 [95% CI, 0.58-0.98] and 0.75 [0.56-1.0], respectively).</li> <li>The pooled aHR per increase of category was 0.86 (95% CI, 0.74-0.99). The pooled aHR for IBD in 1-year-olds with high vs low fish intake was 0.70 (95% CI, 0.49-1.0), and this diet showed an association with a reduced risk for UC (pooled aHR, 0.46; 95% CI, 0.21-0.99). Higher vegetable intake at 1 year was also associated with a risk reduction in IBD (HR, 0.72; 95% CI, 0.55-0.95). It has been hypothesized that intake of vegetables and vegetable fibers may have <span class="Hyperlink">programming effects</span> on the immune system.</li> <li>AutoWith 72% of children reportedly consuming SSBs at age 1, pooled aHRs showed that some vs no intake of SSBs was associated with an increased risk for later IBD (pooled aHR, 1.42; 95% CI, 1.05-1.90). </li> <li>There were no obvious associations between overall IBD or CD/UC risk and meat, dairy, fruit, grains, potatoes, and foods high in sugar and/or fat. Diet at age 3 years was not associated with incident IBD (pooled aHR, 1.02; 95% CI, 0.76-1.37), suggesting that the risk impact of diet is greatest on very young and vulnerable microbiomes.</li> </ul> <p>Ms. Guo noted that a <span class="Hyperlink"><a href="https://www.livsmedelsverket.se/globalassets/matvanor-halsa-miljo/kostrad-matvanor/matvaneundersokningar/riksmaten-_-barn_2003_livsmedels_och_naringsintag_bland_barn_i_sverige1.&#13;pdf">Swedish national survey</a></span> among 4-year-olds found a mean SSB consumption of 187 g/d with a mean frequency of once daily. The most desired changes in food habits are a lower intake of soft drinks, sweets, crisps, cakes, and biscuits and an increase in the intake of fruits and vegetables. A similar <span class="Hyperlink"><a href="https://www.fhi.no/globalassets/dokumenterfiler/rapporter/2020/kostholdsundersokelser/smabarnskost-3---barn-2-ars-alder.pdf">Norwegian survey</a></span> among 2-year-olds showed that SSBs were consumed by 36% of all children with a mean intake of 40 g/d.<br/><br/>The exact mechanism by which sugar affects the intestinal microbiota is not established. “However, what we do know is that an excessive intake of sugar can disrupt the balance of the gut microbiome,” Ms. Guo said. “And if the child has a high intake of foods with high in sugar, that also increases the chances that the child’s overall diet has a lower intake of other foods that contribute to a diverse microbiome such as fruits and vegetables.”</p> <h2>An ‘Elegant’ Study</h2> <p>In an <span class="Hyperlink"><a href="http://press.psprings.co.uk/gut/january/gut331849.pdf">accompanying editorial</a></span>, gastroenterologist Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, of Mass General Brigham and the Mass General Research Institute, Boston, cautioned that accurately measuring food intake in very young children is difficult, and dietary questionnaires in this study did not address food additives and emulsifiers common in commercial baby food, which may play a role in the pathogenesis of IBD.</p> <p>[[{"fid":"290153","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Ashwin N. Ananthakrishnan, associate professor of medicine at Massachusetts General Hospital in Boston","field_file_image_credit[und][0][value]":"Mass General Brigham","field_file_image_caption[und][0][value]":"Dr. Ashwin N. Ananthakrishnan"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]Another study limitation is that the dietary questionnaire used has not been qualitatively or quantitatively validated against other more conventional methods, said Dr. Ananthakrishnan, who was not involved in the research.<br/><br/>Nevertheless, he called the study “elegant” and expanding of the data on the importance of this period in IBD development. “Although in the present study there was no association between diet at 3 years and development of IBD (in contrast to the association observed for dietary intake at 1 year), other prospective cohorts of adult-onset IBD have demonstrated an inverse association between vegetable or fish intake and reduced risk for CD while sugar-sweetened beverages <span class="Hyperlink"><a href="https://onlinelibrary.wiley.com/doi/10.1111/apt.17149">have been linked</a></span> to a higher risk for IBD.” <br/><br/>As to the question of recommending early preventive diet for IBD, “thus far, data on the impact of diet very early in childhood, outside of breastfeeding, on the risk for IBD has been lacking,” Dr. Ananthakrishnan said in an interview. “This important study highlights that diet as early as 1 year can modify subsequent risk for IBD. This raises the intriguing possibility of whether early changes in diet could be used, particularly in those at higher risk, to reduce or even prevent future development of IBD. Of course, more works needs to be done to define modifiability of diet as a risk factor, but this is an important supportive data.”<br/><br/>In his editorial, Dr. Ananthakrishnan stated that despite the absence of gold-standard interventional data demonstrating a benefit of dietary interventions, “in my opinion, it may still be reasonable to suggest such interventions to motivate individuals who incorporate several of the dietary patterns associated with lower risk for IBD from this and other studies. This includes ensuring adequate dietary fiber, particularly from fruits and vegetables, intake of fish, minimizing sugar-sweetened beverages and preferring fresh over processed and ultra-processed foods and snacks.” According to the study authors, their novel findings support further research on the role of childhood diet in the prevention of IBD.<br/><br/>The All Babies in Southeast Sweden Study is supported by Barndiabetesfonden (Swedish Child Diabetes Foundation), the Swedish Council for Working Life and Social Research, the Swedish Research Council, the Medical Research Council of Southeast Sweden, the JDRF Wallenberg Foundation, ALF and LFoU grants from Region Östergötland and Linköping University, and the Joanna Cocozza Foundation.<br/><br/>The Norwegian Mother, Father and Child Cohort Study is supported by the Norwegian Ministry of Health and Care Services and the Ministry of Education and Research.<br/><br/>Ms. Guo received grants from the Swedish Society for Medical Research and the Henning and Johan Throne-Holst Foundation to conduct this study. Co-author Karl Mårild has received funding from the Swedish Society for Medical Research, the Swedish Research Council, and ALF, Sweden’s medical research and education co-ordinating body. The authors declared no competing interests. Dr. Ananthakrishnan is supported by the National Institutes of Health, the Leona M. and Harry B. Helmsley Charitable Trust, and the Chleck Family Foundation. He has served on the scientific advisory board for Geneoscopy.<span class="end"/></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM GUT

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

Late-Stage Incidence Rates Support CRC Screening From Age 45

Article Type
Changed
Mon, 04/29/2024 - 10:34

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg
%3Cp%3EDr.%20Eric%20M.%20Montminy%3C%2Fp%3E


The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.

“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”

A 2020 study in JAMA Network Open demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.

“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.

Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:

  • Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
  • Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
  • Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
  • The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

 

 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg
%3Cp%3EDr.%20Joshua%20Meyer%3C%2Fp%3E

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

Publications
Topics
Sections

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg
%3Cp%3EDr.%20Eric%20M.%20Montminy%3C%2Fp%3E


The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.

“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”

A 2020 study in JAMA Network Open demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.

“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.

Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:

  • Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
  • Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
  • Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
  • The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

 

 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg
%3Cp%3EDr.%20Joshua%20Meyer%3C%2Fp%3E

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg
%3Cp%3EDr.%20Eric%20M.%20Montminy%3C%2Fp%3E


The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.

“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”

A 2020 study in JAMA Network Open demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.

“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.

Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:

  • Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
  • Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
  • Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
  • The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

 

 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg
%3Cp%3EDr.%20Joshua%20Meyer%3C%2Fp%3E

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

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>167483</fileName> <TBEID>0C04F390.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F390</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>IRs up for advanced CRCs</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240426T182455</QCDate> <firstPublished>20240429T091047</firstPublished> <LastPublished>20240429T092924</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240429T091047</CMSDate> <articleSource>FROM JAMA NETWORK OPEN</articleSource> <facebookInfo/> <meetingNumber/> <byline>Diana Swift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</bylineFull> <bylineTitleText>MDedge News</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>In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in</metaDescription> <articlePDF/> <teaserImage/> <teaser>Stage stratification is key because it provides insight into the relationship between time and cancer incidence, said Dr. Eric Montminy.</teaser> <title>Late-Stage Incidence Rates Support CRC Screening From Age 45</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>3</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> <term>21</term> <term>15</term> <term>31</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> </sections> <topics> <term canonical="true">344</term> <term>213</term> <term>263</term> <term>67020</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Late-Stage Incidence Rates Support CRC Screening From Age 45</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years</span>, a cross-sectional study of stage-stratified CRC found.</p> <p>It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.<br/><br/>Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2816222"><span class="Hyperlink">in</span><em> JAMA Network Open</em></a>.<br/><br/>The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.<br/><br/>“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”<br/><br/>A 2020 study <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759846"><span class="Hyperlink">in </span><em>JAMA Network Open</em></a> demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.<br/><br/>“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.<br/><br/>Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:</p> <ul class="body"> <li>Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6). </li> <li>Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).</li> <li>Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are <span class="Hyperlink">double those for pancreatic cancer</span> of all stages combined.</li> <li>The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).</li> </ul> <p>“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”<br/><br/>His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.<br/><br/></p> <h2>Findings From 2000 to 2020</h2> <p>During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).</p> <p>As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.<br/><br/>Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.<br/><br/></p> <h2>Why the CRC Uptick?</h2> <p>“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”</p> <p>Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.<br/><br/>More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”<br/><br/>There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”<br/><br/>This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.<span class="end"/></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM JAMA NETWORK OPEN

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